Brand Name

    US Brand Name

    Kwell

    Thionex

    Canadian Brand Name

    Kwellada Lotion 1%

    Lindane

    Pms-Lindane


    Description

    Lindane , formerly known as gamma benzene hexachloride, is an insecticide and is used to treat scabies and lice infestations.

    Lindane cream and lotion are usually used to treat only scabies infestation. Lindane shampoo is used to treat only lice infestations.

    Lindane is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Shampoo

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Infants and children or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of using this medicine with your doctor. In addition, use of lindane is not to be used in premature infants.

    Geriatric

    Elderly people or people who weigh less than 110 pounds (50 kilograms) are especially sensitive to the effects of lindane. This may increase the chance of serious side effects during treatment. Be sure you have discussed the risks and benefits of this medicine with your doctor.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Amifampridine
    • Bupropion
    • Donepezil

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alcohol use that is excessive, or
    • Brain tumor or
    • Head injuries, history of, or
    • HIV Infection or
    • Liver disease, or
    • Seizures, history of
    • Suddenly stopping the regular use of alcohol or sedatives —Patients with these conditions should use lindane carefully because these patients have a greater risk of having a seizure
    • Hypersensitivity to lindane
    • Seizure disorder—This medicine should not be used in patients with seizure disorders
    • Skin conditions—This medicine should not be used in people with crusted scabies, atopic dermatitis, or psoriasis. These problems of the skin could cause more lindane to be absorbed in your body and result in serious side effects.

    Proper Use

    Lindane is poisonous. Keep it away from the mouth because it is harmful and may be fatal if swallowed.

    Use lindane only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of absorption through the skin and the chance of lindane poisoning.

    Keep lindane away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water at once and contact your doctor.

    Do not use lindane on open wounds, such as cuts or sores on the skin or scalp. To do so may increase the chance of lindane poisoning.

    When applying lindane to another person, you should wear plastic disposable or rubber gloves made of latex or vinyl, especially if you are pregnant or are breast-feeding. Do not use natural latex gloves because lindane can go through those gloves and be absorbed by your skin. Wash hands very well after applying the lotion. This will prevent lindane from being absorbed through your skin. If you have any questions about this, check with your healthcare professional.

    Put lindane lotion under fingernails, and trim fingernails short. Use a toothbrush to get the lindane lotion under fingernails, and throw out the toothbrush when finished.

    Do not cover the area completely. Use a light clothing.

    Lindane comes with patient directions. Be sure that you read them very carefully before using lindane. If you have any questions check with your healthcare professional.

    Your sexual partner or partners, especially, and all members of your household may need to be treated also, since the infestation may spread to persons in close contact. If these persons have not been checked for an infestation or if you have any questions about this, check with your healthcare professional

    To use the cream or lotion form of lindane for scabies :

    • If your skin has any cream, lotion, ointment, or oil on it, wash, rinse, and dry your skin well before applying lindane.
    • If you take a warm bath or shower before using lindane, dry the skin well before applying it.
    • Apply enough lindane to your dry skin to cover the entire skin surface from the neck down, including the soles of your feet, and rub in well.
    • Leave lindane on for 8 to 12 hours, then remove by washing thoroughly.

    To use the shampoo form of lindane for lice:

    • If your hair has any cream, lotion, ointment, or oil-based product on it, shampoo, rinse, and dry your hair and scalp well before applying lindane.
    • If you apply this shampoo in the shower or in the bathtub, make sure the shampoo is not allowed to run down on other parts of your body. Also, do not apply this shampoo in a bathtub where the shampoo may run into the bath water in which you are sitting. To do so may increase the chance of absorption through the skin. When you rinse out the shampoo, be sure to thoroughly rinse your entire body also to remove any shampoo that may have gotten on it.
    • Apply enough shampoo to your dry hair (1 ounce or less for short hair, 1½ ounces for medium length hair, and 2 ounces or less for long hair) to thoroughly wet the hair and skin or scalp of the affected and surrounding hairy areas.
    • Thoroughly rub the shampoo into the hair and skin or scalp and allow to remain in place for 4 minutes. Then, use just enough water to work up a good lather.
    • Rinse thoroughly and dry with a clean towel.
    • When the hair is dry, comb with a fine-toothed comb to remove any remaining nits (eggs) or nit shells.
    • Do not use as a regular shampoo.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For cream and lotion dosage forms:
      • For scabies:
        • Adults and children—Apply to the affected area(s) of the skin one time.
        • Premature infants—Use is not recommended.
    • For shampoo dosage form:
      • For lice:
        • Adults and children—Apply to the scalp or the affected area(s) of the skin one time.
        • Premature infants—Use is not recommended.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.


    Precautions

    To help prevent reinfestation or spreading of the infestation to other persons:

    • For scabies—All recently worn underwear and pajamas and used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
    • For lice—All recently worn clothing and used bed linens and towels should be washed in very hot water or dry-cleaned.

    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor as soon as possible if any of the following side effects occur:

    Rare

    • Convulsions (seizures)
    • dizziness, clumsiness, or unsteadiness
    • fast heartbeat
    • muscle cramps
    • nervousness, restlessness, or irritability
    • vomiting
    • skin irritation not present before use of lindane
    • skin rash

    After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

    Serious side effects have resulted in patients using lindane. Sometime it has occurred even when used according to the labeled directions. Serious side effects have been reported following lindane use with repeat or prolonged use, but also in rare cases following a single application. You should discuss these possible effects with your doctor.

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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