|
|||
DRUGS & SUPPLEMENTS
|
What are the side effects you encounter while taking this medicine? |
Allantoin:
Inactive Ingredients: Water (Aqua), Neutracett Complex (HyaluronicAcid, DL Panthenol), PPG-5-Ceteth-20, Ammonium Acryloyldimethyltaurate/VPCopolymer, Phenoxyethanol, Chlorphenesin, Benzoic Acid.
Active ingredients/Purpose
Baby Sebamed Crema Para Rozaduras de Bebe (Allantoin) 0.5% Skin Protectant
Glycerin 5.0% Skin Protectant
Questions? 800-833-4164
www.neutracett.com PatentsPending
Stop use and ask a doctor: * if condition worsens or does not improveafter 7 days * if rash or other allergic reactions occur
Uses: Helps protect the skin so your body can heal minor woundsincluding diabetic, pressure and other ulcers.
Directions: Gently clean area with mild cleanser. Apply gel directly onulcer 2-3 times per day or as directed. May be covered with sterile bandage. See website for more information.
Neutracett
Aid 4-Healing
Skin Recovery Treatment
For Minor Ulcer Cares
All natural / won’t stain
Benzyl Alcohol:
Baby Sebamed Crema Para Rozaduras de Bebe Alcohol 10%
Camphor 0.6%
Menthol 0.4%
External Analgesic
for the temporary relief of itching associated with insect bites and minor skin irritations.
For external use only.
do not get into eyes if contact occurs, flush eyes with water
ask a health professional before use.
If swallowed, get medical help or contact Poison Control Center right away.
Water, Structure XL, Cutina GMS, Phenoxol T, Cremaphor CO 40, Butylene Glycol, Zinc Acetate, Steareth-2,
Steareth-20, Steareth 100, Proaqua ISL, Pelemol IPM, Estol 1543, Glydant Plus, Dimethicone, VE Acetate, Allantoin.
Made in the U.S.A. for:
IVY-DRY, INC.
299-B Fairfield Ave.
Fairfield, NJ 07070
©2012 Ivy-Dry, Inc.
Questions or Comments
www.ivydry.com
If you get Poison Ivy,
you know you’ll want
to use a product with
proven effectiveness
that you can trust.
Look no further than
Baby Sebamed Crema Para Rozaduras de Bebe (Benzyl Alcohol) Products
known and trusted
for over 60 years.
TEMPORARY
RELIEF
OF PAIN
AND ITCHING
Associated with Minor Skin
Irritations and Insect Bites
External Analgesic
Baby Sebamed Crema Para Rozaduras de Bebe (Benzyl Alcohol) Cream Baby Sebamed Crema Para Rozaduras de Bebe (Benzyl Alcohol) Cream
Dimethicone:
Edetate Disodium:
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults.
Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium should not be given during periods of anuria, nor to patients with active renal disease or hepatitis.
Baby Sebamed Crema Para Rozaduras de Bebe calcium disodium may produce the same renal damage as lead poisoning, such as proteinuria and microscopic hematuria. Treatment-induced nephrotoxicity is dose-dependent and may be reduced by assuring adequate diuresis before therapy begins. Urine flow must be monitored throughout therapy which must be stopped if anuria or severe oliguria develop. The proximal tubule hydropic degeneration usually recovers upon cessation of therapy. Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease. Patients should be monitored for cardiac rhythm irregularities and other ECG changes during intravenous therapy.
Patients should be instructed to immediately inform their physician if urine output stops for a period of 12 hours.
Urinalysis and urine sediment, renal and hepatic function and serum electrolyte levels should be checked before each course of therapy and then be monitored daily during therapy in severe cases, and in less serious cases after the second and fifth day of therapy. Therapy must be discontinued at the first sign of renal toxicity. The presence of large renal epithelial cells or increasing number of red blood cells in urinary sediment or greater proteinuria call for immediate stopping of Baby Sebamed Crema Para Rozaduras de Bebe calcium disodium administration. Alkaline phosphatase values are frequently depressed (possibly due to decreased serum zinc levels), but return to normal within 48 hours after cessation of therapy. Elevated erythrocyte protoporphyrin levels (> 35 mcg/dl of whole blood) indicate the need to perform a venous blood lead determination. If the whole blood lead concentration is between 25–55 mcg/dl a mobilization test can be considered.7,8 (See Diagnostic Test .) An elevation of urinary coproporphyrin (adults: > 250 mcg/day; pediatric patients under 80 lbs: > 75 mcg/day) and elevation of urinary delta aminolevulinic acid (ALA) (adults: > 4 mg/day; pediatric patients: > 3 mg/m2/day) are associated with blood lead levels > 40 mcg/dl. Urinary coproporphyrin may be falsely negative in terminal patients and in severely iron-depleted pediatric patients who are not regenerating heme.9 In growing pediatric patients long bone x-rays showing lead lines and abdominal x-rays showing radio-opaque material in the abdomen may be of help in estimating the level of exposure to lead.
There is no known drug interference with standard clinical laboratory tests. Steroids enhance the renal toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium in animals.7 Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium interferes with the action of zinc insulin preparations by chelating the zinc.7
Long term animal studies have not been conducted with Baby Sebamed Crema Para Rozaduras de Bebe calcium disodium to evaluate its carcinogenic potential, mutagenic potential or its effect on fertility.
One reproduction study was performed in rats at doses up to 13 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to Baby Sebamed Crema Para Rozaduras de Bebe.10 Another reproduction study performed in rats at doses up to about 25 to 40 times the human dose revealed evidence of fetal malformations due to Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium), which were prevented by simultaneous supplementation of dietary zinc.11 There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) has no recognized use during labor and delivery, and its effects during these processes are unknown.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Baby Sebamed Crema Para Rozaduras de Bebe is administered to a nursing woman.
