Lindane

Information from www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=4863#section-3

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

1. cannot tolerate other approved therapies, or
2. 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.

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.

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.

Precautions

General
Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.

Information for Patients (and Caregivers)

• This product can be poisonous if misused.
• Other important information is found in the Medication Guide, which by law, must be dispensed with Lindane Shampoo.
• If putting Lindane Shampoo on another person, the person applying shampoo should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex should be avoided because it is more permeable to lindane.
• If the person applying Lindane Shampoo could be pregnant, contact with Lindane Shampoo should be avoided as much as possible.
• If the patient could be pregnant, other treatments may be preferable.
• Use Lindane Shampoo for lice only.
• The use of oil treatments, oil based hair dressings or conditioners immediately before and after applying Lindane Shampoo should be avoided. Oils can make the Lindane Shampoo go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).
• Information for Use 
  • Shake Lindane Shampoo well. 
  • Hair should be completely dry prior to application of Lindane Shampoo.
  • Use only enough Lindane Shampoo to lightly coat the hair and scalp.
  • 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 and behind the ears.
  • 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.
  • Towel briskly and then remove nits with nit comb or tweezers.
  • There may be some Lindane Shampoo left in the bottle. Close the bottle with the leftover Lindane Shampoo and immediately throw away the bottle in a trash can out of the reach of children.
  • Do not cover the hair with anything that does not breathe, like a shower cap or towel.
  • Do not ingest. Keep away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if open wounds, cuts or sores are present, unless specifically directed by your physician.
  • Wash all recently worn clothing, underwear and pajamas, hats, and used sheets, pillowcases, and towels in very hot water or dry-clean.
  • Patients may still itch after using Lindane Shampoo. This does not mean the medicine did not work. Lindane Shampoo sometimes makes this itch even worse. Other medications can be used to soothe the itch. Do not use more Lindane Shampoo. 
  • If there are any questions or concerns about the condition or use of the Lindane Shampoo, contact your physician

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.