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Lindane (Topical)


VA CLASSIFICATION
Primary: AP300
Secondary: AP900

[Former name—Gamma Benzene Hexachloride]
Commonly used brand name(s): Bio-Well; G-well; GBH; Hexit; Kildane; Kwell; Kwellada; Kwildane; PMS Lindane; Scabene; Thionex.

Another commonly used name is
gamma benzene hexachloride
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Pediculicide—Lindane Shampoo; Lindane Cream; {29}Lindane Lotion{27}{28}{29};

Scabicide—Lindane Cream; Lindane Lotion;

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Pediculosis capitis (treatment) or
Pediculosis pubis (treatment)—Lindane shampoo, [cream] , {29} and [ lotion] {27} {28} {29} are indicated for the treatment of pediculosis (lice) infestations caused by Pediculus humanus var. capitis (head louse) and Phthirus pubis (pubic or crab louse) and their ova. {01}

Scabies (treatment)—Lindane cream and lotion are indicated for the treatment of scabies infestation caused by Sarcoptes scabiei . {02} {03} {29}

Unaccepted
In the U.S., lindane cream and lotion are no longer indicated for the treatment of pediculosis capitis (head lice) or pediculosis pubis (pubic or crab lice). {02} {03}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    290.83

Mechanism of action/Effect:

Lindane is a central nervous system (CNS) stimulant when absorbed systemically. Following absorption through the chitinous exoskeleton of arthropods, lindane is presumed to stimulate the nervous system, resulting in convulsions and death.

Absorption:

Lindane is absorbed significantly through the skin.

Lotion—In one study, a mean peak blood concentration of 28 nanograms per mL occurred in infants and children 6 hours after total body application of lindane lotion for scabies. {02}

Shampoo—In one study, a mean peak blood concentration of 3 nanograms per mL occurred in persons 6 hours after topical use of lindane shampoo. {01}

Half-life:

In one study, the half-life of lindane was 18 hours in infants and children treated for scabies using total body application of lindane lotion. {02}


Precautions to Consider

Carcinogenicity

Studies in animals have not shown lindane to have carcinogenic properties. {01} {02} {03}

Tumorigenicity

In one study, despite the high incidence of tumors in the control group, lindane was thought to be associated with a significant increase in the incidence of hepatoma. {01} {02} {03}

Mutagenicity

Studies have not shown lindane to have mutagenic properties. {01} {02} {03}

Pregnancy/Reproduction

Pregnancy—
Adequate and well-controlled studies in humans have not been done. Because lindane is absorbed through the skin and has the potential for causing CNS toxicity, {01} {02} {03} some clinicians do not recommend the use of lindane during pregnancy. {05} If lindane is used, however, the recommended dosage should not be exceeded in pregnant women, and these women should not be treated more than twice during pregnancy {01} {02} {03}.

Studies in animals have not shown that lindane causes adverse effects on the fetus.

FDA Pregnancy Category B. {01} {02} {03}

Breast-feeding

Problems in humans have not been documented; however, lindane is systemically absorbed and is distributed into breast milk. {01} {02} {03} {23} Although the concentrations found in human blood following topical application of lindane make it unlikely that breast milk will contain amounts of lindane sufficient to cause toxicity, {01} {02} {03} an alternate method of feeding the infant should be used for 2 days. {01} {02} {03} {23} {26}

Pediatrics

Caution is recommended in infants and children, since studies have shown that the potential for toxic effects of topically applied lindane is greater in the young than in adults. {01} {02} {03}

Lindane is not recommended for use in premature neonates, {22} because their skin is likely to {23} be more permeable than that of full-term neonates and their liver enzymes may not be sufficiently developed to metabolize the medication. {01} {02} {03}


Geriatrics


Although appropriate studies on the relationship of age to the effects of lindane have not been performed in the geriatric population, no geriatrics-specific problems have been documented to date. However, some experts believe that absorption of lindane may be increased in the elderly because of possible increased permeability of their skin. {23} {26} In addition, elderly patients with a history of seizure activity may be especially sensitive to the CNS toxicity effects of lindane. {23}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