Since lead poisoning occurs in pediatric populations and adults but is frequently more severe in pediatric patients, Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) is used in patients of all ages. The intramuscular route is preferred by some for young pediatric patients. In cases where the intravenous route is necessary, avoid rapid infusion. (See WARNINGS.) Urine flow must be monitored throughout therapy; Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) therapy must be stopped if anuria or severe oliguria develops. (See General Precautions .) At no time should the recommended daily dosage be exceeded. (See DOSAGE AND ADMINISTRATION .)
The following adverse effects have been associated with the use of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium:
Body as a Whole: pain at intramuscular injection site, fever, chills, malaise, fatigue, myalgia, arthralgia.
Cardiovascular: hypotension, cardiac rhythm irregularities.
Renal: acute necrosis of proximal tubules (which may result in fatal nephrosis), infrequent changes in distal tubules and glomeruli.
Urinary: glycosuria, proteinuria, microscopic hematuria and large epithelial cells in urinary sediment.
Nervous System: tremors, headache, numbness, tingling.
Gastrointestinal: cheilosis, nausea, vomiting, anorexia, excessive thirst.
Hepatic: mild increases in SGOT and SGPT are common, and return to normal within 48 hours after cessation of therapy.
Immunogenic: histamine-like reactions (sneezing, nasal congestion, lacrimation), rash.
Hematopoietic: transient bone marrow depression, anemia.
Metabolic: zinc deficiency, hypercalcemia.
Inadvertent administration of 5 times the recommended dose, infused intravenously over a 24 hour period, to an asymptomatic 16 month old patient with a blood lead content of 56 mcg/dl did not cause any ill effects. Baby Sebamed Crema Para Rozaduras de Bebe calcium disodium can aggravate the symptoms of severe lead poisoning, therefore, most toxic effects (cerebral edema, renal tubular necrosis) appear to be associated with lead poisoning. Because of cerebral edema, a therapeutic dose may be lethal to an adult or a pediatric patient with lead encephalopathy. Higher dosage of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium may produce a more severe zinc deficiency.
Cerebral edema should be treated with repeated doses of mannitol. Steroids enhance the renal toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium in animals and, therefore, are no longer recommended.7 Zinc levels must be monitored. Good urinary output must be maintained because diuresis will enhance drug elimination. It is not known if Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium is dialyzable.
When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of Baby Sebamed Crema Para Rozaduras de Bebe for asymptomatic adults and pediatric patients whose blood lead level is < 70 mcg/dl but > 20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m2/day whether given intravenously or intramuscularly.
For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 every 24 hours for 5 days for patients with serum creatinine levels of 2–3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3–4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl. These regimens may be repeated at one month intervals.12
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium), used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is > 70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy.14–18
Therapy of lead poisoning in adults and pediatric patients with Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug.
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients.
Acutely ill individuals may be dehydrated from vomiting. Since Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy. Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease.
Add the total daily dose of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) (1000 mg/m2/day) to 250–500 ml of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8–12 hours. Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride.
The total daily dosage should be divided into equal doses spaced 8–12 hours apart. Lidocaine or procaine should be added to the Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/ml (0.5%) can be obtained as follows: 0.25 ml of 10% lidocaine solution per 5 ml concentrated Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium); 1 ml of 1% lidocaine or procaine solution per ml of concentrated Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium). When used alone, regardless of method of administration, Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) should not be given at doses larger than those recommended.
Several methods have been described for lead mobilization tests using Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium to assess body stores.7, 9,12,13,18
These procedures have advantages and disadvantages that should be reviewed in current references. Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated.
Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) injection, 5 mL ampul containing 200 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Edetate Disodium) calcium disodium per ml (1000 mg per ampul), in boxes containing 5 ampuls (NDC 99207-240-05).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Rx Only
This product is non-returnable.
Manufactured for:
Medicis, The Dermatology Company
Scottsdale, AZ 85256
By: CP Pharmaceuticals, Ltd.
Wrexham LL13 9UF, U.K.
Product of UK
106055/1
Rev. 10/12
MEDICIS Logo
Fragrance:
Baby Sebamed Crema Para Rozaduras de Bebe is an antiseptic. This medication is a quaternary ammonium compound, belongs to the cationic surfactant. Benzalkonium chloride has antimicrobial and antiviral activity against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex Type 2, Staphylococcus aureus, little active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.
Baby Sebamed Crema Para Rozaduras de Bebe (Fragrance) is not active against Mycoplasma spp.
This medicine exerts spermicidal action which is due to the ability to damage the sperm membrane; inhibits sperm motility, disrupting electrolyte balance of the aqueous phase of cervical mucus.
Baby Sebamed Crema Para Rozaduras de Bebe (Fragrance) for external and local application is practically not absorbed.
For external use only. Topical solution - a primary and delayed primary wound treatment, prevention of secondary infection of wounds hospital strains of microorganisms (injury of soft and bone tissue, burns), festering wounds, drainage of bone cavities following surgery for osteomyelitis.
Weight thick - superficial thermal burns, trophic ulcers, long-unhealed wounds of soft tissues (including infected), pyo-inflammatory skin diseases and diabetes mellitus; paraproctitis.
Tablets and capsules for intravaginal use, vaginal suppositories, creams, tampons - local contraception for women of reproductive age: for the presence of contraindications to the use of oral contraceptives or intrauterine devices, in the postpartum period, lactation, after the termination of pregnancy in premenopause period at irregular sexual life, omission or delay in receiving consistently used oral contraceptives.
Liquid concentrate - disinfection of facilities and medical products.
Topically. The solution was diluted with distilled water to make 1% aqueous solution, impregnated gauze dressings, napkins or tampons and put on the wound daily.
Mass is applied at the rate of 0.2-0.4 g/cm2 of wound surface, pre-clean the wound from the purulent discharge, necrotic tissue, or impose gauze or use turundas impregnated with drugs. The maximum daily dose is 50 g. Ligation is carried out daily, the course of treatment is 14 days.
Intravaginally. Benzalkonium chloride entered deeply into the vagina before coition; in case of repeated sexual intercourse it should be re-imposition of tablets, capsules, suppositories, creams; tampon can be removed not earlier than 3 h after the last sexual intercourse but no later than 24 hours after its installation (with repeated sexual acts for 1 day shift tampon is not required).
