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Lindane Lotion

Lindane(lindane) – Various

BOXED WARNING

Used only for patients who are intolerant of or have failed first-line therapy with safer medications. Seizures and deaths reported with repeat or prolonged use, rarely with single application. Caution in infants, children, elderly, individuals with other skin conditions, and those who weigh <110 lbs (50kg) due to risk of serious neurotoxicity. Contraindicated in premature infants and those with uncontrolled seizure disorders. Instruct on proper use and inform that itching occurs after successful killing of scabies or lice and is not necessarily an indication for retreatment.

THERAPEUTIC CLASS

Ectoparasiticide/ovicide

INDICATIONS

(Lot) Treatment of scabies (infestations of Sarcoptes scabei) in patients who cannot tolerate other approved therapies, or failed treatment with other approved therapies. (Shampoo) Treatment of head lice (infestations of Pediculus humanus capitis), crab lice (infestations of Pthirus pubis) and their ova in patients in patients who cannot tolerate other approved therapies, or failed treatment with other approved therapies.

ADULT DOSAGE

Adults: (Lot) Apply a thin layer all over skin from neck down; apply only once. Usual: 1 oz. is sufficient for an average adult. Max: 2 oz. for larger adults. Wash off after 8-12 hrs. Do not retreat. (Shampoo) Usual: 1 oz. Some may require 2 oz. based on the length and density of hair. Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 min only. Fine hairs along the neck should be given special attention. Add small quantities of water to hair after 4 min until good lather forms then rinse immediately. Avoid unnecessary contact of lather with other body surfaces. Max: 2 oz. for larger adults. Do not retreat.

PEDIATRIC DOSAGE

Pediatrics: (Lot) Apply a thin layer all over skin from neck down; apply only once. Wash off after 8-12 hrs. Do not retreat. (Shampoo) Usual: 1 oz. Some may require 2 oz. based on the length and density of hair. Apply shampoo directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 min only. Fine hairs along the neck should be given special attention. Add small quantities of water to hair after 4 min until good lather forms then rinse immediately. Avoid unnecessary contact of lather with other body surfaces. Do not retreat.

HOW SUPPLIED

Lot, Shampoo: 1% [2 fl. oz.]

CONTRAINDICATIONS

Premature infants, crusted (Norwegian) scabies, other skin conditions (eg, atopic dermatitis, psoriasis) that may increase systemic absorption of the drug, uncontrolled seizure disorders.

WARNINGS/PRECAUTIONS

Adverse events with serious outcomes reported. Caution in those at increased risk of seizure (eg, HIV infection, history of head trauma or prior seizure, CNS tumor, severe hepatic cirrhosis, excessive alcohol use, abrupt alcohol or sedative withdrawal). Avoid contact with eyes; flush immediately with water if contact occurs. Consult physician if irritation or sensitization occurs.

ADVERSE REACTIONS

Neurotoxicity, itching, CNS stimulation (dizziness, seizure), dermatitis, alopecia, headache, pain, paresthesia, pruritus, urticaria.

DRUG INTERACTIONS

Caution with drugs that may lower seizure threshold (eg, antipsychotics, antidepressants, theophylline, cyclosporine, mycophenolate mofetil, tacrolimus cap, penicillins, imipenem, quinolone antibiotics, chloroquine sulfate, pyrimethamine, isoniazid, meperidine, radiographic contrast agents, centrally active anticholinesterases, methocarbamol). (Lot) Avoid simultaneous use of creams, ointments or oils; potential enhanced systemic absorption. (Shampoo) Avoid oil treatments, or oil-based hair dressings or conditioners immediately before and after application due to potential for enhanced systemic absorption.

PREGNANCY

Category C, not for use in nursing.

MECHANISM OF ACTION

Ectoparasiticide/ovicide; exerts parasiticidal action by being directly absorbed into parasites and their ova.

PHARMACOKINETICS

Absorption: (Lot) Cmax=28ng/mL, Tmax=6 hrs. Distribution: Found in breast milk. Elimination: T1/2=18 hrs.

ASSESSMENT

Assess for current infestation with lice/scabies and uncontrolled seizure disorders. Assess for conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for seizures, itching, irritation, sensitization, neurotoxicity, and other adverse reactions.

