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DRUGS & SUPPLEMENTS
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HB-Rich Syrup
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HB-Rich Syrup uses
HB-Rich Syrup consists of Ammonium Citrate, Folic Acid, Haemoglobin, Sorbitol, Vitamin B12.Ammonium Citrate:
- Indications and usage
- Contraindications
- Warning
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.
CONTRAINDICATIONS
HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.
WARNING
Sun exposure (natural or artificial sunlight) to areas of the skin treated with HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.
PRECAUTIONS
General -
For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.
Information for Patients
Patients using HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% should receive the following information and instructions:
- This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
- Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
- This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
- If the skin condition worsens with treatment, the medication should be promptly discontinued.
Carcinogenesis, Mutagenesis, Impairment of Fertility -
The topical treatment of CD-1 mice with 12%, 21% or 30% HB-Rich Syrup lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% HB-Rich Syrup (Ammonium Citrate) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.
The mutagenic potential of HB-Rich Syrup (Ammonium Citrate) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.
In dermal Segment I and III studies with HB-Rich Syrup (Ammonium Citrate) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m2/day), approximately 0.4 times the human topical dose.
Pregnancy:
Teratogenic effects:
Pregnancy Category B -
Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to HB-Rich Syrup (Ammonium Citrate) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, HB-Rich Syrup (Ammonium Citrate) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.
Nursing Mothers -
Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when HB-Rich Syrup (Ammonium Citrate) lactate is administered to a nursing woman.
Pediatric Use -
Safety and effectiveness of HB-Rich Syrup lactate have been demonstrated in infants and children. No unusual toxic effects were reported.
Geriatric Use -
Clinical studies of HB-Rich Syrup (Ammonium Citrate) lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.
ADVERSE REACTIONS
The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).
OVERDOSAGE
The oral administration of HB-Rich Syrup (Ammonium Citrate) lactate to rats and mice showed this drug to be practically non-toxic (LD50>15 mL/kg).
DOSAGE AND ADMINISTRATION
Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.
HOW SUPPLIED
HB-Rich Syrup Lactate Lotion, 12% is available as follows:
225 g bottle (NDC 45802-419-54)
400 g bottle (NDC 45802-419-26)
STORAGE
Store at 20-25°C (68-77°F).
Manufactured By Perrigo, Bronx, NY 10457
Distributed By Perrigo, Allegan, MI 49010
0K5A7 RC F6
Rev 01-17
Folic Acid:
- Indications and usage
- Contraindications
- Precautions
- Adverse reactions
- Dosage and administration
- How supplied
- Storage
INDICATIONS AND USAGE
HB-Rich Syrup (Folic Acid)® is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
| WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. |
PRECAUTIONS
HB-Rich Syrup (Folic Acid) acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of HB-Rich Syrup (Folic Acid) acid.
DOSAGE AND ADMINISTRATION
One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.
HOW SUPPLIED
HB-Rich Syrup (Folic Acid)® tablets are supplied in child-resistant bottles of 90 tablets (NDC 0037-6885-90)
KEEP OUT OF REACH OF CHILDREN.
STORAGE
Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F).
Dispense in a tight, light-resistant container to protect from light and moisture.
To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch
Distributed by:
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120
© 2014 Meda Pharmaceuticals Inc.
U.S. Patent Nos. 7,585,527 and 8,080,520
Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
HB-Rich Syrup (Folic Acid) and the BIFERA logo are registered trademarks and the HB-Rich Syrup (Folic Acid) logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.
MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.
IN-6885-02 Rev 6/2014
Sorbitol:
- Active ingredient (in each tablespoonful=15 ml )
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
Active ingredient
HB-Rich Syrup (Sorbitol) 13.5gPurpose
Laxative
Uses
- relieves occasional constipation and irregularity
- generally produces bowel movement in 1/4 to 1 hour when used rectally
- as a pharmaceutical aide (sweetner)
- for other uses, as your doctor
Warnings
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
- are taking mineral oil
- have noticed a sudden change in bowel habits that lasts over 2 weeks
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.
Directions
- do not exceed recommended dose| 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. |
Other information
- 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
Inactive ingredient
water
GERICARE
NDC 57896-435-16
HB-Rich Syrup (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)
Vitamin B12:
Pharmacological action
HB-Rich Syrup refers to a group of water-soluble vitamins. It has high biological activity. HB-Rich Syrup (Vitamin B12) is necessary for normal hematopoiesis (promotes maturation of erythrocytes). Involved in the processes of transmethylation, hydrogen transport, synthesis of methionine, nucleic acids, choline, creatine. Contributes to the accumulation in erythrocytes of compounds containing sulfhydryl groups. Has a beneficial effect on liver function and the nervous system. Activates the coagulation of blood in high doses causes an increase in the activity of thromboplastin and prothrombin.