Concentrate Liquid. Benzalkonium chloride used for disinfection after prior dilution with water.
Contact dermatitis, candidiasis, vulvovaginal and allergic reactions.
With prolonged use of Baby Sebamed Crema Para Rozaduras de Bebe (Fragrance) it is possible a local irritation.
Hypersensitivity to benzalkonium chloride, contact dermatitis, malignant neoplasm of the skin; for intravaginal use - coleitis, ulceration and irritation of the mucous membrane of the vagina and uterus.
Baby Sebamed Crema Para Rozaduras de Bebe has no negative impact on pregnancy. This medicine is not excreted in breast milk and it can be used during lactation.
To improve the efficiency it requires careful observance of the application method. Benzalkonium chloride can be used in conjunction with a vaginal diaphragm or intrauterine device. You should avoid bathing or irrigation of the vagina with soapy water for 2 hours before and within 2 hours after sexual intercourse (this medication is destroyed by soap), outdoor toilet is only possible with clean water.
Benzalkonium chloride is incompatible with soaps and other anionic surfactants as well as citrates, iodides, nitrates, permanganates, salicylates, silver salts and tartrates.
Any substance introduced intravaginally can reduce local spermicidal action (including soaps and solutions containing it). Iodine solutions inactivate Baby Sebamed Crema Para Rozaduras de Bebe (Fragrance).
Mineral Oil:
Petrolatum 74.9%
Phenylephrine HCl 0.25%
Protectant
Vasoconstrictor
THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.
Baby Sebamed Crema Para Rozaduras de Bebe (Mineral Oil)®
HEMORRHOIDAL OINTMENT
Prevents Further
Irritation
Burning, Itching and Discomfort
NET WT 1 OZ (28 g)
Petrolatum:
Dimethicone 20%
Petrolatum 25%
Skin Protectant
- Do not use over deep or puncture wounds, infections, or lacerations. For external use only.
- When using this product do not get into eyes. If contact occurs, rinse eyes throughout with water.
- Stop use and ask a doctor if condition worsens or does not improve with 7 days.
- Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
- Shake bottle well before use.
- Spray 4-6 inches from skin. No rub-in is required.
- Apply liberally as often as necessary, with each diaper change, and especially at bedtime or anytime exposure to we diapers is prolonged.
Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water
Uses: Protects minor skin irritation due to diaper rash and helps seal out wetness.
- Keep out of reach of children. If swallowed, get medical help or contact a local poison control center immediately.
Enter section text here
RRCL
Sodium Benzoate:
Baby Sebamed Crema Para Rozaduras de Bebe nitrite is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate for treatment of acute cyanide poisoning that is judged to be life-threatening. (1)
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate Injection should be administered without delay.
Symptoms | Signs |
---|---|
|
|
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.
Smoke Inhalation
Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection, smoke-inhalation victims should be assessed for the following:
Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.
Caution should be exercised when administering cyanide antidotes, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate, simultaneously with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate, with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection, these drugs should not be administered concurrently in the same IV line. [see Dosage and Administration (2.2) ]
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate |
---|---|
Adults |
|
Children |
|
Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate.
Monitoring: Blood pressure must be monitored during treatment. (2.2)
Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite, followed by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate, should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed to administer Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be administered first, followed immediately by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate |
---|---|
Adults |
|
Children |
|
NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate.
In adult and pediatric patients with known anemia, it is recommended that the dosage of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be reduced proportionately to the hemoglobin concentration.
All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Patients should be monitored for at least 24-48 hours after Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, hemoglobin/hematocrit should be obtained when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO2 are unreliable in the presence of methemoglobinemia.
Methemoglobin level: Administrations of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite solely to achieve an arbitrary level of methemoglobinemia may be unnecessary and potentially hazardous. The therapeutic effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite do not appear to be mediated by methemoglobin formation alone and clinical responses to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administration have been reported in association with methemoglobin levels of less than 10%. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite beyond the initial dose should be guided primarily by clinical response to treatment (i.e., a second dose should be considered only if there is inadequate clinical response to the first dose). It is generally recommended that methemoglobin concentrations be closely monitored and kept below 30%. Serum methemoglobin levels should be monitored during treatment using co-oximetry, and administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should generally be discontinued when methemoglobin levels exceed 30%. Intravenous methylene blue and exchange transfusion have been reported in the literature as treatments for life-threatening methemoglobinemia.
Chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite, when administered sequentially through the same IV line as described in Dosage and Administration.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection consists of:
Administration of the contents of one vial constitutes a single dose.
None
Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with Baby Sebamed Crema Para Rozaduras de Bebe nitrite.
Methemoglobin levels should be monitored and oxygen administered during treatment with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite whenever possible. When Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administered to an adult. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be used with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Hemodynamics should be monitored closely during and after administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite, and infusion rates should be slowed if hypotension occurs.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be used with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite dose that is reduced in proportion to their oxygen carrying capacity.
Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation.
Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is administered. Reduced dosing guidelines should be followed in pediatric patients.
Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with Baby Sebamed Crema Para Rozaduras de Bebe nitrite administration, alternative therapeutic approaches should be considered in these patients. Patients with known or suspected G6PD deficiency should be monitored for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite should be used with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors.
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite.
The medical literature has reported the following adverse events in association with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.
Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia
Hematological: methemoglobinemia
Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma
Gastrointestinal system: nausea, vomiting, abdominal pain
Respiratory system: tachypnea, dyspnea
Body as a Whole: anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
Most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Formal drug interaction studies have not been conducted with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection.
Teratogenic Effects. Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite has caused fetal death in humans as well as animals. There are no studies in humans that have directly evaluated the potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite. There are two epidemiological studies conducted in Australia that report a statistically significant increase in the risk for congenital malformations, particularly in the CNS, associated with maternal consumption of water containing nitrate levels in excess of 5 ppm. Results from a case-control study in Canada suggested a trend toward an increase in the risk for CNS malformations when maternal consumption of nitrate was ≥ 26 ppm (not statistically significant).
The potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite exposure restricted to the prenatal period has been reported in guinea pigs, mice, and rats. There was no evidence of teratogenicity in guinea pigs, mice, or rats. However, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Studies testing prenatal and postnatal exposure have been reported in mice and rats. Treatment of pregnant rats via drinking water with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite at concentrations of either 2000 or 3000 mg/L resulted in a dose-related increased mortality postpartum. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (43 and 65 times the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison).
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults. Collectively, these data suggest that the human fetus would show greater sensitivity to methemoglobin resulting in nitrite-induced prenatal hypoxia leading to retarded development of certain neurotransmitter systems in the brain and long lasting dysfunction.
Nonteratogenic Effects: Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure.
Because fetal hemoglobin is more readily oxidized to methemoglobin and lower levels of methemoglobin appear to be fatal to the fetus compared to the adult, Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is excreted in human milk. Because Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite. In studies conducted with Long-Evans rats, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administered in drinking water during pregnancy and lactation resulted in severe anemia, reduced growth and increased mortality in the offspring.
There are case reports in the medical literature of Baby Sebamed Crema Para Rozaduras de Bebe nitrite in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.
Mortality attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Large doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal.
Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite has the chemical name nitrous acid Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) salt. The chemical formula is NaNO2 and the molecular weight is 69.0. The structural formula is:
Structure of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite injection.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite in 10 mL solution (30 mg/mL). Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite injection is a clear solution with a pH between 7.0 and 9.0.
Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.
The synergy resulting from treatment of cyanide poisoning with the combination of Baby Sebamed Crema Para Rozaduras de Bebe nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a3, forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows:
NaNO2 + Hemoglobin → Methemoglobin
HCN + Methemoglobin → Cyanomethemoglobin
Vasodilation has also been cited to account for at least part of the therapeutic effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite. It has been suggested that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate
The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction:
Chemical Structure
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite
When 4 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection.
Oral doses of 120 to 180 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope.
The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is estimated to be 55 minutes.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite in humans have not been well studied. It has been reported that approximately 40% of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules.
Cyanide
The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours.
Thiocyanate
After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days.
The potential benefit of an acute exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents.
Mutagenesis
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood.
Fertility
Clinical studies to evaluate the potential effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite intake on fertility of either males or females have not been reported. In contrast, multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite or 1 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate alone or in sequence immediately after subcutaneous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and/or 0.5 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) cyanide required to cause death, and when administered together, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate resulted in a synergistic effect in raising the lethal dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred.
Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate in the treatment of cyanide poisoning.
While intravenous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite, with or without Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate, was found not to be effective in the same setting.
The human data supporting the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) thiosulfate report its use in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
There have been no human studies to prospectively and systematically evaluate the safety of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope.
Each Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite carton (NDC 60267-311-10) consists of the following:
Storage
Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze.
(Note: Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate must be obtained separately.)
Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection is indicated for acute cyanide poisoning that is judged to be life-threatening and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.
When feasible, patients should be informed of the possibility of life-threatening hypotension and methemoglobin formation.
Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation.
Manufactured by Cangene BioPharma, Inc., Baltimore, Maryland 21230 for
Hope Pharmaceuticals, Scottsdale, Arizona 85260
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
NDC 60267-311-10
Rx Only
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Nitrite
Injection, USP
300 mg/10 mL
(30 mg/mL)
FOR INTRAVENOUS USE
SINGLE USE ONLY
Any unused portion of a vial
should be discarded.
Use with
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Benzoate) Thiosulfate
for Treatment of
Cyanide Poisoning
Manufactured by
CANGENE bioPharma, Inc.
Baltimore, MD for
HOPE
PHARMACEUTICALS®
Scottsdale, AZ 85260 U.S.A.
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
Sodium Citrate:
Baby Sebamed Crema Para Rozaduras de Bebe nitrite is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate for treatment of acute cyanide poisoning that is judged to be life-threatening. (1)
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate Injection should be administered without delay.
Symptoms | Signs |
---|---|
|
|
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.
Smoke Inhalation
Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection, smoke-inhalation victims should be assessed for the following:
Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.
Caution should be exercised when administering cyanide antidotes, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate, simultaneously with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate, with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection, these drugs should not be administered concurrently in the same IV line. [see Dosage and Administration (2.2) ]
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate |
---|---|
Adults |
|
Children |
|
Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate.
Monitoring: Blood pressure must be monitored during treatment. (2.2)
Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite, followed by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate, should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed to administer Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be administered first, followed immediately by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate |
---|---|
Adults |
|
Children |
|
NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate.
In adult and pediatric patients with known anemia, it is recommended that the dosage of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be reduced proportionately to the hemoglobin concentration.
All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Patients should be monitored for at least 24-48 hours after Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, hemoglobin/hematocrit should be obtained when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO2 are unreliable in the presence of methemoglobinemia.
Methemoglobin level: Administrations of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite solely to achieve an arbitrary level of methemoglobinemia may be unnecessary and potentially hazardous. The therapeutic effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite do not appear to be mediated by methemoglobin formation alone and clinical responses to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administration have been reported in association with methemoglobin levels of less than 10%. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite beyond the initial dose should be guided primarily by clinical response to treatment (i.e., a second dose should be considered only if there is inadequate clinical response to the first dose). It is generally recommended that methemoglobin concentrations be closely monitored and kept below 30%. Serum methemoglobin levels should be monitored during treatment using co-oximetry, and administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should generally be discontinued when methemoglobin levels exceed 30%. Intravenous methylene blue and exchange transfusion have been reported in the literature as treatments for life-threatening methemoglobinemia.
Chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite, when administered sequentially through the same IV line as described in Dosage and Administration.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection consists of:
Administration of the contents of one vial constitutes a single dose.
