NYSTALOCAL Cream Ref.[28289] Active ingredients: Chlorhexidine Dexamethasone Nystatin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: ADL Pharmaceutical Products Ltd, 12 Agiou Spyridonos str., 7102 Aradippou, P.O. Box 40981, 6308 Larnaca, Cyprus, Tel.: 0035724667878

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Corticosteroids, moderately potent, other combinations
ATC code: D07XB05

Nystatin has fungistatic and fungicidal properties. The growth of susceptible fungi species is inhibited due to the formation of a complex of nystatin with sterols of the cytoplasmic membrane resulting in the modification of the membrane permeability of the fungi.

Nystatin is mainly active against Candida albicans, but also against cryptococcus, Histoplasma and Blastomyces dermatitidis. Gram-positive and Gram-negative bacteria as well as well as protozoa are resistant against nystatin.

Dexamethasone is a monofluorinated, moderately potent corticoid of potency class II and has anti-inflammatory, antipruritic, anti-exudative and anti-allergic properties.

Chlorhexidine has a good antimicrobial activity against gram-positive and a lower against gram-negative bacteria. The antimicrobial activity is based on the association of the cationic part to the cell membrane of the microorganisms and the resulting change of the cell membrane permeability.

5.2. Pharmacokinetic properties

Locally applied, nystatin and chlorhexidine are absorbed only to a lower extent by the intact skin and mucus membrane. Detailed data on absorption and pharmacokinetic do not exist.

The grade of penetration and permeation of dexamethasone depends on the body region, the skin condition, the galenic formulation, the age and the application mode. Under normal conditions, only small part of the locally applied corticosteroid is systemically available.

5.3. Preclinical safety data

Dexamethasone is teratogenic in animal tests and mutagenic in various test systems.

Nystatin has mutagenic properties. There is no conclusive data available on the carcinogenicity of the three components.

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