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LINDANE LOTION, USP 1%

DESCRIPTION

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:

INDICATIONS

Lindane Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei) only in patients who:

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

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 (lice) 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.

HOW SUPPLIED

Lindane Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles. SHAKE WELL BEFORE USING

Store at controlled room temperature, 15 ° - 30 °C (59 ° - 86 °F) [see USP].

Manufactured By: Morton Grove Pharmaceuticals, Inc. Morton Grove, IL 60053. REV. 06-05. Distributed By: Alliant Pharmaceuticals, Inc. Alpharetta, GA 30004. FDA Rev date: 10/9/2001

SIDE EFFECTS

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.

DRUG INTERACTIONS

Oils may enhance absorption of Lindane, therefore, patients or caregivers applying Lindane Lotion should be warned about simultaneous use of creams, ointments, or oils. In addition, there are many drugs that may lower the seizure threshold, and Lindane Lotion 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

WARNINGS

(See BOXED WARNINGS.)

Seizures and deaths have been reported following Lindane Lotion's use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. It is not known how soon after application of a single dose of Lindane Lotion that a second dose of Lindane Lotion can be safely applied.

There have been cases of adverse events reported for Lindane Lotion and Lindane Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.4 In approximately 20% of the total reported cases, Lindane Lotion and Shampoo were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many cases which were remote from the time of actual Lindane use. Lindane toxicity, verified by autopsy was the cause of one infant's death, was the cause of death reported for an adult who ingested it orally in a successful suicide. The direct causes of death for the other cases were attributed to reasons other than Lindane. Most of these adverse events occurred with Lindane Lotion.

Infants, children, the elderly, and individuals with other skin conditions and those who weigh < 110 lbs (50 kg) may be at greater risk of serious neurotoxicity. (See Pediatric Use and Geriatric Use.) Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.

Careful consideration should be given before prescribing Lindane Lotion to patients with conditions that may increase the risk of seizure, such as HIV infection, history of head trauma or a prior seizure, CNS tumor, the presence of severe hepatic cirrhosis, excessive use of alcohol, abrupt withdrawal from alcohol or sedatives, as well as concomitant use of medications known to lower seizure threshold. (See PRECAUTIONS: DRUG INTERACTIONS.)

Patients should be instructed on proper use of Lindane Lotion, especially the amount to apply, how long to leave the lotion on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.

A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law.

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 Lotion.
• If someone other than the patient will be applying Lindane Lotion to the patient, they should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex gloves should be avoided because they are more permeable to lindane.
• If the person applying Lindane Lotion could be pregnant, contact with Lindane Lotion should be avoided as much as possible.
• If the patient could be pregnant