Lindane

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Rx only

WARNINGS

Boxed Warning section

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 .)

DESCRIPTION

DESCRIPTION SECTION

Lindane Shampoo USP, 1%, is an ectoparasiticide and ovicide effective against Pediculosis humanis capitis (head lice), Pthirus pubis (crab lice), and their ova. In addition to the active ingredient, lindane, it contains acetone, citric acid, polysorbate 60, purified water and triethanolamine lauryl sulfate to form a shampoo base. The pH may be adjusted with citric acid and/or triethanolamine. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula: C 6 H 6 Cl 6 M.W. 290.83

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibach 1 reported approximately 10% absorption of a lindane acetone solution 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 al 2 reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane-containing product. Ginsburg 3 found a mean peak blood level of 28 ng/mL 6 hours after total body application of Lindane Lotion to scabietic infants and children. The half-life in blood was determined to be 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 There are no clinical dose ranging studies for Lindane Shampoo.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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.

WARNINGS

WARNINGS SECTION

(See boxed WARNINGS .) 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. There have been cases of adverse events reported for Lindane Shampoo and Lindane Lotion in which a serious outcome (hospitalization, disability or death) has occurred. 4 In approximately 20% of these cases, the shampoo and lotion were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many of which were remote from the time of actual Lindane use. Lindane toxicity, verified by autopsy was the cause of one infant's death, and was the cause of death reported for an adult 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 a 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 Shampoo 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 the proper use of Lindane Shampoo, especially the amount to apply, how long to leave shampoo on, and the need to avoid retreatment. Patients should be informed that itching may occur after the successful killing of lice and repeat treatment may not be necessary. A Lindane Shampoo Medication Guide must be given to the patient each time Lindane Shampoo is dispensed, as required by law.

PRECAUTIONS

PRECAUTIONS SECTION

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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 .)

OVERDOSAGE

OVERDOSAGE SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

Lindane Shampoo USP, 1% is supplied in 2 fl oz (60 mL) NDC 61748-400-02 bottles. SHAKE WELL BEFORE USING

REFERENCES

REFERENCES SECTION

Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol. , 28:126, 1974. Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966. Ginsburg, C.M., et al., J. Pediatr. 91:6, 998–1000, 1977. FDA AERS database search, January 2003

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured by: AL&S, LLC De Kalb, MS 39328 Marketed by: VersaPharm Incorporated Marietta, GA 30062 IVP40002-00 Issued: 05-24-2011 PHARMACIST—PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

SPL MEDGUIDE SECTION

Lindane (LIHN-dane) Shampoo USP, 1% You must read and follow all instructions before using Lindane Shampoo. Read the information you get every time you or a family member get Lindane Shampoo. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Lindane Shampoo, ask your doctor or pharmacist.

PRINCIPAL DISPLAY PANEL- CONTAINER LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61748-400-02 LINDANE SHAMPOO USP, 1% POISON: FOR EXTERNAL USE ONLY HARMFUL OR FATAL IF SWALLOWED WARNING : KEEP OUT OF REACH OF CHILDREN Do not use if the seal is broken or missing. Rx Only NET: 2 fl oz (60 mL)