Lindane Lotion

Lindane Lotion, USP 1%, is an ectoparasitcide 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. Ginsburg3 found the greatest peak blood level of 64 ng/mL, 6 hours after total body application of Lindane Lotion in 1 of 8 non-scabieic 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 β-elimination phase.1,2,3

REFERENCES

1 Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol.,28:126, 1974.

2. Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47,1966.

3. Ginsburg, C.M., et al., J. Pediatr.91:6, 998-1000,1977.

Do not use lindane topical without the first talking to your doctor if you

• have ever had an allergic or bad reaction to it;
• have epilepsy or another seizure disorder;
• have many open sores or broken skin;
• have used lindane lotion or shampoo in the last few months;
• have HIV or AIDS;
• have risk factors for seizures such as a head injury, tumor in the brain or spinal cord, cirrhosis of the liver, or heavy alcohol use; or
• are treating an infant or baby, an elderly person, or an adult or child who weighs less than 110 pounds (50 kg).

You may not be able to use lindane topical, or you may require a dosage adjustment or special monitoring during treatment.

Lindane topical is in the pregnancy category C. This means that it is not known whether lindane topical will be harmful to an unborn baby. Do not use lindane topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Lindane passes into breast milk, and may be harmful to a nursing baby. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

Lindane topical may have increased side effects when used by elderly individuals. Talk to your doctor before using lindane topical if you are 65 years of age or older.

Lindane topical is only applied once, so you are not likely to miss a dose.

Your pharmacist has additional information about lindane topical written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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• If you have an allergy to lindane or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have used lindane in the past, talk with your doctor.
• If you are breast-feeding. Do not breast-feed while you take lindane lotion.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take lindane lotion with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness.
• Seizures.
• Very bad irritation where lindane lotion is used.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Rx only

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.)

Lindane Lotion has been reported to cause central nervous system stimulation ranging from dizziness to seizures. 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 Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported. (See WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)

Postmarketing Experience

The following adverse reactions reflect additional postmarketing experience of Lindane Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Lindane therapy is unknown.