Brand Name(s):

Gamene^® ¶
Kwell^® ¶
Scabene^® ¶

IMPORTANT WARNING

Lindane is used to treat lice and scabies, but it may cause serious side effects. Safer medications are available to treat these conditions. You should only use lindane if there is some reason you cannot use the other medications or if you have tried the other medications and they have not worked.

In rare cases, lindane has caused seizures and death. Most patients who experienced these severe side effects used too much lindane or used lindane too often or for too long, but a few patients experienced these problems even though they used lindane according to the directions. Babies; children; older people; people who weigh less than 110 lb; and people who have skin conditions such as psoriasis, rashes, crusty scabby skin, or broken skin are more likely to have serious side effects from lindane. These people should use lindane only if a doctor decides it is needed.

Lindane should not be used to treat premature babies or people who have or have ever had seizures, especially if the seizures are hard to control.

Lindane may cause serious side effects if too much is used or if it is used for too long or too often. Your doctor will tell you exactly how to use lindane. Follow these directions carefully. Do not use more lindane or leave the lindane on for a longer time than you are told. Do not use a second treatment of lindane even if you still have symptoms. You may be itchy for several weeks after your lice or scabies are killed.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lindane and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

WHY is this medicine prescribed?

Lindane is used to treat scabies (mites that attach themselves to the skin) and lice (small insects that attach themselves to the skin on the head or pubic area ['crabs']). Lindane is in a class of medications called scabicides and pediculicides. It works by killing lice and mites.

Lindane does not stop you from getting scabies or lice. You should only use lindane if you already have these conditions, not if you are afraid that you may get them.

HOW should this medicine be used?

Lindane comes as a lotion to apply to the skin and a shampoo to apply to the hair and scalp. It should only be used once and then should not be used again. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lindane exactly as directed. Do not use more or less of it or use it more often than directed by your doctor.

Lindane should only be used on the skin and hair. Never apply lindane to your mouth and never swallow it. Avoid getting lindane into your eyes.

If lindane gets into your eyes, wash them with water right away and get medical help if they are still irritated after washing.

When you apply lindane to yourself or someone else, wear gloves made of nitrile, sheer vinyl, or latex with neoprene. Do not wear gloves made of natural latex because they will not prevent lindane from reaching your skin. Dispose of your gloves and wash your hands well when you are finished.

Lindane lotion is used only to treat scabies. Do not use it to treat lice. To use the lotion, follow these steps:

Your fingernails should be trimmed short and your skin should be clean, dry, and free of other oils, lotions, or creams. If you need to bathe or shower, wait 1 hour before applying lindane to allow your skin to cool.
Shake the lotion well.
Put some lotion on a toothbrush. Use the toothbrush to apply the lotion under your fingernails. Wrap the toothbrush in paper and dispose of it. Do not use this toothbrush again to brush your teeth.
Apply a thin layer of lotion all over your skin from your neck down to your toes (including the soles of your feet). You might not need all of the lotion in the bottle.
Close the lindane bottle tightly and dispose of it safely, so that it is out of the reach of children. Do not save leftover lotion to use later.
You may dress in loose fitting clothing, but do not wear tight or plastic clothing or cover your skin with blankets. Do not put plastic lined diapers on a baby who is being treated.
Leave the lotion on your skin for 8-12 hours, but no longer. If you leave the lotion on longer, it will not kill any more scabies, but it may cause seizures or other serious side effects. Do not let anyone else touch your skin during this time. Other people may be harmed if their skin touches the lotion on your skin.
After 8-12 hours have passed, wash off all of the lotion with warm water. Do not use hot water.

Lindane shampoo is used only for pubic lice ('crabs') and head lice. Do not use the shampoo if you have scabies. To use the shampoo, follow these steps:

Wash your hair with your regular shampoo at least 1 hour before applying lindane and dry it thoroughly. Do not use any creams, oils, or conditioners.
Shake the shampoo well. Apply just enough shampoo to make your hair, scalp, and the small hairs on the back of your neck wet. If you have pubic lice, apply the shampoo to the hair in your pubic area and the skin underneath. You might not need all of the shampoo in the bottle.
Close the lindane bottle tightly and dispose of it safely, so that it is out of the reach of children. Do not save leftover shampoo to use later.
Leave the lindane shampoo on your hair for exactly 4 minutes. Keep track of the time with a watch or clock. If you leave the lotion on for longer than 4 minutes, it will not kill any more lice, but it may cause seizures or other serious side effects. Keep your hair uncovered during this time.
At the end of 4 minutes, use a small amount of warm water to lather the shampoo. Do not use hot water.
Wash all of the shampoo off of your hair and skin with warm water.
Dry your hair with a clean towel.
Comb your hair with a fine tooth comb (nit comb) or use tweezers to remove nits (empty egg shells). You will probably need to ask someone to help you with this, especially if you have head lice.

After using lindane, sanitize all the clothing, underwear, pajamas, sheets, pillowcases, and towels you have used recently. These items should be washed in very hot water or dry-cleaned.

Itching may still occur after successful treatment. Do not reapply lindane.

Are there OTHER USES for this medicine?

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using lindane,

tell your doctor and pharmacist if you are allergic to lindane or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antidepressants (mood elevators); antibiotics such as ciprofloxacin (Cipro), gatifloxacin (Tequin), gemifloxacin (Factive), imipenem/cilastatin (Primaxin), levofloxacin (Levaquin), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and penicillin; chloroquine sulfate; isoniazid (INH, Laniazid, Nydrazid); medications for mental illness; medications that suppress the immune system such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate mofetil (CellCept), and tacrolimus (Prograf); meperidine (Demerol); methocarbamol (Robaxin); neostigmine (Prostigmin); pyridostigmine (Mestinon, Regonol); pyrimethamine (Daraprim); radiographic dyes; sedatives; sleeping pills; tacrine (Cognex); and theophylline (TheoDur, Theobid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
in addition to the conditions mentioned in the IMPORTANT WARNING section, tell your doctor if you have or have ever had human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); seizures; a head injury; a tumor in your brain or spine; or liver disease. Also tell your doctor if you drink, used to drink, or have recently stopped drinking large amounts of alcohol and if you have recently stopped using sedatives (sleeping pills).
tell your doctor if you are pregnant or are breast-feeding. If you are pregnant, wear gloves when applying lindane to another person to prevent its absorption through your skin. If you are breast-feeding, pump and discard your milk for 24 hours after you use lindane. Feed your baby stored breastmilk or formula during this time, and do not allow your baby's skin to touch the lindane on your skin.
tell your doctor if you have recently used lindane.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If you accidentally get lindane in your mouth, call your local poison control center right away to find out how to get emergency help.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Your prescription is not refillable. See your doctor if you feel you need additional treatment.

Lice are generally spread by close head-to-head contact or from items which come in contact with your head. Do not share combs, brushes, towels, pillows, hats, scarves, or hair accessories. Be sure to check everyone in your immediate family for head lice if another family member is being treated for lice.

If you have scabies or pubic lice, tell your doctor if you have a sexual partner. This person should also be treated so he or she will not reinfect you. If you have head lice, all people who live in your household or who have been in close contact with you may need to be treated.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2017.