VIDENE Cutaneous solution Ref.[49820] Active ingredients: Povidone iodine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Ecolab Deutschland GmbH, Ecolab-Allee 1, D-40789 Monheim am Rhein, Germany

5.1. Pharmacodynamic properties

ATC Code: D08AG02
Dermatologicals/Antiseptics and Disinfectants/povidone-iodine

Iodinated povidone has antiseptic activity and is used mainly for the treatment of contaminated wounds and pre-operative preparation of skin and mucous membranes. It is considered to be less irritant than iodine.

5.2. Pharmacokinetic properties

Iodinated povidone is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat.

5.3. Preclinical safety data

Iodinated povidone had a low acute toxicity in both dogs and rats following either oral or intraperitoneal administration. Absorption of iodine through intact skin is low following the application of solutions of iodinated povidone although systemic absorption of iodine is greatly increased if the solutions are applied to broken skin, mucous membranes or are introduced into the cavities of the body. At subcutaneous dose levels of up to 75mg/kg/day, iodinated povidone was non-teratogenic in rabbits following administration to pregnant animals during the period of organogenesis.

Some early in vitro studies indicated a possible mutagenic action for iodinated povidone. However, a number of later studies, using in vitro and in vivo test systems, do not indicate a significant level of mutagenic/genotoxic activity for iodinated povidone. Although conflicting data have been published, there is no convincing evidence to suggest that iodinated povidone adversely affects wound healing. Concentrations of 0.05 and 0.5% iodinated povidone did not cause significant ocular damage when administered into the vitreous cavities of rabbits' eyes. There is some evidence to suggest that iodinated povidone-containing solutions applied to the round window of the chinchilla ear could result in high frequency hearing loss.

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