PERMETHRIN CREAM 5% W/W Rx Only

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 ₂₁H ₂₀Cl ₂O 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.

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.
Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with ¹⁴C-labeled permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

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

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

If hypersensitivity to Permethrin Cream 5% w/w occurs, discontinue use.

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.

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.

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.

Permethrin Cream 5% w/w is available as follows:
NDC 68071-1624-6 BOX OF 60G


STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].



Manufactured by:

Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate,

Makaim, Post: Mardol,

Ponda Goa- 403 404- India.



Distributed by:

Encube Ethicals, Inc.

200 Meredith Avenue,

Suite 101A

Durham,

NC 27713

USA



Rev 01

April 2019

PDP