Lindane

Ectoparasiticides, Including Scabicides
Topical Scabicides

Lindane is administered topically. Do not apply to the face and avoid getting into the eyes. If contact with eyes occurs, immediately flush eyes with water. Do not use if open wounds, cuts or sores are present. Do not ingest.
Caregivers applying these products to another person should wear gloves less permeable to lindane such as nitrile, latex with neoprene or sheer vinyl, and thoroughly clean hands after application. Natural latex gloves should be avoided because they are more permeable to lindane.
Instruct patient on appropriate use of the product; the official Medication Guide of the manufacturer, by law, must be dispensed with the lindane product prescribed.

Lindane Lotion:
Use for the treatment of scabies only.
The skin should be clean and without any other lotion, cream, or oil on it. Oils can increase the risk of systemic absorption of lindane and possibly increase the risk of neurotoxicity (e.g., seizures).
Wait at least 1 hour after bathing or showering before putting the lotion on the skin. Wet or warm skin can increase the risk of systemic absorption of lindane and possibly increase the risk of neurotoxicity (e.g., seizures).
Shake well before use.
Apply lotion under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the same brush in the mouth could lead to poisoning.
Use only a single application, applied as a very thin layer over all skin from the neck down.
Close the bottle with the leftover lotion and immediately throw it away in a trash can out of the reach of children.
Do not use any covering over the applied lotion that does not breathe, like diapers with plastic lining, plastic clothes, tight clothes, or blankets.
Wash completely off after 8 to 12 hours. Warm, but not hot, water can be used. Never leave on for more than 12 hours.
The patient may still itch after using the lotion. This does not mean the medicine did not work. Even after all the scabies are dead, they can still make the skin itch for a few weeks. Other treatments can be used to soothe the itch. Do not use more lindane lotion.

Lindane Shampoo:
Use for the treatment of lice only.
Lice management should include visual inspection to ensure patient is currently infested with live lice (empty egg casings or 'nits' can remain on hair shaft long after true infestation).
The use of oil treatments, oil based hair dressings or conditioners immediately before and after applying the shampoo should be avoided. Oils can increase the risk of systemic absorption of lindane and possibly increase the risk of neurotoxicity (e.g., seizures).
Shake well before use.
The hair should be completely dry prior to application.
Use only enough shampoo to lightly coat the hair and scalp; apply directly to dry hair without adding water. Work thoroughly into the hair and allow to remain in place for 4 minutes only. Special attention should be given to the fine hairs along the neck and behind the ears.
After 4 minutes, add small quantities of water to hair until a good lather forms.
Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces.
Towel briskly and then remove nits with nit comb or tweezers.
Do not cover the hair with anything that does not breathe, like a shower cap or towel.
There may be some shampoo left in the bottle. Close the bottle and immediately throw away the bottle in a trash can out of the reach of children.
Wash clothing, used betting, and towels in very hot water. Personal articles that cannot be washed may be dry-cleaned, sealed in a plastic bag for 4 weeks, or sprayed with a product specifically designed for this purpose.
Evaluate and treat sexual contacts simultaneously.

seizures / Delayed / Incidence not known

contact dermatitis / Delayed / Incidence not known
neurotoxicity / Early / Incidence not known

paresthesias / Delayed / 0-1.0
urticaria / Rapid / 0-1.0
alopecia / Delayed / 0-1.0
pruritus / Rapid / 0-1.0
headache / Early / 0-1.0
xerosis / Delayed / Incidence not known
skin irritation / Early / Incidence not known
rash / Early / Incidence not known
dizziness / Early / Incidence not known
restlessness / Early / Incidence not known
vomiting / Early / Incidence not known
nausea / Early / Incidence not known

Lindane is a poison and causes serious neurotoxicity and seizures if significant amounts of the drug are absorbed systemically; death has occurred in some patients. Toxicities and deaths have been reported following repeat or prolonged application of lindane, but also in rare cases following a single application reportedly used according to directions. A patient with neurotoxicity may feel sleepy, dizzy, experience tremors, or may experience convulsions. Proper use of lindane is essential to ensure safety and to lessen the risk for toxicity. However, neurotoxicity has occurred even under conditions of proper use. Lindane is for external topical use only. Avoid accidental exposure via ingestion, inhalation, or ocular exposure. Do not use in populations or under conditions that contraindicate lindane use. Also, properly store these products; keep out of reach of kids and pets. Contact local emergency services and regional poison control center immediately for instructions on poisoning management in the case of accidental internal exposure to lindane. The recommended dosage of lindane should not be exceeded. An occlusive dressing or covering should not be used over the treated areas. It is not known how soon after application of a single dose that a second dose of can be safely applied. Patients should be instructed on proper use of the specific product, especially the amount to apply, how long to leave it on, and the need to avoid retreatment. Patients should be informed that itching may occur, and even worsen, after the successful killing of scabies. Repeat treatment is usually not necessary.

GBH, Lindane

Rx

Topical scabicide; is the gamma isomer of potent insecticide hexachlorocyclohexane (also known as BHC); used as an ectoparasitacide in scabies and pediculosis (lice). Due to concerns over neurotoxicity, lindane is a second line treatment for those intolerant or unresponsive to other therapies; some patients are more at risk; instruct patient thoroughly on proper drug use; a black-box warning has been issued in the official product labeling.

Apply a thin layer of 1% lotion over all skin from the neck down. One ounce (30 mL) is sufficient for most patients; maximum 60 mL for larger patients. Apply only once. Wash off in 8 to 12 hours. Do not retreat. Use with caution in those less than 50 kg and the elderly. Guidelines suggest as second line therapy due to toxicity.

