Wednesday, October 19, 2016

Lindane


Class: Scabicides and Pediculicides
CAS Number: 58-98-9



  • Use only in patients who have not responded to or cannot tolerate other recommended therapies.117



  • CNS Toxicity


  • Seizures and deaths have been reported following repeated or prolonged topical application; however, rare cases reported after a single application.117 118 (See CNS Effects under Cautions.)




  • Increased risk of serious neurotoxicity in infants, children, geriatric patients, patients weighing <50 kg, and patients with certain other skin conditions.117 118




  • Contraindicated in premature neonates and patients with uncontrollable seizure disorders.117 118



  • Proper Use


  • Instruct patients or their caregivers on the proper use of shampoo or lotion, including the amount to apply, how soon to wash the drug off, and the importance of avoiding repeated application.117 118




  • Inform patients that pruritus may persist after successful treatment and is not an indication for further treatment.117 118




Introduction

A scabicide and pediculicide.122


Uses for Lindane


Pediculosis


Used as a second-line agent for the topical treatment of pediculosis capitis (head lice infestation) caused by Pediculus humanus var capitis in patients who have not responded to or who cannot tolerate other recommended therapies.103 117


Used as a second-line agent for the topical treatment of pediculosis pubis (pubic lice infestation) caused by Phthirus pubis in patients who have not responded to or cannot tolerate other recommended therapies.117


Not recommended as initial therapy for pediculosis capitis or pediculosis pubis because of reports of resistance and neurotoxicity (e.g., seizures).101 103 104 112 117 (See CNS Effects under Cautions.)


Scabies


Used as a second-line agent for the topical treatment of scabies in patients who have not responded to or cannot tolerate other recommended therapies.104


Not recommended for the treatment of Norwegian scabies because of the risks of neurotoxicity with heavy application and denuded skin.104 117 118 (See CNS Effects under Cautions.)


Not effective in the prophylaxis of scabies; does not prevent infestation or reinfestation.118


Used as treatment of individuals (e.g., household, family, and sexual contacts) who have had close personal contact with a patient with scabies within the previous month.103 104 109 113


Has been used for treatment of scabies epidemics in institutional settings (e.g., nursing homes, hospitals, residential facilities and communities).104 115 However, permethrin is recommended as a scabicide of choice in institutional outbreaks.114


Lindane Dosage and Administration


General


Measures to Avoid Reinfestation and Transmission



  • To avoid reinfestation or transmission following treatment, all clothing, bed linens, and towels used within the last 72 hours should be machine-washed in hot water and dried in a hot dryer or dry-cleaned; fumigation of living areas is not necessary.117 118 119 120 121




  • For lice infestation, it is recommended that items that cannot be laundered or dry-cleaned be removed from contact and sealed in a plastic bag for 10 days.103




  • Combs and brushes used by the infected patient may be disinfected by soaking in hot water (temperature exceeding 53°C) for 5 minutes;103 alternatively, soaking in a pediculicide for 1 hour may be used.102 Combs and brushes may be washed with lindane shampoo, but they should be rinsed thoroughly with water to remove the drug.122



Pediculosis



  • Pruritus does not indicate treatment failure and is not an indication for further treatment.117 118 Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.103 109 113 (See Dermatologic and Sensitivity Reactions under Cautions.)



Scabies



  • Follow-up examinations of patients recommended 2 and 4 weeks after treatment.109 If patient is not clear of new lesions at either examination, it should be considered a treatment failure (secondary to failure to treat all exposed individuals or failure to apply the drug properly).109 If patient is clear of new lesions when examined at 2 weeks but has new lesions at 4 weeks, it should be considered a reinfestation rather than a treatment failure.109




  • Pruritus does not indicate treatment failure and is not an indication for further treatment.117 118 Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.103 109 113 (See Dermatologic and Sensitivity Reactions under Cautions.)




