Elimite Cream
( 5% permethrin cream )

Side Effects: Itching, tingling, numbness, redness or irritation may occur. If these effects continue, inform your doctor.

Notify your doctor if you develop :- a skin rash, burning or swelling skin. If you notice other effects not listed above, contact your doctor or pharmacist.

How to Use :- See label/instructions on medicine.

• Wash your entire body or take a shower.
• Thoroughly massage the cream into your skin over your entire body, from your head to your toes.
• Leave the cream on for 8-14 hours.
• Wash the cream off after 8-14 hours by taking another shower.

Chemical Name :- Permethrin :- 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 Elimite Cream 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.

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Clinincal Study :-

Clinincal Studies shows that 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.

Indications :-

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

Contraindication :-

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


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Before using permethrin :-

1. tell your doctor and pharmacist if you are allergic to permethrin or any other drugs.
2. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
3. tell your doctor if you are pregnant or are breast-feeding. If you are pregnant, wear gloves when applying permethrin to another person to prevent its absorption through your skin.

Warnings :-

If hypersensitivity to ELIMITE® Cream occurs, discontinue use.

Precautions To Take

General :- Scabies infestation is often accompanied by pruritus, edema and erythema. Treatment with ELIMITE® Cream 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® Cream.
• In clinical trials approximately 75% of patients treated with ELIMITE® Cream who continued to manifest pruritus at 2 weeks had cessation by 4 weeks.
• If irritation persists, they should consult their physician.
• ELIMITE® 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® Cream gets in the eyes.

Less common or rare Side Effects :- Burning, itching, numbness, rash, redness, stinging, swelling, or tingling of the scalp


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.


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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.

Children :- ELIMITE® Cream is safe and effective in pediatric patients 2 months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Clinical studies :- 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.


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Side Effects :-

In clinical trials, generally mild and transient burning and stinging followed application with ELIMITE® 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 effect combine with ELIMITE® (permethrin) 5% Cream include: headache, fever, dizziness, abdominal pain, diarrhea and nausea and/or vomiting.

Dosage of Elimite Cream :—

Follow your doctor's orders or the directions on the label. The following information includes only the average dose of permethrin. If your dose is different, do not change it unless your doctor tells you to do so.

• For topical dosage forms (cream and lotion):
  • For head lice:
    • Adults and children 2 years of age and older—Apply to the hair and scalp one time.
    • Children up to 2 years of age—Use and dose must be determined by your doctor.
  • For scabies:
    • Adults and children 2 months of age and older—Apply to the skin one time.
    • Children up to 2 months of age—Use and dose must be determined by your doctor.

Overdosage :-

No instance of accidental ingestion of ELIMITE® Cream has been reported. If ingested, gastric lavage and general supportive measures should be employed. Excessive topical use (see recommended dosage) may result in increased irritation and erythema.

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.

Available :-

ELIMITE® (permethrin) 5% (wt./wt.) Cream is supplied in tubes in the following sizes: 30 g NDC 0023-7915-30 and 60 g NDC 0023-7915-60.

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

How to Order Elimite Cream Online :-


1. Select power and quantities of Elimite Cream.
   
2. Submit your FREE online consultation and place your order for Elimite Cream.
   
3. Receive Elimite Cream the next business day!
   (after approval by one of our board certified physicians)