None
Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with Baby Sebamed Crema Para Rozaduras de Bebe nitrite.
Methemoglobin levels should be monitored and oxygen administered during treatment with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite whenever possible. When Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administered to an adult. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be used with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Hemodynamics should be monitored closely during and after administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite, and infusion rates should be slowed if hypotension occurs.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be used with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite dose that is reduced in proportion to their oxygen carrying capacity.
Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation.
Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is administered. Reduced dosing guidelines should be followed in pediatric patients.
Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with Baby Sebamed Crema Para Rozaduras de Bebe nitrite administration, alternative therapeutic approaches should be considered in these patients. Patients with known or suspected G6PD deficiency should be monitored for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite should be used with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors.
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite.
The medical literature has reported the following adverse events in association with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.
Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia
Hematological: methemoglobinemia
Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma
Gastrointestinal system: nausea, vomiting, abdominal pain
Respiratory system: tachypnea, dyspnea
Body as a Whole: anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
Most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Formal drug interaction studies have not been conducted with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection.
Teratogenic Effects. Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite has caused fetal death in humans as well as animals. There are no studies in humans that have directly evaluated the potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite. There are two epidemiological studies conducted in Australia that report a statistically significant increase in the risk for congenital malformations, particularly in the CNS, associated with maternal consumption of water containing nitrate levels in excess of 5 ppm. Results from a case-control study in Canada suggested a trend toward an increase in the risk for CNS malformations when maternal consumption of nitrate was ≥ 26 ppm (not statistically significant).
The potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite exposure restricted to the prenatal period has been reported in guinea pigs, mice, and rats. There was no evidence of teratogenicity in guinea pigs, mice, or rats. However, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Studies testing prenatal and postnatal exposure have been reported in mice and rats. Treatment of pregnant rats via drinking water with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite at concentrations of either 2000 or 3000 mg/L resulted in a dose-related increased mortality postpartum. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (43 and 65 times the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison).
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults. Collectively, these data suggest that the human fetus would show greater sensitivity to methemoglobin resulting in nitrite-induced prenatal hypoxia leading to retarded development of certain neurotransmitter systems in the brain and long lasting dysfunction.
Nonteratogenic Effects: Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure.
Because fetal hemoglobin is more readily oxidized to methemoglobin and lower levels of methemoglobin appear to be fatal to the fetus compared to the adult, Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is excreted in human milk. Because Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite. In studies conducted with Long-Evans rats, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administered in drinking water during pregnancy and lactation resulted in severe anemia, reduced growth and increased mortality in the offspring.
There are case reports in the medical literature of Baby Sebamed Crema Para Rozaduras de Bebe nitrite in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.
Mortality attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Large doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal.
Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite has the chemical name nitrous acid Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) salt. The chemical formula is NaNO2 and the molecular weight is 69.0. The structural formula is:
Structure of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite injection.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite in 10 mL solution (30 mg/mL). Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite injection is a clear solution with a pH between 7.0 and 9.0.
Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.
The synergy resulting from treatment of cyanide poisoning with the combination of Baby Sebamed Crema Para Rozaduras de Bebe nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a3, forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows:
NaNO2 + Hemoglobin → Methemoglobin
HCN + Methemoglobin → Cyanomethemoglobin
Vasodilation has also been cited to account for at least part of the therapeutic effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite. It has been suggested that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate
The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction:
Chemical Structure
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite
When 4 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection.
Oral doses of 120 to 180 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope.
The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is estimated to be 55 minutes.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite in humans have not been well studied. It has been reported that approximately 40% of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules.
Cyanide
The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours.
Thiocyanate
After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days.
The potential benefit of an acute exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents.
Mutagenesis
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood.
Fertility
Clinical studies to evaluate the potential effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite intake on fertility of either males or females have not been reported. In contrast, multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite or 1 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate alone or in sequence immediately after subcutaneous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and/or 0.5 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) cyanide required to cause death, and when administered together, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate resulted in a synergistic effect in raising the lethal dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred.
Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate in the treatment of cyanide poisoning.
While intravenous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite, with or without Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate, was found not to be effective in the same setting.
The human data supporting the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) thiosulfate report its use in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
There have been no human studies to prospectively and systematically evaluate the safety of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope.
Each Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite carton (NDC 60267-311-10) consists of the following:
Storage
Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze.
(Note: Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate must be obtained separately.)
Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection is indicated for acute cyanide poisoning that is judged to be life-threatening and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.
When feasible, patients should be informed of the possibility of life-threatening hypotension and methemoglobin formation.
Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation.
Manufactured by Cangene BioPharma, Inc., Baltimore, Maryland 21230 for
Hope Pharmaceuticals, Scottsdale, Arizona 85260
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
NDC 60267-311-10
Rx Only
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Nitrite
Injection, USP
300 mg/10 mL
(30 mg/mL)
FOR INTRAVENOUS USE
SINGLE USE ONLY
Any unused portion of a vial
should be discarded.
Use with
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Citrate) Thiosulfate
for Treatment of
Cyanide Poisoning
Manufactured by
CANGENE bioPharma, Inc.
Baltimore, MD for
HOPE
PHARMACEUTICALS®
Scottsdale, AZ 85260 U.S.A.
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
Sodium Lactate:
Baby Sebamed Crema Para Rozaduras de Bebe nitrite is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate for treatment of acute cyanide poisoning that is judged to be life-threatening. (1)
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection is indicated for sequential use with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate for the treatment of acute cyanide poisoning that is judged to be life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitroprusside.
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate Injection should be administered without delay.
Symptoms | Signs |
---|---|
|
|
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.
Smoke Inhalation
Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection, smoke-inhalation victims should be assessed for the following:
Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.
Caution should be exercised when administering cyanide antidotes, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate, simultaneously with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate, with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection, these drugs should not be administered concurrently in the same IV line. [see Dosage and Administration (2.2) ]
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate |
---|---|
Adults |
|
Children |
|
Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate.
