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LINDANE SHAMPOO, USP 1% (Alpharma)

Description

Lindane Shampoo, USP 1% is an ectoparasiticide and ovicide effective against Pediculosis capitis (head lice), Pediculosis pubis (crab lice) and their ova. In addition to the active ingredient, lindane, it contains trolamine lauryl sulfate, polysorbate 60, acetone and water to form a cosmetically pleasant shampoo. The pH may be adjusted with Citric Acid and/or Trolamine. Lindane, which is the highly purified gamma isomer of 1, 2, 3, 4, 5, 6, hexachlorocyclohexane, has the following structural formula:

images/10/07701501.jpg

C 6 H 6 Cl 6                                                                               290.83

Clinical Pharmacology

Lindane exerts its parasiticidal action by being directly absorbed into the parasites and their ova. Dale, et al 1 , reported a blood level of 290 ng/mL associated with convulsions following the accidental ingestion of a lindane containing product. Analysis of blood taken from subjects before and after the use of lindane shampoo showed a mean peak blood level of only 3 ng/mL which appeared at six hours and disappeared at eight hours after the shampoo was applied.

Indications and Usage

Because post-treatment pruritus is common and may lead to misuse, lindane shampoo is indicated only for the treatment of patients with pediculosis capitis (head lice) and pediculosis pubis (crab lice) 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.

Contraindications

Lindane shampoo is contraindicated for premature neonates because their skin may be more permeable than full term infants and their liver enzymes may not be sufficiently developed. It is also contraindicated for patients with known seizure disorders and for individuals with a known sensitivity to the product or any of its components.

Warnings

LINDANE PENETRATES HUMAN SKIN AND HAS THE POTENTIAL FOR CNS TOXICITY (SEE CLINICAL PHARMACOLOGY SECTION). LINDANE SHAMPOO SHOULD BE USED ACCORDING TO RECOMMENDED DOSAGE (SEE 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 excitation can be controlled by the administration of pentobarbital, phenobarbital or diazepam.

Precautions

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.

Information for Patients:   Patients must be instructed on the proper use of the medication, especially as to amount applied and duration of use. Patient's Directions for Use must accompany the product.

Laboratory Tests:   No laboratory tests are needed for the proper use of this medication.

Drug Interactions:   Oils may enhance absorption, therefore, avoid using oil treatments, or oil based hair dressings or conditioners immediately before and after applying lindane shampoo.

Carcinogenesis:   Although no studies have been conducted with lindane shampoo, 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 2 , Goto 3 and Hanada 4 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 5 also evaluated the carcinogenic potential of lindane in mice but could find no evidence of lindane carcinogenicity. The National Cancer Institute 6 had also found no evidence of carcinogenicity.

Thorpe and Walker 7 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 in the incidence of hepatoma and thus, considered it a tumorigen.

Orr 8 and Kashyap, et al 9 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 response, 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 shampoo 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 shampoo, if there is any concern, an alternate method of feeding may be used for 4 days.

Pediatric Use:   Refer to the CONTRAINDICATIONS and WARNINGS sections.

Adverse Reactions

Lindane has been reported to cause central nervous stimulation ranging from dizziness to convulsions. Cases of convulsions have been reported in connection with lindane shampoo 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 shampoo is not subject to abuse, nor is there any dependence on the drug.

Overdosage

Overdosage or oral ingestion of lindane shampoo can cause central nervous system excitation and, if taken in sufficient quantities, convulsions may occur.

If accidental ingestion occurs, prompt gastric lavage should be instituted. However, since oils favor absorption, saline cathartics for intestinal evacuation should be given rather than oil laxatives. If central nervous system manifestations occur, they can be antagonized by the administration of pentobarbital, phenobarbital or diazepam.

Dosage and Administration

CAUTION: USE ONLY AS DIRECTED. DO NOT EXCEED RECOMMENDED DOSAGE.

No residual effects of lindane shampoo 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 SHAMPOO FOR HEAD AND PUBIC LICE ONLY. DO NOT USE FOR SCABIES. USE ONLY IN AMOUNTS DIRECTED BELOW. IN NO CASE SHOULD MORE THAN 2 OUNCES BE USED BY ONE PERSON IN ONE APPLICATION. DO NOT INGEST. KEEP AWAY FROM MOUTH AND EYES. DO NOT USE IF OPEN WOUNDS, CUTS OR SORES ARE PRESENT ON SCALP OR GROIN, UNLESS DIRECTED BY YOUR PHYSICIAN.

AVOID USING OIL TREATMENTS, OIL BASED HAIR DRESSINGS OR CONDITIONERS IMMEDIATELY BEFORE AND AFTER APPLYING LINDANE SHAMPOO.

(SHAKE WELL)

  1. BEFORE APPLYING LINDANE SHAMPOO, USE REGULAR SHAMPOO (WITHOUT CONDITIONERS), RINSE AND COMPLETELY DRY HAIR.
  2. USE 1 OUNCE (HALF OF A 2 OUNCE BOTTLE) FOR SHORT HAIR; 1.5 OUNCES (THREE-QUARTERS OF A 2 OUNCE BOTTLE) FOR MEDIUM LENGTH HAIR; AND FULL 2 OUNCE BOTTLE FOR LONG HAIR.
  3. APPLY SHAMPOO DIRECTLY TO DRY HAIR WITHOUT ADDING WATER. WORK THOROUGHLY INTO THE HAIR AND ALLOW TO REMAIN IN PLACE FOR 4 MINUTES ONLY.
  4. AFTER 4 MINUTES, ADD SMALL QUANTITIES OF WATER TO HAIR UNTIL A GOOD LATHER FORMS.
  5. IMMEDIATELY RINSE ALL LATHER AWAY. AVOID UNNECESSARY CONTACT OF LATHER WITH OTHER BODY SURFACES.
  6. TOWEL BRISKLY AND REMOVE NITS WITH NIT COMB OR TWEEZERS.
  7. AVOID UNNECESSARY CONTACT WITH YOUR SKIN IF YOU ARE APPLYING SHAMPOO TO ANOTHER PERSON. IF TREATING MORE THAN ONE PERSON, PERSON APPLYING SHAMPOO (ESPECIALLY PREGNANT AND/OR NURSING WOMEN) SHOULD WEAR RUBBER GLOVES.

