LINDANE- lindane lotion
VersaPharm Incorporated
Rx only
WARNINGS
Lindane Lotion should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies. (See INDICATIONS AND USAGE.)
Neurologic Toxicity
Seizures and deaths have been reported following Lindane Lotion use with repeat or prolonged application, but also in rare cases following a single application used according to directions. Lindane Lotion should be used with caution for infants, children, the elderly, and individuals with other skin conditions (e.g., atopic dermatitis, psoriasis) and in those who weigh < 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.
Contraindications
Lindane Lotion is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.
Proper Use
Instruct patients on the proper use of Lindane Lotion, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of scabies and is not necessarily an indication for retreatment with Lindane Lotion. (See DOSAGE AND ADMINISTRATION.)
DESCRIPTION
Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide. In addition to the active ingredient, lindane, it contains 2-amino-2-methyl-1-propanol, butylparaben, carrageenan, cetyl alcohol, glyceryl monostearate, methylparaben, perfume compound, purified water, stearic acid and triethanolamine to form a lotion. The pH range is between 6.5 and 8.5. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:
Chemical Structure
C6 H6 Cl6 M.W. 290.83
CLINICAL PHARMACOLOGY
Lindane Lotion USP, 1%, is an ectoparasiticide and ovicide effective against Sarcoptes scabiei (scabies). Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibach1 reported approximately 10% systemic absorption of a lindane acetone solution when applied to the forearm of human subjects and left in place for 24 hours. This vehicle was different from the approved product and the percutaneous penetration of lindane is dependent on the vehicle. Therefore, the clinical significance of these observations is unknown. Dale, et al2 reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane-containing product. Ginsburg 3 found the greatest peak blood level of 64 ng/mL, 6 hours after total body application of Lindane Lotion in 1 of 8 non-scabietic pediatric patients. The half-life in blood was determined to be approximately 18 hours.
Data available in the literature suggest that lindane has a rapid distribution phase followed by a longer ?-elimination phase.1, 2, 3
INDICATIONS AND USAGE
Lindane Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei) only in patients who:
cannot tolerate other approved therapies, or
have failed treatment with other approved therapies.
Lindane Lotion should be used in the context of an overall scabies management program that includes:
Microscopic evaluation of skin scrapings to confirm the diagnosis.
Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned.
Caregivers applying this product to patients should wear gloves less permeable to Lindane, such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to Lindane.
Lindane Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.