Monitoring: Blood pressure must be monitored during treatment. (2.2)
Comprehensive treatment of acute cyanide intoxication requires support of vital functions. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite, followed by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate, should be considered adjunctive to appropriate supportive therapies. Airway, ventilatory and circulatory support, and oxygen administration should not be delayed to administer Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite injection and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate injection are administered by slow intravenous injection. They should be given as early as possible after a diagnosis of acute life-threatening cyanide poisoning has been established. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be administered first, followed immediately by Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate. Blood pressure must be monitored during infusion in both adults and children. The rate of infusion should be decreased if significant hypotension is noted.
Age | Intravenous Dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate |
---|---|
Adults |
|
Children |
|
NOTE: If signs of poisoning reappear, repeat treatment using one-half the original dose of both Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate.
In adult and pediatric patients with known anemia, it is recommended that the dosage of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be reduced proportionately to the hemoglobin concentration.
All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Patients should be monitored for at least 24-48 hours after Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection administration for adequacy of oxygenation and perfusion and for recurrent signs and symptoms of cyanide toxicity. When possible, hemoglobin/hematocrit should be obtained when treatment is initiated. Measurements of oxygen saturation using standard pulse oximetry and calculated oxygen saturation values based on measured PO2 are unreliable in the presence of methemoglobinemia.
Methemoglobin level: Administrations of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite solely to achieve an arbitrary level of methemoglobinemia may be unnecessary and potentially hazardous. The therapeutic effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite do not appear to be mediated by methemoglobin formation alone and clinical responses to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administration have been reported in association with methemoglobin levels of less than 10%. Administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite beyond the initial dose should be guided primarily by clinical response to treatment (i.e., a second dose should be considered only if there is inadequate clinical response to the first dose). It is generally recommended that methemoglobin concentrations be closely monitored and kept below 30%. Serum methemoglobin levels should be monitored during treatment using co-oximetry, and administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should generally be discontinued when methemoglobin levels exceed 30%. Intravenous methylene blue and exchange transfusion have been reported in the literature as treatments for life-threatening methemoglobinemia.
Chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and hydroxocobalamin and these drugs should not be administered simultaneously through the same IV line. No chemical incompatibility has been reported between Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite, when administered sequentially through the same IV line as described in Dosage and Administration.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection consists of:
Administration of the contents of one vial constitutes a single dose.
None
Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with Baby Sebamed Crema Para Rozaduras de Bebe nitrite.
Methemoglobin levels should be monitored and oxygen administered during treatment with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite whenever possible. When Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administered to an adult. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be used with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Hemodynamics should be monitored closely during and after administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite, and infusion rates should be slowed if hypotension occurs.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be used with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite dose that is reduced in proportion to their oxygen carrying capacity.
Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation.
Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is administered. Reduced dosing guidelines should be followed in pediatric patients.
Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with Baby Sebamed Crema Para Rozaduras de Bebe nitrite administration, alternative therapeutic approaches should be considered in these patients. Patients with known or suspected G6PD deficiency should be monitored for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite should be used with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors.
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite.
The medical literature has reported the following adverse events in association with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed.
Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia
Hematological: methemoglobinemia
Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma
Gastrointestinal system: nausea, vomiting, abdominal pain
Respiratory system: tachypnea, dyspnea
Body as a Whole: anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
Most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Formal drug interaction studies have not been conducted with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection.
Teratogenic Effects. Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite has caused fetal death in humans as well as animals. There are no studies in humans that have directly evaluated the potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite. There are two epidemiological studies conducted in Australia that report a statistically significant increase in the risk for congenital malformations, particularly in the CNS, associated with maternal consumption of water containing nitrate levels in excess of 5 ppm. Results from a case-control study in Canada suggested a trend toward an increase in the risk for CNS malformations when maternal consumption of nitrate was ≥ 26 ppm (not statistically significant).
The potential reproductive toxicity of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite exposure restricted to the prenatal period has been reported in guinea pigs, mice, and rats. There was no evidence of teratogenicity in guinea pigs, mice, or rats. However, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite treatment of pregnant guinea pigs with 60 or 70 mg/kg/day resulted in abortion of the litters within 1-4 days of treatment. All animals treated subcutaneously with 70 mg/kg, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite died within 60 minutes of treatment. Further studies demonstrated that a dose of 60 mg/kg resulted in measurable blood levels of methemoglobin in the dams and their fetuses for up to 6 hours post treatment. Maternal methemoglobin levels were higher than the levels in the offspring at all times measured. Based on a body surface area comparison, a 60 mg/kg dose in the guinea pig that resulted in death was only 1.7 times higher than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Studies testing prenatal and postnatal exposure have been reported in mice and rats. Treatment of pregnant rats via drinking water with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite at concentrations of either 2000 or 3000 mg/L resulted in a dose-related increased mortality postpartum. This exposure regimen in the rat model would result in dosing of approximately 220 and 300 mg/kg/day (43 and 65 times the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning, based on a body surface area comparison).
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite produces methemoglobin. Fetal hemoglobin is oxidized to methemoglobin more easily than adult hemoglobin. In addition, the fetus has lower levels of methemoglobin reductase than adults. Collectively, these data suggest that the human fetus would show greater sensitivity to methemoglobin resulting in nitrite-induced prenatal hypoxia leading to retarded development of certain neurotransmitter systems in the brain and long lasting dysfunction.
Nonteratogenic Effects: Behavioral and neurodevelopmental studies in rats suggest persistent effects of prenatal exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite that were detectable postnatally. Specifically, animals that were exposed prenatally to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite demonstrated impaired discrimination learning behavior (both auditory and visual) and reduced long-term retention of the passive-avoidance response compared to control animals. Additional studies demonstrated a delay in the development of AchE and 5-HT positive fiber ingrowth into the hippocampal dentate gyrus and parietal neocortex during the first week of life of prenatal nitrite treated pups. These changes have been attributed to prenatal hypoxia following nitrite exposure.
