Malathion

Clinical summary

Indications and usage INDICATIONS AND USAGE Malathion lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. Dosage and administration DOSAGE AND ADMINISTRATION Apply malathion lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying malathion lotion. Wash hands after applying to scalp. Allow hair to dry naturally - use no electric heat source, and allow hair to remain uncovered. After 8 to 12 hours, the hair should be shampooed. Rinse and use a fine - toothed (nit) comb to remove dead lice and eggs. If lice are still present after 7 - 9 days, repeat with a second application of malathion lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment. Warnings and cautions WARNINGS Malathion lotion is flammable. The lotion and wet hair should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. Allow hair to dry naturally and to remain uncovered after application of malathion lotion. Malathion lotion should only be used on children under the direct supervision of an adult. If malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists. If skin irritation occurs, discontinue use of product until irritation clears. Reapply the malathion lotion, and if irritation reoccurs, consult a physician. Chemical burns including second-degree burns and stinging sensations may occur with the use of malathion lotion. General Keep out of reach of children. Close eyes tightly during product application. If accidentally placed in the eye, flush immediately with water. Use only on scalp hair. Information to Patients Malathion lotion is flammable. The lotion and hair wet with lotion should not be exposed to open flames or electric heat sources, including hair dryers and electric curlers. Do not smoke while applying lotion or while hair is wet. The person applying malathion lotion should wash hands after application. Allow hair to dry naturally and to remain uncovered after application of malathion lotion. Malathion lotion should only be used on children under the direct supervision of an adult. Children should be warned to stay away from lighted cigarettes, open flames, and electric heat sources while the hair is wet. In case of accidental ingestion of malathion lotion by mouth, seek medical attention immediately. If you are pregnant or nursing, you should contact your physician before using malathion lotion. If malathion lotion comes into contact with the eyes, flush immediately with water. Consult a physician if eye irritation persists or if visual changes occur. If skin irritation occurs, wash scalp and hair immediately. If the irritation clears, malathion lotion may be reapplied. If irritation reoccurs, consult a physician. Burns and stinging sensations may occur when using malathion lotion. Apply malathion lotion on the scalp hair in an amount just sufficient to thoroughly wet hair and scalp. Pay particular attention to the back of the head and neck when applying malathion lotion. Anyone applying malathion lotion should wash hands immediately after the application process is complete. Allow hair to dry naturally and to remain uncovered. Shampoo hair after 8 to 12 hours, again paying attention to the back of the head and neck while shampooing. Rinse hair and use a fine - toothed (nit) comb to remove dead lice and eggs. If lice are still present after 7 - 9 days, repeat with a second application of malathion lotion. Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment. Laboratory Tests There are no special laboratory tests needed in order to use this medication. Carcinogenesis Mutagenesis, and Impairment of Fertility Carcinogenesis, mutagenesis and impairment of fertility have not been studied with malathion lotion (0.5% pharmaceutical grade malathion). However, following long-term oral administration of technical grade malathion to rodents via dietary supplementation, increased incidences of hepatocellular neoplastic lesions were observed in B6C3F1 mice dosed for 18 months at malathion doses greater than 1500 mg/kg/day, and in female F344 rats dosed for 2 years at malathion doses greater than 400 mg/kg/day. These tumors occurred only in association with severe hepatic toxicity and chronic suppression of acetylcholinesterase activity, or at doses causing excessive mortality. Based on body surface area, doses at which carcinogenic effects were observed in rodents following life-time exposures to malathion were approximately 14- to 26-fold greater than the maximum dose anticipated in a 10 kg chi