  • Scabies rarely affects the head of adults but may affect the head of infants and young children.122



Administration


Topical Administration


Lindane shampoo is indicated only for the treatment of lice.117 Lindane lotion is indicated only for the treatment of scabies.118


Apply topically to the skin.122


Lindane preparations are for external use only and should not be ingested.117 120


Do not apply to patients with extensive dermatitis or to those with acutely inflamed skin or raw, weeping surfaces.122 Do not use if open wounds, cuts, or sores are present at the site of application.117 118


Avoid contact with the eyes and mouth.117 118 119 120 If contact with the eyes occurs, immediately flush the eyes with water.117 118 120


Not a suitable alternative for infants, young children, pregnant and lactating women, or in those with extensive dermatitis because of the drug’s topical toxicity profile.103 104 (See CNS Effects under Cautions.)


Parents or caregivers who apply lindane on an infected individual should wear gloves made of nitrile, latex with neoprene, or sheer vinyl; natural latex gloves should not be used since lindane can diffuse through natural latex gloves.117 118 119 120 Hands should be thoroughly cleaned after application is completed.119 120


Shampoo

Apply to hair that is clean and completely dry.117 119


Hair may be washed at least 1 hour before applying lindane shampoo with regular shampoo (without conditioner) and dried completely.119


Avoid use of oil treatments or oil-based hair preparations immediately before or after applying lindane shampoo.117 119 (See Oils and Oil-based Preparations under Interactions.)


Apply 30–60 mL of shampoo to hair; use just enough to lightly coat hair and scalp.119 Work shampoo thoroughly into hair and allow to stay in place for 4 minutes.117 Special attention should be given to the fine hairs along the neck and behind the ears.117 After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.117 Avoid unnecessary contact of lather with other body parts.117


One treatment usually is effective in eradicating pediculosis capitis and pediculosis pubis.117 118


If symptoms persist, do not retreat with lindane because of concerns about neurotoxicity.117 118 (See CNS Effects under Cautions.) Retreatment with an alternative pediculicide may be appropriate at the advice of the clinician if live lice or nits are detected after 1 week.117 118


For further information on application of lindane shampoo, consult manufacturer’s patient information.119


Lotion

Apply a thin layer of lotion to skin that is clean and free of any creams, ointments, or oil.118 120 120 Do not apply to the skin immediately after a bath or shower;104 118 patients should wait at least 1 hour after bathing or showering and the skin should be completely dry before applying lotion.118 120 (See Oils and Oil-based Preparations under Interactions.)


Apply uniformly and gently massage into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).120 Do not apply to the face, eyes, mucous membranes, or urethral meatus.122 After 8–12 hours, completely wash lotion off the body using warm (not hot) water.118 120 Do not leave lotion on the skin for >12 hours.118


One treatment usually is successful.117 118 If symptoms persist, do not retreat with lindane because of concerns about neurotoxicity.117 118 Additional treatment with an alternative scabicide generally is warranted only if live mites can be demonstrated.117 118


For further information on application of lindane lotion, consult manufacturer’s patient information.120


Dosage


Pediatric Patients


Use with caution in children weighing <50 kg, especially infants.117 118 (See Pediatric Use under Cautions.)


Pediculosis

Topical

Children ≥2 years of age: Apply about 30–60 mL of shampoo once to hair; amount of shampoo needed depends on the length of the hair (most patients require only 30 mL).117 After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.117


Because of concerns about neurotoxicity, retreatment with lindane is not recommended.117 118 (See CNS Effects under Cautions.)


Scabies

Topical

Children ≥2 years of age: Apply lotion once into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).120


After 8–12 hours, lotion must be completely washed off the body using warm (not hot) water.118 120 Do not leave on the skin for >12 hours.118


Because of concerns about neurotoxicity, retreatment with lindane is not recommended.117 118 (See CNS Effects under Cautions.)


Adults


Pediculosis

Topical

Apply about 30–60 mL of shampoo once to hair; amount of shampoo needed depends on the length of the hair (most patients require only 30 mL).117 After 4 minutes, add small quantities of water to the hair to form a good lather and then immediately and thoroughly rinse hair until all the lather is gone.117


Because of concerns about neurotoxicity, retreatment with lindane is not recommended.117 118 (See CNS Effects under Cautions.)