Because fetal hemoglobin is more readily oxidized to methemoglobin and lower levels of methemoglobin appear to be fatal to the fetus compared to the adult, Baby Sebamed Crema Para Rozaduras de Bebe nitrite should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is excreted in human milk. Because Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection may be administered in life-threatening situations, breast-feeding is not a contraindication to its use. Because many drugs are excreted in human milk, caution should be exercised following Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection administration to a nursing woman. There are no data to determine when breastfeeding may be safely restarted following administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite. In studies conducted with Long-Evans rats, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administered in drinking water during pregnancy and lactation resulted in severe anemia, reduced growth and increased mortality in the offspring.
There are case reports in the medical literature of Baby Sebamed Crema Para Rozaduras de Bebe nitrite in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite must be used with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.
Mortality attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite was reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Large doses of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal.
Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite has the chemical name nitrous acid Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) salt. The chemical formula is NaNO2 and the molecular weight is 69.0. The structural formula is:
Structure of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite injection.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite in 10 mL solution (30 mg/mL). Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite injection is a clear solution with a pH between 7.0 and 9.0.
Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.
The synergy resulting from treatment of cyanide poisoning with the combination of Baby Sebamed Crema Para Rozaduras de Bebe nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is thought to exert its therapeutic effect by reacting with hemoglobin to form methemoglobin, an oxidized form of hemoglobin incapable of oxygen transport but with high affinity for cyanide. Cyanide preferentially binds to methemoglobin over cytochrome a3, forming the nontoxic cyanomethemoglobin. Methemoglobin displaces cyanide from cytochrome oxidase, allowing resumption of aerobic metabolism. The chemical reaction is as follows:
NaNO2 + Hemoglobin → Methemoglobin
HCN + Methemoglobin → Cyanomethemoglobin
Vasodilation has also been cited to account for at least part of the therapeutic effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite. It has been suggested that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite-induced methemoglobinemia may be more efficacious against cyanide poisoning than comparable levels of methemoglobinemia induced by other oxidants. Also, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite appears to retain some efficacy even when the formation of methemoglobin is inhibited by methylene blue.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate
The primary route of endogenous cyanide detoxification is by enzymatic transulfuration to thiocyanate (SCN-), which is relatively nontoxic and readily excreted in the urine. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate is thought to serve as a sulfur donor in the reaction catalyzed by the enzyme rhodanese, thus enhancing the endogenous detoxification of cyanide in the following chemical reaction:
Chemical Structure
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite
When 4 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite was administered intravenously to six healthy human volunteers, the mean peak methemoglobin concentration was 7%, achieved at 30-60 minutes after injection, consistent with reports in cyanide poisoning victims. Supine systolic and diastolic blood pressures dropped approximately 20% within 10 minutes, a drop which was sustained throughout the 40 minutes of testing. This was associated with a 20 beat per minute increase in pulse rate that returned to baseline in 10 minutes. Five of these subjects were unable to withstand orthostatic testing due to fainting. One additional subject, who received a 12 mg/kg dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite, experienced severe cardiovascular effects and achieved a peak methemoglobin concentration of 30% at 60 minutes following injection.
Oral doses of 120 to 180 mg of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administered to healthy volunteers caused minimal cardiovascular changes when subjects were maintained in the horizontal position. However, minutes after being placed in the upright position subjects exhibited tachycardia and hypotension with syncope.
The half life for conversion of methemoglobin to normal hemoglobin in a cyanide poisoning victim who has been administered Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is estimated to be 55 minutes.
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite in humans have not been well studied. It has been reported that approximately 40% of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is excreted unchanged in the urine while the remaining 60% is metabolized to ammonia and related small molecules.
Cyanide
The apparent terminal elimination half life and volume of distribution of cyanide, in a patient treated for an acute cyanide poisoning with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate administration, have been reported to be 19 hours and 0.41 L/kg, respectively. Additionally, an initial elimination half life of cyanide has been reported to be approximately 1-3 hours.
Thiocyanate
After detoxification, in healthy subjects, thiocyanate is excreted mainly in the urine at a rate inversely proportional to creatinine clearance. In healthy subjects, the elimination half-life and volume of distribution of thiocyanate have been reported to be 2.7 days and 0.25 L/kg, respectively. However, in subjects with renal insufficiency the reported elimination half life is approximately 9 days.
The potential benefit of an acute exposure to Baby Sebamed Crema Para Rozaduras de Bebe nitrite as part of a cyanide antidote outweighs concerns raised by the equivocal findings in chronic rodent studies. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 35, 70, or 130 mg/kg for males and 0, 40, 80, or 150 mg/kg for females) was orally administered to rats (Fischer 344 strain) for 2 years via drinking water. There were no significant increases in the incidence of tumor in either male or female rats. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite (0, 750, 1500, or 3000 ppm equivalent to average daily doses of approximately 0, 60, 120, or 220 mg/kg for males and 0, 45, 90, or 165 mg/kg for females) was administered to B6C3F1 mice for 2 years via the drinking water. Equivocal results were obtained in female mice. Specifically, there was a positive trend toward an increase in the incidence of squamous cell papilloma or carcinoma in the forestomach of female mice. Although the incidence of hyperplasia of the glandular stomach epithelium was significantly greater in the high-dose male mice compared to controls, there were no significant increases in tumors in the male mice. Numerous reports in the published literature indicate that Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite may react in vivo with secondary amines to form carcinogenic nitrosamines in the stomach. Concurrent exposure to Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and secondary amines in feed or drinking water resulted in an increase in the incidence of tumors in rodents.
