ELIMITE® (permethrin) 5% Cream is a topical scabicidal agent for the treatment of infestation with Sarcoptes scabiei (scabies). It is available in an off-white, vanishing cream base. ELIMITE® 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 C ₂₁ H ₂₀ Cl ₂ O ₃ and a molecular weight of 391.29. It is a yellow to light orange-brown, low melt-ing solid or viscous liquid.

Active Ingredient:   Each gram contains permethrin 50 mg (5%).

Inactive Ingredients:   Butylated hydroxytoluene, carbomer 934P, 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.

ELIMITE® (permethrin) 5% Cream is indicated for the treatment of infestation with Sarcoptes scabiei (scabies).

Adults and children: Thoroughly massage ELIMITE® 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.

ELIMITE® (permethrin) 5% (wt./wt.) Cream is supplied in tubes in the following size: 60 g NDC 0023-7915-60.

Note:   Store at 15° to 25°C (59° to 77°F).

Rx only

Manufactured for:

Allergan, Inc.

Irvine, CA 92612, U.S.A.

by Catalytica Pharmaceuticals, Inc.

Research Triangle Park, NC 27709

In clinical trials, generally mild and transient burning and stinging followed application with ELIMITE® 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).

No Information Provided.

If hypersensitivity to ELIMITE® occurs, discontinue use.

General:   Scabies infestation is often accompanied by pruritus, edema and erythema. Treatment with ELIMITE® may temporarily exacerbate these conditions.

Information for patients:   Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE®. In clinical trials approximately 75% of patients treated with ELIMITE® who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE® 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® gets in the eyes.

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 alveolar-cell 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: 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.

Pediatric use:   ELIMITE® 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.

No instance of accidental ingestion of ELIMITE® has been reported. If ingested, gastric lavage and general supportive measures should be employed.

ELIMITE® is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

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 ¹⁴ C-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.

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of ELIMITE®. In clinical trials approximately 75% of patients treated with ELIMITE® who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. ELIMITE® 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® gets in the eyes.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PERMETHRIN CREAM - TOPICAL

(purr-METH-rin)

COMMON BRAND NAME(S): Elimite

USES: This medication is used to treat scabies, a condition caused by tiny insects called mites that infest and irritate your skin. Permethrin belongs to a class of drugs known as pyrethrins. Permethrin works by paralyzing and killing the mites and their eggs.

HOW TO USE: This medication is for use on the skin only. Apply this medication as soon as possible after it is prescribed. Apply the medicine from your head to the soles of your feet, including under your nails and in skin folds such as between the toes, as directed. Massage the cream into the skin. Do not use more medication than prescribed. Wash off the cream after 8-14 hours by showering or taking a bath.

Avoid getting the cream into your eyes, nose, mouth, or vagina. If the medication gets in your eyes, flush the eyes with plenty of water. Consult your doctor if irritation persists.

Symptoms of scabies include an intense itching that is usually worse at bedtime. You may also see small, fine, wavy lines on the skin with a tiny insect at the end (a burrow). Burrows are usually found on finger/toe webs, wrists, elbows, armpits, belt line, lower buttocks, female nipples, or male genitals. Even if permethrin kills all the scabies, the dead mites can still make you itch for up to 4 weeks after treatment. Ask your doctor about other medications that may be used to soothe the itching. Inform your doctor if your condition persists or worsens 2 weeks after treatment. Your doctor may need to look for living mites and recommend more treatment.

SIDE EFFECTS: Skin irritation, including itching, swelling, and redness, may occur with scabies and temporarily worsen after treatment with permethrin. Mild burning or stinging may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using permethrin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections, asthma.

Constant or forceful scratching of the skin/scalp may lead to a bacterial skin infection. Tell your doctor immediately if you develop worsening redness or pus.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this drug passes into breast milk. This drug may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Pump your breast milk and discard it for 24 hours after using permethrin. During this time, feed your baby formula or breast milk you stored before you used permethrin.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medication may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canadian residents should call a provincial local poison control center directly.

NOTES: Do not share this medication with others.

One application is usually all that is needed. To avoid giving scabies to another person or getting it again, clothing and bed linens that have been in contact with your skin less than 2 days before treatment should be machine-washed with hot water and dried in a hot dryer for 20 minutes, dry cleaned, or removed from body contact for 72 hours.

People who are in close contact with the infected person, such as members of the same household, should also be checked for scabies.

MISSED DOSE: Not applicable.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.