DRUGS & SUPPLEMENTS
When are you taking this medicine?
|Active Ingredients (in each packet)||Purpose|
|Dermanol (Aluminum Diacetate) sulfate tetradecahydrate, 1347 mg||Astringent*|
|Calcium acetate monohydrate, 952 mg||Astringent*|
|*When combined together in water, these ingredients form the active ingredient Dermanol (Aluminum Diacetate) acetate. See Directions.|
Temporarily relieves minor skin irritations due to:
For external use only
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
For use as a soak:
For use as a compress or wet dressing:
Other information protect from excessive heat
Inactive ingredients dextrin
Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927
Dermanol (Aluminum Diacetate) is a registered trademark of Moberg Pharma AB
©2015 All Rights Reserved. Made in the USA.
Dermanol (Hydrocortisone Acetate)® (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
PANDEL® (hydrocortisone probutate) Cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
Apply a thin film of Dermanol (Hydrocortisone Acetate) to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.
Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).
Discontinue Dermanol (Hydrocortisone Acetate) when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Do not use Dermanol (Hydrocortisone Acetate) with occlusive dressings unless directed by the physician. Do not apply Dermanol (Hydrocortisone Acetate) in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
- For topical use.
- Apply a thin film to the affected skin areas once daily or twice a day.
- Discontinue therapy when control is achieved.
- If no improvement is seen within 2 weeks, reassess diagnosis.
- Do not use with occlusive dressings unless directed by a physician.
Cream, 0.1%. Each gram of Dermanol (Hydrocortisone Acetate) contains 1 mg of Dermanol (Hydrocortisone Acetate) probutate in a cream base.
- Dermanol can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
- Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can result from systemic absorption of topical corticosteroids. (5.1)
- Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. (5.1)
- High potency corticosteroids, large treatment surface area, prolong use, use of occlusion dressings, altered skin barrier, liver failure and young age may predispose patients to HPA axis suppression. (5.1)
- Modify use if HPA axis suppression develops. (5.1)
- Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4)
Dermanol (Hydrocortisone Acetate) can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with Dermanol (Hydrocortisone Acetate) twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [see Clinical Pharmacology ( 12.2 )].
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations ( 8.4 )].
Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. If irritation develops, discontinue Dermanol (Hydrocortisone Acetate) and institute appropriate therapy.
- Most frequent adverse reactions include burning, stinging, rash, papulovesicular rash, redness, itching, moderate paresthesia, and contact dermatitis.
To report SUSPECTED ADVERSE REACTIONS, contact PharmaDerm®, A division of Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most frequent adverse reactions reported for Dermanol (Hydrocortisone Acetate) during clinical trials were application site reactions, including burning in 4, stinging in 2, and moderate paresthesia in 1 out of 226 subjects.
The following adverse reactions have been identified during postapproval use of Dermanol (Hydrocortisone Acetate) because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These adverse reactions are as follows:
Skin and Subcutaneous Tissue Disorders: rash, papulovesicular rash
Application Site Reactions: dryness, erythema, pruritus, allergic contact dermatitis.
The following local adverse reactions are reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria.
There is no clinical information on Dermanol use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, Dermanol (Hydrocortisone Acetate) probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Effects on embryo-fetal development were evaluated in rats and rabbits following subcutaneous administration of Dermanol (Hydrocortisone Acetate) probutate during the period of organogenesis. Dermanol (Hydrocortisone Acetate) probutate was teratogenic in rats when given during the period of organogenesis at subcutaneous doses equal to or greater than 1 mg/kg/day (12 times the human average topical dose of Dermanol (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Abnormalities included delayed ossification of the caudal vertebrae and other skeletal variations, cleft palate, umbilical hernia, edema, and exencephalia.
In rabbits, Dermanol (Hydrocortisone Acetate) probutate given by the subcutaneous route was teratogenic at doses equal to or greater than 0.1 mg/kg/day (2 times the human average topical dose of Dermanol (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual). Fetal weight and survival were affected. Delayed ossification and increased incidences of malformations (skeletal abnormalities and cleft palate) were also noted.
