TOPISCAB 5 %

INDICATIONS AND USAGE Permethrin cream 5% is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

DOSAGE AND ADMINISTRATION Adults and children - Thoroughly massage permethrin cream 5% into the skin from the head to the soles of the feet. Scabies rarely infests the scalp of adults, although the hairline, neck, temple, and forehead may be infested in infants and geriatric patients. Usually 30 grams is sufficient for an average adult. The cream should be removed by washing (shower or bath) after 8 to 14 hours. Infants should be treated on the scalp, temple, and forehead. ONE APPLICATION IS GENERALLY CURATIVE. Patients may experience persistent pruritus after treatment. This is rarely a sign of treatment failure and is not an indication for retreatment. Demonstrable living mites after 14 days indicate that retreatment is necessary.

WARNINGS If hypersensitivity to permethrin cream 5% occurs, discontinue use.

ADVERSE REACTIONS In clinical trials, generally mild and transient burning and stinging followed application with permethrin cream 5% 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% 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% treatment. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.