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Lindane Lotion
Lindane Lotion, USP 1% is an ectoparasiticide and ovicide effective against Sarcoptes scabiei (scabies). Each gram of Lindane Lotion, USP 1%, for topical administration, contains lindane 10 mg as the active ingredient. In addition, each gram contains the following inactive ingredients: 2-amino-2-methyl-1-propanol; Carrageenan, NF; Cetyl Alcohol, NF; Fragrance; Glyceryl Monostearate, NF; Methylparaben, NF; Propylene Glycol, USP; Propylparaben, NF; Purified Water, USP; Stearic Acid, NE and Trolamine, NF. Lindane, which is the highly purified gamma
isomer of 1,2,3,4,5,6,
hexachlorocyclohexane has the following empirical
formula: C6H6Cl6 with a molecular
weight: M.W. 290.83.
Lindane Lotion exerts its parasiticidal action
by being directly absorbed into the parasites and their ova. Feldmann
and Maibach reported approximately 10% absorption
of a lindane acetone
solution applied to
the forearm and left
in place up to 24 hours. Dale et al reported a blood
level of 290 ng/mL associated with convulsions following the accidental
ingestion of a lindane
containing product. Ginsburg found a mean
peak blood level of 28
ng/mL 6 hours after total body
application of lindane
lotion to scabietic infants
and children. The half-life
was determined to be 18 hours.
Because post-treatment pruritus is common and may lead to misuse, lindane lotion is indicated only for the treatment of patients infested with Sarcoptes scabiei (scabies) who have either failed to respond to adequate doses, or are intolerant of other approved therapies. Reinfestation should be considered carefully before attributing the posttreatment presence of ectoparasites to a failure of response to adequate doses of other approved therapies.
USE ONLY AS DIRECTED. DO NOT EXCEED RECOMMENDED DOSAGE. No residual effects of lindane treatment have been demonstrated, therefore, this product should not be used to ward off a possible infestation. However, sexual contacts should be treated simultaneously. Note: PLEASE READ CAREFULLY. DIRECTIONS FOR USE Warning: THIS PRODUCT CAN BE POISONOUS IF MISUSED. CHILDREN MUST NOT BE ALLOWED TO APPLY THIS DRUG WITHOUT DIRECT ADULT SUPERVISION. USE LOTION FOR SCABIES ONLY. APPLY ONLY ONCE. USE ONLY ENOUGH TO COVER THE BODY IN A THIN LAYER. 1 OUNCE (HALF OF A 2 OUNCE CONTAINER) SHOULD BE ALL THAT IS NEEDED FOR CHILDREN UNDER 6 YEARS OF AGE 1 TO 2 OUNCES FOR OLDER CHILDREN AND ADULTS. DO NOT LEAVE ON FOR MORE T.A. 12 HOURS. DO NOT INGEST. KEEP A.A. FROM MOUTH AND EYES. COVER INFANTS’ HANDS AND FEET DURING TREATMENT TO PREVENT SUCKING AND LICKING OF LOTION. DO NOT USE IF OPEN WOUNDS, CUTS OR SORES ARE PRESENT, UNLESS DIRECTED BY YOUR PHYSICIAN. (Lotion: Shake Well) After one application, itching will continue for several weeks. This is normal and does not require reapplication. If you have any questions or concerns about your condition or use of the lotion, contact your physician. HOW SUPPLIED Lindane Lotion, USP 1 % is supplied in bottles of patient-size 2 fl. oz. (60 mL), pharmacy-size only 1 Pint (473 mL) and pharmacy-size only 1 Gallon (3785 mL). REFERENCES
Lindane has been reported to cause central nervous stimulation ranging from dizziness to convulsions. Cases of convulsions have been reported in connection with Lindane Lotion therapy. However, these incidents were almost always associated with accidental oral ingestion or misuse of the product. In exceedingly rare cases, seizures have been reported when used according to directions. Eczematous eruptions due to irritation from this product have also been reported. Incidence of these adverse reactions is relatively infrequent, occurring in less than 1 in 100,000 patients. Drug Abuse and Dependence: Lindane Lotion is not subject to abuse, nor is there any dependence on the drug.
Oils may enhance absorption. Therefore, simultaneous use of creams,
ointments or oils should be avoided.
