"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
(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.
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):
- This product can be poisonous if misused.
- Other important information is found in the Medication Guide, which by law, must be dispensed with Lindane Shampoo.
- If putting Lindane Shampoo on another person, the person applying shampoo should wear less permeable gloves such as nitrile, latex with neoprene, or sheer vinyl, and thoroughly clean their hands after application. Natural latex should be avoided because it is more permeable to lindane.
- If the person applying Lindane Shampoo could be pregnant, contact with Lindane Shampoo should be avoided as much as possible.
- If the patient could be pregnant, other treatments may be preferable.
- Use Lindane Shampoo for lice only.
- The use of oil treatments, oil based hair dressings or conditioners immediately before and after applying Lindane Shampoo should be avoided. Oils can make the Lindane Shampoo go through the skin faster and possibly increase the risk of neurotoxicity (e.g., seizures).
- Information for Use
- Shake Lindane Shampoo well.
- Hair should be completely dry prior to application of Lindane Shampoo.
- Use only enough Lindane Shampoo to lightly coat the hair and scalp.
- 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 and behind the ears.
- 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.
- Towel briskly and then remove nits with nit comb or tweezers.
- There may be some Lindane Shampoo left in the bottle. Close the bottle with the leftover Lindane Shampoo and immediately throw away the bottle in a trash can out of the reach of children.
- Do not cover the hair with anything that does not breathe, like a shower cap or towel.
- Do not ingest. Keep away from mouth and eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if open wounds, cuts or sores are present, unless specifically directed by your physician.
- Wash all recently worn clothing, underwear and pajamas, hats, and used sheets, pillowcases, and towels in very hot water or dry-clean.
- Patients may still itch after using Lindane Shampoo. This does not mean the medicine did not work. Lindane Shampoo sometimes makes this itch even worse. Other medications can be used to soothe the itch. Do not use more Lindane Shampoo.
- If there are any questions or concerns about the condition or use of the Lindane Shampoo, contact your physician.
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 in vivo 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: 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 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 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. 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.
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 when lindane is applied to the entire body for the treatment of scabies).
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.
4. FDA AERS database search, January 2003This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/22/2008
Additional Lindane Shampoo Information
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