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STROMECTOL is indicated for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus.
NOTE: STROMECTOL has no activity against adult Onchocerca volvulus parasites.
STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.
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.
Onchocerciasis: The patient should be reminded that treatment with STROMECTOL does not kill the adult Onchocerca parasites, and therefore repeated follow-up and retreatment is usually required.
STROMECTOL is excreted in human milk in low concentrations.
In four clinical studies involving a total of 109 patients given either one or two doses of 170-200 degrees mu g/kg of STROMECTOL, the following adverse reactions were reported as possibly, probably, or definitely related to STROMECTOL:
In comparative trials, patients treated with STROMECTOL experienced more abdominal distention and chest discomfort than patients treated with albendazole.
The Mazzotti-type and ophthalmologic reactions associated with the treatment of onchocerciasis or the disease itself would not be expected to occur in strongyloidiasis patients treated with STROMECTOL.
In clinical trials involving 109 patients given either one or two doses of 170-200 degrees mu g/kg STROMECTOL, the following laboratory abnormalities were seen irrespective of drug relationship: elevation in ALT and/or AST (2 percent), decrease in leukocyte count (3 percent).
In clinical trials involving 963 adult patients treated with 100 to 200 degrees mu g/kg STROMECTOL, worsening of the following Mazzotti reactions during the first 4 days post-treatment were reported: arthralgia/synovitis (9.
In clinical trials, ophthalmological conditions were examined in 963 adult patients before treatment, at day 3, and months 3 and 6 after treatment with 100 to 200 degrees mu g/kg STROMECTOL.