Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: OTHER ANTIFUNGALS FOR TOPICAL USE

ATC code: D01AE14

The active substance in MYCOSTER is Ciclopirox, an antifungal agent belonging to the pyridone group.

85009                                                                                          2 Ciclopirox is a broad-spectrum antimycotic agent which is active against dermatophytes (Trichophytons, Microsporum canis, Epidermophytons), yeasts (Candida, Torulopsis, Trichosporum, Geotrichum), moulds (Scopulariopsis, Aspergillus) and actinomycetes, together with a few gram-positive and gram-negative bacteria.

Any fungus species that does not belong to aforementioned genera should be studied in vitro in order to determine its level of susceptibility.

MYCOSTER is a formulation containing 8 per cent ciclopirox in a lacquer base. Once applied to the nail, the solvents (ethyl acetate and isopropanol) and the film-forming agent (copolymer of methylvinyl ether and maleic acid monobutylester) evaporate and ensure that ciclopirox adheres to the nail.

The fungicidal activity of ciclopirox is based on the inhibition of absorption, by fungal cells, of certain substances (metal ions, phosphate and potassium ions).

Ciclopirox accumulates in the fungal cell, in which it binds irreversibly to certain structures such as the cell membrane, mitochondria, ribosomes and microsomes.

Pharmacokinetic Properties

5.2 Pharmacokinetic properties

The fate of the medicinal product has been studied in situ in the healthy human (healthy nail).
Ciclopirox is rapidly diffused in the nail plate: th
- Fungicide concentrations are detected from the 7 day of the daily application, - The maximum concentrations detected in the distal part of the nail reflect saturation of the nail plate; these are obtained: th        th
Between the 14 and 30 day of application for fingernails,
th           th
Between the 30 and the 45 day of application for toenails.

If treatment is stopped, the shtrudelresidual effect of ciclopirox is demonstrated by active concentrations that persist for 7 to 14 days.