Lindane (4 brand names, 3 dosage forms, 1 route)
Available dosage forms: SHAMPOO, LOTION, CREAM.
Routes of administration: TOPICAL.
Brand Names
- GAMENE
- KWELL
- LINDANE
- SCABENE
Boxed Warning
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 AND USAGE.) 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.)
Indications and Usage
Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who cannot tolerate other approved therapies, or have failed treatment with other approved therapies. Lindane Shampoo should be used in the context of an overall lice management program that includes: Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or “nits” can remain on hair shaft long after true infestation). Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp. Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies. All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed 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 Shampoo does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
Dosage and Administration
Most patients will require only 1 ounce of Lindane Shampoo. Based on the length and density of hair, some patients may require 2 ounces of Lindane Shampoo. Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces. Do not prescribe more than 2 ounces for larger adults. Do not retreat. (See boxed WARNINGS.) Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.) A Lindane Shampoo Medication Guide must be given to the patient each time LINDANE Shampoo is dispensed as required by law. The Lindane Shampoo Medication Guide is an important part of the risk management program for the patient.
Contraindications
Lindane Shampoo is contraindicated for premature infants because their skin may be more permeable than that of full term infants and their liver enzymes may not be sufficiently developed to metabolize Lindane. Lindane Shampoo is also contraindicated for patients with crusted (Norwegian) scabies and other skin conditions (e.g., atopic dermatitis, psoriasis) that may increase systemic absorption of the drug. Lindane Shampoo is contraindicated for patients with known uncontrolled seizure disorders and for individuals with a known sensitivity to the product or any of its components.
Adverse Reactions
Central nervous system stimulation ranging from dizziness to seizures, has been reported particularly with use of Lindane Lotion. Although seizures were almost always associated with ingestion or misuse of the product (to include repeat treatment), seizures and deaths have been reported when Lindane Shampoo was used according to directions. Irritant dermatitis from contact with this product has also been reported. (See WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)
Drug Interactions
Oils may enhance absorption of lindane, therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying Lindane Shampoo. In addition, there are many drugs that may lower the seizure threshold, and Lindane Shampoo should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following: Antipsychotics Antidepressants Theophylline Cyclosporine, mycophenolate mofetil, tacrolimus capsules Penicillins, imipenem, quinolone antibiotics Chloroquine sulfate, pyrimethamine Isoniazid Meperidine Radiographic contrast agents Centrally active anticholinesterases Methocarbamol
Overdosage
Contact the closest Poison Control Center in the event of suspected overdosage with Lindane Shampoo. 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 manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.