DRUGS & SUPPLEMENTS
When are you taking this medicine?
Scabex-S (Lindane) Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:
Scabex-S (Lindane) Lotion should be used in the context of an overall scabies management program that includes:
Caregivers applying this product to patients should wear gloves less permeable to Scabex-S (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 Scabex-S (Lindane).
Scabex-S (Lindane) Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.
Scabex-S (Lindane) Lotion 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 Scabex-S (Lindane).
Scabex-S (Lindane) Lotion 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.
Scabex-S (Lindane) Lotion is contraindicated for patients with known uncontrolled seizure disorders and for individuals with a known sensitivity to the product or any of its components.
Seizures and deaths have been reported following Scabex-S (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 Scabex-S (Lindane) Lotion that a second dose of Scabex-S (Lindane) Lotion can be safely applied.
There have been cases of adverse events reported for Scabex-S (Lindane) Lotion and Scabex-S (Lindane) Shampoo in which a serious outcome (hospitalization, disability or death) has occurred.4 In approximately 20% of the total reported cases, Scabex-S (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 Scabex-S (Lindane) use. Scabex-S (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 Scabex-S (Lindane). Most of these adverse events occurred with Scabex-S (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. 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 Scabex-S (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.
Patients should be instructed on proper use of Scabex-S (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 Scabex-S (Lindane) Lotion Medication Guide must be given to the patient each time Scabex-S (Lindane) Lotion is dispensed, as required by law.
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.
Oils may enhance absorption of Scabex-S, therefore, patients or caregivers applying Scabex-S (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 Scabex-S (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:
Although no studies have been conducted with Scabex-S (Lindane) 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 (lindane) and delta isomers. Both oral and topical applications have been evaluated. Increased incidences of neoplasms were not clearly related to administration of Scabex-S (Lindane). The results of mutagenicity tests in bacteria do not indicate that Scabex-S (Lindane) is mutagenic. Scabex-S (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.
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.
Scabex-S Lotion should be given to pregnant women only if clearly needed. There are no adequate and well-controlled studies of Scabex-S (Lindane) Lotion in pregnant women. There are no known maternal or fetal health risks if the scabies is not treated. Scabex-S (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 Scabex-S (Lindane) during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown.
Animal data suggest that Scabex-S (Lindane) 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 Scabex-S (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.
When rats received Scabex-S (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 Scabex-S (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).
Scabex-S is lipophilic and is present in human breast milk, but exact quantities are not known. There may be a risk of toxicity if Scabex-S (Lindane) is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when Scabex-S (Lindane) Lotion is applied topically to the chest area. Nursing mothers who require treatment with Scabex-S (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 Scabex-S (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 Scabex-S (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. Scabex-S (Lindane) Lotion should be used with extreme caution in patients who weigh less than approximately 110 lbs (50 kg) and especially in infants. Scabex-S (Lindane) Lotion is indicated only for the treatment of scabies; patients with lice should use Scabex-S (Lindane) Shampoo according to the labeled instructions.
There have been no studies of Scabex-S (Lindane) Lotion in the elderly. There are four postmarketing reports of deaths in elderly patients who were treated for scabies with Scabex-S (Lindane) Lotion. Two patients died within 24 hours of Scabex-S (Lindane) Lotion application, and the third patient died 41 days after application of Scabex-S (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 Scabex-S (Lindane) Lotion treatment for scabies was administered.
Scabex-S 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 Scabex-S (Lindane) Lotion was used according to directions. Irritant dermatitis from contact with this product has also been reported.
The following adverse reactions reflect additional postmarketing experience of Scabex-S (Lindane) Lotion. These events include alopecia, dermatitis, headache, pain, paresthesia, pruritus and urticaria. The relationship of some of these events to Scabex-S (Lindane) therapy is unknown.
Contact the closest Poison Control Center in the event of suspected overdosage with Scabex-S (Lindane) 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.
Apply a thin layer of Scabex-S (Lindane) Lotion over all skin from the neck down. One ounce is sufficient for an average adult. Do not prescribe more than 2 ounces for larger adults. Apply only once. Wash off in 8 to 12 hours. Do not retreat.
Patients should be provided specific information on use of product. Patients should be instructed on proper use of Scabex-S (Lindane) Lotion, especially the amount to apply, how long to leave on and the need to avoid retreatment. Patients should be informed that itching occurs after the successful killing of scabies (mites) and continued itching is not necessarily an indication for retreatment with Scabex-S (Lindane) Lotion.
