Lindane

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Lotion, External:

Generic: 1% (60 mL [DSC])

Shampoo, External:

Generic: 1% (60 mL)

Pharmacology

Mechanism of Action

Directly absorbed by parasites and ova through the exoskeleton; stimulates the nervous system resulting in seizures and death of parasitic arthropods

Pharmacokinetics/Pharmacodynamics

Absorption

~10% systemically; absorption higher when applied to weeping or excoriated skin (Ginsburg, 1977)

Metabolism

Hepatic

Excretion

Urine and feces

Time to Peak

Serum: Infants ≥5 months and Children: 6 hours

Half-Life Elimination

Infants ≥5 months and Children ≤8 years (Ginsburg 1977): Healthy skin: 21.4 hours; Infected skin: 17.9 hours

Use: Labeled Indications

Lotion: Treatment of Sarcoptes scabiei (scabies)

Shampoo: Treatment of Pediculus capitis (head lice) and Phthirus pubis (crab lice)

Note: Not recommended for first line-treatment; use should be reserved for patients who are intolerant to or have failed first-line agents.

Contraindications

Hypersensitivity to lindane or any component of the formulation; premature infants; uncontrolled seizure disorders; crusted (Norwegian) scabies or other skin conditions (eg, atopic dermatitis, psoriasis) which may increase systemic absorption

Dosage and Administration

Dosing: Adult

Note: Lindane lotion has been discontinued in the US for more than 1 year.

Scabies: Topical: Apply a thin layer of lotion and massage it on skin from the neck to the toes; after 8-12 hours, bathe and remove the drug; most patients will require 30 mL; larger adults may require up to 60 mL. Do not re-treat. Do not leave on for more than 12 hours. CDC STD guidelines recommend an 8 hour application (CDC [Workowski 2015]).

Head lice, crab lice: Topical: Apply shampoo to dry hair and massage into hair for 4 minutes; add small quantities of water to hair until lather forms, then rinse hair thoroughly and comb with a fine tooth comb to remove nits. Amount of shampoo needed is based on length and density of hair; most patients will require 30 mL (maximum: 60 mL). Do not re-treat.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Although FDA approved, lindane is not recommended as a treatment option for head lice or scabies in pediatric patients <50 kg due to safety concerns (AAP [Devore 2015]; Red Book [AAP 2015]) and use should be avoided if possible. Alternative agents should be considered. Lindane lotion has been discontinued in the US for more than 1 year.

Head lice; second-line: Infants, Children, and Adolescents: Shampoo: Topical: Apply shampoo to dry hair and massage into hair for 4 minutes. After 4 minutes, add small amounts of water to form lather, then immediately rinse lather away, towel dry hair, and comb with a fine tooth comb to remove nits. Amount of shampoo needed is based on length and density of hair; most patients require ≤30 mL; maximum dose: 60 mL. Do not re-treat.

Scabies; second-line: Infants, Children, and Adolescents: Lotion: Topical: Apply a thin layer of lotion and massage it on skin from the neck to the toes. Most patients require ≤30 mL; maximum dose: 60 mL. Wash off after 8 to 12 hours; do not leave on for more than 12 hours. Do not re-treat.

Infants and Children: Wash off 6 hours after application (Pramanik 1979)

Administration

Shake well prior to use. For topical use only; never administer orally. Caregivers should apply with gloves (avoid natural latex, may be permeable to lindane). Rinse off with warm (not hot) water.

Lotion: Apply to dry, cool skin; do not apply to face or eyes. Wait at least 1 hour after bathing or showering (wet or warm skin increases absorption). Skin should be clean and free of any other lotions, creams, or oil prior to lindane application. Do not use on open wounds or sores. Do not use occlusive dressings.

Shampoo: Apply to clean, dry hair. Wait at least 1 hour after washing hair before applying lindane shampoo. Hair should be washed with a shampoo not containing a conditioner; hair and skin of head and neck should be free of any lotions, oils, or creams prior to lindane application. Do not cover with shower cap or towel.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Frequency not defined.

Central nervous system: Ataxia, dizziness, localized burning, neurotoxicity (risk greater in patients <110 lbs [50 kg]), restlessness, seizure, stinging sensation

Dermatologic: Contact dermatitis, eczematous rash

Hematologic & oncologic: Aplastic anemia (CDC 2010)

<1%, postmarketing, and/or case reports: Alopecia, dermatitis, headache, pain, paresthesia, pruritus, urticaria

Warnings/Precautions

Concerns related to adverse effects:

• Neurotoxicity: [US Boxed Warning]: May be associated with severe neurologic toxicities. Seizures and death have been reported with use (may occur with prolonged, repeated, or single use). Use is contraindicated in patients with uncontrolled seizure disorders and in premature infants. Use with caution in infants, small children, the elderly, patients with other skin conditions, patients weighing <50 kg, or patients with a history of seizures, head trauma, or HIV infection; use caution with conditions which may increase risk of seizures or medications which decrease seizure threshold.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment.

Special populations:

• Pediatric: [US Boxed Warning]: Use is contraindicated in premature infants; the skin of premature infants may be more permeable and their liver enzymes may not be fully developed when compared to full-term infants.

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Not a drug of first choice; use only in patients who have failed or cannot tolerate first-line agents. Instruct patients on proper use, including the amount to apply, how long to leave on, and to avoid re-treatment. Itching may occur as a result of killing lice and does not necessarily indicate treatment failure or need for re-treatment. Because of the potential for systemic absorption and CNS side effects, lindane should be used with caution; consider permethrin or crotamiton agent first. Oil-based hair dressing may increase toxic potential. For external use only; avoid contact with face, eyes, mucous membranes, and urethral meatus. For treatment only; not to be used to prevent infestation. Should be used as a part of an overall lice management program.

Pregnancy

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Animal studies suggest possible neurologic abnormalities due to the increased susceptibility of drug and the immature central nervous system of the fetus. Lindane is lipophilic and may accumulate in the placenta. Use in pregnant women has been associated with neural tube defects and mental retardation (CDC [Workowski 2015]).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber dizziness, seizures, or severe skin irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.