Elimite

What is Elimite and how is it used?

Elimite is a prescription medicine used to treat the symptoms of Scabies, Head Lice and Nits (eggs). Elimite may be used alone or with other medications.

Elimite belongs to a class of drugs called Scabicidal Agents; Pediculicides, Topical.

It is not known if Elimite is safe and effective in children younger than 2 months of ages.

What are the possible side effects of Elimite?

Elimite may cause serious side effects including:

• severe burning,
• stinging,
• redness, and
• swelling

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Elimite include:

• mild burning,
• stinging,
• itching,
• mild rash,
• numbness or tingling where the medicine was applied,
• headache,
• dizziness,
• fever,
• stomach pain,
• nausea,
• vomiting, and
• diarrhea

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Elimite. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

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 C₂₁H₂₀CI₂O₃ 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.

INDICATIONS

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

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

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].

Manufactured for Prestium Pharma, Inc., Newtown, PA 18940. by Perrigo Pharmaceuticals, Allegan, MI 49010. Rev. Aug 2015

SIDE EFFECTS

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 (see PRECAUTIONS - General). 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 (see DOSAGE AND ADMINISTRATION), rare occurrences of seizure have been reported. None have been medically confirmed as associated with ELIMITE™ treatment.

DRUG INTERACTIONS

No information provided.

WARNINGS

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

PRECAUTIONS

General

Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with ELIMITE™ (permethrin) 5% Cream may temporarily exacerbate these conditions.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Six carcinogenicity bioassays were evaluated with permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolarcell carcinomas and benign liver adenomas only in female mice when permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.

Pregnancy

Teratorgenic 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.

Pediatric Use

ELIMITE™ (permethrin) 5% Cream is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use

Clinical studies of ELIMITE™ (permethrin) 5% Cream did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

OVERDOSE

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 (see DOSAGE AND ADMINISTRATION) may result in increased irritation and erythema.

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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.

PATIENT INFORMATION

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE™ (permethrin) 5% Cream. In clinical trials, approximately 75% of patients treated with ELIMITE™ (permethrin) 5% Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE™ (permethrin) 5% Cream may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if ELIMITE™ (permethrin) 5% Cream gets in the eyes.