Mutagenesis
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite is mutagenic in S. typhimurium strains TA100, TA1530, TA1535 with and without metabolic activation; however, it was negative in strain TA98, TA102, DJ460 and E. coli strain WP2UVRA/PKM101. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite has been reported to be genotoxic to V79 hamster cells in vitro and in the mouse lymphoma assay, both assays conducted in the absence of metabolic activation. Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite was negative in the in vitro chromosomal aberrations assay using human peripheral blood lymphocytes. Acute administration of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite to male rats or male mice did not produce an increased incidence of micronuclei in bone marrow. Likewise, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite administration to mice for 14-weeks did not result in an increase in the incidence of micronuclei in the peripheral blood.
Fertility
Clinical studies to evaluate the potential effects of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite intake on fertility of either males or females have not been reported. In contrast, multigenerational fertility and reproduction studies conducted by the National Toxicology Program did not detect any evidence of an effect of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite (0.0, 0.06, 0.12, and 0.24% weight/volume) on either fertility or any reproductive parameter in Swiss CD-1 mice. This treatment protocol resulted in approximate doses of 125, 260, and 425 mg/kg/day. The highest exposure in this mouse study is 4.6 times greater than the highest clinical dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite that would be used to treat cyanide poisoning (based on a body surface area comparison).
Due to the extreme toxicity of cyanide, experimental evaluation of treatment efficacy has predominantly been completed in animal models. The efficacy of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate treatment alone to counteract the toxicity of cyanide was initially reported in 1895 by Lang. The efficacy of amyl nitrite treatment in cyanide poisoning of the dog model was first reported in 1888 by Pedigo. Further studies in the dog model, which demonstrated the utility of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite as a therapeutic intervention, were reported in 1929 by Mladoveanu and Gheorghiu. However, Hugs and Chen et al. independently reported upon the superior efficacy of the combination of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate in 1932-1933. Treatment consisted of intravenously administered 22.5 mg/kg (half the lethal dose) Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite or 1 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate alone or in sequence immediately after subcutaneous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) cyanide into dogs over a range of doses. Subsequent doses of 10 mg/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and/or 0.5 g/kg Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate were administered when clinical signs or symptoms of poisoning persisted or reappeared. Either therapy administered alone increased the dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) cyanide required to cause death, and when administered together, Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate resulted in a synergistic effect in raising the lethal dose of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) cyanide. The combined therapy appeared to have reduced efficacy when therapy was delayed until signs of poisoning (e.g. convulsions) appeared; however, other investigators have reported survival in dogs that were administered antidotal treatment after respiratory arrest had occurred.
Animal studies conducted in other species (e.g., rat, guinea pig, sheep, pigeon and cat) have also supported a synergistic effect of intravenous Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate in the treatment of cyanide poisoning.
While intravenous injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite and Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate was effective in reversing the effects of lethal doses of cyanide in dogs, intramuscular injection of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite, with or without Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate, was found not to be effective in the same setting.
The human data supporting the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite for cyanide poisoning consists primarily of published case reports. There are no randomized controlled clinical trials. Nearly all the human data describing the use of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) thiosulfate report its use in conjunction with Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite. Dosing recommendations for humans have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.
There have been no human studies to prospectively and systematically evaluate the safety of Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) nitrite in humans. Available human safety information is based largely on anecdotal case reports and case series of limited scope.
Each Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite carton (NDC 60267-311-10) consists of the following:
Storage
Store at controlled room temperature between 20°C and 25°C (68°F to 77°F); excursions permitted from 15 to 30°C (59 to 86°F). Protect from direct light. Do not freeze.
(Note: Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate must be obtained separately.)
Baby Sebamed Crema Para Rozaduras de Bebe Nitrite Injection is indicated for acute cyanide poisoning that is judged to be life-threatening and in this setting, patients will likely be unresponsive or may have difficulty in comprehending counseling information.
When feasible, patients should be informed of the possibility of life-threatening hypotension and methemoglobin formation.
Where feasible, patients should be informed of the need for close monitoring of blood pressure and oxygenation.
Manufactured by Cangene BioPharma, Inc., Baltimore, Maryland 21230 for
Hope Pharmaceuticals, Scottsdale, Arizona 85260
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
NDC 60267-311-10
Rx Only
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Nitrite
Injection, USP
300 mg/10 mL
(30 mg/mL)
FOR INTRAVENOUS USE
SINGLE USE ONLY
Any unused portion of a vial
should be discarded.
Use with
Baby Sebamed Crema Para Rozaduras de Bebe (Sodium Lactate) Thiosulfate
for Treatment of
Cyanide Poisoning
Manufactured by
CANGENE bioPharma, Inc.
Baltimore, MD for
HOPE
PHARMACEUTICALS®
Scottsdale, AZ 85260 U.S.A.
PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton
Sorbitol:
Laxative
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a
Poison Control Center right away.
Age | Dose |
adults and children 12 years and over | For rectal use only. Enema dosage is 120 mL of a 25 to 30% w/v solution (1 part of this product with 2.3 parts water) in a single daily dose as needed, or as directed by your doctor. |
children under 12 years | Ask a doctor. |
- store at room temperature 15-30C (59-86F)
- below 59F cloudiness and thickening may occur; warming will restore clarity and fluidity without affecting product quality
- do not freeze
- store in original container
- for institutional use only
water
GERICARE
NDC 57896-435-16
Baby Sebamed Crema Para Rozaduras de Bebe (Sorbitol) SOLUTION USP
70% W/W
LAXATIVE
TAMPER EVIDENT: Do not use this product if inner seal over mouth of bottle is missing or broken.
16 FL OZ (473 mL)
Titanium Dioxide:
Water:
Baby Sebamed Crema Para Rozaduras de Bebe (Water) 99.8%
Emergency eyewash
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
Sperian Eye and Face Protection, Inc.
(a Honeywell Company)
825 East Highway 151
Platteville, WI 53818 USA
Depending on the reaction of the Baby Sebamed Crema Para Rozaduras de Bebe after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Baby Sebamed Crema Para Rozaduras de Bebe not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Baby Sebamed Crema Para Rozaduras de Bebe addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
There are no reviews yet. Be the first to write one! |
The information was verified by Dr. Rachana Salvi, MD Pharmacology