RE-TREATMENT IS USUALLY NOT NECESSARY, BUT PRESENCE OF LIVING LICE IN HAIR 7 DAYS AFTER TREATMENT INDICATES THAT RE-TREATMENT MAY BE NECESSARY. DO NOT RE-TREAT WITHOUT THE ADVICE OF A PHYSICIAN.

How Supplied

Lindane Shampoo, USP 1% in patient-size 2 fl oz (59 mL) and pharmacy-size only pint (473 mL) bottles.

SHAKE WELL BEFORE USING.

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

References

  1. Dale, W.E., Curly, A. and Cueto, C. Life Sci 5:47, 1966.
  2. Nagasaki, T., Tomii, S., Mega, T., Marugami, M. and Ito, N. Gann (Cancer) 63(3):373, 1972.
  3. Goto, M., Hattori, M., Miyagawa, T. and Enomoto, M., Chemosphere 6:279, 1972.
  4. Hanada, M., Yatani, C., Miyaji, T., Gann 64:511, 1973.
  5. Weisse, I., and Herbst, M., Toxicol. 7:233, 1977.
  6. Technical Report Series, NCI-CG-TR-14, HEW PUBLICATIONS, No. (NIH) 77-814.
  7. Thorpe, E., and Walker, A.I.T., Food Cosmetic Toxicol. 11:433, 1973.
  8. Orr, J.W., Nature 162:189, 1948.
  9. Kashyap, S.K. et al, J. Environ. Sci. Health 14:305-318, 1979.

Manufactured by

Alpharma USPD Inc.

Baltimore, MD 21244

FORM NO. 0572-02 Rev. 3/00

VC1664

PHARMACIST -- DETACH AND GIVE TO PATIENT

LINDANE SHAMPOO, USP 1%

A SHAMPOO

FOR THE TREATMENT OF HEAD OR PUBIC LICE

CAUTION: USE ONLY AS DIRECTED. DO NOT EXCEED RECOMMENDED DOSE.

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 SHAMPOO FOR HEAD AND PUBIC LICE ONLY. DO NOT USE FOR SCABIES. USE ONLY IN AMOUNTS DIRECTED BELOW. IN NO CASE SHOULD MORE THAN 2 OUNCES BE USED BY ONE PERSON IN ONE APPLICATION. DO NOT INGEST. KEEP AWAY FROM MOUTH AND EYES. DO NOT USE IF OPEN WOUNDS, CUTS OR SORES ARE PRESENT ON SCALP OR GROIN, UNLESS DIRECTED BY YOUR PHYSICIAN.

AVOID USING OIL TREATMENTS, OIL BASED HAIR DRESSINGS OR CONDITIONERS IMMEDIATELY BEFORE AND AFTER APPLYING LINDANE SHAMPOO.

(SHAKE WELL)

  1. BEFORE APPLYING LINDANE SHAMPOO, USE REGULAR SHAMPOO (WITHOUT CONDITIONERS), RINSE AND COMPLETELY DRY HAIR.
  2. USE 1 OUNCE (HALF OF A 2 OUNCE BOTTLE) FOR SHORT HAIR; 1.5 OUNCES (THREE-QUARTERS OF A 2 OUNCE BOTTLE) FOR MEDIUM LENGTH HAIR; AND FULL 2 OUNCE BOTTLE FOR LONG HAIR.
  3. APPLY SHAMPOO DIRECTLY TO DRY HAIR WITHOUT ADDING WATER. WORK THOROUGHLY INTO THE HAIR AND ALLOW TO REMAIN IN PLACE FOR 4 MINUTES ONLY.
  4. AFTER 4 MINUTES, ADD SMALL QUANTITIES OF WATER TO HAIR UNTIL A GOOD LATHER FORMS.
  5. IMMEDIATELY RINSE ALL LATHER AWAY. AVOID UNNECESSARY CONTACT OF LATHER WITH OTHER BODY SURFACES.
  6. TOWEL BRISKLY AND REMOVE NITS WITH NIT COMB OR TWEEZERS.
  7. AVOID UNNECESSARY CONTACT WITH YOUR SKIN IF YOU ARE APPLYING SHAMPOO TO ANOTHER PERSON. IF TREATING MORE THAN ONE PERSON, PERSON APPLYING SHAMPOO (ESPECIALLY PREGNANT AND/OR NURSING WOMEN) SHOULD WEAR RUBBER GLOVES.

RE-TREATMENT IS USUALLY NOT NECESSARY, BUT PRESENCE OF LIVING LICE IN HAIR 7 DAYS AFTER TREATMENT INDICATES THAT RE-TREATMENT MAY BE NECESSARY. DO NOT RE-TREAT WITHOUT THE ADVICE OF A PHYSICIAN.

                                                                                VC1664

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