Nix (Permethrin)

NIX® Creme Rinse

Warner-Lambert Consumer Healthcare

Permethrin

Topical Pediculicide – Ovicide

Action And Clinical Pharmacology: Permethrin is a synthetic pyrethroid, 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.

In vitro data indicate that permethrin has excellent pediculicidal and ovicidal activity against Pediculus humanus var. capitis. The high cure rate of permethrin in patients with head lice following a single application is attributable to a combination of its pediculicidal and ovicidal activities and its residual persistence on the hair which may also prevent reinfestation.

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 1% cream rinse has not been determined precisely, preliminary data suggest it is less than 2% of the amount applied. Residual persistence of permethrin is detectable on the hair for at least 10 days following a single application.

Indications And Clinical Uses: For the single-application treatment of infestation with Pediculus humanus var. capitis (the head louse) and its nits (eggs). Retreatment for recurrences is required in less than 1% of patients since the ovicidal activity may be supplemented by residual persistence of permethrin in the hair. If live lice are observed after at least 7 days following the initial application, a second application can be given.

Contra-Indications: In patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin, or to chrysanthemums.

Manufacturers’ Warnings In Clinical States: If hypersensitivity to permethrin occurs, discontinue use.

Precautions: Head lice infestation is often accompanied by pruritus, erythema and edema. Treatment with permethrin may temporarily exacerbate these conditions.

Pregnancy: Reproduction studies have been performed in mice, rats and rabbits 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.

Lactation: 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: Permethrin is safe and effective in children 2 years of age and older. Safety and effectiveness in children less than 2 years of age have not been established.

Adverse Reactions: The most frequent adverse reaction to permethrin is pruritus. This is usually a consequence of head lice infestation itself, but may be temporarily aggravated following treatment with permethrin. Mild temporary itching was experienced by 5.9% of patients enrolled in clinical studies; 3.4% experienced mild transient burning/stinging, tingling, numbness or scalp discomfort; and 2.1% experienced mild transient erythema, edema or rash of the scalp.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: No instance of accidental ingestion has been reported. If ingested, gastric lavage and general supportive measures should be employed.

Dosage And Administration: Adults and Children: For use after the hair has been washed with conditioner-free shampoo, rinsed with water and towel dried. Apply a sufficient volume of permethrin to saturate the hair and scalp. It should remain on the hair for 10 minutes before being rinsed off with water. A single treatment is sufficient to eliminate head lice infestation. Remove nits using a fine toothed (nit) comb.

Shake well before using.

Availability And Storage: Each g of creme rinse contains: permethrin 1% w/w. Nonmedicinal ingredients: balsam Canada, cetyl alcohol, citric acid, FD&C Yellow No. 6, hydrolyzed animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben , perfume, polyoxyethylene 10 cetyl ether, propylene glycol, propylparaben and stearalkonium chloride. Plastic squeeze bottles of 56 g (59 mL). Store at 15 to 25°C.

NIX® Creme Rinse Warner-Lambert Consumer Healthcare Permethrin Topical Pediculicide – Ovicide

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