País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
MEBENDAZOLE (UNII: 81G6I5V05I) (MEBENDAZOLE - UNII:81G6I5V05I)
Bryant Ranch Prepack
MEBENDAZOLE
MEBENDAZOLE 100 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
MEBENDAZOLE- MEBENDAZOLE TABLET, CHEWABLE BRYANT RANCH PREPACK ---------- MEBENDAZOLE TABLETS, USP DESCRIPTION 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 H N O 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. CLINICAL PHARMACOLOGY Following administration of 100 mg twice daily for three consecutive days, plasma levels of mebendazole and its primary metabolite, the 2-amine, do not exceed 0.03 mcg/mL and 0.09 mcg/mL, respectively. All metabolites are devoid of anthelmintic activity. In man, approximately 2% of administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite. MODE OF ACTION Mebendazole inhibits the formation of the worms’ microtubules and causes the worms’ glucose depletion. INDICATIONS AND USAGE 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 Hookworm 16 13 3 3 (enterobiasis) (trichuriasis) (ascariasis) CURE RATES mean 95% 68% 98% 96% EGG REDUCTION mean — Llegiu el document complet