Apply a thin layer of 1% lotion over all skin from the neck down. One ounce (30 mL) is sufficient for most patients; maximum 60 mL for larger patients. Apply only once. Wash off in 8 to 12 hours. Do not retreat. Use with caution in those less than 50 kg. Guidelines suggest as second line therapy due to toxicity.

Not recommended due to toxicity.

Apply 15 to 30 mL (amount dependent on length/density of hair; 30 mL is sufficient for most patients, some may require 60 mL) to dry hair without adding water. Maximum of 60 mL for larger adults. Work thoroughly into hair and leave in place for 4 minutes only. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces. Apply only once. Do not retreat. Use with caution in those less than 50 kg and the elderly. Guidelines do not recommend for pediculosis pubis.

Apply 15 to 30 mL (amount dependent on length/density of hair; 30 mL is sufficient for most patients, some may require 60 mL) to dry hair without adding water. Maximum of 60 mL for larger patients. Work thoroughly into hair and leave in place for 4 minutes only. After 4 minutes, add small quantities of water to hair until a good lather forms. Immediately rinse all lather away. Avoid unnecessary contact of lather with other body surfaces. Apply only once. Do not retreat. Use with caution in those less than 50 kg. Guidelines do not recommend for pediculosis pubis.

Specific guidelines for dosage adjustments are not available; metabolism of systemically absorbed lindane may be impaired in patients with severe hepatic disease and may increase the risk of neurotoxicity.

Specific guidelines for dosage adjustments are not available.

There are no drug interactions associated with Lindane products.

GBH/Lindane Topical Shampoo: 1%

>= 50 kg: 60 ml topically of shampoo or lotion. 
< 50 kg: Use not recommended.

Use not recommended.

>= 50 kg: 60 ml topically of shampoo or lotion. 
< 50 kg: Use not recommended.

>= 50 kg: 60 ml topically of shampoo or lotion. 
< 50 kg: Use not recommended.

Use not recommended. 
Premature Infants: Use contraindicated.

Mechanism of Action: Lindane (gamma hexachlorocyclohexane) exerts its parasiticidal action by being directly absorbed into the parasites and their ova. The drug, dependent on the vehicle of application, is effective against Pediculosis humanis capitis (head lice), Pthirus pubis (crab lice), Sarcoptes scabiei (scabies), and their ova.When absorbed systemically, lindane is a CNS stimulant, producing adverse effects similar to those of DDT. Hexachlorocyclohexane (also known as BHC), is less toxic to the environment than DDT, undergoing biotransformation to produce chlorophenols. Excessive stimulation of the CNS is probably caused by blockade of the effects of gamma-aminobutyric acid (GABA).

For human use as a scabicide and pediculocide, lindane is applied topically as a lotion or shampoo. Lindane is slowly and incompletely absorbed through intact skin, through the GI tract when ingested, and through mucous membranes when inhaled. According to the manufacturer, the half-life of lindane in the blood was determined to be 18 hours. Data available in the literature suggest that lindane has a rapid distribution phase followed by a longer ß-elimination phase. Lindane is stored in body fats and is significantly metabolized in the liver; 4 major primary metabolites and two major secondary metabolites have been identified. Metabolites are excreted in urine and feces.

Lindane is slowly and incompletely absorbed through intact skin, through the GI tract when ingested, and through mucous membranes when inhaled. Systemic lindane can be identified, however, following topical administration. For example, Feldmann and Maibach reported approximately 10% absorption of a lindane acetone solution applied to the forearm of human subjects and left in place for 24 hours. This vehicle was different from commercially available lindane products and the percutaneous penetration of lindane is known to be dependent on the vehicle of the product. Absorption is greater through damaged or occluded skin; application of lindane should be avoided if skin conditions that might increase systemic absorption are present (see Contraindications). Literature data reveal that systemic absorption of lindane is higher after re-application of lindane versus with initial treatment, indicating that drug accumulation may occur with repeat topical applications.

Lindane is classified as FDA pregnancy risk category C. Use should be avoided in pregnancy when possible; pregnant caregivers should also avoid application of lindane to another person when possible. There are no adequate and well-controlled studies of lindane in pregnant women. There are no known maternal or fetal health risks if the scabies or lice are not treated. Lindane is lipophilic and may accumulate in the placenta. There has been a single case report of a stillborn infant following multiple maternal exposures to lindane during pregnancy. The relationship of the maternal exposures to the fetal outcome is unknown. Animal data suggest that lindane exposure of the fetus may increase the likelihood of neurologic developmental abnormalities, based on findings at systemic exposures close to that expected in humans when lindane lotion is used to treat scabies. The immature central nervous system (as in the fetus) may have increased susceptibility to the effects of the drug.

Lindane is not recommended for use while breast-feeding. Lindane is lipophilic and is present in human breast milk, but exact quantities are not known. Absorption rates of 10% to 90% have been reported depending on the solvents used. Transdermal absorption may also be increased with skin damage. After topical administration, breast milk concentrations in treated lactating women was 60 times higher compared to that untreated women. Guidelines warn against the use of lindane in lactating women and recommend the use of permethrin or pyrethrins with piperonyl butoxide. There may be a risk of toxicity (i.e. neurological side effects) if lindane is ingested from breast milk, or from skin absorption from mother to baby in the course of breast-feeding when lindane is applied topically to the chest area. The manufacturer recommends that nursing mothers who require treatment with lindane should be advised of the potential risks and be counseled to avoid large areas of skin-to-skin contact with the infant during use, as well as to interrupt breast-feeding, with expression and discarding of milk, for at least 24 hours following use. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.