PATIENT COUNSELING

Inform the patient that the medication can be poisonous if misused. Inform that other important information is found in the Medication Guide. Inform the individual who is applying the treatment to wear gloves made of nitrile, latex with neoprene, or sheer vinyl, and to thoroughly clean hands after applying medication. Instruct to avoid application by pregnant women; if the patient could be pregnant, other treatments may be preferable. Inform that lotion should be used for scabies, and shampoo, for lice only. Instruct not to apply medication to open wounds or sores unless directed by physician. Instruct on proper use of the medication.

ADMINISTRATION/STORAGE

Administration: Topical route. Shake well before using. Refer to PI for instructions for use. Storage: 20-25°C (68-77°F).


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    Lindane Lotion

    Lindane Lotion

    Dosage Form: lotion

    For ProfessionalsSide EffectsInteractionsMore…

    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.)

    Lindane Lotion 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, butylparaben, carrageenan, cetyl alcohol, glyceryl monostearate, methylparaben, perfume compound, purified water, stearic acid and triethanolamine 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:

    C6H6Cl6                            M.W. 290.83

    Lindane Lotion – 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 for Lindane Lotion

    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:

    • Microscopic evaluation of skin scrapings to confirm the diagnosis.
    • Evaluation and treatment of sexual contacts simultaneously. Sexual contacts should be prescribed 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 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)

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

    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:

    • 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 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.

    Lindane Lotion 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 is Lindane Lotion Supplied

    Lindane Lotion USP, 1% is supplied in 2 fl oz (60 mL) NDC 61748-401-02 bottles.

    SHAKE WELL BEFORE USING

    Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

    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

    Manufactured by:

    AL&S, LLC

    De Kalb, MS 39328

                                                                                                                                                              

    Marketed by: 

    VersaPharm Incorporated

    Marietta, GA 30062

     

    IVP40102-00

    Issued: 05-24-2011

     

    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.

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

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

    • Do not use 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 Lindane Lotion more than 1 time to treat an attack of scabies. Do not use 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 Lindane Lotion. Even if you still itch after using 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 Lindane Lotion than your doctor tells you.
    • Do not keep Lindane Lotion on your skin for more than 8 to 12 hours.
    • Do not put Lindane Lotion in your mouth because it is a poison if taken by mouth. If you get Lindane Lotion in your mouth or swallow Lindane Lotion, call your area Poison Control Center right away and get emergency help.

    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:

    • if you do not have scabies. Lindane Lotion does not stop you from getting scabies. 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 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 Lindane Lotion before. Do not use 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 Lindane Lotion or any of its ingredients. The active ingredient is lindane. See the end of this Medication Guide for a list of all the ingredients in Lindane Lotion.
    • if you need to treat a premature or young baby. More lindane can go through the skin of babies and go to their brains where it can harm them.
    • while you are breast-feeding. Lindane Lotion can get in your milk and be fed to your baby. 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 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 Lindane Lotion.

    Tell your doctor if you:

    • used 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. Lindane Lotion may cause seizures even if you never had them before.
    • are pregnant. Lindane Lotion can reach your baby and may harm it. Ask your doctor for a safer medicine. Use 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 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 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:

    • Make sure you know how to use it exactly as your doctor prescribes.
    • If you are putting 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 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 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 Lindane Lotion on your skin. Wet or warm skin can make the Lindane Lotion go through your skin faster and may increase the risk of seizures.

    When you put it on:

    • Shake the bottle of Lindane Lotion well.
    • Put Lindane Lotion under your fingernails, because the scabies really like to stay there. Trim your fingernails short. Use a toothbrush to get the 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 Lindane Lotion on your skin from the neck down. You may have some Lindane Lotion left in the bottle.
    • Do not cover over the 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 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 Lindane Lotion off your skin after 8 to 12 hours. You must wash the Lindane Lotion off your body completely. Use warm, but not hot water. Lindane Lotion will not kill any more scabies after 8 to 12 hours. After 8 to 12 hours, Lindane Lotion can cause serious health problems, such as seizures and death.

    After you wash off the 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 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 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?

    • Do not get 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 Lindane Lotion on. Make sure your skin does not touch your baby or small child.
    • If you are pregnant, do not use Lindane Lotion, or apply 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 Lindane Lotion on others.
    • Do not use oils on your skin or hair just before or after using Lindane Lotion. Oils include skin lotions and moisturizers, and oil-based hair products and conditioners.
    • Do not get 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 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:

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

    These are not all of the possible side effects of Lindane Lotion. For more information, ask your doctor or pharmacist.

