Albendazole 400mg tablets

(i) ROUTE OF ADMINISTRATION

Oral

DOSAGE AND ADMINISTRATION
The tablets may be chewed , swallowed or crushed and mixed with food. No special procedures such as fasting or purging are required.
Adults and children (over two years):Hookworm , roundworm , pinworm , and whipworm infestations.One tablet as a single dose.
Threadworm and tapeworm infestations
One tablet once daily for three consecutive days.
Giardiasis:
400 mg once daily for 5 days.
Children (1-2 years): Half the adult dose.
If the patient is not cured after three weeks, a second course of treatment is indicated.
Parenchymal Neurocysticercosis:
Patients weighing 60 kg : 400 mg orally twice daily with meals for 8 – 30 days.
Patients weighing less than 60 kg : 15 mg/kg/day (to a maximum of 800mg/day) in two divided doses.

(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS

Health 2000 Albendazole 400mg tablet is indicated in the treatment of threadworm , roundworm ,whipworm ,hookworm , pinworm , tapeworm and mixed helminthic infestations. It is also indicated in Hydatid disease and Neurocysticercosis. Albendazole is also indicted in the treatment of Giardiasis in children over 2 years of age.

(iii) DESCRIPTION OF DOSAGE FORM

Health 2000 Albendazole 400mg tablet exhibits vermicidal , ovicidal and larvicidal activity. The drug probably exerts its anthelmintic effect by blocking glucose uptake by the susceptible helminthes , thereby depleting their energy level until it becomes inadequate for survival. Albendazole initially immobilizes , then kills the susceptible helminthes.

(iv) CONTRAINDICATIONS

Hypersensitivity to the drug.

WARNING AND PRECAUTIONS
DRUG INTERACTIONS
No interactions involving albendazole , either pharmacodynamic or pharmacokinetic have been reported
PREGNANCY
There are no adequate and well controlled studies of albendazole in pregnant women. Albendazole should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS
It is not known whether albendazole is excreted in human milk. Because many drugs are excreted in human milk , caution should be exercised when albendazole is administered to a nursing woman.

Symptoms and treatment for overdosage and antidote(s)
In animals , symptoms were demonstrated in a dose – response relationship and included diarrhea , vomiting , tachycardia and respiratory distress.
No untoward effect was reported. In case of overdosage , symptomatic therapy (e.g. gastric lavage and activated charcoal) and general supportive measures are recommended.

(v) SIDE EFFECTS

Occasional gastrointestinal disturbances, dizziness and headache have been reported . With high doses , rarely reversible alopecia and rash have been reported during the first few days of treatment.

(vi) TOXIC EFFECTS

CARCINOGENICITY No evidence of carcinogenic activity was observed in mice given albendazole in the diet at doses up to 400 mg/kg/day for 25 months. In rats, dietary administration of doses of 3.5, 7 and 20 mg/kg/day did not affect the total incidence of adrenocortical tumours (adenoma plus carcinoma), however, in females there was an increased incidence of adrenocortical carcinomas.
MUTAGENICITY Mutagenicity tests with bacterial cells and an assay of chromosomal damage in vivo have shown no clear evidence that albendazole has genotoxic activity. A cell transformation assay showed a slight dose-related increase in the transformation rate of cultured mouse cells in the presence of metabolic activation
TERATOGENICITY The use of Albendazole in human pregnancy has not been studied, but in animal studies it is teratogenic in more than one species. In animal studies oral treatment with maternotoxic doses of albendazole (30 mg/kg/day) during the period of organogenesis was associated with multiple malformations in rats and ectrodactyly in rabbits. In one study in rats, an oral dose (10 mg/kg/day) similar to the human therapeutic dose was not maternotoxic, but was associated with microphthalmia and microfetalis. The latter occurred alone and together with multiple malformations including cranioschisis, talipes and renal agenesis. There is no information on the possible effect of albendazole on the human foetus.