Permethrin

Indications

INDICATIONS AND USAGE ELIMITE ® (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Adults and Children - Thoroughly massage ELIMITE ® (permethrin) 5% Cream 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.

Contraindications

CONTRAINDICATIONS ELIMITE ® (permethrin) 5% Cream is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

Warnings and precautions

WARNINGS If hypersensitivity to ELIMITE ® (permethrin) 5% Cream occurs, discontinue use.

Pregnancy

Pregnancy - 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.

Storage and supply

HOW SUPPLIED ELIMITE ® Cream, 5% contains 50 mg permethrin per gram. The off-white, greaseless, uniform mass is available as follows: Carton containing one 60 g tube NDC 59651-834-60 STORAGE: Store at 20° to 25°C (68° to 77°F) Distributed by: Aurobindo Pharma USA, Inc.

Source: Permethrin (Elimite) — US FDA prescribing information, 2024-01-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.