Lindane (Monograph)

Drug class: Scabicides and Pediculicides
CAS number: 58-98-9

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 lindane^{117 118} 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}

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

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 Spectrum

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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

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