STROMECTOL SUMMARY
STROMECTOL (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 A1a and less than 10% 5-
O
-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, H2 B1a and H2 B1b, respectively.
STROMECTOL is indicated for the treatment of the following infections:
Strongyloidiasis of the intestinal tract. STROMECTOL 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 from 64-100% of infected patients were cured following a single 200-mcg/kg dose of ivermectin. (See CLINICAL PHARMACOLOGY,
Clinical Studies.)
Onchocerciasis. STROMECTOL 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: STROMECTOL 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.
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