    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.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

    What are the ingredients in Lindane Lotion?

    Active Ingredient: Lindane.

    Inactive Ingredients: 2-amino-2-methyl-1-propanol, butylparaben, carrageenan, cetyl alcohol, glyceryl monostearate, methylparaben, perfume compound, purified water, stearic acid and triethanolamine.

    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.

     

    Manufactured by:

    AL&S, LLC

    De Kalb, MS 39328

     

    Marketed by: 

    VersaPharm Incorporated

    Marietta, GA 30062

     

    GVP40102-00

    Issued: 05-24-2011

    PRINCIPAL DISPLAY PANEL-CONTAINER LABEL

    NDC 61748-401-02

    LINDANE

    LOTION

    USP, 1%

    POISON: FOR EXTERNAL USE ONLY

    HARMFUL OR FATAL IF SWALLOWED

    WARNING : KEEP OUT OF REACH OF CHILDREN

    Do not use if the seal

    is broken or missing.

    Rx Only

    NET: 2 fl oz (60 mL)

    LINDANE 

    Lindane Lotion

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61748-401
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LINDANE (LINDANE) LINDANE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    AMINOMETHYLPROPANOL  
    BUTYLPARABEN  
    CARRAGEENAN  
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    METHYLPARABEN  
    WATER  
    STEARIC ACID  
    TROLAMINE  
    Packaging
    # Item Code Package Description
    1 NDC:61748-401-02 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
    1 60 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA087313 12/05/2011
    Labeler - VersaPharm Incorporated (956741896)
    Establishment
    Name Address ID/FEI Operations
    AL&S, LLC 962555715 MANUFACTURE

    Revised: 12/2011   VersaPharm Incorporated

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    Lindane lotion

    Lindane lotion

    Generic Name: lindane (LIN-dane)

    Brand Name: Generic only. No brands available.

    Only use lindane lotion if you have already tried other safer treatments and experienced severe side effects or the treatments did not work. Seizures and death have occurred following repeated or prolonged use of lindane lotion, and rarely after a single use according to the directions. Do not use lindane lotion if you have a history of seizures or certain skin conditions where the skin is irritated or broken (eg, atopic dermatitis, psoriasis) or to treat premature infants. Use lindane lotion with extreme caution to treat infants or children, if you are elderly, or if you weigh less than 110 lbs (50 kg) because you may be at greater risk of serious nervous system side effects. Follow the directions for using lindane lotion very carefully. You may experience symptoms such as continued itching after using lindane lotion, even if it has worked well. If itching continues, contact your doctor. Do not use more of lindane lotion or use lindane lotion more often than prescribed by your doctor.

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Lindane lotion is used for:

    Treating scabies only after safer medicines have failed or have caused side effects.

    Lindane lotion is a scabicide. It works by killing the scabies mites and their eggs.

    Do NOT use lindane lotion if:

    • you are allergic to any ingredient in lindane lotion
    • you have a history of seizures or certain skin conditions in which the skin is irritated or broken (eg, atopic dermatitis, psoriasis) or if you have crusted (Norwegian) scabies
    • you are breast-feeding
    • you have used lindane lotion in the last few months
    • you are treating a premature infant

    Contact your doctor or health care provider right away if any of these apply to you.

    Before using lindane lotion:

    Some medical conditions may interact with lindane lotion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine (especially seizure medicines), herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you weigh less than 110 pounds (50 kg)
    • if you have a history of skin conditions (eg, psoriasis, dermatitis), crusted or broken skin, HIV or AIDS, a history of head trauma or seizures, a brain or spinal cord tumor, or severe liver disease (cirrhosis)
    • if you drink alcohol in excess, are taking sedatives, or have abruptly stopped drinking alcohol or taking sedatives

    Some MEDICINES MAY INTERACT with lindane lotion. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Phenothiazines (eg, thioridazine), isoniazid, sedatives (eg, phenobarbital, diazepam), theophylline, or tricyclic antidepressants (eg, amitriptyline) because side effects of lindane lotion may be increased

    This may not be a complete list of all interactions that may occur. Ask your health care provider if lindane lotion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use lindane lotion:

