Lindane Information
Lindane ()
Lindane () Warnings
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 .)
Lindane () Description
Lindane () Shampoo, USP 1%, is an ectoparasiticide and ovicide effective against (head lice), (crab lice), and their ova. In addition to the active ingredient, Lindane () , it contains triethanolamine lauryl sulfate, polysorbate 60, hydrochloric acid, acetone and purified water to form a shampoo base. The pH may be adjusted with 10% hydrochloric acid solution and/or 10% sodium hydroxide solution. Lindane () is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:
Lindane () Clinical Pharmacology
Lindane () exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibach 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 reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a Lindane () -containing product. Ginsburg 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.
There are no clinical dose ranging studies for Lindane () Shampoo.
Lindane () Indications And Usage
Lindane () Shampoo is indicated for the treatment of head lice (infestations of ), crab lice (infestations of ), and their ova only in patients who
Lindane () Shampoo should be used in the context of an overall lice management program that includes:
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.
Lindane () Contraindications
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.
Lindane () Warnings
(See .)
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. 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
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 .)
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.
Lindane () Precautions
Oils may enhance absorption of Lindane () , therefore, patients and caregivers applying the shampoo to others should avoid using oil treatments, or oil-based hair dressings or conditioners immediately before and after applying Lindane () Shampoo.
In addition, there are many drugs that may lower the seizure threshold, and Lindane () Shampoo should be prescribed with caution in patients taking these medications. Drugs that may lower the seizure threshold include, but are not limited to the following:
Lindane () Adverse Reactions
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 , , and .)
Lindane () Overdosage
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.
Lindane () Dosage And Administration
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 .)
Patients should be provided specific information on use of product. (See and .)
A 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.
Lindane () How Supplied
Lindane () Shampoo, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.
SHAKE WELL BEFORE USING
Lindane ()
Lindane () Medication Guide
Lindane () Shampoo is a medicine that is used to treat lice. It kills lice and their eggs. Lice are very small bugs that attach to the skin on your head or pubic (crotch) area and lay eggs called nits in your hair. Some people call crotch lice "crabs". Lice can cause severe itching. Lindane () Shampoo gets into the lice and the nits and kills them. It also goes through your skin. Lindane () Shampoo is used only after safer medicines have not made your lice go away. The only time Lindane () Shampoo is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Lindane () Shampoo. Especially tell your doctor if you take medicines called sedatives (drugs to help you sleep).
Before you put it on:
When you put it on:
When you are supposed to wash it off:
After you wash off Lindane () Shampoo:
You may still itch after you have used Lindane () Shampoo. This does not mean you need more Lindane () Shampoo. Even after all the lice (bugs) are dead, they can still make your skin itch for a long time. Lindane () Shampoo sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.
Lindane () Shampoo may cause serious side effects such as seizures (convulsions, fits) or death (See the section, ""). Lindane () Shampoo can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.
The most common side effects of Lindane () Shampoo are:
These are not all of the possible side effects of Lindane () Shampoo. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Lindane () Shampoo for any condition for which it was not prescribed. Do not give Lindane () Shampoo to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Lindane () Shampoo. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Lindane () Shampoo that is written for health professionals.
Active Ingredient: Lindane () .
Inactive Ingredients: triethanolamine lauryl sulfate, polysorbate 60, hydrochloric acid, acetone and purified water.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Lindane () is only available by a prescription from your doctor.
Product No.: 8834
A50-8834-60REV. 09-09
Lindane () Principal Display Panel - Ml Bottle Carton