A Scabex-S (Lindane) Lotion Medication Guide must be given to the patient each time Scabex-S (Lindane) Lotion is dispensed, as required by law. The Scabex-S (Lindane) Lotion Medication Guide is an important part of the risk management program for the patient.
Scabex-S (Lindane) Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.
SHAKE WELL BEFORE USING
Store at 20° to 25°C (68° to 77°F).
Product No.: 8833
Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054
Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
PHARMACIST-PATIENT MEDICATION GUIDE PROVIDED BELOW
Scabex-S (Lindane) (LIHN-dane) Lotion, USP 1%
You must read and follow all instructions before using Scabex-S (Lindane) Lotion. Read the information you get every time you or a family member get Scabex-S (Lindane) Lotion. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Scabex-S (Lindane) Lotion, ask your doctor or pharmacist.
What is the most important information I should know about Scabex-S (Lindane) Lotion?
Scabex-S (Lindane) Lotion is a poison if you do not use it the right way. Scabex-S (Lindane) Lotion goes through your skin and may affect your brain and nerves. Scabex-S (Lindane) Lotion can cause seizures, also called convulsions, "fits" or epilepsy.
If you or a family member has a seizure while using Scabex-S (Lindane) Lotion, get emergency help right away.
What is Scabex-S (Lindane) Lotion?
Scabex-S (Lindane) Lotion is a medicine that is used to treat scabies. It kills scabies and their eggs. Scabies are very small bugs (mites) that crawl under your skin, lay eggs, and cause severe itching. Scabex-S (Lindane) Lotion goes through your skin and kills the scabies and their eggs. Scabex-S (Lindane) Lotion is used only after safer medicines have not made your scabies go away. The only time Scabex-S (Lindane) Lotion is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.
Scabex-S (Lindane) Lotion is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds, use Scabex-S (Lindane) Lotion only if your doctor thinks it is really needed. People who weigh less than 110 pounds and the elderly have higher chances for side effects because more Scabex-S (Lindane) may go through their skin.
Who should not use Scabex-S (Lindane) Lotion?
Do not use Scabex-S (Lindane) Lotion:
Tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may increase your chances of having a seizure if you take them while using Scabex-S (Lindane) Lotion. Especially, tell your doctor if you take medicines called sedatives (drugs to help you sleep).
How do I use Scabex-S (Lindane) Lotion?
Before you put it on:
When you put it on:
When you are supposed to wash it off:
After you wash off the Scabex-S (Lindane) Lotion:
You may still itch after you use Scabex-S (Lindane) Lotion. This does not mean you need more Scabex-S (Lindane) Lotion. Even after all the scabie bugs (mites) are dead, they can still make your skin itch for a few weeks. Scabex-S (Lindane) Lotion sometimes makes this itch even worse. Talk to your doctor about things you can do to soothe the itch.
What should I avoid while using Scabex-S (Lindane) Lotion?
What are the possible side effects of Scabex-S (Lindane) Lotion?
Scabex-S (Lindane) Lotion may cause serious side effects such as seizures (convulsions, fits) or death Lotion?"). Scabex-S (Lindane) Lotion can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.
The most common side effects of Scabex-S (Lindane) Lotion are:
These are not all of the possible side effects of Scabex-S (Lindane) Lotion. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General Information about Scabex-S (Lindane) Lotion:
Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Scabex-S (Lindane) Lotion for any condition for which it was not prescribed. Do not give Scabex-S (Lindane) Lotion to other people, even if they have the same symptoms that you have. It may harm them. Keep Scabex-S (Lindane) Lotion and all medicines out of the reach of children.
This Medication Guide summarizes the most important information about Scabex-S (Lindane) Lotion. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Scabex-S (Lindane) Lotion that is written for health professionals.
What are the ingredients in Scabex-S (Lindane) Lotion?
Active Ingredient: Scabex-S (Lindane).
Inactive Ingredients: 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene glycol, propylparaben, purified water, stearic acid and trolamine.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This medication is available only by a prescription from your doctor.
Product No.: 8833
Wockhardt USA, LLC., Parsippany, NJ 07054
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Depending on the reaction of the Scabex-S after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Scabex-S not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Scabex-S addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology