Permethrin
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.
- 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.
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)
Indications
- ELIMITE™ (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptesscabiei (scabies).
Dosing
- Safety and efficacy have not been established in pediatric patients 2 months or younger.
- 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 patients. 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 (Pediatric)
Guideline-Supported Use
Indications and Dosage
- Safety and efficacy have not been established in pediatric patients 2 months or younger.
- 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.
- 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.
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 Warnings of Permethrin in patients.
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 Drug Interactions of Permethrin in patients.
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
- Presence of lice
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
- .It acts on the nerve cell membrane to disrupt the sodium channel current causing delayed repolarization and paralysis of the pests.
- 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.
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
Absorption Topical: 2% or less absorbed.
Excretion
Topical: Renal.
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
There is limited information regarding Permethrin Patient Counseling Information in the drug label.
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
There is limited information regarding Permethrin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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