Amorolfine, 5% 5 ml

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, yeasts and molds (if no more than 2/3 of the nail plate is affected). Prevention of fungal nail lesions.

Active ingredient

Amorolfin

Composition

1 ml:

• amorolfin hydrochloride 64 mg, which corresponds to the content of amorolfin 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,
• ethanol absolute – 552 mg.

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How to take, the dosage

It is used externally. The dose and duration of treatment depend on the indication and the dosage form used.

Special Instructions

When working with organic solvents, impervious gloves must be worn (to protect nails covered with nail polish). The use of cosmetic nail polish and false nails should be avoided during treatment.

Contraindications

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

Side effects

Burning, hyperemia and itching in the application area.

Pregnancy use

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

Similarities

Lotseril, Oflomil nail polish, Exorolfinlac, Onichelp, Amorolfin