Ovide Information
Ovide (Malathion)
Ovide (Malathion) Description
Ovide (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 CHOPS, and has the following chemical structure:
Ovide (Malathion) Clinical Pharmacology
Malathion is an organophosphate agent which acts as a pediculicide by inhibiting cholinesterase activity . 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 ). Because the potential for transdermal absorption of malathion from Ovide (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.
Ovide (Malathion) Indications And Usage
Ovide (Malathion) Lotion is indicated for patients infected with (head lice and their ova) of the scalp hair.
Ovide (Malathion) Contraindications
Ovide (Malathion) Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Ovide (Malathion) Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.
Ovide (Malathion) Warnings
Carcinogenesis, mutagenesis and impairment of fertility have not been studied with Ovide (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 child following a single use of Ovide (Malathion) Lotion, assuming 100% bioavailability. Actual systemic exposures are expected to be less than 10% of the administered dose.
The malathion of greater than pharmaceutical-grade purity used in Ovide (Malathion) Lotion has not been tested for genotoxicity. The technical-grade malathion (95% pure) was found to be negative in , equivocally positive in the mouse lymphoma cell assay, and positive in chromosomal aberration and 425 sister chromatid exchange assays. Fifteen separate gene mutation studies with malathion of unknown purity have reported negative results, while three studies reported malathion to be mutagenic in bacterial cells. Both technical grade (94–96.5%) and purified (98-99%) malathion have been reported to cause chromosomal aberrations and sister chromatid exchanges in human and hamster cell lines. chromosomal aberration and micronucleus studies of technical-grade malathion are reported to be positive, whereas an chromosomal aberration study of >99% pure malathion was reported to be negative. Furthermore, mice exposed to malathion in their drinking water for 7 weeks demonstrated no evidence of chromosome damage in bone marrow cells, spermatogonia, or primary spermatocytes. Lack of details makes independent evaluation of the results of these assays impossible. Ashby and Purchase have suggested that impurities may be responsible for some of the observed genetic activity of malathion.
Reproduction studies performed with malathion in rats at doses over 180 fold greater than those anticipated in a 60 kg adult (based on body surface area and assuming 100% bioavailability) revealed no evidence of impaired fertility.
Ovide (Malathion) Adverse Reactions
Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis.
It is not known if Ovide (Malathion) Lotion has the potential to cause contact allergic sensitization.
Ovide (Malathion) Overdosage
Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.
Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.
Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.
Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long - range prognosis.
Ovide (Malathion) Dosage And Administration
Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.
Ovide (Malathion) How Supplied
Ovide (Malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5276-4.
Ovide (Malathion)
Ovide (Malathion) Principal Display Panel - Ml Carton
NDC 51672-5276-4
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