Source: Web Search Revision Year: 2015 Publisher: Recordati Ireland Ltd., Raheens East, Ringaskiddy, Co. Cork, Ireland
Pharmacotherapy groups: Antifungal for topical use, Imidazole derivatives
ATC code: D01AC12
Lomexin is a broad spectrum antimycotic.
Lomexin also has an antibacterial action against Gram-positive microorganisms. Presumed action mechanism: blocking of oxidant enzymes with accumulation of peroxides and necrosis of the fungal cell; direct action on the membrane.
An entirely negligible absorption by the transcutaneous route resulted from the pharmacokinetic tests, both in animals and humans. After the skin application under an occlusive dressing of 2% cream or 2% spray solution of fenticonazole nitrate in humans, the absorption is negligible: less than 0.5% of the administered dose after cream application or 1.62% after spray application.
LD50 in mice: oral 3000 mg/kg; i.p. 1276 mg/kg (M), 1265 mg/kg (F).
LD50 in rats: oral 3000 mg/kg; s.c. 750 mg/kg; i.p. 440 mg/kg (M), 309 mg/kg (F).
Chronic toxicity: 40-80-160 mg/kg/day by mouth for 6 months in rats and dogs was well tolerated, except for some mild signs of general toxicity (increased liver weight in rats at dose of 160 mg/kg without other histopathological alterations, and in dogs a transient increase in SGPT at doses of 80 and 160 mg/kg associated with increased liver weight).
LOMEXIN was not mutagenic in 6 mutagenesis tests.
LOMEXIN tolerability was satisfactory in guinea pigs and rabbits. Results in dwarf pigs, whose skin is morphologically and functionally similar to human skin and generally manifests strong sensitivity to various irritants, were excellent.
LOMEXIN has shown no signs of sensitisation, phototoxicity or photoallergy. Studies in animals (rats) have shown that Fenticonazole does not interfere with the function of male and female gonads, and does not modify the first phases of reproduction. In addition, with the administration to rats and rabbits of very high doses of Fenticonazole (80 mg/kg) fetotoxic and embryotoxic effects have occurred. No teratogenic effects were seen in rats or rabbits. In lactating rats, Fenticonazole and/or its metabolites can be detected in the milk.
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