ZENTEL

What it is

ZENTEL is a chewable tablet containing albendazole 400 mg as the active ingredient. The tablets are mottled pale orange rounded oblong biconvex tablets with a score line on one side and embossed "ALB 400" on the reverse, with a characteristic fruity odour. Albendazole is a member of the benzimidazole group of anthelmintic agents.

Approved indications

— Treatment of hydatid cysts caused by E. granulosus in adults and children over 6 years of age, where surgical intervention is not feasible because of anatomic site or the presence of multiple cysts. — Adjunctive treatment to surgical excision of hydatid cysts either prior to surgical intervention, or post-operatively if pre-operative treatment was too short or if viable cysts are found at surgery. — Treatment of neurocysticercosis (NCC) in courses as short as 7 days. — Treatment against Capillaria philippinensis in courses of 10 days.

Dosing overview

ZENTEL tablets should be taken with a meal to increase systemic bioavailability in the treatment of tissue helminth infections. The tablets may be crushed, chewed, or swallowed whole, and young children may be encouraged to chew the tablets with a little water or take crushed tablets with water. For hydatid disease, the 28-day treatment period may be repeated after a 14-day drug-free period for a total of three cycles.

Key safety warnings

In clinical trials involving patients with hydatid disease, approximately 16% of subjects experienced mild to moderate elevations of liver enzymes during the treatment cycle, with rare severe cases associated with histological hepatocellular damage, which may be irreversible, and jaundice. Enzyme abnormalities have usually normalised on discontinuation of treatment. In patients with hydatid disease, liver function tests should be obtained before the start of each treatment cycle and at least every two weeks during treatment. ZENTEL has been shown to cause bone marrow suppression and blood counts should be performed at the start and every two weeks during each 28-day cycle. Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anaemia, agranulocytosis and leukopenia and therefore warrant closer monitoring of blood counts. The therapeutic action of albendazole in the treatment of neurocysticercosis may exacerbate presenting symptoms or precipitate new neurological disturbances such as headache, nausea, convulsions, and visual changes. These symptoms should be anticipated and patients treated accordingly. Oral or intravenous corticosteroids are recommended to prevent cerebral hypertensive episodes during the first week of treatment.

Contraindications

ZENTEL should not be administered during pregnancy or in women thought to be pregnant. Albendazole has been shown to be teratogenic and embryotoxic in rats and rabbits. Women of childbearing age should be advised to take effective precautions against conception during and within one month of completion of treatment with ZENTEL. ZENTEL is contraindicated in persons who are known to be hypersensitive to albendazole, other benzimidazole derivatives, or any component of the tablets. There is limited experience of use of ZENTEL in children under six years of age, therefore use in this age group is not recommended.

PBS listing

ZENTEL 200 mg tablet is listed on the PBS with 2 items. The restriction type is streamlined with an ex-manufacturer price of A$14.63.

Regulatory history

ZENTEL was first approved on 9 October 2003. The brand ZENTEL with albendazole 200 mg chewable tablets in blister pack and bottle formats were first listed on the ARTG on 1 December 1994.