Lindane Shampoo
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Questions & Answers
Side Effects & Adverse Reactions
(See boxed WARNINGS.)
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.4 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 < 110 lbs (50 kg) may be at a greater risk of serious neurotoxicity. (See Pediatric Use and Geriatric Use.) Animal studies have shown increased susceptibility to neurologic adverse events in younger animals. Children have a larger body surface area to volume ratio that may result in a proportionately larger systemic exposure.
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 PRECAUTIONS: Drug Interactions.)
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Lindane Shampoo is indicated for the treatment of head lice (infestations of Pediculosis humanis capitis), crab lice (infestations of Pthirus pubis), and their ova only in patients who
- cannot tolerate other approved therapies, or
- have failed treatment with other approved therapies.
Lindane Shampoo should be used in the context of an overall lice management program that includes:
- Visual inspection to ensure that the patient is currently infested with live lice (empty egg casings or "nits" can remain on hair shaft long after true infestation).
- Manual removal of nits using a comb designed for this purpose and/or individual removal with tweezers followed by close examination of the hair and scalp.
- Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Lindane Shampoo only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
- All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
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.
History
There is currently no drug history available for this drug.
Other Information
Lindane Shampoo USP, 1%, is an ectoparasiticide and ovicide effective against Pediculosis humanis capitis (head lice), Pthirus pubis (crab lice), and their ova. In addition to the active ingredient, lindane, it contains acetone, citric acid, polysorbate 60, purified water and triethanolamine lauryl sulfate to form a shampoo base. The pH may be adjusted with citric acid and/or triethanolamine. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:
C6H6Cl6 M.W. 290.83
Sources
Lindane Shampoo Manufacturers
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Olta Pharmaceuticals Corporation
![Lindane Shampoo [Olta Pharmaceuticals Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Lindane Shampoo | Olta Pharmaceuticals Corporation
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 boxed WARNINGS.)
Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.)
A Lindane Shampoo Medication Guide 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.
-
Morton Grove Pharmaceuticals, Inc.
Lindane Shampoo | Morton Grove Pharmaceuticals, Inc.
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 boxed WARNINGS.)
Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.)
A Lindane Shampoo Medication Guide 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.
-
Versapharm Incorporated
Lindane Shampoo | Versapharm Incorporated
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 boxed WARNINGS.)
Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and Lindane Shampoo Medication Guide.)
A Lindane Shampoo Medication Guide 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 Shampoo [Morton Grove Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=13ddf5e6-ac0e-41e6-b95d-d5bdd6b26fcd&name=lindane-shampoo-02.jpg)
![Lindane Shampoo [Versapharm Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ece04acb-bc22-46e4-8a97-e098bccca8e6&name=ece04acb-bc22-46e4-8a97-e098bccca8e6-02.jpg)
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