Elimite

Name: Elimite

Indications

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

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.

Elimite Overdose

If you use too much Elimite, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

What is Elimite (permethrin topical)?

Permethrin is an anti-parasite medication.

Permethrin topical (for the skin) is used to treat head lice and scabies.

Permethrin topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Elimite (permethrin topical)?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before using Elimite (permethrin topical)?

You should not use this medicine if you are allergic to permethrin or to chrysanthemums.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions.

Permethrin topical is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant.

It is not known whether permethrin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Permethrin topical should not be used on a child younger than 2 months old.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you think you have used too much, or if anyone has accidentally swallowed the medication.

What should I avoid while using Elimite (permethrin topical)?

Rinse with water if this medicine gets in your eyes.

Lice and scabies infections are highly contagious. Avoid sexual or intimate contact with others until your lice or scabies infection has cleared up. Avoid sharing hair brushes, combs, hair accessories, hats, clothing, bed linens, and other articles of personal use.

Avoid using other medications on the areas you treat with permethrin topical, unless your doctor tells you to.

What are some things I need to know or do while I take Elimite?

  • Tell all of your health care providers that you take Elimite. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not use on a child younger than 2 months of age without first checking with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Elimite

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

Adverse Reactions

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.

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

How is Elimite Supplied

Elimite™ 5% Cream is available as follows:

60 g tube (NDC 40076-115-60)

In Summary

More frequent side effects include: local pruritus. See below for a comprehensive list of adverse effects.

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