Version May 2024
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.
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.
Lindane is contraindicated in premature infants and individuals with known uncontrolled seizure disorders.
Note: Lindane shampoo 1% has been discontinued in the United States for >1 year.
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.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Lindane (United States and Canada: Not available): Pediatric drug information")
Head lice (alternative agent): Note: Although FDA approved, lindane is not recommended for treatment of lice due to safety concerns; use should be avoided if possible (Ref).
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 repeat treatment.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
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
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
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.
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. 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 conditions that increase the risk of seizure (eg, history of seizures, head trauma, CNS tumor) or who are receiving medications that decrease seizure threshold. Due to availability of other effective treatments, lindane is not recommended for the treatment of lice in pediatric patients (AAP [Nolt 2022]; Red Book [AAP 2021]).
Lindane shampoo 1% has been discontinued in the United States for >1 year.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Shampoo, External:
Generic: 1% (60 mL [DSC])
Yes
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.
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.
For topical use only; never administer orally or to mucosal surfaces; avoid contact with eyes.
Shampoo: Prior to application, wash hair with shampoo only and then 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 (oils or other shampoos may increase absorption). Caregivers should apply with gloves (avoid natural latex; may be permeable to lindane; apply with nitrile, latex with neoprene, or sheer vinyl gloves).
Shake well prior to use. Apply shampoo to dry hair and massage into hair for 4 minutes; do not leave on longer than 4 minutes and do not cover with shower cap or towel. After 4 minutes, add small amounts of water to form lather, then immediately rinse lather away with warm (not hot) water, towel dry hair, and comb with a fine-tooth comb to remove nits. Do not leave any lindane shampoo on head, hair, or any skin; caregivers should wash hands after application.
Hazardous agent; use appropriate precautions for handling and disposal (EPA, U-listed).
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.
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.
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]).
None known.
There are no known significant interactions.
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.
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]).
Directly absorbed by parasites and ova through the exoskeleton; stimulates the nervous system resulting in seizures and death of parasitic arthropods
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
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
