Each chewable tablet contains:

active ingredient: Albendazole – 400.0 mg

For a full list of excipients, (see section List of excipients).

Route of administration: Oral.

Dosage: Dosages are dependent on the parasite involved, the weight of the patient, and the severity of the infection:

Intestinal parasites and cutaneous larva migrans

Systemic helminthic infections (long-term treatment with higher doses)

Treatment may need to be prolonged for months or years. Continuous treatment at the same dose has been used for periods of up to 20 months.

Method of administration

Albendazole should be taken with meals. Some people, particularly young children, may experience difficulties swallowing the tablets whole and should be encouraged to chew the tablets with a little water, alternatively tablets may be crushed.

Cystic Echinococcosis

1. Inoperable and multiple cysts

Up to three 28-day cycles of albendazole may be given for the treatment of liver, lung and peritoneal cysts. More prolonged treatment may be required for sites such as bone and brain.

2. Pre-operative

Two 28-day cycles should be given where possible prior to surgery.

Where surgical intervention is necessary before completion of two cycles, albendazole should be given for as long as possible.

3. Post-operative

Where only a short pre-operative course has been given (less than 14 days) and in cases where emergency surgery is required, albendazole should be given post-operatively for two 28-day cycles separated by 14 drug-free days.

Additionally, where cysts are found to be viable following pre-surgical treatment or where spillage has occurred, a full two-cycle course should be given.

4. After percutaneous cyst drainage. Treatment as for post-surgery above.

Alveolar Echinococcosis

Treatment is normally given in 28 day cycles as for cystic echinococcosis. It may have to be continued for months or even years. Current follow up suggests that survival times are substantially improved following prolonged treatment. Continuous treatment has been shown in a limited number of patients to lead to apparent cure.

Special Populations

Children

There has been limited experience to date with the use of albendazole in children under six years of age; therefore, usage in children less than six years is not recommended. The recommended dose for older children is 12 mg/kg body weight/day in divided doses.

Elderly

Experience in patients 65 years of age or older is limited. Reports indicate that no dosage adjustment is required; however, albendazole should be used with caution in elderly patients with evidence of hepatic dysfunction (see „Hepatic impairment‟ below and „Pharmacokinetic Properties‟).

Renal impairment

Since renal elimination of albendazole and its primary metabolite, albendazole sulfoxide, is negligible, it is unlikely that clearance of these compounds would be altered in these patients. No dosage adjustment is required; however, patients with evidence of renal impairment should be carefully monitored.

Hepatic impairment

Since Albendazole is rapidly metabolised by the liver to the primary pharmacologically active metabolite, albendazole sulfoxide, hepatic impairment would be expected to have significant effects on the pharmacokinetics of albendazole sulfoxide. Patients with abnormal liver function test results (transaminases) prior to commencing albendazole therapy should be carefully evaluated and therapy should be discontinued if liver enzymes are significantly increased or full blood count decreased by a clinically significant level (see „Special Warnings and Precautions for Use‟ and „Undesirable Effects‟).

Pharmacotherapeutic group: anthelmintic

ATC code: P02CA03

List of excipients

Lactose

Microcrystalline cellulose Povidone

Magnesium stearate

Sodium starch glycolate

Maize starch

Sodium lauryl sulphate

Color red Е-129

Sodium saccharin

Sodium carboxymethylcellulose

Raspberry flavor

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134425/1736329537406.pdf