Skin, scalp, or hair preparations, other, such as creams, lotions, ointments, or oils{01}{02}{03}    (simultaneous application may increase the percutaneous absorption of lindane)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Convulsive disorders    (sufficient systemic absorption of lindane may induce seizures {01} {02} {03} {22} {23})


Sensitivity to lindane
Skin rash or raw or broken skin{01}{02}{03}    (possible increased absorption of lindane {05})




Side/Adverse Effects

Note: Lindane is absorbed through the skin and has the potential for CNS toxicity, especially in infants, children, and possibly {26} the elderly. {01} {02} {03} {23} {26}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Skin irritation not present before therapy —if lindane is applied incorrectly or repeatedly, the incidence of skin irritation is increased{01}{02}{03}{22}
    
skin rash{01}{02}{03}

Symptoms of CNS toxicity
    
Convulsions{01}{02}{03}
    
dizziness,{01}{02}{03} clumsiness, or unsteadiness
    
fast heartbeat
    
muscle cramps
    
nervousness, restlessness, or irritability
    
vomiting



Those indicating need for medical attention if they occur and continue or are bothersome after medication is discontinued
Itching of skin
—acquired sensitivity to mites and their products; may continue for one to several weeks{02}{03}{22}




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Lindane (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to lindane

Pregnancy—Lindane is absorbed through the skin and has the potential for causing toxic effects in the CNS of the fetus; not increasing the amount, frequency, or length of therapy that physician ordered; not being treated more than twice during a pregnancy





Breast-feeding—Lindane is distributed into breast milk; another method of feeding infant should be used for 2 days after use of lindane





Use in children—Caution is recommended, since infants and children are especially sensitive to the effects of lindane; in addition, use is not recommended in premature infants






Use in the elderly—Absorption may be increased in the elderly because of increased permeability of their skin; elderly patients with a history of seizure activity may be especially sensitive to the CNS toxicity effects of lindane

Proper use of this medication
» Poison; importance of keeping away from mouth

» Importance of not using more lindane than the amount prescribed

» Avoiding contact with the eyes

» Not using on open wounds, {22} such as cuts or sores on skin or scalp, to minimize systemic absorption

When applying lindane to another person: Wearing plastic disposable or rubber gloves to prevent systemic absorption, especially if you are pregnant or are breast-feeding

Proper administration:

Reading patient directions carefully before using

If necessary, treating sexual partner or partners, especially, and all members of household, since infestation may spread to persons in close contact; checking with doctor if these persons have not been checked or if there are any questions {23}

For cream or lotion dosage form {23}
For scabies
Washing, rinsing, and drying skin well before using lindane if skin has any cream, lotion, ointment, or oil on it

Drying {22} skin well if warm bath or shower is taken before using lindane

Applying enough lindane to dry skin to cover entire skin surface from neck down; rubbing in well

Leaving lindane on skin for 8 hours {26}

Removing lindane by washing thoroughly

For shampoo dosage form {23}
For lice
Shampooing, rinsing, and drying {22} hair and scalp well before using lindane if hair or scalp has any cream, lotion, ointment, or oil-based product on it
» If applying shampoo in the shower or in the bathtub, making sure shampoo does not run down on other parts of body; also, not applying shampoo in a bathtub where shampoo may run into bath water in which patient is sitting; this minimizes systemic absorption; when rinsing out the shampoo, thoroughly rinsing entire body to remove any shampoo that may have gotten on it {05}

Applying enough to dry {22} hair (1 ounce or less {23} for short hair, 11/2 ounces for medium length hair and 2 ounces or less {23} for long hair) to thoroughly wet the hair and skin or scalp of affected and surrounding hairy areas

Rubbing thoroughly into hair and skin or scalp; allowing to remain in place for 4 minutes

Using just enough water to work up a good lather {22}

Rinsing thoroughly; drying with clean towel

When hair is dry, combing with fine-toothed comb to remove any remaining nits or nit shells

» Not using as a regular shampoo {22}

» Proper dosing

» Proper storage

Precautions while using this medication
To help prevent reinfestation or spreading of the infestation to other persons:

