Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/283
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Lindane (Shampoo, Suspension)
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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 oflather with other body surfaces. Do not prescribe more than 2 ounces for larger adults. Do not retreat. Patients should be provided specific information on use of product. 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.
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| dailymed-instance:descripti... |
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 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:
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| dailymed-instance:clinicalP... |
Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibachreported 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 alreported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane-containing product. Ginsburgfound 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��-elimination phase. There are no clinical dose ranging studies for Lindane Shampoo.
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Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.
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| dailymed-instance:supply |
Lindane Shampoo, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles. SHAKE WELL BEFORE USING Store at controlled room temperature, 15�����30��C (59�����86��F) [see USP].
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| dailymed-instance:boxedWarn... |
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.<br/>Neurologic Toxicity: 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. Lindane Shampoo should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh<110 lbs (50 kg) as they may be at risk of serious neurotoxicity.<br/>Contraindications: Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.<br/>Proper Use: Instruct patients on proper use of Lindane Shampoo, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for retreatment with Lindane Shampoo.
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| dailymed-instance:overdosag... |
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.
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Lindane
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Lindane (Shampoo, Suspension)
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| dailymed-instance:adverseRe... |
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.<br/>Postmarketing Experience: The following adverse reactions reflect the additional postmarketing experience of Lindane Shampoo. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to lindane therapy is unknown.
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| dailymed-instance:warning |
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.<br/>Neurologic Toxicity: 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. Lindane Shampoo should be used with caution in infants, children, the elderly, and individuals with other skin conditions, and those who weigh<110 lbs (50 kg) as they may be at risk of serious neurotoxicity.<br/>Contraindications: Lindane Shampoo is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.<br/>Proper Use: Instruct patients on proper use of Lindane Shampoo, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for retreatment with Lindane Shampoo.
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| dailymed-instance:indicatio... |
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 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.
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Lindane
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