Estezifin cutaneous spray 1% bottle 15 ml

Instructions for Estezifin cutaneous spray 1% bottle 15 ml

Composition

active ingredient: naftifine hydrochloride;

1 ml of spray contains 10 mg of naftifine hydrochloride, calculated on 100% dry matter;

Excipients: propylene glycol, ethanol 96%, purified water.

Dosage form

Skin spray.

Main physicochemical properties: transparent solution from colorless to light yellow with an alcohol odor.

Pharmacotherapeutic group

Antifungal agents for use in dermatology.

ATX code D01A E22.

Pharmacological properties

Pharmacodynamics

Estezifin is an antifungal agent of the allylamine class, the mechanism of action of which is associated with the inhibition of the action of ergosterol.

Estesifin is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeasts (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix Schenckii). Naftifine has fungicidal activity against dermatophytes and Aspergillus in vitro, and fungicidal or fungistatic activity against yeasts, depending on the strain of the microorganism.

Estesifin also exhibits antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections along with mycotic lesions.

In addition, Estesifin has anti-inflammatory properties, which helps to quickly eliminate symptoms of inflammation and itching.

Pharmacokinetics

Due to the rapid penetration of the drug into the skin and the formation of stable antifungal concentrations in different layers of the skin, Estezifin can be used once a day.

Indication

Topical treatment of fungal infections caused by pathogens sensitive to naftifine:

- fungal infections of the skin and skin folds;

- interdigital mycoses;

- fungal nail infections (onychomycosis);

- cutaneous candidiasis;

- lichen planus;

- inflammatory dermatomycoses, accompanied by itching or without it.

Contraindication

Hypersensitivity to naftifine or propylene glycol. The drug should not be applied to the wound surface. Do not use for eye treatment.

Interaction with other medicinal products and other types of interactions

No cases of interaction with other drugs have been identified.

Application features

The drug should only be used externally!

The drug contains ethanol, so avoid getting the solution in the eyes and on open wounds.

Use during pregnancy or breastfeeding

If the drug is used according to the instructions, the effect of Estezifin on the fetus and newborn child is unlikely. The results of teratogenicity studies indicate the absence of any embryotoxic effect of naftifine. The drug can be used during pregnancy or breastfeeding only after a careful assessment of the benefit/risk ratio, which is determined by the doctor.

Breastfeeding mothers should prevent the drug from getting on the baby's skin and digestive tract.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Method of administration and doses

Estesifin solution should be applied to the affected area of skin and adjacent areas once a day after it has been thoroughly cleaned and dried, capturing approximately 1 cm of healthy skin around the edges of the affected area.

Duration of treatment: for dermatomycoses – 2–4 weeks (if necessary – up to 8 weeks); for candidiasis – 4 weeks; for nail infections – up to 6 months.

For fungal nail diseases, the drug is recommended to be used 2 times a day. Before the first use, it is necessary to remove as much of the affected part of the nail as possible with scissors or a nail file (to facilitate this procedure, on the recommendation of a doctor, the nails can be treated with a special softener).

To prevent relapse, treatment with the drug should be continued for at least 2 weeks after the main symptoms of the disease have disappeared.

Children

Data on the efficacy and safety of the drug in children are insufficient, therefore it is not recommended to prescribe Estesifin to patients in this age category.

Overdose

Acute overdose with topical application of naftifine has not been observed.

Systemic intoxication with external use of the drug is unlikely due to the fact that the amount of active substance absorbed through the skin is insignificant.

In case of accidental ingestion of the drug, symptomatic treatment should be initiated.

Adverse reactions

In rare cases, local reactions may occur: dry skin, redness and burning sensation, erythema, itching, local irritation.

Side effects are usually reversible and do not require discontinuation of treatment.

Expiration date

2 years.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging

15 ml or 20 ml in a bottle. 1 bottle in a pack.

Vacation category

Without a prescription.

Producer

PJSC "Farmak".

Location of the manufacturer and its business address

Ukraine, 04080, Kyiv, Frunze St., 74.