Scabies

Topical

Apply lotion once into all skin surfaces (entire trunk and extremities) from the neck to the toes (including the soles of the feet).


Approximately 30 mL of the lotion is recommended for an average adult.118


After 8–12 hours, lotion must be completely washed off the body using warm (not hot) water.118 120 Do not leave on the skin for >12 hours.118


Because of concerns about neurotoxicity, retreatment with lindane is not recommended.117 118 (See CNS Effects under Cautions.)


Prescribing Limits


Pediatric Patients


Pediculosis

Topical

Children ≥2 years of age: Do not leave shampoo in the hair for >4 minutes and do not retreat.117


Scabies

Topical

Children ≥2 years of age: Do not leave lotion on the skin for >12 hours and do not retreat.118


Adults


Pediculosis

Topical

Do not leave shampoo in the hair for >4 minutes and do not retreat.117


Scabies

Topical

Do not leave lotion on the skin for >12 hours and do not retreat.118


Special Populations


Hepatic Impairment


No specific dosage recommendations.


Renal Impairment


No specific dosage recommendations.


Geriatric Patients


No specific dosage recommendations.


Cautions for Lindane


Contraindications


Premature neonates.117 118


Uncontrollable seizure disorders.117 118


Norwegian scabies (crusted scabies) and in those with other skin disorders (e.g., atopic dermatitis, psoriasis).117 118


Known sensitivity to lindane or any ingredient in the formulations.117 118


Warnings/Precautions


Sensitivity Reactions


Dermatologic and Sensitivity Reactions

If primary irritation or hypersensitivity occurs, discontinue treatment and remove the drug with soap and water.122


Alopecia,117 118 dermatitis,117 118 pruritus,117 118 and urticaria have been reported.117 118


Pruritus (caused by an acquired sensitivity to the ectoparasites and their products) frequently persists for one to several weeks following treatment, does not indicate treatment failure, and is not an indication for further treatment.117 118 Oral antihistamines and/or topical corticosteroids may be used to help relieve pruritus.103 109 113


Major Toxicities


CNS Effects

Neurotoxicity, including seizures and deaths, has occurred following repeated or prolonged topical application; however, rare cases reported after a single application.117 118 Serious CNS effects have occurred more frequently with lindane lotion than with lindane shampoo.117 118


Infants, children, geriatric patients, patients weighing <50 kg, and patients with certain other skin conditions may be at greater risk of serious neurotoxicity than other individuals.117 118


Dizziness, headache, pain, and paresthesia have been reported.117 118


Use with caution in patients at increased risk of seizure (e.g., patients with HIV infection, a history of head trauma, seizure history, CNS tumor, severe hepatic cirrhosis, excessive alcohol consumption, or concomitant use of agents that lower the seizure threshold [see Specific Drugs under Interactions], or who are undergoing abrupt discontinuance of alcohol or sedatives).117 118


Specific Populations


Pregnancy

Category C.117 118


Lactation

Distributed into milk.117 118 Risk of toxicity if lindane were absorbed through the skin in the course of breast-feeding if the mother has applied lindane to the chest area.117 118 Discontinue nursing for at least 24 hours following application of lindane117 118 and avoid large areas of skin-to-skin contact with the infant while lindane is applied.118


Pediatric Use

Pediatric patients have a higher surface-to-volume ratio than adults; increased risk of greater systemic absorption and serious neurotoxicity following topical application in infants and small children.117 118 In addition, infants and children may be at greater risk than older individuals because of immature organ systems (e.g., skin, liver).117 118


Use not recommended in infants and children <2 years of age.104


Contraindicated in premature neonates, since their skin might be more permeable than full-term neonates and their liver enzymes not sufficiently developed to metabolize lindane.117 118


If used in children, take care to prevent ingestion of the drug as from thumb-sucking (by covering hands and feet).122 Children must not be allowed to apply lindane without adult supervision.122