For scabies—Washing in very hot water or dry-cleaning all recently worn underwear and pajamas and used sheets, pillowcases, and towels {26}

For lice—Washing in very hot water or dry-cleaning all recently worn clothing and used bed linens and towels {26}


Side/adverse effects
Risk of systemic absorption greater in infants and children than in adults; use not recommended in premature neonates, because risk of systemic absorption greater than in older infants

Signs of potential side effects, especially skin irritation or rash not present before therapy or CNS toxicity


General Dosing Information
{23}Since lindane has no continuing effect after treatment, it is not effective as a prophylaxis against possible future infestation. {01} {02} {03}
For scabies {23} (using the cream or lotion)
Sexual partners and persons living in the same household should receive prophylactic treatment for scabies, {24} since the signs of scabies can appear as late as 1 to 2 months after exposure {24} and scabies can be transmitted during this period of time. {01} {02} {03} {22} {23} {24}

Although a total body application is considered to be from the neck down including the soles of the feet, scabies may also affect the heads of infants (scabies rarely affects the heads of children or adults). {02} {03} Consideration should be given to treating the head also if the patient is an infant.

If the skin has any cream, lotion, ointment, or oil on it, the skin should be washed, rinsed, and dried well before application of the medication. {02} {03}

If a warm bath or shower is taken before the cream or lotion is used, the skin should be well dried {02} {03} {22} {27} prior to application. The cream or lotion should be applied to dry skin {02} {03} {10} {27} in an amount sufficient to cover the entire body surface from the neck down including the soles of the feet {02} {03} (usually 1 to {23} 2 ounces {02} {03} {10} for an adult). The medication should be left on for 8 hours, {02} {10} {26} {27} then removed by thorough washing. {02} {10} {27}

To help prevent reinfestation or spreading of the infestation, all recently worn underwear and pajamas and used sheets, pillowcases, and towels should be washed in very hot water or dry-cleaned. {26} {27}

For pediculosis {23} (using the shampoo)
Sexual partners and other persons in close contact or living in the same household should be checked for infestation and treated if necessary, since the infestation may spread to persons in close contact. {01} {02} {03} {22} {23} {27}

If the hair or scalp has any cream, lotion, ointment, or oil-based product on it, shampoo, rinse, and dry {22} hair and scalp well before the application of lindane. {01}

A sufficient amount of shampoo should be used on dry {22} {27} hair (1 ounce or less {23} for short hair, 11/2 ounces for medium length hair, and 2 ounces or less {23} for long hair) to thoroughly wet the hair and skin or scalp of the affected and surrounding hairy areas. {09} {27} The shampoo should be rubbed thoroughly into the hair and skin or scalp and allowed to remain in place for 4 minutes. {09} {27} Then, just enough water should be used to work up a good lather. {09} {22} {27} The hair and skin or scalp should be rinsed thoroughly and dried with a clean towel. {09} {27} When the hair is dry, patient should use a fine-toothed comb to remove any remaining nits or nit shells. {01} {09} {27}

Lindane shampoo should not be used as a regular shampoo. {01} {22} {27}

For treatment of eyelashes, petroleum jelly can be applied 3 times a day for 1 week. {22}

To help prevent reinfestation or spreading of the infestation, all recently worn clothing and used bed linens and towels should be washed in very hot water or dry-cleaned. {26} {27}

For treatment of toxicity {22}
Recommended treatment includes

   • If accidental ingestion occurs, it may be life threatening and {23} prompt gastric lavage {01} {02} {03} is recommended.
   • Since oils favor absorption, saline cathartics should be administered rather than oily cathartics for intestinal evacuation. {01} {02} {03}
   • If CNS manifestations occur, they may be treated {05} by the administration of pentobarbital, phenobarbital, or diazepam. {01} {02} {03}



Topical Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling

LINDANE CREAM USP

Usual adult and adolescent dose
[Pediculicide] or
Scabicide
Topical, to the skin, as a 1% cream for one application. {03}


Usual pediatric dose
[Pediculicide] or
Scabicide
Premature neonates: Use is not recommended. {03}

Infants and children: See Usual adult and adolescent dose. {03}



Strength(s) usually available
U.S.—


1% (Rx) [Kwell]

Canada—


1% (Rx) [Kwellada{30}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Poison.
   • For external use only.

