ESKAZOLE

What it is

ESKAZOLE is a chewable tablet formulation 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 methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate and is a member of the benzimidazole group of anthelmintic agents.

Approved indications

— Long-term 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. — Use as an adjunct 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 in courses as short as 7 days. — Treatment of *Capillaria philippinensis* in courses of 10 days.

Dosing overview

ESKAZOLE tablets may be crushed, chewed, or swallowed whole. To increase the systemic bioavailability of albendazole in the treatment of tissue helminth infections, ESKAZOLE tablets should be taken with a meal.

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. 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. If enzymes are significantly increased (greater than twice the upper limit of normal) during treatment, ESKAZOLE should be discontinued; treatment may be reinstituted when levels have returned to normal limits, but liver function should be monitored frequently during repeat therapy. ESKAZOLE 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 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 (for example, headache, nausea, convulsions, 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

ESKAZOLE should not be administered during pregnancy or in women thought to be pregnant. Women of childbearing age should be advised to take effective precautions against conception during and within one month of completion of treatment with ESKAZOLE. ESKAZOLE 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 ESKAZOLE in children under six years of age, therefore use in this age group is not recommended.

PBS listing

ESKAZOLE 400 mg tablet is listed on the PBS as a streamlined authority-required item with an ex-manufacturer price of A$95.53.

Regulatory history

ESKAZOLE albendazole 400 mg chewable tablet was first registered on the ARTG on 9 October 2003 in both blister pack and bottle formulations. The most recent amendment to the product information was on 11 July 2024.