Geriatric Use

Safety and efficacy not specifically studied in geriatric patients.117 118 However, increased risk of serious and potentially fatal neurotoxicity; use with caution.117 118


Immunocompromised Patients

Increased risk of developing Norwegian scabies in immunocompromised individuals, including those with HIV infection; such patients should be managed in consultation with an expert.104 108 113


Common Adverse Effects


Itching and burning skin, dry skin, skin rash.117 118


Interactions for Lindane


Oils and Oil-based Preparations


Possible pharmacokinetic interaction (increased percutaneous absorption of lindane).117 118 Avoid use of oil treatments or oil-based hair preparations immediately before or after applying lindane shampoo;117 119 lindane lotion should not be applied simultaneously with any other cream (e.g., conditioner), ointment, or oil.117 118 120


Specific Drugs






















































Drug



Interaction



Comments



Antidepressants



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Antipsychotics



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Anticholinesterase agents, centrally active



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Chloroquine sulfate117 118



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Cyclosporine



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Imipenem



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Isoniazid



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Meperidine



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Methocarbamol



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Mycophenolate mofetil



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Penicillins



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Pyrimethamine



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Quinolones



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Radiographic contrast agents



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Tacrolimus



Possible increased risk of seizures117 118



Use concomitantly with caution117 118



Theophylline



Possible increased risk of seizures117 118



Use concomitantly with caution117 118


Lindane Pharmacokinetics


Absorption


Bioavailability


Slowly and incompletely absorbed through intact skin when applied topically, from the GI tract when ingested, and through the mucous membranes when inhaled.122


Following topical application, 5.6–13% (mean 9.3%) of the dose was absorbed systemically.122 Percutaneous absorption usually is greater when the drug is applied to the face, scalp, axillae, neck, scrotum, or damaged or occluded skin.122


Total body application of lindane lotion in infants and children with scabies resulted in mean peak blood concentrations of 28 ng/mL 6 hours after application.117


Special Populations


Increased systemic absorption in patients with Norwegian scabies (crusted scabies); in those with other skin disorders (e.g., atopic dermatitis, psoriasis); and in pediatric patients, especially premature infants.117 118


Distribution


Data suggest a rapid distribution phase followed by a longer elimination phase.117 118


Extent


Stored in body fat.117 118 Lindane is lipophilic and may accumulate in the placenta.117 118


Elimination


Metabolism


Metabolized by the liver.117 118


Elimination Route


Excreted in urine and feces.117 118


Half-life


Approximately 18 hours.117 118


Stability


Storage


Topical


Shampoo and Lotion

15–30°C.117 118


Actions and SpectrumActions



  • Toxic to the parasitic arthropod Sarcoptes scabiei (the causative organism of scabies) and their eggs; also toxic to Pediculus humanus var capitis (head louse), Pediculus humanus var corporis (body louse), and Phthirus pubis (pubic or crab louse), and possibly their nits.122




  • Resistance to lindane may develop in strains of Pediculus humanus var capitis. Although resistance of Sarcoptes scabiei to the drug has been reported, it has not been conclusively demonstrated.122




  • A CNS stimulant when absorbed systemically.122




  • Following absorption through the chitinous exoskeleton of arthropods, presumably stimulates the nervous system, resulting in seizures and death.122



Advice to Patients



  • Importance of using only as directed.117 118




  • Importance of giving a medication guide for lindane lotion or shampoo to the patient each time the product is dispensed as required by law. The medication guides are important parts of the risk management program for the patient.117 118




  • Importance of instructing patients or their caregivers on the proper use of lindane shampoo or lotion, including the amount to apply, how soon to wash the drug off, and the importance of avoiding repeated application of lindane.117 118




  • Importance of advising patients that pruritus may persist after successful treatment of pediculosis or scabies and is not an indication for further treatment.117 118




  • Risk of potentially fatal seizures.122 Importance of following recommended application procedures and not exceeding recommended dosages.122




