Permethrin 5% W/w

INDICATIONS AND USAGE Permethrin Cream 5% w/w is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).

ADVERSE REACTIONS In clinical trials, generally mild and transient burning and stinging followed application with Permethrin Cream 5% w/w in 10% of patients and was associated with the severity of infestation. Pruritus was reported in 7% of patients at various times post-application. Erythema, numbness, tingling, and rash were reported in 1 to 2% or less of patients (see PRECAUTIONS - General ). Other adverse events reported since marketing Permethrin Cream 5% w/w include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed (see DOSAGE AND ADMINISTRATION ), rare occurrences of seizure have been reported. None have been medically confirmed as associated with Permethrin Cream 5% w/w treatment.

Pregnancy: Teratogenic Effects: Pregnancy Category B Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

WARNINGS If hypersensitivity to Permethrin Cream 5% w/w occurs, discontinue use. CONTRAINDICATIONS Permethrin Cream 5% w/w is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.