Kwell Topical

This section provides information on the proper use of a number of products that contain lindane. It may not be specific to Kwell. Please read with care.

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.

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:

• 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.

This medication is used to treat head and crab (pubic) lice. Lice are tiny insects that lay eggs (nits) on hair shafts. Lice can easily spread to those in close contact with you. Lindane works by killing the lice and nits. An infection with lice is also called an infestation. This drug should not be used to prevent lice infestation or re-infestation.

How to use Kwell Shampoo

Read the Medication Guide provided by your pharmacist before you start using lindane. If you have any questions, consult your doctor or pharmacist.

This drug can be poisonous if used incorrectly. Do not take this drug by mouth, and avoid contact with your eyes, nose, or mouth. If lindane gets in these areas, rinse with water immediately and seek immediate medical attention if a burning feeling remains. Do not use if there is skin irritation (e.g., open wounds, rash, cuts, or sores) on the area to be treated unless directed to do so by your doctor. Do not apply any oil-based hair products (such as oil treatments or oil-based hair dressings/conditioners) immediately before or after using lindane. If you are currently using any of these products, they must be washed off before you apply lindane. Oil-based products may increase the absorption of lindane, increasing the risk of side effects.

Wash your hair with your regular shampoo (without conditioner) and dry it well. Wait at least 1 hour after drying your hair before using lindane shampoo.

Most adults require only 1 ounce (30 milliliters), but those with longer and thicker hair should use no more than 2 ounces (60 milliliters).

Shake the bottle well before use. For application, use gloves made of nitrile, latex with neoprene, or sheer vinyl to avoid unnecessary contact with your skin. Do not use natural latex gloves because more lindane can penetrate that type of glove. Apply a small amount of lindane to lightly coat your hair and scalp as directed by your doctor. Work thoroughly (do not lather) through dry hair. Do not add water. Make sure to include the fine hairs along your neck and behind your ears. Leave lindane in your hair for exactly 4 minutes (use a timer or clock). Do not cover your hair with anything (e.g., shower cap, towel). After 4 minutes, add a small amount of warm (not hot) water, rub until a lather forms, then immediately rinse away all lather. Try to keep lindane from touching other parts of your body. Do not re-apply. Dry your hair with a towel, then use the special nit comb or tweezers to remove the nits. It is best to have someone else do this for you to make sure all the nits are removed. They should wear gloves while removing the nits.

Close the bottle with any remaining lindane and throw it away out of reach from children and pets. Wash your hands well after treatment.

If an infant or young child is prescribed lindane, watch the child carefully while the lindane shampoo is in the hair to make sure the child does not touch the hair then put the hands in the mouth.

If you are putting lindane shampoo on someone else, use gloves as directed above. Wash your hands well afterwards.

The easiest way to tell if you have lice is to look for small gray-white nits fixed to the hair shafts. Symptoms of lice include an intense itching, mostly on the scalp, but also possibly on the eyebrows, eyelashes, beard, or groin. Itching may continue even after treatment with lindane shampoo. Even if the lindane kills all the lice, the dead lice can still make you itch for a long time after treatment. Ask your doctor about other medications that may be used to soothe the itching.

Inform your doctor if your condition persists or worsens 1-2 weeks after treatment.

See also Warning section.

Before using lindane shampoo, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other skin conditions (e.g., psoriasis, dermatitis), HIV infection, history of serious head injury, seizures, brain tumors, severe liver disease, alcohol abuse, sudden stopping of regular alcohol or sedative use.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having an imaging test (e.g., X-rays, CT scan) requiring the use of dye, tell your doctor that you have used this medication.

This medication is not recommended for use during pregnancy. Consult your doctor for more details. If you are pregnant, do not apply lindane shampoo to others unless it is absolutely necessary and you have discussed it with your doctor. Use gloves as directed. (See How to Use section.)

Lindane passes into breast milk and could have undesirable effects on a nursing infant. Your baby should not come into direct contact with your skin while it has lindane on it. In addition, to lessen the chance of exposing your baby to the medication and possible side effects, pump your breast milk and discard it for 24 hours after using lindane. During this time, feed your baby formula or breast milk you stored from before you used lindane shampoo.

Applies to lindane topical: topical cream, topical lotion, topical shampoo

Along with its needed effects, lindane topical 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 while taking lindane topical:

• 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.

Apply 30 mL of lotion as a thin layer over all skin from the neck down; wash off in 8 to 12 hours.

Maximum Dose: Larger adults may require up to 60 mL.

Comments: Use only once; do not re-treat.

Use: Treatment of scabies (infestations of Sarcoptes scabei) and their ova in patients who cannot tolerate or who have failed treatment with other approved therapies.

There are no controlled data in human pregnancy; however, there is a single case report of a stillborn infant following multiple maternal exposures to this drug during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown. Animal data suggest this drug may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: C Comments: This drug is lipophilic and may accumulate in the placenta.

Animal data has revealed reduced pup survival, increased number of stillborn pups, increased pup mortality, decreased pup weight, increased motor activity, and decreased motor activity habituation when this drug was present in the diet from day 6 of gestation through day 10 of lactation.

Use of another agent is preferred during breastfeeding. Excreted into human milk: Yes Comments: -Topical application of this drug can increase drug levels in breastmilk for at least several days. -An environmental contaminant, this drug is potentially toxic in infants and has possible estrogenic effects that could decrease lactation as well as affect the nursing infant. -Advise breastfeeding patients to avoid large areas of skin-to-skin contact with their infants while the lotion formulation of this drug is applied, and to interrupt breastfeeding (including expression and discarding of milk) for at least 24 hours following use of this drug.