ZENTAR PLUS Tablet

For the treatment of the following infections;

- Strongyloidiasis of the intestinal tract

This medicine is indicated for the treatment of intestinal (i.e. Nondisseminated Strongyloidiasis due to the nematode parasite Strongyloides stercoralis.

- Onchocerciasis

This medicine is indicated for the treatment of Onchocerciasis due to the nematode parasite Onchocerca volvulus.

- Neurocysticercosis

This medicine is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larva! forms of the pork tapeworm, Taenia solium.

Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74-88% reduction in number of cysts: 40-70% of albendazole-treated patients showed resolution of all active cysts.

- Hydatid Disease

This medicine is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

Dosage and Directions for use

The recommended dosage for the treatment of strongyloidiasis is a single oral dose. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.

The recommended dosage for the treatment of onchocerciasis is a single oral dose. Patients should take tablets on an empty stomach with water. In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.

In patients with known hypersensitivity to the benzimidazole class of compounds or any components of this medicine.

Gastrointestinal discomfort, diarrhoea, headache and dizziness have been reported. Hypersensitivity reactions including rash, pruritus and urticaria have been reported less frequently.

Praziquantel has been reported to increase the plasma levels of the albendazole active metabolite.

Pregnancy

Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.

Nursing Mothers

Treatment should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn.

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of anti cysticercal therapy.

(See the package insert about the details.)

Albendazole is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against intestinal and tissue parasites. Animal studies have shown that albendazole exhibits vermicidal, ovicidal and larvicidal activity and exerts its anthelmintic effect by inhibiting tubulin polymerization. This causes the disruption of the helminth metabolism, including energy depletion, which immobilizes and then kills the susceptible helminth.

Ivermectin is a member of the avermectin class of broad-spectrum antiparasitic agents which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve, and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma amino butyric acid (GABA).

Ivermectin is active against various life cycle stages of many but not all nematodes. It is active against the tissue microfilariae of Onchocerca volvulus but not against the adult form. Its activity against Strongyloides stercoralis is limited to the intestinal stages.