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Basic Drug Info

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Drug Name:	STROMECTOL
Manufacturer:	Merck & Co., Inc.
Other Info:	The recommended dosage of STROMECTOL for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.) In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months. Table 2: Dosage Guidelines for STROMECTOL for Onchocerciasis Body Weight (kg)Single Oral Dose Number of 3-mg Tablets 15-251 tablet 26-44 2 tablets 45-64 3 tablets 65-84 4 tablets ?85150 mcg/kg

Clinical Trials:	NIH - Clinical Trials

Indications and Usage

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 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.

Strongyloidiasis -- Infection with nematodes of the genus STRONGYLOIDES. The presence of larvae may produce pneumonitis and the presence of adult worms in the intestine could lead to moderate to severe diarrhea.

Onchocerciasis -- Infection with nematodes of the genus ONCHOCERCA. Characteristics include the presence of firm subcutaneous nodules filled with adult worms, PRURITUS, and ocular lesions.

SUBCUTANEOUS NODULE --

Contraindications

STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis.

These reactions are probably due to allergic and inflammatory responses to the death of microfilariae.

Patients treated with STROMECTOL for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself.

(See ADVERSE REACTIONS, Onchocerciasis.) The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials.

Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension.

Antihistamines and/or aspirin have been used for most mild to moderate cases.