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LINDANE SHAMPOO, USP 1%
WARNINGS
Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice. (See INDICATIONS.)
Neurologic Toxicity
Seizures and deaths have been reported following Lindane Shampoo use with repeat or prolonged application, but also in rare cases following a single application according to directions. Lindane Shampoo should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh < 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.
Contraindications
Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.
Proper Use
Instruct patients on proper use of Lindane Shampoo, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for retreatment with Lindane Shampoo. (See DOSAGE AND ADMINISTRATION.)
Lindane Shampoo, USP 1%, is an ectoparasiticide and ovicide effective against Pediculosis humanis capitis (head lice), Pthirus pubis(crab lice), and their ova. In addition to the active ingredient, lindane, it contains triethanolamine lauryl sulfate, polysorbate 60, hydrochloric acid, acetone and purified water to form a shampoo base. The pH may be adjusted with 10% hydrochloric acid solution and/or 10% sodium hydroxide solution. Lindane is the gamma isomer of 1,2,3,4,5,6 hexachlorocyclohexane having the following structural formula:
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Last reviewed on RxList: 4/22/2008
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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