Note: When dispensing, include patient instructions.



LINDANE LOTION USP

Usual adult and adolescent dose
[Pediculicide] or
Scabicide
Topical, to the skin, as a 1% lotion for one application. {02}


Usual pediatric dose
[Pediculicide] or
Scabicide
Premature neonates: Use is not recommended. {02}

Infants and children: See Usual adult and adolescent dose. {02}



Strength(s) usually available
U.S.—


1% (Rx) [Bio-Well] [G-well] [Kildane] [Kwell] [Kwildane] [Scabene] [Thionex][Generic]{33}

Canada—


1% (Rx) [GBH] [Kwellada] [{30}PMS Lindane][Generic]{32}

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Poison.
   • For external use only.
   • Shake well.

Note: When dispensing, include patient instructions.



LINDANE SHAMPOO USP

Usual adult and adolescent dose {22}
Pediculicide
Topical, to the scalp or skin, as a 1% shampoo for one application, repeated after seven days if necessary. {23}


Usual pediatric dose
Pediculicide
Premature neonates: Use is not recommended. {01}

Infants and children: See Usual adult and adolescent dose.



Strength(s) usually available
U.S.—


1% (Rx) [Bio-Well] [GBH] [G-well] [Kildane] [Kwell] [Kwildane] [Scabene][Generic]

Canada—


1% (Rx) [GBH] [Hexit] [{31}Kwellada] [{30}PMS Lindane][Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Poison.
   • For external use only.
   • Shake well.

Note: When dispensing, include patient instructions.




Revised: 08/15/1994



References
  1. Kwell Shampoo package insert (Reed & Carnrick—US), Rev 8/87, Rec 6/88.
  1. Kwell Lotion package insert (Reed & Carnrick—US), Rev 8/87, Rec 6/88.
  1. Kwell Cream package insert (Reed & Carnrick—US), Rev 6/86, Rec 6/88.
  1. Hold
  1. Panel comments, 7/87.
  1. Hold
  1. Hold
  1. Hold
  1. Kwell Shampoo package insert (Reed & Carnrick—US), Rev 86, Rec 6/88.
  1. Kwell Lotion package insert (Reed & Carnrick—US), Rec 6/88.
  1. Hold
  1. Hold
  1. GBH Shampoo package insert (Rorer—Canada), Rec 6/88.
  1. GBH Lotion package insert (Rorer—Canada), Rec 6/88.
  1. G-Well Lotion package insert (Goldline-US), Rev 10/81, Rec 5/88.
  1. G-Well Shampoo package insert (Goldline—US), Rev 10/81, Rec 5/88.
  1. Stiefel Labs manufacturer's product list dated 2/88 lists: Scabene Lotion. Scabene Shampoo.
  1. Hold
  1. Hold
  1. Hold
  1. Hold
  1. Panel comments, 12/87.
  1. Panel comments, 9/88.
  1. Scabies; Report of the committee on Infectious Diseases. Red book 1986; Montvale, NJ: Medical Economics Data, 1986: 321-3.
  1. Hold
  1. Dermatology Panel Meeting, 5/89.
  1. PMS Lindane Shampoo and Lotion (Pharmascience—Canada), Rec 5/90.
  1. GBH Shampoo and Lotion (Rorer). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 25th ed. Ottawa: Canadian Pharmaceutical Association, 1990: 435.
  1. Kwellada Cream, Lotion, and Shampoo (R&C). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 25th ed. Ottawa: Canadian Pharmaceutical Association, 1990: 551.
  1. Kwellada Cream, Lotion, and Shampoo (R&C). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 635.
  1. Hexit Shampoo (Odan). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 535.
  1. Lindane Lotion and Shampoo (Ecopharm). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 654.
  1. Personal communication, Shelley Furr—Barre-National, 4/18/94, 8/16/94.
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