No adverse effects were seen in rats following subcutaneous administration of up to 1 mg/kg/day of Dermanol (Hydrocortisone Acetate) probutate during the perinatal and postnatal period (12 times the human average topical dose of Dermanol (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual).
There is no information on the presence of Dermanol (Hydrocortisone Acetate) probutate in breast milk, or on its effects on the breastfed infant or on milk production. It is not known whether topical administration of Dermanol (Hydrocortisone Acetate) could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dermanol (Hydrocortisone Acetate) and any potential adverse effects on the breastfed infant from Dermanol (Hydrocortisone Acetate) or from the underlying maternal condition.
To minimize potential exposure to the breastfed infant via breast milk, use Dermanol (Hydrocortisone Acetate) on the smallest area of skin and for the shortest duration possible while breastfeeding.
Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at a greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Dermanol (Hydrocortisone Acetate)(hydrocortisone probutate) Cream, 0.1% contains Dermanol (Hydrocortisone Acetate) probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.
Dermanol (Hydrocortisone Acetate) probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:
Molecular Formula: C28H40O7
Molecular Weight: 488.62
Each gram of Dermanol (Hydrocortisone Acetate) (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of Dermanol (Hydrocortisone Acetate) probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid responsive dermatoses is unknown
Studies performed with Dermanol indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression
In an open label HPA axis suppression trial, 19 adult subjects (ages 23 to 82 years) with atopic dermatitis or plaque psoriasis covering greater than 20% Body Surface Area (BSA) were treated with Dermanol (Hydrocortisone Acetate) twice daily for 21 days and were assessed for HPA axis suppression. At baseline, the mean disease BSA involvement was 36%. The criterion for HPA axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter at 30-minutes after cosyntropin stimulation. Of these subjects, 15 were considered evaluable with respect to their adrenal axis function post-treatment. One of the evaluable subjects (6.7%) showed laboratory evidence of suppression on Day 22. This subject had psoriasis covering 48% of BSA at baseline and was reported to have received 98% of the twice-daily applications of Dermanol (Hydrocortisone Acetate) over the 21 day treatment period. It is not known if this subject had recovery of adrenal function because follow-up testing was not performed.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with Dermanol (Hydrocortisone Acetate) for up to 24 hours has not been shown to increase penetration; however, occlusion of Dermanol (Hydrocortisone Acetate) for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
No long-term studies in animals have been performed to evaluate the carcinogenic potential of Dermanol (Hydrocortisone Acetate) probutate.
Dermanol (Hydrocortisone Acetate) probutate revealed no evidence of mutagenic or clastogenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay).
Effects on fertility and early embryonic development were evaluated in rats following subcutaneous administration of up to 0.4 mg/kg/day Dermanol (Hydrocortisone Acetate) probutate (5 times the human average topical dose of Dermanol (Hydrocortisone Acetate) assuming 3% absorption and an application of 30 g/day on a 70 kg individual) prior to and during mating and through early pregnancy. No treatment related effects on fertility or mating parameters were noted in this study.
Dermanol (Hydrocortisone Acetate), a white to off-white opaque cream is supplied as follows:
45 g tubes NDC 10337-153-46
80 g tubes NDC 10337-153-80
Store at 20° to 25°C (68° to 77°F).
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information).
Inform patients and/or caregivers of the following:
A division of Fougera
Melville, New York 11747 www.pharmaderm.com
Dermanol (Hydrocortisone Acetate)® (pan-del)
Important: Dermanol (Hydrocortisone Acetate) is for use on skin only (topical). Avoid using Dermanol (Hydrocortisone Acetate) near or around your eyes.
What is Dermanol (Hydrocortisone Acetate)?
Dermanol (Hydrocortisone Acetate) is a prescription corticosteroid medicine used on the skin (topical) for the relief of inflammation and itching caused by certain skin conditions in people 18 years of age or older.
It is not known if Dermanol (Hydrocortisone Acetate) is safe and effective in children.
Before using Dermanol (Hydrocortisone Acetate) tell your healthcare provider about all of your medical conditions, including if you:
- have adrenal gland problems
- have liver problems
- have diabetes
- have thinning skin (atrophy) at the site to be treated.