LINDANE PENETRATES HUMAN SKIN AND HAS THE POTENTIAL FOR CENTRAL NERVOUS SYSTEM (CNS) TOXICITY (SEE CLINICAL PHARMACOLOGY SECTION). LINDANE LOTION SHOULD BE USED ACCORDING TO RECOMMENDED DOSAGE (SEE DOSAGE AND ADMINISTRATION, DIRECTIONS FOR USE) ESPECIALLY ON INFANTS, PREGNANT WOMEN AND NURSING MOTHERS. ANIMAL STUDIES INDICATE THAT POTENTIAL TOXIC EFFECTS OF TOPICALLY APPLIED LINDANE ARE GREATER IN THE YOUNG. SEIZURES AND, IN RARE INSTANCES, DEATHS HAVE BEEN REPORTED AFTER EXCESS DOSAGE, OVER-EXPOSURE, FREQUENT REAPPLICATIONS, AND ACCIDENTAL AND INTENTIONAL INGESTION OF LINDANE. THESE INSTANCES OF PATIENT MISUSE HAVE BEEN ASSOCIATED WITH LACK OF PATIENT UNDERSTANDING OF DIRECTIONS FOR USE, PRESCRIBING OR DISPENSING EXCESSIVE QUANTITIES, AND IMPROPER REAPPLICATIONS. IN EXCEEDINGLY RARE CASES SEIZURES HAVE BEEN REPORTED WHEN USED ACCORDING TO DIRECTIONS. NO RESIDUAL EFFECTS OF LINDANE TREATMENT HAVE BEEN DEMONSTRATED: THEREFORE, THIS PRODUCT SHOULD NOT BE USED TO WARD OFF A POSSIBLE INFESTATION. If accidental ingestion occurs, prompt gastric lavage is indicated. Because oils may enhance absorption, saline rather than oily cathartics should be used. Central nervous system excitation can be controlled by the administration of pentobarbital, phenobarbital or diazepam.
General Care should be taken to avoid contact with the eyes. If such contact occurs, eyes should be immediately flushed with water. If irritation or sensitization occurs, the patient should be advised to consult a physician. Geriatric Dosage may have to be reduced due to the possibility of increased absorption through elderly skin. Laboratory Tests No laboratory tests are needed for the proper use of this medication. Carcinogenesis, Mutagenesis, Impairment of Fertility Although no studies have been conducted with Lindane Lotion, numerous long-term feeding studies have been conducted in mice and rats to evaluate the carcinogenic potential of the technical grade of hexachlorocyclohexane (BHC) as well as the alpha, beta, gamma (lindane) and delta isomers. Both oral and topical applications have been evaluated. Nagasaki et al, Goto, and Hanada found varying amounts of benign and malignant hepatomas associated with BHC and the alpha, delta and epsilon isomers. None reported a carcinogenic potential for lindane. Tumors were found only in the animals which had received the alpha isomer. Weisse and Herbst also evaluated carcinogenic potential of lindane in mice but could find no evidence of lindane carcinogenicity. The National Cancer Institute also found m evidence of carcinogenicity. Thorpe and Walker compared beta BHC with lindane, dieldrin, DDT and hexabarbital in mice. Despite the unusually high incidence of tumors in the control group, they concluded that 600 ppm of lindane was associated with a significant increase of hepatoma and thus considered it a tumorigen. Orr and Kashyap evaluated the carcinogenic potential in mice of topically applied BHC. In neither study was there any evidence of a tumorigenic or carcinogenic potential associated with topical application of BHC. Mutagenicity tests have been used as predictive information about the carcinogenicity of various chemical compounds. Numerous types of mutagenicity tests have been performed with lindane. The results of these tests do not indicate that lindane is mutagenic. Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction, including multigeneration, studies have been performed in mice, rats, rabbits, pigs and dogs at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to orally administered lindane. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, the recommended dosage should not be exceeded on pregnant women. They should be treated no more than twice during a pregnancy. Nursing Mothers Lindane is secreted in human milk in low concentrations. Studies conducted in the United States as well as in Europe and South America found levels of lindane in human milk ranging from 0 to 113 ppb, as the result of ingestion of foods which had been treated with lindane. There appeared to be no difference in concentrations between country and urban dwellers. Although the levels of lindane found in blood after topical application with Lindane Lotion make it unlikely that amounts of lindane, sufficient to cause serious adverse reactions will be excreted in the milk of nursing mothers who have used Lindane Lotion, an alternate method of feeding may be used for 4 days if there is any concern. Pediatric Use Refer to CONTRAINDICATIONS
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