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Drug Information For:

LINDANE 1% SHAMPOO

Ingredient Name:

LINDANE (LIN-dane)

Drug Manufacturer:

MORTON GROVE PHARMACEUTICALS

Common Uses:

This medicine is a scabicide used to treat head and crab (pubic) lice after safer medicines have failed, or if safer medicines caused side effects. It works by killing the lice, which are very small insects, and their eggs (nits).

Before Using This Medicine:

WARNING: Lindane should only be used after safer medicines have failed, or if safer medicines caused side effects. Infrequently, lindane has caused seizures (and possibly death) after prolonged or repeated use. Rare (possibly fatal) nervous system reactions such as seizures may even occur after correct one-time use of lindane. Lindane should not be used in premature infants or those with poorly controlled seizure disorders. Lindane should be used with caution in infants, children, the elderly, those with other skin conditions (such as dermatitis or psoriasis), and those who weigh less than 110 pounds (50 kg) as they may be at higher risk of side effects. Read the patient instruction sheet and Medication Guide before use, and ask your doctor or pharmacist about any information that is unclear to you. Itching may occur either after successful treatment or with treatment failures. Avoid re-applying lindane within a few months after use (consult your doctor or pharmacist for details). INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Do not use other creams, lotions, ointments, or oils immediately before or after applying lindane. Oil-based products may increase the absorption of lindane, increasing the risk of side effects. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking medicines which might increase seizure risk (decrease seizure threshold) when combined with lindane, such as phenothiazines (e.g., thioridazine), tricyclic antidepressants (e.g., amitriptyline), isoniazid (INH), or theophylline among others. Consult your doctor or pharmacist for details. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of a poorly controlled seizure disorder. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you have a history of skin conditions (e.g. psoriasis, dermatitis), broken/crusted skin, HIV infection, serious head injury, seizures, brain tumors, severe liver disease (cirrhosis), alcohol abuse, or sudden stopping of regular alcohol or sedative use. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

How to Use This Medicine:

FOLLOW THE DIRECTIONS for using this medicine provided by your doctor or pharmacist. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Wash hair with your regular shampoo (without conditioner) and dry your hair well. Wait at least one hour before using the lindane shampoo, to lessen the chance of absorbing the lindane through your skin. SHAKE WELL before using this medicine. Wear disposable gloves (made of nitrile, latex with neoprene, or sheer vinyl) when applying this medicine. Do not use natural latex gloves because more lindane can penetrate that glove. Apply the medicine to dry hair without using water. Work it in well (without lathering) and leave it in your hair for exactly four minutes (use a timer or clock). After four minutes add a little warm water until shampoo lathers well. DO NOT USE HOT WATER. Rinse off the shampoo immediately after it lathers. Dry hair with a towel and remove nits (eggs) from hair with a nit comb or tweezers. Wash your hands when you are done. Discard gloves and lindane container into the trash, out of the reach of children and pets. All recently worn clothing, underwear, pajamas, bed sheets, pillows, towels, and stuffed animals should be washed in very hot water or dry-cleaned. Do not use lindane shampoo again without checking with your doctor. STORE THIS MEDICINE at room temperature between 59 and 86 degrees F (15 and 30 degrees C) in a tightly-closed container away from heat, moisture, and light. Do not freeze.

Cautions:

THIS MEDICINE MAY CAUSE DIZZINESS OR DROWSINESS. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. LIMIT ALCOHOL INTAKE while using this medicine. DO NOT EXCEED THE RECOMMENDED DOSE or use this medicine for longer than prescribed without checking with your doctor. AVOID GETTING THIS MEDICINE in your eyes or on the inside of your nose or mouth. Rinse eyes with water immediately if lindane gets into them, and contact your doctor immediately if a burning sensation continues. DO NOT TAKE THIS MEDICINE BY MOUTH. DO NOT USE THIS MEDICINE on cuts or broken skin. Caution should be used when treating the elderly with lindane since they may be more sensitive to the effects of the medicine (see Before Using section). Caution should be used when treating infants and children with lindane since they may be more sensitive to the effects of the medicine (see Before Using section). If an infant is prescribed lindane, watch them carefully to make sure they do not put hands or feet into their mouth while the medication is on their skin. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Do not apply lindane to others while you are pregnant, unless it is absolutely necessary and you have discussed it with your doctor. Use gloves as directed (see How to Use section). THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. For 24 hours after using lindane, pump your breast milk and discard it. This will lessen the chance of exposing your baby to the medicine and possible side effects.

Possible Side Effects:

SIDE EFFECTS that may occur while using this medicine include skin rash, stinging, burning, or redness of skin. If they continue or are bothersome, check with your doctor promptly. It may indicate that some of the medicine was absorbed through the skin. CONTACT YOUR DOCTOR IMMEDIATELY if you experience the following unlikely but serious side effects including vomiting, seizures, dizziness, or drowsiness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist (See also Before Using section). This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose:

If overdose is suspected, contact your local poison control center or emergency room immediately. This medicine may be harmful if swallowed. Symptoms of overdose may include nausea, vomiting, restlessness, unsteadiness, seizures, irregular heartbeat, and bloody urine.

Additional Information:

If your symptoms do not improve within a few days or if they become worse, check with your doctor. Itching may continue for up to several weeks due to sensitivity to mites. This does not indicate treatment failure. Because lice are easily transferred from one person to another, all family members and close contacts (especially if you have crab/pubic hair lice) should be examined. Soak all possibly infested combs, brushes, and other hair care items in water heated to 130 degrees F (54 degrees C) for 5 to 10 minutes. This medicine is used to treat a current lice infestation only. It cannot be used to prevent future lice infestations. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets.

Copyright 2014 Wolters Kluwer Health, Inc.

Disclaimer

- This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.