ZENTEPY ALBENDAZOLE ORAL SUSPENSION USP 200MG/5 ML
COMPOSITION :
Each 5ml contains:
Albendazole U.S.P……….200 mg.
Flavoured syrupy base…Q.S.
Colour : Erythrosine
COMPOSITION :
Each 5ml contains :
Albendazole U.S.P :…….200 mg.
Flavoured syrupy base…Q.S.
Colour : Tartrazine
COMPOSITION :
Each 5ml contains :
Albendazole U.S.P………..200 mg.
Flavoured syrupy base….Q.S.
Colour: Ponceau 4R
The chemical name of albendazole is methyl [5-(propylthio)-1 H-benzimidazol-2-yl] carbamate.
PHARMACOLOGICALACTION:
Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal, ovacidal and larvacidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth. In man, after oral administration, albendazole is absorbed and completely metabolized. At a dose of 6.6 mg/kg of albendazole the plasma concentration of its main metabolite, the sulfoxide, attains a maximum of 0.25 to 0.30 micrograms/mL after approximately 21/2 hours. The half-life of the sulfoxide in the plasma is 8% hours. The metabolite is essentially eliminated via the urine
WARNINGS:
It has been noted that leucopaenia has occurred when used for periods longer than recommended.
In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.
INDICATIONS:
ALBENDAZOLE is indicated in the treatment of single or mixed intestinal parasites. Clinical studies have shown albeneffective in the treatment of Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm), Enterobius vermicularis (pinworm/threadworm), Ancylostoma duodenale and Necator americanus (hookworm), Taenia spp. (tapeworm) and Strongyloides stercoralis.
ALBENDAZOLE has been shown to be effective in the treatment of Giardia (duodenalis or intestinalis or lamblia) infections in children.
CONTRA-INDICATIONS:
Albendazole is known to be teratogenic and embryotoxic in animals. The safety of albendazole during pregnancy has not been established, and ALBENDAZOLE should not be taken by pregnant women at any stage of their pregnancy or by women who are likely to become pregnant, during or shortly after the course of therapy. ALBENDAZOLE is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents.
DOSAGE AND DIRECTIONS FOR USE:
Usual Dose: 10 mL (400 mg) of ZENTEPYX suspension as a single dose in both adults and children over two years of age. The usual dose in children between one and two years of age is 10 mL (400 mg) of ZENTEPYX suspension as a single dose. In heavy mixed infestation involving Strongyloides or Taeniasis, a single daily dose may be inadequate and the dose may be given for three consecutive days. Note:
If the patient is not cured after three weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required.
Albendazole has not been adequately studied in children under one year of age.
Giardiasis (dose in children overt years of age):
Asingle 400 mg daily dose (10 mL suspension) forfive days and they should be taken with food.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported. Hypersensitivity reactions including rash. pruritus and urticaria have been reported less frequently.
Interactions:
Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If poisoning or excessive overdosage is suspected it is recommended, on general principles, that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.
PRESENTATION:
ZENTEPYX suspension is available in 10 mL bottles.
STORAGE INSTRUCTIONS: Store in a cool & dry place Protect from light.
Keep medicines out of reach of Children.
Marketed by:
PYXUS PHARMACEUTICALS PVT. LTD.
