Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
Malathion (UNII: U5N7SU872W) (Malathion - UNII:U5N7SU872W)
Taro Pharmaceuticals U.S.A., Inc.
Malathion
Malathion 0.0005 g in 1 mL
TOPICAL
PRESCRIPTION DRUG
OVIDE Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. OVIDE Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. OVIDE Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.
OVIDE® (malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5293-4. Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Flammable. Keep away from heat and open flame.
Abbreviated New Drug Application
OVIDE- MALATHION LOTION TARO PHARMACEUTICALS U.S.A., INC. ---------- OVIDE (MALATHION) LOTION, 0.5% NDC 51672-5293-4 RX ONLY For topical use only. Not for oral or ophthalmic use. DESCRIPTION OVIDE 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 OVIDE 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 OVIDE Lotion is indicated for patients infected with _Pediculus humanus capitis_ (head lice and their ova) of the scalp hair. CONTRAINDICATIONS OVIDE Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. OVIDE Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle. WARNINGS 1. OVIDE 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 ® 10 19 6 2 or while hair is wet. Allow hair to dry naturally and to remain uncovered after application of OVIDE Lotion. 2. OVIDE Lotion should only b Lees het volledige document