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Lindane: Drug information

Lindane: Drug information
(For additional information see "Lindane: Patient drug information" and see "Lindane: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Appropriate use:

Lindane should only be used in patients who cannot tolerate or have failed first-line treatment with safer medications for the treatment of lice. Instruct patients on the proper use of lindane, the amount to apply, how long to leave it on, and avoiding re-treatment. Inform patients that itching occurs after the successful killing of lice and is not necessarily an indication for re-treatment with lindane.

Neurologic toxicity:

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

Pediatrics:

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

Pharmacologic Category
  • Antiparasitic Agent, Topical;
  • Pediculocide
Dosing: Adult
Head lice, crab lice

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Lindane: Pediatric drug information")

Note: Although FDA approved, lindane is not recommended as a treatment option for head lice 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.

Head lice; second-line

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Shampoo, External:

Generic: 1% (60 mL)

Generic Equivalent Available: US

Yes

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Lindane shampoo: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/LindaneLotionMedGuide.pdf.

Administration: Adult

Topical: 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. 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. Rinse off with warm (not hot) water.

Administration: Pediatric

For topical use only; never administer orally or to mucosal surfaces; avoid contact with eyes. Shake well prior to use. Caregivers should apply with gloves (avoid natural latex, may be permeable to lindane; apply with nitrile, latex with neoprene, or sheer vinyl gloves). Rinse off with warm (not hot) water. Caregivers should wash hands after application.

Shampoo: Apply to clean, dry hair. Wait at least 1 hour after washing and drying 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.

Hazardous Drugs Handling Considerations

Hazardous agent; use appropriate precautions for handling and disposal (EPA, U-listed).

Use: Labeled Indications

Pediculosis capitis: Treatment of Pediculus capitis (head lice).

Pediculosis pubis: Treatment of 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.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Lindane, when used in pediatric patients <10 years of age or weighing <50 kg, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of seizure or spasm (moderate recommendation; low quality of evidence) (PPA [Meyers 2020]).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined:

Dermatologic: Contact dermatitis, skin rash, xeroderma

Hematologic & oncologic: Aplastic anemia (CDC 2010)

Nervous system: Central nervous system stimulation, dizziness, neurotoxicity (risk greater in patients <110 lbs [50 kg]), seizure

Postmarketing:

Dermatologic: Alopecia, dermatitis, pruritus, urticaria

Nervous system: Headache, pain, paresthesia

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

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.

Warnings: Additional Pediatric Considerations

Risk of neurologic toxicities increased in infants, children, and patients <50 kg compared to older and larger patients; risk is also higher if other skin conditions (eg, atopic dermatitis) are present. Due to availability of other effective treatments, lindane is no longer recommended for the treatment of scabies or lice in pediatric patients (AAP [Devore 2015]; Frankowski 2010; Red Book [AAP 2015]). Use is contraindicated in premature infants and patients with uncontrolled seizure disorders. Premature infants have an increased systemic exposure due to increased permeability of skin, larger skin surface area to volume ratio, and immature hepatic development compared to full-term infants; use should be avoided. Use with caution in patients with a history of seizures, head trauma, HIV infection, or with conditions which may increase risk of seizures or medications which decrease seizure threshold.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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 2021]).

Due to toxicity, lindane is not recommended for the treatment of pediculosis during pregnancy (CDC [Workowski 2021]). Pregnant patients should avoid contact with lindane as much as possible if applying to others.

Breastfeeding Considerations

Lindane is present in breast milk.

According to the manufacturer, breastfeeding mothers should interrupt breastfeeding and express and discard milk for at least 24 hours following use. In addition, skin-to-skin contact between the infant and affected area should be avoided. Due to toxicity, lindane is not recommended for the treatment of pediculosis in patients who are breastfeeding (CDC [Workowski 2021]).

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

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

Metabolism: Hepatic

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

Time to peak, serum: Infants ≥5 months and Children: 6 hours

Excretion: Urine and feces

Pricing: US

Shampoo (Lindane External)

1% (per mL): $2.28

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Agalin (PL);
  • Aphtiria (FR);
  • Aprurol (UY);
  • Ascabiol (IN);
  • B.C. Cream (TW);
  • Benhex Cream (NZ);
  • Bexarid (IN);
  • Davesol (EC);
  • Delitex (DE);
  • Demar (VE);
  • Desintan (FI, GB);
  • Elentol (FR);
  • Esoderm (AE);
  • GAB (IN);
  • Gambex (ZA);
  • Gamma-Scab (AR);
  • Gatox (HR);
  • GBHC (IN);
  • Herklin (MX);
  • Hexa-Defital (AR);
  • Hexin (TH);
  • Jacutin (CZ, DE, HN, LU, PL, SG);
  • Kwell (AE, SA);
  • Kwellada (GR);
  • Lencid (BE, LU);
  • Lendianon (BR);
  • Lindano (AR);
  • Lindano-GBHG (PY);
  • Linden Lotion (KR);
  • Milinor (HR);
  • Nedax (BR);
  • Paracid (BE);
  • Parakil (LB);
  • Plomurol (CL);
  • Pruritrat (BR);
  • Quellada (BE, IE, LU);
  • Quellada Cream (AU);
  • Quellada Creme Rinse (AU);
  • Quellada Head Lice Treatment (AU);
  • Quellada Lotion (AU);
  • Sarcoderma (PT);
  • Scabcur (LK);
  • Scabecid (FR);
  • Scabene (PK);
  • Scabi (TW);
  • Scabix (BR);
  • Scaboma (LK, MY, VN);
  • Skabicid (CZ);
  • Somergan (VE);
  • Texa (BE)


For country code abbreviations (show table)
  1. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.
  2. Centers for Disease Control and Prevention (CDC), "Sexually Transmitted Diseases Treatment Guidelines, 2010," MMWR Recomm Rep, 2010, 59(RR-12):1-110. [PubMed 21160459]
  3. Devore CD, Schutze GE, Council on School Health and Committee on Infectious Diseases, American Academy of Pediatrics. Head lice. Pediatrics. 2015;135(5):e1355-1365. Erratum in: Devore CD, Schutze GE, Council on School Health and Committee on Infectious Diseases, American Academy of Pediatrics. Head lice. Pediatrics. 2015;136(4):781-782. [PubMed 25917986]
  4. Frankowski BL and Bocchini JA Jr, “Head Lice,” Pediatrics, 2010, 126(2):392-403. [PubMed 20660553]
  5. Ginsburg CM, Lowry W, and Reisch JS, "Absorption of Lindane (Gamma Benzene Hexachloride) in Infants and Children," J Pediatr, 1977, 91(6):998-1000. [PubMed 72815]
  6. Healthcare Environmental Resource Center (HERC). Pharmaceuticals—Hazardous Waste. http://www.hercenter.org/hazmat/pharma.cfm#listed. Published 2015. Accessed October 23, 2016.
  7. Lindane shampoo [prescribing information]. Parsippany, NJ: Wockhardt USA LLC; September 2009.
  8. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  9. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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