LINDANE Lotion Ref.[49541] Active ingredients: Lindane

Source: FDA, National Drug Code (US)  Revision Year: 2011 

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.

10. Dosage and Administration

Apply a thin layer of Lindane Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in 8 to 12 hours. Do not retreat. (See boxed WARNINGS.)

Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and the Medication Guide.) Patients should be instructed on proper use of Lindane Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (mites) and continued itching is not necessarily an indication for retreatment with Lindane Lotion.

A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law. The Lindane Lotion Medication Guide is an important part of the risk management program for the patient.

9. Overdosage

Contact the closest Poison Control Center in the event of suspected overdosage with Lindane Lotion.

If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils enhance absorption, saline cathartics for intestinal evacuation should be given rather than oil laxatives. If central nervous system (CNS) manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.

12. Storage and Handling

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

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