İHALE DÜNYASI
Mebendazole is a (synthetic) broad-spectrum anthelmintic available as chewable tablets, each containing 100 mg of mebendazole. Inactive ingredients are: anhydrous lactose NF, corn starch, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, stearic acid, and FD&C Yellow #6. Mebendazole is methyl 5-benzoylbenzimidazole-2-carbamate and has the following structural formula: Molecular Formula: C 16 H 13 N 3 O 3 Mebendazole is a white to slightly yellow powder with a molecular weight of 295.29. It is less than 0.05% soluble in water, dilute mineral acid solutions, alcohol, ether and chloroform, but is soluble in formic acid. mebendazole structural formula
Mebendazole tablets are indicated for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), Necator americanus (American hookworm) in single or mixed infections. Efficacy varies as a function of such factors as preexisting diarrhea and gastrointestinal transit time, degree of infection, and helminth strains. Efficacy rates derived from various studies are shown in the table below: Pinworm (enterobiasis) Whipworm (trichuriasis) Common Roundworm (ascariasis) Hookworm Cure rates mean 95% 68% 98% 96% Egg reduction mean - 93% 99% 99%
The same dosage schedule applies to children and adults. The tablet may be chewed, swallowed, or crushed and mixed with food. Pinworm (enterobiasis) Whipworm (trichuriasis) Common Roundworm (ascariasis) Hookworm Dose 1 tablet, once 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days 1 tablet morning and evening for 3 consecutive days If the patient is not cured three weeks after treatment, a second course of treatment is advised. No special procedures, such as fasting or purging, are required.
Mebendazole is contraindicated in persons who have shown hypersensitivity to the drug.
Gastrointestinal Transient symptoms of abdominal pain and diarrhea in cases of massive infection and expulsion of worms. Hypersensitivity Rash, urticaria and angioedema have been observed on rare occasions. Central Nervous System Very rare cases of convulsions have been reported. Liver There have been liver function test elevations [AST (SGOT), ALT (SGPT), and GGT] and rare reports of hepatitis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended. Hematologic Neutropenia and agranulocytosis. (See WARNINGS ).
There is no evidence that mebendazole, even at high doses, is effective for hydatid disease. There have been rare reports of neutropenia and agranulocytosis when mebendazole was taken for prolonged periods and at dosages substantially above those recommended.
Preliminary evidence suggests that cimetidine inhibits mebendazole metabolism and may result in an increase in plasma concentrations of mebendazole.