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Lindane

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Overview

What is Lindane?

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:



What does Lindane look like?



What are the available doses of Lindane?

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What should I talk to my health care provider before I take Lindane?

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How should I use Lindane?

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.

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.


What interacts with Lindane?

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.



What are the warnings of Lindane?

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

(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 < 110 lbs (50 kg) may be at a greater risk of serious neurotoxicity. (See and .) 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 .)

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.


What are the precautions of Lindane?

General

Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.

Information for Patients (and Caregivers)













              Drug Interactions























                                    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:

                                    Carcinogenesis, Mutagenesis, and Fertility

                                    Although no studies have been conducted with Lindane Shampoo, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane as well as the alpha, beta, gamma (lindane) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of lindane. The results of mutagenicity tests in bacteria do not indicate that lindane is mutagenic. Lindane did not cause sister chromatid exchange in an assay. The number of spermatids in the testes of rats 2 weeks after oral administration of a single dose of 30 mg/kg body weight (12 times the estimated human exposure for scabies on a body surface area comparison and assuming 50% rat oral bioavailability and 10% human bioavailability) was significantly reduced compared to the control rats.

                                    Pregnancy

                                    All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Predictions of fetal risk from drug exposure rely heavily on animal data. However, animal studies may fail to predict effects in humans or may overstate such risks. Even if human data are available, the data may not be sufficient to determine whether there is an increased risk to the fetus, and individual reports of adverse outcomes in pregnancy in association with a drug may not reflect a causal relationship.

                                    Lindane Shampoo should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Lindane Shampoo in pregnant women. There are no known maternal or fetal health risks described if lice are not treated, but risk of transmission of the lice to other household members is an additional consideration when deciding whether to use lice treatments. Lindane is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures during pregnancy to Lindane Lotion. The relationship of the maternal exposures to the fetal outcome is unknown.

                                    Animal data suggest that lindane may increase the likelihood of neurologic developmental abnormalities (see ), based on findings at systemic exposures close to that expected in humans when Lindane Lotion is used to treat scabies. The immature central nervous system (as in the fetus) may have increased susceptibility to the effects of the drug. Systemic exposure resulting from Lindane Shampoo applied to hair covered areas is expected to be lower than that from Lindane Lotion that covers the entire body surface area.

                                    Nursing Mothers

                                    Lindane is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if lindane is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding if Lindane Shampoo is applied topically to the chest area. Nursing mothers who require treatment with Lindane Shampoo should be advised of the potential risks and be instructed not to use the product on the skin as would be done for treatment of scabies. They should also be counseled to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use.

                                    Pediatric Use

                                    Animal data demonstrated increased risk of adverse events in the young across species. Pediatric patients have a higher surface to volume ratio and may be at risk of greater systemic exposure when Lindane Shampoo is applied. Infants and children may be at an even higher risk due to immaturity of organ systems such as skin and liver. Lindane Shampoo should be used with caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Lindane Shampoo is indicated only for the treatment of lice; patients with scabies should use Lindane Lotion according to the labeled instructions.

                                    Geriatric Use

                                    There have been no studies of Lindane Shampoo in the elderly. There are four postmarketing reports of deaths in elderly patients treated with Lindane Lotion for the indication of scabies. Two patients died within 24 hours of Lindane Lotion application, and the third patient died 41 days after application of Lindane Lotion, having suffered a seizure on the day of death. A fourth patient died of an unreported cause of death on the same day that Lindane Lotion treatment for scabies was administered.


                                    What are the side effects of Lindane?

                                    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 .)

                                    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.


                                    What should I look out for while using Lindane?

                                    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.

                                    (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 < 110 lbs (50 kg) may be at a greater risk of serious neurotoxicity. (See and .) 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 .)

                                    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.


                                    What might happen if I take too much Lindane?

                                    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.


                                    How should I store and handle Lindane?

                                    Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Lindane Shampoo, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.SHAKE WELL BEFORE USINGLindane Shampoo, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.SHAKE WELL BEFORE USING


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                                    Clinical Information

                                    Chemical Structure

                                    No Image found
                                    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.

                                    Non-Clinical Toxicology
                                    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.

                                    (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 < 110 lbs (50 kg) may be at a greater risk of serious neurotoxicity. (See and .) 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 .)

                                    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.

                                    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:

                                    Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician.

                                    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 .)

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                                    Reference

                                    This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
                                    "https://dailymed.nlm.nih.gov/dailymed/"

                                    While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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                                    Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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                                    Interactions

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