Permethrin Cream 5% W/W

Description

DESCRIPTION Permethrin Cream 5% w/w is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. Permethrin Cream 5% w/w is for topical use only. Chemical Name - The permethrin used is an approximate 1:3 mixture of the cis and trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2- dimethylcyclopropanecarboxylic acid, ( 3-phenoxyphenyl) methyl ester. Permethrin has a molecular formula of C 21 H 20 Cl 2 O 3 and a molecular weight of 391.29. It is a yellow to light orange-brown, low melting solid or viscous liquid. Active Ingredient - Each gram contains permethrin 50 mg (5%). Inactive Ingredients - Carbomer homopolymer type B, medium-chain triglycerides, glycerin, mono-and diglycerides, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene (20) cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative. structure.jpg

What Is Permethrin Cream 5% W/W Used For?

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

Dosage and Administration

DOSAGE AND ADMINISTRATION Adults and children - Thoroughly massage Permethrin Cream 5% w/w 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.

Side Effects (Adverse Reactions)

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.

Contraindications

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

Pregnancy and Breastfeeding

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.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Overdosage

OVERDOSAGE No instance of accidental ingestion of Permethrin Cream 5% w/w has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see DOSAGE AND ADMINISTRATION ) may result in increased irritation and erythema.

How Supplied

HOW SUPPLIED Permethrin Cream 5% w/w is available as follows: 60 g tube 68788-8439-6 STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa – 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713 USA Rev 04 May 2025 Relabeled By: Preferred Pharmaceuticals Inc.