Averroes Pharma
Full Prescribing Info
DENZOL Film Coated Tablet: Each tablet contains Albendazole 200 mg.
DENZOL Suspension: Each 1 ml contains Albendazole 20 mg.
Pharmacology: Pharmacodynamics: Albendazole is a broad spectrum anthelmintic with activity against most nematodes and some cestodes. Albendazole acts by destruction of cytoplasmic microtubules in the worm's intestinal or absorptive cells and inhibition of glucose uptake and other nutrients in susceptible helminths, resulting in death of the worm.
Pharmacokinetics: Albendazole is poorly absorbed from GI tract, and is rapidly metabolized in the liver to the active albendazole sulphoxide, which is approximately 70% bound to the plasma protein. Peak plasma concentrations occur in 2-5 hours after dosing. It has a plasma half-life of about 8.5 hours and is primarily eliminated in the bile.
Albendazole is use in patient with Enterobiasis, Ascariasis, Ancylostomiasis, Trichuriasis, Strongyloidiasis, Taeniasis, Capillariasis, Neurocysticerosis, Trichostrongyliasis, Hydatid Disease (Echinococcus granulosus), and Filariasis, in combination with other Anthelmintics.
Dosage/Direction for Use
DENZOL is for oral administration and should be taken with meals.
Enterobiasis, ascariasis, ancylostomiasis, or trichuriasis: Adults & children above 2 years of age: 400 mg as a single dose.
Children up to 2 years of age: 200 mg as a single dose.
The dose may be repeated in 3 weeks.
Taeniasis, strongyloidiasis: 400 mg/day for 3 days.
Capillariasis: 400 mg/day for 10 days.
Neurocysticerosis: 15 mg/kg/day for 30 days.
Trichostrongyliasis: 400 mg single dose.
Hydatid disease: Patients over 60 kg body weight: 400 mg twice daily for 28 days followed by 2 weeks drug free interval.
Dose may be repeated for 2-3 cycles and if the case is inoperable, up to 5 cycles.
Patients under 60 kg body weight: 10 - 15 mg/kg/day for 28 days.
Filariasis: 400 mg with diethyl carbamazine 6 mg/kg given once. This regimen is given every year for 4 - 6 years.
Symptoms of an albendazole overdose are not known.
DENZOL must not be used in patient known hypersensitivity to the product and in pregnancy.
Special Precautions
Patients receiving high doses of Albendazole should be supervised closely with blood counts and liver function being monitored.
Use In Pregnancy & Lactation
Should not be administered during confirmed or suspected pregnancy.
In pregnancy, albendazole was found to have embryotoxic and teratogenic effects.
Side Effects
Transient abdominal pain, diarrhea, headache, dizziness, elevated transaminases, leucopenia and thrombocytopenia.
Drug Interactions
Plasma concentrations of Albendazole sulphoxide have been increased by concomitant administration of dexamethasone, praziquantel or cimetidine.
DENZOL Film Coated Tablet: Store at temperature below 30°C. Protect from light.
DENZOL Suspension: Store at temperature below 30°C. Protect from light.
Shelf Life: 36 months from the date of manufacture if kept as recommended.
MIMS Class
ATC Classification
P02CA03 - albendazole ; Belongs to the class of benzimidazole derivative agents. Used as antinematodal.
FC tab 200 mg (white, round, biconvex smooth, engraved E1A3 from one side) x 1 x 2's, 100 x 2's. Oral susp 20 mg/mL (homogenous syrupy, white to off white colour with a banana like odour) x 20 mL.
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