    Use lindane lotion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Lindane lotion comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get lindane lotion refilled.
    • Lindane lotion is for external use only.
    • Shake well before using.
    • Do not use other creams, lotions, ointments, or oils immediately before or after applying lindane. Oil-based products may increase the absorption of lindane through your skin and into your bloodstream, increasing the risk of serious side effects.
    • Wait at least 1 hour after bathing or showering before using lindane lotion. Wet or warm skin can make lindane lotion go through the skin faster, increasing the risk of serious side effects.
    • Apply a thin layer of lindane lotion over all of the skin from the neck down to the bottoms of your feet.
    • Apply lindane lotion only once. Do not use it again without checking with your doctor.
    • Thoroughly wash the medicine off in a shower or bath with warm (not hot) water after 8 to 12 hours. Never leave lindane lotion on the treated area for more than 12 hours. Leaving it on for a longer than 8 to 12 hours will not kill more scabies, but may cause serious health problems, such as a seizure (and in some cases death). Do not re-treat.
    • Put lindane lotion under the fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply lindane lotion under the fingernails. The toothbrush should be wrapped in paper and thrown away immediately after using. Do not use the same toothbrush in your mouth because this could lead to poisoning.
    • If applying lindane to another person, wear disposable gloves (made of nitrite, latex with neoprene, or sheer vinyl). Do not use natural latex gloves because more lindane can penetrate them. Hands should be thoroughly washed after applying lindane lotion.
    • Do not cover the treated areas with bandages or other dressings that do not breathe, such as diapers with plastic lining, plastic clothes, tight clothes, or blankets.
    • Discard the lindane container (and gloves if you used them) in the trash out of the reach of children and away from pets.
    • If you miss a dose of lindane lotion, use it as soon as you remember. Continue to use it as directed by your doctor.

    Ask your health care provider any questions you may have about how to use lindane lotion.

    Important safety information:

    • Lindane lotion may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to lindane lotion. Using lindane lotion alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
    • Use lindane lotion exactly as directed by your health care provider and only for scabies. Do not exceed the recommended dose or use lindane lotion for longer than prescribed without checking with your doctor.
    • Avoid getting lindane lotion in your eyes, nose, or mouth. Rinse eyes with water immediately if lindane gets into them, and contact your doctor immediately if a burning sensation continues.
    • Do not take lindane lotion by mouth. If you get lindane lotion in your mouth or you swallow it, call your poison control center right away and get emergency help.
    • If you or a family member has a seizure while using lindane lotion, get emergency help right away.
    • Do not use lindane lotion if you have open wounds, cuts, or sores that are present, unless advised to do so by your health care provider.
    • Your health care provider should instruct you on how to properly use lindane lotion, especially the amount to apply, how long to leave it on the treated area, and the need to avoid re-treatment. This product can be poisonous if misused.
    • If you have a sexual partner, your partner should be checked and treated for scabies so you do not contract them again. Do not share lindane lotion with your partner or anyone else.
    • All recently worn clothing, underwear, pajamas, used bed sheets, pillows, stuffed animals, towels, etc. should be washed in very hot water or dry cleaned.
    • Itching may continue for up to several weeks due to sensitivity to mites. This does not indicate treatment failure.
    • Because scabies can be easily transferred from one person to another, all family members and close contacts should be examined.
    • Lindane lotion is used to treat a current scabies infestation only. It cannot be used to prevent future infestations.
    • Do not touch other people’s skin while you have lindane lotion on your skin.
    • Use lindane lotion with caution in the ELDERLY because they may be more sensitive to its effects.
    • Caution is advised when using lindane lotion in CHILDREN because they may be more sensitive to its effects.
    • PREGNANCY and BREAST-FEEDING: It is unknown if lindane lotion can cause harm to the fetus. If you become pregnant while taking lindane lotion, discuss with your doctor the benefits and risks of using lindane lotion during pregnancy. It is unknown if lindane lotion is excreted in breast milk. Do not breast-feed while taking lindane lotion.

    Possible side effects of lindane lotion:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Burning; redness of skin; skin rash; stinging.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; drowsiness; seizures; vomiting.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    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. Lindane lotion may be harmful if swallowed.

    Proper storage of lindane lotion: Store lindane lotion 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 lindane lotion out of the reach of children and away from pets.

    General information:

    • If you have any questions about lindane lotion, please talk with your doctor, pharmacist, or other health care provider.
    • Lindane lotion is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take lindane lotion or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about lindane lotion. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lindane lotion. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using lindane lotion.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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