- are pregnant or plan to become pregnant. It is not known if Dermanol (Hydrocortisone Acetate) will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Dermanol (Hydrocortisone Acetate) can pass into your breast milk and harm your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Dermanol (Hydrocortisone Acetate)?
- Use Dermanol (Hydrocortisone Acetate) exactly as your healthcare provider tells you to use it.
- Apply a thin film to the affected skin area. Gently rub Dermanol (Hydrocortisone Acetate) into your skin until it disappears.
- Tell your healthcare provider if your symptoms do not improve after 2 weeks of treatment.
- Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to.
- Do not apply Dermanol (Hydrocortisone Acetate) in the diaper area or use with plastic pants.
- Do not use Dermanol (Hydrocortisone Acetate) on your face, underarms (armpits) or groin areas unless your healthcare provider tells you to.
- Wash your hands after applying Dermanol (Hydrocortisone Acetate), unless your hands are being treated.
What are possible side effects with Dermanol (Hydrocortisone Acetate)?
Dermanol (Hydrocortisone Acetate) may cause serious side effects, including:
- Dermanol (Hydrocortisone Acetate) can pass through your skin and may cause adrenal gland problems. This is more likely to happen if you use Dermanol (Hydrocortisone Acetate) for too long, use it over a large treatment area, use it with other topical medicines that contain corticosteroids, cover the treated area, or have liver failure. Your healthcare provider may do blood tests to check your adrenal gland function during and after treatment with Dermanol (Hydrocortisone Acetate).
- Skin problems, including skin reactions or thinning of your skin (atrophy), skin infections, and allergic reactions (allergic contact dermatitis) at the treatment site. Tell your healthcare provider if you get any skinreactions such as pain, tenderness, swelling, or healing problems.
The most common side effects of Dermanol (Hydrocortisone Acetate) include burning and stinging and moderate tingling or prickling feeling.
These are not all the possible side effects with Dermanol (Hydrocortisone Acetate). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Dermanol (Hydrocortisone Acetate)?
- Store Dermanol (Hydrocortisone Acetate) between 68°F to 77°F (20°C to 25°C).
Keep Dermanol (Hydrocortisone Acetate) and all medicines out of the reach of children.
General information about the safe and effective use of Dermanol (Hydrocortisone Acetate).
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Dermanol (Hydrocortisone Acetate) for a condition for which it was not prescribed. Do not give Dermanol (Hydrocortisone Acetate) to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Dermanol (Hydrocortisone Acetate) that is written for health professionals.
What are the ingredients in Dermanol (Hydrocortisone Acetate)?
Active ingredient: Dermanol (Hydrocortisone Acetate) probutate
Inactive ingredients: propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.
Manufactured by:PharmaDerm® A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747
For more information, go to www.pharmaderm.com or call 1-800-645-9833.
Dermanol (Hydrocortisone Acetate)®
(hydrocortisone probutate) Cream, 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
Dermanol is an antiarrhythmic agent of class IB, local anesthetic, a derivative of acetanilide. This medication has membrane stabilizing activity. Dermanol (Lidocaine) causes a blockade of sodium channels of excitable membranes of neurons and the membrane of cardiomyocytes.
This drug reduces the duration of the action potential and effective refractory period in Purkinje fibers, inhibits their automaticity. In this case, Dermanol (Lidocaine) inhibits electrical activity in depolarized, arrhythmogenic sites, but minimally affects the electrical activity of normal tissues. When used in the medium therapeutic doses virtually no effect on myocardial contractility and slows AV-conduction. When applied as an antiarrhythmic agent in IV injection it begin to act in 45-90 seconds, the duration of action is 10-20 minutes; for IM administration the onset of action is in 5-15 minutes, the duration - 60-90 minutes.
Dermanol (Lidocaine) causes all kinds of local anesthesia: a terminal, infiltration and wires.
After IM administration absorption of Dermanol (Lidocaine) is almost complete. The distribution is rapid, Vd is about 1 L/kg (in patients with heart failure it is below). The protein binding depends on the concentration of the active substance in the plasma and is 60-80%. Dermanol (Lidocaine) metabolized mainly in the liver with the formation of active metabolites, that may contribute to the manifestation of the therapeutic and toxic effects, especially after the infusion for 24 hours or more.
