XYLOPROCT Ointment Ref.[50625] Active ingredients: Hydrocortisone Lidocaine

The onset of action of lidocaine is 3-5 minutes on mucous membranes. Lidocaine can be absorbed following application to mucous membranes with metabolism taking place in the liver. Metabolites and unchanged drug are excreted in the urine.

Absorption of hydrocortisone may occur from normal intact skin and mucous membranes. Corticosteroids are metabolised mainly in the liver but also in the kidney, and are excreted in the urine.

Lidocaine and hydrocortisone acetate are well established active ingredients.

In animal studies the toxicity noted after high doses of lidocaine consisted of effects on the central nervous and cardiovascular systems. No drug-related adverse effects were seen in reproduction toxicity studies, neither did lidocaine show a mutagenic potential in either in vitro or in vivo mutagenicity tests. Cancer studies have not been performed with lidocaine, due to the area and duration of therapeutic use for this drug.

Genotoxicity tests with lidocaine showed no evidence of mutagenic potential. A metabolite of lidocaine, 2,6-xylidine, showed weak evidence of activity in some genotoxicity tests. The metabolite 2,6-xylidine has been shown to have carcinogenicity potential in preclinical toxicological studies evaluating chronic exposure. Risk assessments comparing the calculated maximum human exposure from intermittent use of lidocaine, with the exposure used in preclinical studies, indicate a wide margin of safety for clinical use.