LINDANE LOTION, USP 1%

LINDANE - lindane lotion 
Morton Grove Pharmaceuticals, Inc.

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LINDANE LOTION, USP 1%

Rx only

WARNINGS

Lindane Lotion should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of scabies. (See INDICATIONS AND USAGE.)

Neurologic Toxicity

Seizures and deaths have been reported following Lindane Lotion use with repeat or prolonged application, but also in rare cases following a single application used according to directions. Lindane Lotion should be used with caution for infants, children, the elderly, and individuals with other skin conditions (e.g., atopic dermatitis, psoriasis) and in those who weigh < 110 lbs (50 kg) as they may be at risk of serious neurotoxicity.

Contraindications

Lindane Lotion is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.

Proper Use

Instruct patients on the proper use of Lindane Lotion, the amount to apply, how long to leave it on, and avoiding retreatment. Inform patients that itching occurs after the successful killing of scabies and is not necessarily an indication for retreatment with Lindane Lotion. (See DOSAGE AND ADMINISTRATION.)

DESCRIPTION

Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide. In addition to the active ingredient, lindane, it contains 2-amino-2-methyl-1-propanol, carrageenan, cetyl alcohol, cocoa butter, glyceryl monostearate, methylparaben, propylene glycol, propylparaben, purified water, stearic acid and trolamine to form a lotion. The pH range is between 6.5 and 8.5. Lindane is the gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane having the following structural formula:

Chemical Structure

C6H6Cl6                                                                M.W. 290.83

CLINICAL PHARMACOLOGY

Lindane Lotion, USP 1%, is an ectoparasiticide and ovicide effective against Sarcoptes scabiei (scabies). Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Feldmann and Maibach1 reported approximately 10% systemic absorption of a lindane acetone solution when applied to the forearm of human subjects and left in place for 24 hours. This vehicle was different from the approved product and the percutaneous penetration of lindane is dependent on the vehicle. Therefore, the clinical significance of these observations is unknown. Dale, et al2 reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane-containing product. Ginsburg 3 found the greatest peak blood level of 64 ng/mL, 6 hours after total body application of Lindane Lotion in 1 of 8 non-scabietic pediatric patients. The half-life in blood was determined to be approximately 18 hours.

Data available in the literature suggest that lindane has a rapid distribution phase followed by a longer β-elimination phase.1, 2, 3

INDICATIONS AND USAGE

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

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

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 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 Lindane.

Lindane Lotion does not prevent infestation or reinfestation and should not be used to ward off a possible infestation.

CONTRAINDICATIONS

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 Lindane.

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.

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.

WARNINGS

(See boxed WARNINGS.)

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.

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)

Drug Interactions

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:

Carcinogenesis, Mutagenesis, and Fertility

Although no studies have been conducted with 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 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 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).

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 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.

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 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.

Geriatric Use

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.

ADVERSE REACTIONS

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.

OVERDOSAGE

Contact the closest Poison Control Center in the event of suspected overdosage with 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 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. (See boxed WARNINGS.)

Patients should be provided specific information on use of product. (See PRECAUTIONS: Information for Patients and the Medication Guide.) Patients should be instructed on proper use of 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 Lindane Lotion.

A Lindane Lotion Medication Guide must be given to the patient each time Lindane Lotion is dispensed, as required by law. The Lindane Lotion Medication Guide is an important part of the risk management program for the patient.

HOW SUPPLIED

Lindane Lotion, USP 1% is supplied in patient-size 2 fl oz (60 mL) bottles.

SHAKE WELL BEFORE USING

Store at controlled room temperature, 15 ° – 30 °C (59 ° – 86 °F) [see USP].

REFERENCES

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

Rx Only

Product No.: 8833

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

A50-8833-60
REV. 01-09

PHARMACIST—PATIENT MEDICATION GUIDE PROVIDED BELOW

MEDICATION GUIDE

Lindane (LIHN-dane) Lotion, USP 1%

You must read and follow all instructions before using Lindane Lotion. Read the information you get every time you or a family member get 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 Lindane Lotion, ask your doctor or pharmacist.

What is the most important information I should know about Lindane Lotion?

Lindane Lotion is a poison if you do not use it the right way. Lindane Lotion goes through your skin and may affect your brain and nerves. Lindane Lotion can cause seizures, also called convulsions, "fits" or epilepsy.

If you or a family member has a seizure while using Lindane Lotion, get emergency help right away.

What is Lindane Lotion?

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. Lindane Lotion goes through your skin and kills the scabies and their eggs. Lindane Lotion is used only after safer medicines have not made your scabies go away. The only time Lindane Lotion is used first is when someone cannot use safer medicines, which may include permethrin and crotamiton.

Lindane Lotion is mainly for adults and children who weigh at least 110 pounds. If you weigh less than 110 pounds, use 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 lindane may go through their skin.

Who should not use Lindane Lotion?

Do not use 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 Lindane Lotion. Especially, tell your doctor if you take medicines called sedatives (drugs to help you sleep).

How do I use 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 Lindane Lotion:

You may still itch after you use Lindane Lotion. This does not mean you need more Lindane Lotion. Even after all the scabie bugs (mites) are dead, they can still make your skin itch for a few weeks. 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 Lindane Lotion?

What are the possible side effects of Lindane Lotion?

Lindane Lotion may cause serious side effects such as seizures (convulsions, fits) or death (See the section, "What is the most important information I should know about Lindane Lotion?"). Lindane Lotion can also make you feel sleepy, dizzy, or can cause body shaking that you cannot control.

The most common side effects of Lindane Lotion are:

These are not all of the possible side effects of 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 Lindane Lotion:

Medicines are sometimes prescribed for purposes other than those listed in Medication Guides. Do not use Lindane Lotion for any condition for which it was not prescribed. Do not give Lindane Lotion to other people, even if they have the same symptoms that you have. It may harm them. Keep Lindane Lotion and all medicines out of the reach of children.

This Medication Guide summarizes the most important information about Lindane Lotion. If you want more information, talk with your doctor. You can ask your doctor or pharmacist for information about Lindane Lotion that is written for health professionals.

What are the ingredients in Lindane Lotion?

Active Ingredient: 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 By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053

A50-8833-60
REV. 01-09

PRINCIPAL DISPLAY PANEL - 60 mL Bottle

MGP

NDC 60432-833-60

LINDANE
LOTION,
USP 1%

POISON: FOR EXTERNAL USE ONLY
HARMFUL OR FATAL IF SWALLOWED
WARNING: KEEP OUT OF
REACH OF CHILDREN

Rx Only

NET: 2 fl oz (60 mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

MGP

NDC 60432-833-60

LINDANE
LOTION,
USP 1%

POISON: FOR EXTERNAL USE ONLY
HARMFUL OR FATAL IF SWALLOWED
WARNING: KEEP OUT OF
REACH OF CHILDREN

Rx Only

NET: 2 fl oz (60 mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

LINDANE 
lindane   lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)60432-833
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lindane (Lindane) Lindane10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
propylene glycol 
carrageenan 
methylparaben 
propylparaben 
trolamine 
2-amino-2-methyl-1-propanol 
glyceryl monostearate 
cetyl alcohol 
stearic acid 
cocoa butter 
Product Characteristics
ColorYELLOW ( Pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
160432-833-6060 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08819008/16/1984

Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)
Revised: 06/2009Morton Grove Pharmaceuticals, Inc.