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STROMECTOL (IVERMECTIN): PRESCRIBING INFORMATION
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-Odemethyl-22,23-dihydroavermectin A1a and less than 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro25-(1-methylethyl)avermectin A1a, generally referred to as 22,23-dihydroavermectin B1a and B1b, or H2B1a and
H2B1b, respectively. The respective empirical formulas are C48H74O14 and C47H72O14, with molecular weights of 875.10 and 861.07, respectively.
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.
Stromectol is available in 3-mg tablets containing the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, magnesium stearate, anhydrous citric acid powder, and butylated hydroxyanisole.
INDICATIONS AND USAGE
Stromectol indications and usage
Ivermectin (Stromectol) is contraindicated in patients who are hypersensitive to any component of this product.
DOSAGE AND ADMINISTRATION
The recommended dosage of Stromectol (Ivermectin) tablets for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. Patients should take tablets on an empty stomach with water. In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection.
The recommended dosage of Ivermectin (Stromectol) tablets for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. Patients should take tablets on an empty stomach with water. 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.
Stromectol clinical pharmacology
Stromectol clinical studies
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 (Ivermectin) tablets for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself.
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.
USE IN SPECIAL POPULATIONS
Stromectol use in special populations
Stromectol adverse reactions
No. 8495 - Stromectol (Ivermectin) tablets 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side and 32 on the other side. They are supplied as unit dose packages of 20.
Store at temperatures below 30°C (86°F).
Manufactured and distributed by Merck pharmaceutical company and its divisions.
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