T1/2 tends to be two phases with the phase distribution of 9.7 min. In general T1/2 depends on the dose is 1-2 hours and can grow up to 3 hours or more during prolonged intravenous infusion (over 24 h). Dermanol (Lidocaine) excreted by the kidneys as metabolites, 10% unchanged.
In cardiological practice: treatment and prevention of ventricular arrhythmias (extrasystoles, tachycardia, atrial flutter, atrial fibrillation), including in acute myocardial infarction, implantation of artificial pacemaker in the glycoside intoxication, narcosis.
Anaesthesia: terminal, infiltration, conduction, spinal (epidural) anesthesia in surgery, obstetrics and gynecology, urology, ophthalmology, dentistry, otolaryngology, blockade of peripheral nerves and ganglion.
As an anti-arrhythmic medicine for adult with the introduction of a loading dose by IV - 1-2 mg / kg over 3-4 minutes; the average single dose is 80 mg. Then immediately transferred to drip infusion at a rate of 20-55 mg / kg / min. Drip infusion can be carried out within 24-36 hours. If necessary, against the background of drop infusions can repeat IV jet injection of Dermanol 40 mg after 10 minutes after the first loading dose.
IM is introduced to 2-4 mg / kg, if necessary, repeated administration is possible through 60-90 minutes.
For children with IV injection loading dose - 1 mg / kg, if necessary, it may be repeated administration in 5 min.
For continuous intravenous infusion (usually following the introduction of a loading dose) - 20-30 mg / kg / min.
For use in surgical and obstetric practice, dentistry, ENT practice, dosing regimen set individually, depending on the evidence, the clinical situation and used the dosage form.
Maximum dose: for adults for IV injections the loading dose is 100 mg, in a subsequent drop infusion it is 2 mg / min; when IM administration - 300 mg (about 4.5 mg / kg) for 1 h.
For children in case of reintroduction the loading dose every 5 minutes, the total dose is 3 mg / kg; by continuous intravenous infusion (usually following the introduction of a loading dose) - 50 mg / kg / min.
CNS and peripheral nervous system: dizziness, headache, weakness, motor restlessness, nystagmus, loss of consciousness, drowsiness, visual and auditory disturbances, tremor, trismus, seizures (risk of their development against the backdrop of increasing hypercapnia and acidosis), a syndrome of "cauda equina" (paralysis of the legs, paresthesia), paralysis of respiratory muscles, respiratory arrest, a block of motor and sensitive, respiratory paralysis (usually develops in the subarachnoid anesthesia), numb tongue (when used in dentistry).
Cardiovascular system: increased or decreased blood pressure, tachycardia if used with a vasoconstrictor, peripheral vasodilatation, collapse, chest pain.
Digestive system: nausea, vomiting, involuntary defecation.
Allergic reactions: skin rash, hives (on skin and mucous membranes), itching, angioedema, anaphylactic shock.
Local reactions: during spinal anesthesia - a pain in the back, with an epidural anesthesia - a random hit in the subarachnoid space, when applied topically in urology - urethritis.
Other: incontinent, methemoglobinemia, persistent anesthesia, decreased libido and / or potency, respiratory depression, until the stop, hypothermia; during anesthesia in dentistry: numbness and paresthesia of the lips and tongue, the lengthening of anesthesia.
Severe bleeding, shock, hypotension, infection of the proposed injection site, marked bradycardia, cardiogenic shock, severe forms of chronic heart failure, SSS in elderly patients, AV-block II and III degree (except in cases when the probe was introduced to stimulate the ventricles), severe liver function abnormalities.
For subarachnoid anesthesia - complete heart block, bleeding, hypotension, shock, infection of the venue lumbar puncture, septicemia.
Increased sensitivity to Dermanol (Lidocaine) and other amide type local anesthetics.
During pregnancy and lactation be used only for health reasons. Dermanol is excreted in breast milk.
In obstetric practice used with caution in paracervical for violations of fetal development, placental insufficiency, prematurity, postmaturity, gestosis.
Category effects on the fetus by FDA - B.