Pharmacokinetics
After oral administration HB-Rich Syrup (Vitamin B12) absorbed from the gastrointestinal tract. Metabolized in the tissues, becoming a co-enzyme form - adenosylcobalamin which is the active form of cyanocobalamin. Excreted in bile and urine.
Why is HB-Rich Syrup prescribed?
Anemia due to B12-deficiency conditions; in the complex therapy for iron and posthemorrhagic anemia; aplastic anemia caused by toxic substances and drugs; liver disease (hepatitis, cirrhosis); funicular myelosis; polyneuritis, radiculitis, neuralgia, amyotrophic lateral sclerosis; children cerebral palsy, Down syndrome, peripheral nerve injury; skin diseases (psoriasis, photodermatosis, herpetiformis dermatitis, neurodermatitis); to prevent and treat symptoms of deficiency of HB-Rich Syrup (Vitamin B12) (including the application of biguanide, PASA, vitamin C in high doses); radiation sickness.
Dosage and administration
HB-Rich Syrup is used as injections SC, IV, IM, intralumbar, and also oral. With anemia associated with HB-Rich Syrup (Vitamin B12) deficiency is introduced on 100-200 mcg in 2 days. In anemia with symptoms of funicular myelosis and megalocytic anemia with diseases of the nervous system - 400-500 micrograms in the first 7 days daily, then 1 time every 5-7 days. In the period of remission in the absence of events funicular myelosis maintenance dose - 100 mcg 2 times a month, in the presence of neurological symptoms - at 200-400 mcg 2-4 times a month. In acute post-hemorrhagic anemia and iron anemia by 30-100 mcg 2-3 times a week. When aplastic anemia (especially in children) - 100 micrograms before clinical improvement. When nutritional anemia in infants and preterm - 30 mcg / day during 15 days.
In diseases of the central and peripheral nervous system and neurological diseases with a pain syndrome is administered in increasing doses - 200-500 mcg, with the improvement in the state - 100 mcg / day. The course of treatment with HB-Rich Syrup (Vitamin B12) is 2 weeks. In traumatic lesions of peripheral nervous system - at 200-400 mcg every other day for 40-45 days.
When hepatitis and cirrhosis - 30-60 mcg / day or 100 mg every other day for 25-40 days.
Dystrophy in young children, Down syndrome and cerebral palsy - by 15-30 mcg every other day.
When funicular myelosis, amyotrophic lateral sclerosis can be introduced into the spinal canal at 15-30 mcg, gradually increasing the dose of 200-250 micrograms.
In radiation sickness, diabetic neuropathy, sprue - by 60-100 mcg daily for 20-30 days.
When deficiency of HB-Rich Syrup (Vitamin B12) to prevent - IV or IM for 1 mg 1 time a month; for treatment - IV or IM for 1 mg daily for 1-2 weeks, the maintenance dose is 1-2 mg IV or IM from 1 per week, up to 1 per month. Duration of treatment is determined individually.
HB-Rich Syrup (Vitamin B12) side effects, adverse reactions
CNS: rarely - a state of arousal.
Cardiovascular system: rarely - pain in the heart, tachycardia.
Allergic reactions: rarely - urticaria.
HB-Rich Syrup contraindications
Thromboembolism, erythremia, erythrocytosis, increased sensitivity to cyanocobalamin.
HB-Rich Syrup using during pregnancy and breastfeeding
Cyanocobalamin can be used in pregnancy according to prescriptions.
Special instructions
When stenocardia should be used with caution in a single dose of HB-Rich Syrup 100 mcg. During treatment should regularly monitor the blood picture and coagulation. It is unacceptable to enter in the same syringe with cyanocobalamin solutions of thiamine and pyridoxine.
HB-Rich Syrup (Vitamin B12) drug interactions
In an application of HB-Rich Syrup (Vitamin B12) with hormonal contraceptives for oral administration may decrease the concentration of cyanocobalamin in plasma.
In an application with anticonvulsant drugs decreased cyanocobalamin absorption from the gut.
In an HB-Rich Syrup (Vitamin B12) application with neomycin, aminosalicylic acid, colchicine, cimetidine, ranitidine, drugs potassium decreased cyanocobalamin absorption from the gut.
Cyanocobalamin may exacerbate allergic reactions caused by thiamine.
When parenteral application of chloramphenicol may decrease the hematopoietic effects of cyanocobalamin with anemia.
Pharmaceutical incompatibility
Contained in the molecule of cyanocobalamin cobalt ion contributes to the destruction of ascorbic acid, thiamine bromide, riboflavin in one solution.
HB-Rich Syrup pharmaceutical active ingredients containing related brand and generic drugs:
HB-Rich Syrup available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.