  • Importance of informing patients that seizures have been reported in patients receiving lindane following a bath; therefore, patients should wait at least 1 hour after bathing or showering before applying lindane lotion.118 120 Patients should wait at least 1 hour after washing their hair before applying lindane shampoo.117 119




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.122




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed;122 necessity of advising women who are breast-feeding of the potential risks and advising them that they should interrupt breast-feeding and express and discard breast milk for at least 24 hours following application of lindane and avoid large areas of skin-to-skin contact with the infant while lindane is applied.118




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name


















Lindane

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Lotion



1%*



Lindane Lotion



Alliant



Shampoo



1%*



Lindane Shampoo



Alliant


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Lindane 1% Lotion (MORTON GROVE PHARMACEUTICALS): 60/$129.99 or 180/$369.97


Lindane 1% Shampoo (MORTON GROVE PHARMACEUTICALS): 60/$125.99 or 180/$359.96



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



101. Brown S, Becher J, Brady W. Treatment of ectoparasitic infections: review of the English-language literature, 1982-1992. Clin Infect Dis. 1995; 20:S104-9. [IDIS 345865] [PubMed 7540875]



102. Mathieu ME, Wilson BB. Lice (pediculosis). In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:2972-3.



103. Committee on Infectious Diseases, American Academy of Pediatrics. 2000 Red book: report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2000:427-31,506-8.



104. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.



105. Anon. Permethrin for scabies. Med Lett Drugs Ther. 1990; 32:21-2. [PubMed 2179695]



106. Wendel K, Rompalo A. Scabies and pediculosis pubis: an update of treatment regimens and general review. Clin Infect Dis. 2002; 35(Suppl 2):S146-51.



107. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Apr 2002. From the Medical Letter website ( ).



108. Rico MJ, Myers SA, Sanchez MR et al. Guidelines of care for dermatologic conditions in patients infected with HIV. J Am Acad Dermatol. 1997; 37:450-72. [IDIS 392270] [PubMed 9308562]



109. Peterson CM, Eichenfield LF. Scabies. Ped Annals. 1996; 25:97-100.



110. Kerl H, Ackerman AB. Inflammatory diseases that simulate lymphomas: cutaneous pseudolymphomas. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:1315-27.



111. Wilson DC, Leyva WH, King LE. Arthropod bites and stings. In: Fitzpatrick TB, Eisen AZ, Wolff K et al, eds. Dermatology in general medicine. 4th ed. New York: McGraw Hill Inc. 1993:2810-26.



112. Anon. Drugs for head lice. Med Lett Drugs Ther. 1997; 39:6-7. [PubMed 9008683]



113. Kolar KA, Rapini RP. Crusted (Norwegian) scabies. Am Fam Physician. 1991; 44:1317-21. [PubMed 1718155]



114. Degelau J. Scabies in long-term care facilities. Infect Control Hosp Epidemiol. 1992; 13:421-5. [PubMed 1640101]



115. Estes SA, Estes J. Therapy of scabies: nursing homes, hospitals, and the homeless. Semin Dermatol. 1993; 12:26-33. [PubMed 7682834]



116. Reviewers’ comments (personal observations) on permethrin 84:04.12.



117. Lindane Shampoo USP, 1% prescribing information. From the FDA web site ( ). Accessed 2003 Apr 4.



118. Lindane Lotion USP, 1% prescribing information. From the FDA web site ( ). Accessed 2003 Apr 4.



119. Medication guide: Lindane shampoo USP, 1%. From the FDA Web site ( ). Accessed 2003 Apr 4.



120. Medication guide: Lindane lotion USP, 1%. From the FDA web site ( ). Accessed 2003 Apr 4.



121. Mathieu ME, Wilson BB. Scabies. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Douglas, and Bennett’s principles and practices of infectious diseases. 5th ed. New York: Churchill Livingstone; 2000:2974-6.



122. AHFS Drug Information 2005. McEvoy, GK, ed. Lindane. Bethesda, MD: American Society of Health-System Pharmacists; 2005: 3400-3.



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