Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
Ivermectin is indicated for the treatment of the following infections: Ivermectin is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis . This indication is based on clinical studies of both comparative and open-label designs, in which 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin (See CLINICAL PHARMACOLOGY, Clinical Studies ). Ivermectin is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus . This indication is based on randomized, double-blind, placebo-controlled and comparative studies conducted in 1427 patients in onchocerciasis-endemic areas of West Africa. The comparative studies used diethylcarbamazine citrate (DEC-C). NOTE: Ivermectin has no activity against adult Onchocerca volvulus parasites. The adult parasites reside in subcutaneous nodules which are infrequently palpable. Surgical excision of these nodules (nodulectomy) may
Product: 50090-5587 NDC: 50090-5587-0 10 TABLET in a BLISTER PACK / 2 in a CARTON
Abbreviated New Drug Application
IVERMECTIN - IVERMECTIN TABLET A-S MEDICATION SOLUTIONS ---------- IVERMECTIN TABLETS USP, 3MG (IVERMECTIN) DESCRIPTION Ivermectin is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated from the fermentation products of _Streptomyces avermitilis_. Ivermectin is a mixture containing at least 90% 5-_O_-demethyl-22,23-dihydroavermectin A and less than 10% 5-_O-_demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1- methylethyl)avermectin A , generally referred to as 22,23-dihydroavermectin B and B , or H B and H B , respectively. The respective empirical formulas are C H O and C H O , with molecular weights of 875.10 and 861.07, respectively. The structural formulas are: Ivermectin is a white to yellowish-white, nonhygroscopic, crystalline powder with a melting point of about 155°C. It is insoluble in water but is freely soluble in methanol and soluble in 95% ethanol. Ivermectin tablets are available as 3-mg tablets containing the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. CLINICAL PHARMACOLOGY _PHARMACOKINETICS_ Following oral administration of ivermectin, plasma concentrations are approximately proportional to the dose. In two studies, after single 12-mg doses of ivermectin in fasting healthy volunteers (representing a mean dose of 165 mcg/kg), the mean peak plasma concentrations of the major component (H B ) were 46.6 (±21.9) (range: 16.4 to 101.1) and 30.6 (±15.6) (range: 13.9 to 68.4) ng/mL, respectively, at approximately 4 hours after dosing. Ivermectin is metabolized in the liver, and ivermectin and/or its metabolites are excreted almost exclusively in the feces over an estimated 12 days, with less than 1% of the administered dose excreted in the urine. The plasma half-life of ivermectin in man is approximately 18 hours following oral administration. The safety and pharmacok Lugege kogu dokumenti