LINDANE Lotion Ref.[49541] Active ingredients: Lindane

Seizures and deaths have been reported following Lindane Lotion’s use with repeat or prolonged application, but also in rare cases following a single application reportedly used according to directions. It is not known how soon after application of a single dose of Lindane Lotion that a second dose of Lindane Lotion can be safely applied.

There have been cases of adverse events reported for Lindane Lotion and Lindane Shampoo in which a serious outcome (hospitalization, disability or death) has occurred. ⁴ In approximately 20% of the total reported cases, Lindane Lotion and Shampoo were reported to have been used according to the labeled directions. Of these cases, thirteen deaths were reported, many cases which were remote from the time of actual Lindane use. Lindane toxicity, verified by autopsy was the cause of one infant’s death, was the cause of death reported for an adult who ingested it orally 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 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 Lotion 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 proper use of Lindane Lotion, especially the amount to apply, how long to leave the lotion on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.

A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law.

Lindane Lotion has been reported to cause central nervous system stimulation ranging from dizziness to seizures. 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 Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported. (See WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION.)

Postmarketing Experience

The following adverse reactions reflect additional postmarketing experience of Lindane Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Lindane therapy is unknown.

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.

• This product can be poisonous if misused.
• Other important information is found in the Medication Guide, which by law, must be dispensed with Lindane Lotion.
• If someone other than the patient will be applying Lindane Lotion to the patient, they should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex gloves should be avoided because they are more permeable to lindane.
• If the person applying Lindane Lotion could be pregnant, contact with Lindane Lotion should be avoided as much as possible.
• If the patient could be pregnant, other treatments may be preferable.
• Lindane Lotion should be used for scabies only.
• The skin should be clean and without any other lotion, cream, or oil on it. Oils can make the Lindane Lotion go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).
• Wait at least 1 hour after bathing or showering before putting Lindane Lotion on the skin. Wet or warm skin can make the Lindane Lotion go through skin faster.
• Information for Use:
  • Shake Lindane Lotion well.
  • Put Lindane Lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Lindane Lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
  • Use only a single application, applied as a very thin layer over all skin from the neck down.
  • Close the bottle with the leftover Lindane Lotion and immediately throw it away in a trash can out of the reach of children.
  • Do not use any covering over the applied Lindane Lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
  • Wash the Lindane Lotion completely off after 8 to 12 hours. Never leave Lindane Lotion on the skin for more than 12 hours. Warm, but not hot water can be used. Lindane Lotion will not kill any more scabies after 8 to 12 hours, but may cause serious health problems.
  • Keep Lindane Lotion away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if you have open wounds, cuts or sores that are present, unless specifically directed by the prescribing physician.
  • All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • The patient may still itch after using Lindane Lotion. This does not mean the medicine did not work. Even after all the scabies (mites) are dead, they can still make the skin itch for a few weeks. Lindane Lotion sometimes makes this itch even worse. Other treatments can be used to soothe the itch. Do not use more Lindane Lotion.
  • The patient should contact the physician with any questions or concerns about his or her condition or use of the Lindane Lotion.

Oils may enhance absorption of Lindane, therefore, patients or caregivers applying Lindane Lotion should be warned about simultaneous use of creams, ointments, or oils. In addition, there are many drugs that may lower the seizure threshold, and Lindane Lotion 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:

• Antipsychotics
• Antidepressants
• Theophylline
• Cyclosporine, mycophenolate mofetil, tacrolimus capsules
• Penicillins, imipenem, quinolone antibiotics
• Chloroquine sulfate, pyrimethamine
• Isoniazid
• Meperidine
• Radiographic contrast agents
• Centrally active anticholinesterases
• Methocarbamol

Pregnancy Category C

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 Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Lindane Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Lindane is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to lindane during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.

Animal data suggest that lindane exposure of the fetus may increase the likelihood of neurologic developmental abnormalities (see below), 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.

Data

When rats received lindane in the diet from day 6 of gestation through day 10 of lactation, reduced pup survival, decreased pup weight and decreased weight gains during lactation, increased motor activity and decreased motor activity habituation were seen in pups at 5.6 mg/kg (2 times the estimated human exposure) but not at 1.2 mg/kg. An increased number of stillborn pups was seen at 8 mg/kg, and increased pup mortality was seen at 5.6 mg/kg. No gross abnormalities were seen in this study or in a study in which rabbits received up to 20 mg/kg lindane by gavage on gestation day 6–18 (up to 10 times the human exposure on a body surface area comparison and assuming 50% rabbit oral bioavailability and 10% human bioavailability).

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 when Lindane Lotion is applied topically to the chest area. Nursing mothers who require treatment with Lindane Lotion should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant while Lindane Lotion is applied, as well as to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following 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 Lotion is applied to the body. Infants and children may be at an even higher risk due to immaturity of organ systems such as skin and liver. Lindane Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Lindane Lotion is indicated only for the treatment of scabies; patients with lice should use Lindane Shampoo according to the labeled instructions.

There have been no studies of Lindane Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Lindane Lotion. 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.