国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
MALATHION (UNII: U5N7SU872W) (MALATHION - UNII:U5N7SU872W)
Karalex Pharma, LLC, Woodcliff Lake, NJ 07677
MALATHION
MALATHION 5 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Malathion Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. Malathion Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Malathion Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle. The safety and effectiveness of Malathion Lotion in children less than 6 years of age has not been established via well-controlled trials.
Malathion Lotion, USP 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 42043-150-23. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Flammable. Keep away from heat and open flame.
Abbreviated New Drug Application
MALATHION LOTION, 0.5%- MALATHION LOTION, 0.5% LOTION KARALEX PHARMA, LLC, WOODCLIFF LAKE, NJ 07677 ---------- MALATHION LOTION, USP 0.5% RX ONLY For topical use only. Not for oral or ophthalmic use. DESCRIPTION Malathion Lotion contains 0.005 g of malathion per mL in a vehicle of isopropyl alcohol (78%), terpineol, dipentene, and pine needle oil. The chemical name of malathion is (±) - [(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester. Malathion has a molecular weight of 330.36, represented by C H O PS , and has the following chemical structure: CLINICAL PHARMACOLOGY Malathion is an organophosphate agent which acts as a pediculicide by inhibiting cholinesterase activity in vivo. Inadvertent transdermal absorption of malathion has occurred from its agricultural use. In such cases, acute toxicity was manifested by excessive cholinergic activity, i.e., increased sweating, salivary and gastric secretion, gastrointestinal and uterine motility, and bradycardia (see OVERDOSAGE). Because the potential for transdermal absorption of malathion from Malathion Lotion is not known at this time, strict adherence to the dosing instructions regarding its use in children, method of application, duration of exposure, and frequency of application is required. INDICATIONS AND USAGE Malathion Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. CONTRAINDICATIONS Malathion Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Malathion Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle. WARNINGS 1. 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 Lotio 阅读完整的文件