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

Treatment of fungal nail infections caused by dermatophytes, yeasts and molds.
Prevention of fungal nail infections.

Pharmacological effect

Pharmacokinetics

Special instructions

– A file used on affected nails should not be used on healthy nails!
– During treatment, the use of false artificial nails should be avoided.
– Do not allow varnish to get into eyes, ears or mucous membranes.
– The wipe contains a highly flammable substance.
– Persons working with organic solvents (such as paint thinner, gasoline, kerosene, etc.) should wear sealed gloves to protect nail polish.
– To prevent the varnish from drying out, close the lid tightly after use. To prevent the lid from sticking, avoid getting varnish on the threads.
– If you miss applying varnish, you should not apply an excessive amount of it in several layers; it is enough to continue treatment according to the instructions for use.
– Do not dispose of the remaining product at a water or household waste disposal site.
– Patients with conditions predisposing to the development of fungal nail infections (poor peripheral circulation, diabetes mellitus, immunodeficiency), as well as patients with nail dystrophy or a damaged nail plate, psoriasis or other chronic skin diseases, are advised to consult a doctor before using the drug.

If more than 2/3 of the nail plate is damaged or fungal, you should also consult a doctor to prescribe concomitant oral therapy. If systemic or local allergic reactions occur, you should immediately stop using Amorolfine varnish and consult a doctor.

Using nail polish remover, you need to remove the product from your nails. The drug should not be reapplied. The product contains ethanol, so applying it too often or incorrectly can lead to irritation or dryness of the skin around the nail. The tampon contains a highly flammable substance.

Impact on the ability to drive vehicles and machinery
Not studied.

Active ingredient

Amorolfine

Composition

Composition per 1 ml:
Active ingredient:
Amorolfine hydrochloride (in terms of amorolfine 50 mg) – 55.7 mg;

Excipients:
Triacetin (glycerol triacetate) – 10.5 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2:0.2:1] (ammonium methacrylate copolymer (Type A) (EudragitRL100)) – 125.0 mg, ethyl acetate – 150.0 mg, butyl acetate – 50.0 mg, ethanol 95% – up to 1 ml.

Pregnancy

The use of the drug during pregnancy and breastfeeding is not recommended.

Contraindications

Hypersensitivity to amorolfine and other components.
Age up to 18 years.

Side Effects

When using the drug Amorolfine, adverse reactions are rare. Damage to the nails, such as discoloration, destruction of the nail plates, brittle nails, can be the result of fungal nail infections.

Classification of adverse reactions by organs and systems, indicating the frequency of their occurrence: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000), including isolated reports, frequency unknown (frequency not can be estimated based on available data).

Immune system disorders

Frequency unknown – hypersensitivity reactions (systemic allergic reactions).

Skin and subcutaneous tissue disorders

Rarely – damage to the nails, discoloration of the nails, onychoclasia (fragility of the nail plate), onychorrhexis (fragility of the nail plate);

Very rarely – burning sensation of the skin;

Frequency unknown – erythema, itching, contact dermatitis, urticaria, blistering.

If you experience the side effects listed in the instructions, or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

When using the drug in accordance with the instructions for use, an overdose is unlikely. In case of accidental ingestion of the drug, rinse the stomach and, if necessary, carry out symptomatic therapy.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

2 years.
Do not use after expiration date.

Manufacturer

Tula pharmaceutical factory, Russia