Lindane

Dosage Forms & Strengths

lotion/shampoo

• 1%

Scabies

Lotion: Apply thin layer and massage on skin on entire body except face; bathe and remove drug 8-12 hr after application

Head Lice or Crab Lice

Apply 1-2 oz of shampoo (not to exceed 2 oz) on dry hair; leave on 4 min, lather, rinse, remove nits with fine comb

One time application usually sufficient; may use other pediculicide in 1 wk if necessary

Dosage Forms & Strengths

lotion/shampoo

• 1%

Scabies

Lotion: Apply thin layer and massage on skin on entire body except face; bathe and remove drug 8-12 hr after application

Head Lice or Crab Lice

Apply 1-2 oz of shampoo (not to exceed 2 oz) on dry hair; leave on 4 min, lather, rinse, remove nits with fine comb

One time application usually sufficient; may use other pediculicide in 1 wk if necessary

Pregnancy Category: C

Lactation: distributed in breast milk, do not nurse for 24 hr post-application (express milk & discard)

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Lindane Shampoo is a prescription medication used to remove lice. Lindane Lotion is a prescription medication used to treat scabies. Both products are usually only used in adults and children who weigh at least 110 pounds, after safer medications have not made the lice or scabies go away.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Lindane Shampoo and Lindane Lotion may cause serious side effects such as seizures (convulsions, fits) or death. See "Drug Precautions" section.

These medicines can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Lindane Shampoo and Lindane Lotion are:

• Itching skin
• Burning skin
• Dry skin
• A skin rash

These are not all of the possible side effects of Lindane Shampoo and Lindane Lotion. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WARNINGS

Lindane Lotion and Lindane Shampoo should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies.

Neurologic Toxicity

Seizures and deaths have been reported following Lindane Lotion or Lindane Shampoo 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 and Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

Proper Use

Instruct patients on the proper use of Lindane Lotion and 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 scabies and is not necessarily an indication for retreatment with Lindane Lotion and Lindane Shampoo.

Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide. In addition to the active ingredient, Lindane, it contains 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene glycol, propylparaben, purified water, stearic acid and trolamine 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:

C6H6Cl6                                                                M.W. 290.83

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.

(LIN dane)

• Benzene Hexachloride
• Gamma Benzene Hexachloride
• Hexachlorocyclohexane
• Kwell

Adverse events have been observed in animal reproduction studies. Animal studies suggest possible neurologic abnormalities due to the increased susceptibility of drug and the immature central nervous system of the fetus. Lindane is lipophilic and may accumulate in the placenta. Use in pregnant women has been associated with neural tube defects and mental retardation (CDC [Workowski 2015]).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry skin, skin burning, or itching. Have patient report immediately to prescriber seizures, burning or numbness feeling, or severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.