Amorolfine, 5% 2.5ml

Antifungal agent for external use. It has fungistatic and fungicidal action. It damages the cell membrane of fungi, mainly by disrupting the synthesis of sterols.

Decreases ergosterol content, causes accumulation of abnormal nonplanar stereoisomers of sterols.

Active against yeast fungi of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes (Trichophyton spp., Microsporum spp, Epidermophyton spp.), mold fungi (Altemaria, Hendersonula, Scopulariopsis), Dematiaceae fungi (Cladosporium, Fonsecaea, Wangiella), dimorphic fungi (Coccidioides, Histoplasma spp., Sporothrix) and actinomycetes.

Pharmacokinetics

When applied externally in appropriate dosage forms systemic absorption is insignificant.

Indications

Onychomycosis caused by dermatophytes, yeast and mold fungi (if no more than 2/3 of the nail plate is affected). Prevention of fungal nail infections.

Pharmacological effect

Antifungal agent for external use. It has fungistatic and fungicidal effects. Damages the cell membrane of fungi, mainly due to disruption of sterol synthesis.

Reduces ergosterol content and causes the accumulation of abnormal non-planar stereoisomers of sterols.

Active against yeast fungi of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp.), molds (Altemaria, Hendersonula, Scopulariopsis), Dematiaceae fungi (Cladosporium, Fonsecaea, Wangiella), dimorphic fungi (Coccidioides, Histoplasma spp., Sporothrix) and actinomycetes.

Pharmacokinetics

When used externally in appropriate dosage forms, systemic absorption is negligible.

Special instructions

When working with organic solvents, impervious gloves must be worn (to protect nail polish). During treatment, the use of cosmetic varnish and false artificial nails should be avoided.

Active ingredient

Amorolfine

Composition

1 ml:
amorolfine hydrochloride 64 mg, which corresponds to the content of amorolfine base 57.4 mg
Excipients:
methyl methacrylate copolymer,
trimethylammonioethyl methacrylate chloride and ethyl acrylate [1:2:0.2] – 143 mg,
triacetin – 12 mg,
butyl acetate – 57 mg,
ethyl acetate – 172 mg,
absolute ethanol – 552 mg.

Pregnancy

Should not be used during pregnancy or breastfeeding (adequate safety studies have not been conducted).

Contraindications

Hypersensitivity, early childhood (adequate safety studies have not been conducted).

Side Effects

Burning, hyperemia and itching in the area of ​​application.

Manufacturer

Tula pharmaceutical factory, Russia