Permethrin

Permethrin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

Permethrin is a dermatological agent that is FDA approved for the treatment of scabies, Pediculosis capitis. Common adverse reactions include pruritus, erythema, numbness, tingling, rash, headache, fever, dizziness, abdominal pain, diarrhea, nausea and vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• ELIMITE™ (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).

Dosage

• 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. Demonstrable living mites after 14 days indicate that retreatment is necessary.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Indications and Dosing

• Pediculosis capitis: apply to damp hair that has just been shampooed with a nonconditioning shampoo; saturate hair and scalp beginning behind the ears and at back of neck; leave on 10 minutes; rinse with warm water; remove nits with nit comb; repeat application if live lice present 7 days after initial treatment [1]

• Scabies: apply a generous amount of cream from head to feet, leave on for 8 to 14 hours, wash with soap/water, repeat application if living mites present 14 days after initial treatment [2][3]

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Permethrin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Permethrin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Indications and Dosage

• Safety and efficacy have not been established in pediatric patients 2 months or younger [1]

• Pediculosis capitis: apply to damp hair that has just been shampooed with a nonconditioning shampoo; saturate hair and scalp beginning behind the ears and at back of neck; leave on 10 minutes; rinse with warm water; remove nits with nit comb; repeat application if live lice present 7 days after initial treatment [1]

• Scabies: apply a generous amount of cream from head to feet, leave on for 8 to 14 hours, wash with soap/water, repeat application if living mites present 14 days after initial treatment [2][3]

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Permethrin in pediatric patients.

Contraindications

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

Warnings

There is limited information regarding Permethrin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

• In clinical trials, generally mild and transient burning and stinging followed application with ELIMITE™ (permethrin) 5% Cream 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.

Postmarketing Experience

• Other adverse events reported since marketing ELIMITE™ (permethrin) 5% Cream include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting. Although extremely uncommon and not expected when used as directed , rare occurrences of seizure have been reported. None have been medically confirmed as associated with ELIMITE™ treatment.

Drug Interactions

There is limited information regarding Permethrin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Permethrin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Permethrin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Permethrin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Permethrin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Permethrin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Permethrin in geriatric settings.

Gender

There is no FDA guidance on the use of Permethrin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Permethrin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Permethrin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Permethrin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Permethrin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Permethrin in patients who are immunocompromised.

Others

Administration and Monitoring

Administration

Topical

Monitoring

There is limited information regarding Permethrin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Permethrin and IV administrations.

Overdosage

• No instance of accidental ingestion of ELIMITE™ (permethrin) 5% Cream has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use may result in increased irritation and erythema.

Pharmacology

There is limited information regarding Permethrin Pharmacology in the drug label.

Mechanism of Action

• 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.

Structure

• ELIMITE™ (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptesscabiei (scabies). It is available in an off-white, vanishing cream base. ELIMITE™ (permethrin) 5% Cream is for topical use only.

This image is provided by the National Library of Medicine.

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 C21H20Cl2O3 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 - Butylated hydroxytoluene, carbomer homopolymer type B, fractionated coconut oil, glycerin, glyceryl monostearate, isopropyl myristate, lanolin alcohols, mineral oil, polyoxyethylene cetyl ethers, purified water, and sodium hydroxide. Formaldehyde 1 mg (0.1%) is added as a preservative.

Pharmacodynamics

There is limited information regarding Permethrin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Permethrin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Permethrin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Permethrin Clinical Studies in the drug label.

How Supplied

ELIMITE™ 5% Cream is available as follows:

60 g tube (NDC 40076-115-60)

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Permethrin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

ELIMITE™

Look-Alike Drug Names

• (Paired Confused Name 1a) — (Paired Confused Name 1b)
• (Paired Confused Name 2a) — (Paired Confused Name 2b)
• (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.