Label: STROMECTOL- ivermectin tablet

  • NDC Code(s): 0006-0032-20
  • Packager: Merck Sharp & Dohme LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 5, 2024

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  • DESCRIPTION
    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 ...
  • 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 STROMECTOL in fasting ...
  • 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 ...
  • CONTRAINDICATIONS
    STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.
  • 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 ...
  • PRECAUTIONS
    General - After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema ...
  • ADVERSE REACTIONS
    Strongyloidiasis - In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of STROMECTOL, the following adverse reactions were reported as ...
  • OVERDOSAGE
    Cases of neurotoxicity, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death have been reported with ...
  • DOSAGE AND ADMINISTRATION
    Strongyloidiasis - The recommended dosage of STROMECTOL for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight ...
  • HOW SUPPLIED
    Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side and 32 on the other side. They are supplied as follows: NDC 0006-0032-20 unit dose packages of 20 ...
  • SPL UNCLASSIFIED SECTION
    Dist. by: Merck Sharp & Dohme LLC - Rahway, NJ 07065, USA - Manufactured by: Merck Sharp & Dohme BV - Waarderweg 39 - 2031 BN Haarlem - Netherlands - For patent information ...
  • This is a representative sample of the packaging. Please see How Supplied section for a complete list of available packaging. PRINCIPAL DISPLAY PANEL - 3 mg Tablet Blister Pack Carton
    Stromectol® 3 mg - (Ivermectin Tablets) Manuf. by: Merck Sharp & Dohme BV - 2031 BN Haarlem, Netherlands - Ivermectin (active ingred.) Made in Macao. Formulated in - The ...
  • INGREDIENTS AND APPEARANCE
    Product Information