Scabex-S

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Scabex-S uses

Scabex-S consists of Cetrimide, Lindane.

Lindane:


INDICATIONS AND USAGE

Scabex-S (Lindane) Lotion is indicated for the treatment of scabies (infestations of Sarcoptes scabei ) only in patients who:

  • cannot tolerate other approved therapies, or
  • have failed treatment with other approved therapies.

Scabex-S (Lindane) Lotion should be used in the context of an overall scabies management program that includes:

  • Microscopic evaluation of skin scrapings to confirm the diagnosis.
  • Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed Scabex-S (Lindane) Lotion only if they either have failed to respond to adequate doses of other approved therapies or are intolerant of other approved therapies.
  • Washing of all recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels in very hot water or dry-cleaned.

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.

CONTRAINDICATIONS

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.

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WARNINGS

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.

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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

  • This product can be poisonous if misused.
  • Other important information is found in the Medication Guide, which by law, must be dispensed with Scabex-S (Lindane) Lotion.
  • If someone other than the patient will be applying Scabex-S (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 Scabex-S (Lindane).
  • If the person applying Scabex-S (Lindane) Lotion could be pregnant, contact with Scabex-S (Lindane) Lotion should be avoided as much as possible.
  • If the patient could be pregnant, other treatments may be preferable.
  • Scabex-S (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 Scabex-S (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 Scabex-S (Lindane) Lotion on the skin. Wet or warm skin can make the Scabex-S (Lindane) Lotion go through skin faster.
  • Information for Use:
    • Shake Scabex-S (Lindane) Lotion well.
    • Put Scabex-S (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 Scabex-S (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 Scabex-S (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 Scabex-S (Lindane) Lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
    • Wash the Scabex-S (Lindane) Lotion completely off after 8 to 12 hours. Never leave Scabex-S (Lindane) Lotion on the skin for more than 12 hours. Warm, but not hot water can be used. Scabex-S (Lindane) Lotion will not kill any more scabies after 8 to 12 hours, but may cause serious health problems.
    • Keep Scabex-S (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 Scabex-S (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. Scabex-S (Lindane) Lotion sometimes makes this itch even worse. Other treatments can be used to soothe the itch. Do not use more Scabex-S (Lindane) Lotion.
    • The patient should contact the physician with any questions or concerns about his or her condition or use of the Scabex-S (Lindane) Lotion.

Drug Interactions

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:

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

Carcinogenesis, Mutagenesis, and Fertility

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.

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.

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.

Data

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).

Nursing Mothers

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.

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 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.

Geriatric Use

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.

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ADVERSE REACTIONS

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.

Postmarketing Experience

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.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

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.

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HOW SUPPLIED

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).

REFERENCES

  • Feldmann, R.J. and Maibach, H.I., Toxicol. Applied. Pharmacol., 28:126, 1974.
  • Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966.
  • Ginsburg, C.M., et al., J. Pediatr. 91:6, 998–1000, 1977.
  • FDA AERS database search, January 2003

Rx Only

Product No.: 8833

Manufactured For: Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09

PHARMACIST-PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

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.

  • Seizures and death can happen in people who use Scabex-S (Lindane) Lotion too much or too often.
  • Seizures can happen in some people even if they use Scabex-S (Lindane) Lotion exactly as directed.

If you or a family member has a seizure while using Scabex-S (Lindane) Lotion, get emergency help right away.

  • Do not use Scabex-S (Lindane) Lotion unless:
    • You have scabies and were treated with another medicine that did not work for you, or
    • You cannot use other safer medicines to treat your scabies.
  • Do not use Scabex-S (Lindane) Lotion more than 1 time to treat an attack of scabies. Do not use Scabex-S (Lindane) Lotion to treat a second attack of scabies that comes soon after the first episode. Using it more than 1 time can cause seizures and death. No one knows a safe time to reuse Scabex-S (Lindane) Lotion. Even if you still itch after using Scabex-S (Lindane) Lotion, do not use more or use it again. Scabies (mites) can make your skin itch for a few weeks even after all of the bugs (mites) are dead.
  • Do not use more Scabex-S (Lindane) Lotion than your doctor tells you.
  • Do not keep Scabex-S (Lindane) Lotion on your skin for more than 8 to 12 hours.
  • Do not put Scabex-S (Lindane) Lotion in your mouth because it is a poison if taken by mouth. If you get Scabex-S (Lindane) Lotion in your mouth or swallow Scabex-S (Lindane) Lotion, call your area Poison Control Center right away and get emergency help.

