What happens if I overdose Lencid?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody urine; irregular heartbeat; nausea; restlessness; seizures; unsteadiness; vomiting. Lencid shampoo may be harmful if swallowed.
Proper storage of Lencid shampoo:
Store Lencid shampoo at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not freeze. Keep Lencid shampoo out of the reach of children and away from pets.
Overdose of Lencid in details
Contact the closest Poison Control Center in the event of suspected overdosage with Lencid Lotion.
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 (CNS) manifestations occur, they may be antagonized by the administration of pentobarbital, phenobarbital, or diazepam.
What should I avoid while taking Lencid?
Avoid sexual or intimate contact with others until the infection has been cured. Also avoid sharing hair combs, hair accessories, hats, clothing, bed linens, and other articles of personal use. The infections are highly contagious.
Do not use more of this medication than is recommended. Using more than the prescribed amount of Lencid topical may cause seizures or other dangerous side effects.
Do not apply this medication to the face, eyes, nose, or mouth. Flush with water if you get medication in any of these areas. Seek medical attention if Lencid topical is ingested or if irritation is persistent.
Do not apply Lencid topical to open cuts or wounds. Doing so could cause too much medication to be absorbed by the body, which could be very dangerous.
To prevent reinfection, wash all clothing, hats, bed clothes, bed linens, hair brushes, and combs in hot water with a strong cleanser.
Lencid warnings
Seizures and deaths have been reported following Lencid 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 Lencid Lotion that a second dose of Lencid Lotion can be safely applied.
There have been cases of adverse events reported for Lencid Lotion and Lencid Shampoo in which a serious outcome (hospitalization, disability or death) has occurred. In approximately 20% of the total reported cases, Lencid 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 Lencid use. Lencid 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 Lencid. Most of these adverse events occurred with Lencid 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. 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 Lencid 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.
Patients should be instructed on proper use of Lencid 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 Lencid Lotion Medication Guide must be given to the patient each time Lencid Lotion is dispensed, as required by law.
What should I discuss with my healthcare provider before taking Lencid?
Do not use Lencid topical without the first talking to your doctor if you
- have ever had an allergic or bad reaction to it;
- have epilepsy or another seizure disorder;
- have many open sores or broken skin;
- have used Lencid lotion or shampoo in the last few months;
- have HIV or AIDS;
- have risk factors for seizures such as a head injury, tumor in the brain or spinal cord, cirrhosis of the liver, or heavy alcohol use; or
- are treating an infant or baby, an elderly person, or an adult or child who weighs less than 110 pounds (50 kg).
You may not be able to use Lencid topical, or you may require a dosage adjustment or special monitoring during treatment.
Lencid topical is in the pregnancy category C. This means that it is not known whether Lencid topical will be harmful to an unborn baby. Do not use Lencid topical without first talking to your doctor if you are pregnant or could become pregnant during treatment.
Lencid passes into breast milk, and may be harmful to a nursing baby. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
Lencid topical may have increased side effects when used by elderly individuals. Talk to your doctor before using Lencid topical if you are 65 years of age or older.
Lencid precautions
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 Lencid Lotion.
- If someone other than the patient will be applying Lencid 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 Lencid.
- If the person applying Lencid Lotion could be pregnant, contact with Lencid Lotion should be avoided as much as possible.
- If the patient could be pregnant<, other treatments may be preferable.
- Lencid 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 Lencid 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 Lencid Lotion on the skin. Wet or warm skin can make the Lencid Lotion go through skin faster.
- Information for Use:
- Shake Lencid Lotion well.
- Put Lencid Lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Lencid 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 Lencid Lotion and immediately throw it away in a trash can out of the reach of children.
- Do not use any covering over the applied Lencid Lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
- Wash the Lencid Lotion completely off after 8 to 12 hours. Never leave Lencid Lotion on the skin for more than 12 hours. Warm, but not hot water can be used. Lencid Lotion will not kill any more scabies after 8 to 12 hours, but may cause serious health problems.
- Keep Lencid 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 Lencid Lotion. This does not mean the medicine did not work. Even after all the scabies (bugs) are dead, they can still make the skin itch for a few weeks. Lencid Lotion sometimes makes this itch even worse. Other treatments can be used to soothe the itch. Do not use more Lencid Lotion.
- The patient should contact the physician with any questions or concerns about his or her condition or use of the Lencid Lotion.
Carcinogenesis, Mutagenesis, and Fertility: Although no studies have been conducted with Lencid Lotion, 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 (Lencid) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of Lencid. The results of mutagenicity tests in bacteria do not indicate that Lencid is mutagenic. Lencid 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 casual relationship.
Lencid Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Lencid Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Lencid is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to Lencid during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.
Animal data suggest that Lencid exposure of the fetus may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected in humans when Lencid 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 Lencid 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 Lencid 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).
Nursing Mothers: Lencid is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if Lencid is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when Lencid Lotion is applied topically to the chest area. Nursing mothers who require treatment with Lencid Lotion should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant while Lencid Lotion is applied, as well as 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 Lencid 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. Lencid Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Lencid Lotion is indicated only for the treatment of scabies; patients with lice should use Lencid Shampoo according to the labeled instructions.
Geriatric Use: There have been no studies of Lencid Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Lencid Lotion. Two patients died within 24 hours of Lencid Lotion application, and the third patient died 41 days after application of Lencid 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 Lencid Lotion treatment for scabies was administered.
REFERENCES
4. FDA AERS database search, January 2003
What happens if I miss a dose of Lencid?
Lencid topical is only applied once, so you are not likely to miss a dose.
References
- DailyMed. "LINDANE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "lindane". http://www.drugbank.ca/drugs/DB00431 (accessed September 17, 2018).
- Safe Work Australia - HCIS. "lindane (ISO): The Hazardous Chemical Information System (HCIS) at the Safe Work Australia is a database of chemical classifications and workplace exposure standards. It allows users to find information on chemicals that have been classified in accordance with the GHS or which have an Australian Workplace Exposure Standard.". http://hcis.safeworkaustralia.gov.au... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
