Country: United States
Language: English
Source: NLM (National Library of Medicine)
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)
Edenbridge Pharmaceuticals LLC.
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 be considered in the management of patients with onchocerciasis, since this procedure will eliminate the microfilariae-producing adult parasites. Ivermectin tablets are contraindicated in patients who are hypersensitive to any component of this product.
Ivermectin tablets USP, 3 mg are white, round, flat, bevel-edged tablets debossed with "806" on one side and plain on the other side. They are supplied as follows: NDC 42799-806-01 unit dose packages of 20. Store at temperatures below 30°C (86°F).
Abbreviated New Drug Application
IVERMECTIN - IVERMECTIN TABLET EDENBRIDGE PHARMACEUTICALS LLC. ---------- 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 tablets 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 - 101.1) and 30.6 (±15.6) (range: 13.9 - 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 Read the complete document