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:

  • if you do not have scabies. Scabex-S (Lindane) Lotion does not stop you from getting scabies. Scabex-S (Lindane) Lotion only kills the scabies you already have.
  • if you have or have ever had seizures, also called convulsions, "fits" or epilepsy, especially if they have been hard to control.
  • if you used Scabex-S (Lindane) Lotion in the past few months. You should see your doctor if you think you need another treatment.
  • unless it is the only medicine you can use for scabies.
  • if you had a bad reaction to Scabex-S (Lindane) Lotion before. Do not use Scabex-S (Lindane) Lotion again.
  • if you have open sores or crusted (scabby) sores on your skin, or lots of broken skin.
  • if you have head or body lice. These need a different medicine that you use in a different way.
  • if you are allergic to Scabex-S (Lindane) Lotion or any of its ingredients. The active ingredient is Scabex-S (Lindane). See the end of this Medication Guide for a list of all the ingredients in Scabex-S (Lindane) Lotion.
  • if you need to treat a premature or young baby. More Scabex-S (Lindane) can go through the skin of babies and go to their brains where it can harm them.
  • while you are breast-feeding. Scabex-S (Lindane) Lotion can get in your milk and be fed to your baby. Scabex-S (Lindane) Lotion on your skin can also go to your baby. Your baby may get sick. Ask your doctor for a safer medicine. If you use Scabex-S (Lindane) Lotion, pump your breast milk and throw away the milk for at least 24 hours after using the medicine. During this time, feed your baby formula or breast milk you stored from before you used Scabex-S (Lindane) Lotion.

Tell your doctor if you:

  • used Scabex-S (Lindane) Lotion in the past few months.
  • ever had a seizure or problem that could increase your chances of getting a seizure (like a head injury, tumor in your brain or spinal cord, cirrhosis of the liver, or heavy alcohol drinking.)
  • have HIV or AIDS. Scabex-S (Lindane) Lotion may cause seizures even if you never had them before.
  • are pregnant. Scabex-S (Lindane) Lotion can reach your baby and may harm it. Ask your doctor for a safer medicine. Use Scabex-S (Lindane) Lotion only if needed.
  • have a sexual partner. Your partner should get checked and treated for scabies so they don't give them back to you. Don't share your Scabex-S (Lindane) Lotion with your partner.

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:

  • Make sure you know how to use it exactly as your doctor prescribes.
  • If you are putting Scabex-S (Lindane) Lotion on another person, wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves because more Scabex-S (Lindane) can go through that kind of glove. Wash your hands well when you are done.
  • Make sure your skin is clean and does not have any other lotion, cream, or oil on it. Oils can make Scabex-S (Lindane) Lotion go through your skin faster and may increase the risk of seizures.
  • Wait for at least 1 hour after bathing or showering before you put Scabex-S (Lindane) Lotion on your skin. Wet or warm skin can make the Scabex-S (Lindane) Lotion go through your skin faster and may increase the risk of seizures.

When you put it on:

  • Shake the bottle of Scabex-S (Lindane) Lotion well.
  • Put Scabex-S (Lindane) Lotion under your fingernails, because the scabies really like to stay there. Trim your fingernails short. Use a toothbrush to get the Scabex-S (Lindane) Lotion under your fingernails. Wrap this toothbrush in paper and throw this toothbrush away. Do not use it in your mouth.
  • Put a very thin layer of the Scabex-S (Lindane) Lotion on your skin from the neck down. You may have some Scabex-S (Lindane) Lotion left in the bottle.
  • Do not cover over the Scabex-S (Lindane) Lotion on your skin with anything that does not breathe, like diapers with a plastic lining, plastic clothes, tight clothes, or blankets.
  • Close the bottle with the leftover Scabex-S (Lindane) Lotion and throw it away in a trash can out of the reach of children.

When you are supposed to wash it off:

  • Wash the Scabex-S (Lindane) Lotion off your skin after 8 to 12 hours. You must wash the Scabex-S (Lindane) Lotion off your body completely. Use warm, but not hot water. Scabex-S (Lindane) Lotion will not kill any more scabies after 8 to 12 hours. After 8 to 12 hours, Scabex-S (Lindane) Lotion can cause serious health problems, such as seizures and death.

After you wash off the Scabex-S (Lindane) Lotion:

  • All recently worn clothing, underwear, pajamas, used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned.
  • Do not use Scabex-S (Lindane) Lotion again. If you think you need to use it again, you must check with your doctor to find out when it is most safe.

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?

  • Do not get Scabex-S (Lindane) Lotion in your eyes. If you do, rinse your eyes with water right away. Get medical help if your eyes keep hurting.
  • Do not let your skin touch other people's skin while you have Scabex-S (Lindane) Lotion on. Make sure your skin does not touch your baby or small child.
  • If you are pregnant, do not use Scabex-S (Lindane) Lotion, or apply Scabex-S (Lindane) Lotion to others unless it is needed and you have talked to your doctor about using it. See the special glove advice below if you have to put Scabex-S (Lindane) Lotion on others.
  • Do not use oils on your skin or hair just before or after using Scabex-S (Lindane) Lotion. Oils include skin lotions and moisturizers, and oil-based hair products and conditioners.
  • Do not get Scabex-S (Lindane) Lotion on your hands if you are putting it on someone else. Wear special gloves made of nitrile, latex with neoprene, or sheer vinyl. Do not use natural latex gloves. Wash your hands well when you are done.

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:

  • Itching skin
  • Burning skin
  • Dry skin
  • A skin rash

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

Manufactured For:

Wockhardt USA, LLC., Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

A50-8833-60

REV. 09-09

Scabex-S pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Scabex-S available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Scabex-S destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Scabex-S Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Scabex-S pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."LINDANE LOTION [MORTON GROVE PHARMACEUTICALS, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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/dailym... (accessed August 28, 2018).
  3. "lindane". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Scabex-S?

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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Review

sdrugs.com conducted a study on Scabex-S, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Scabex-S consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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