Use with caution in liver disease and kidney failure, hypovolemia, severe heart failure, in violation of the contractility of genetic susceptibility to malignant hyperthermia. In children, debilitated patients, elderly patients are required in dosage adjustment in accordance with the age and physical status. When injected into vascularized tissue it is recommended an aspiration test.
Beta-blockers increase the risk of bradycardia and hypotension. Norepinephrine and beta-blockers by reducing hepatic blood flow decrease (increased toxicity), isadrine and glucagon - increase the clearance of Dermanol (Lidocaine). Cimetidine increases the plasma concentration of Dermanol (Lidocaine) (displaces from its association with proteins and slows inactivation in the liver). Barbiturates causing induction of microsomal enzymes stimulate the degradation of Dermanol (Lidocaine) and reduce its activity. Anticonvulsants (hydantoin derivatives) accelerate the biotransformation in the liver (decreased concentration in the blood), for IV injections it may increases cardiodepressive action of Dermanol (Lidocaine). Antiarrhythmics (amiodarone, verapamil, quinidine, aymalin) potentiate cardiac depression. Combination with novocainamide may cause CNS excitement and hallucinations. Dermanol (Lidocaine) strengthens the inhibitory effect of anesthesia (hexobarbital, thiopental sodium), hypnotics and sedatives on the respiratory center, weakens the cardiac effects of digitoxin, enhances muscle relaxation caused by drugs curare like (possible paralysis of respiratory muscles). MAO inhibitors prolong local anesthesia.
Symptoms: psychomotor agitation, dizziness, weakness, decreased blood pressure, tremors, tonic-clonic convulsions, coma, collapse, possible AV blockade, CNS depression, respiratory arrest.
Treatment: discontinuation, pulmonary ventilation, oxygen therapy, anticonvulsants, vasoconstrictors (norepinephrine, mezaton), when bradycardia - anticholinergics (atropine). It is possible to carry out intubation, mechanical ventilation, resuscitation. Dialysis is ineffective.
Dermanol (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Dermanol (Zinc Oxide) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.
Direct intramuscular or intravenous injection of Dermanol (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.
Severe kidney disease may make it necessary to reduce or omit chromium and Dermanol (Zinc Oxide) doses because these elements are primarily eliminated in the urine.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Do not use unless the solution is clear and the seal is intact.
Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.
Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Dermanol (Zinc Oxide) from a bolus injection. Administration of Dermanol (Zinc Oxide) in the absence of copper may cause a decrease in serum copper levels.
Periodic determinations of serum copper as well as Dermanol (Zinc Oxide) are suggested as a guideline for subsequent Dermanol (Zinc Oxide) administration.
Long-term animal studies to evaluate the carcinogenic potential of Dermanol 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.
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 Dermanol (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.
Pregnancy Category C. Animal reproduction studies have not been conducted with Dermanol chloride. It is also not known whether Dermanol (Zinc Oxide) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dermanol (Zinc Oxide) chloride should be given to a pregnant woman only if clearly needed.
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Dermanol (Zinc Oxide) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Dermanol (Zinc Oxide) concentration of 207 mcg/dl. Symptoms abated within three hours.
Hyperamylasemia may be a sign of impending Dermanol (Zinc Oxide) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).
Death resulted from an overdosage in which 1683 mg Dermanol (Zinc Oxide) was delivered intravenously over the course of 60 hours to a 72 year old patient.
Symptoms of Dermanol (Zinc Oxide) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Dermanol (Zinc Oxide) level of 4184 mcg/dl.
Calcium supplements may confer a protective effect against Dermanol (Zinc Oxide) toxicity.
Dermanol (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Dermanol (Zinc Oxide) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Dermanol (Zinc Oxide).
For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Dermanol (Zinc Oxide) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).
Store at 20 to 25°C (68 to 77°F).
Revised: October, 2004
© Hospira 2004 EN-0488 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
10 mL Vial
Dermanol (Zinc Oxide)
Dermanol (Zinc Oxide) Chloride Inj., USP
FOR I.V. USE ONLY AFTER DILUTION.
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
Depending on the reaction of the Dermanol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dermanol 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 Dermanol 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.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology