Exo-tifin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EKZO-TIFIN (EXO-TIFIN)

Composition:

Active substance: naftifine;

1 ml of the preparation contains naftifine hydrochloride 10 mg;

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

Pharmaceutical form. Topical solution.

Main physico-chemical properties: clear solution, colorless to light yellow, with the smell of ethanol.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. ATC code D01AE22.

Pharmacological properties.

Pharmacodynamics.

An antifungal agent of the allylamine class. Its active component is naftifine hydrochloride, whose mechanism of action is associated with inhibition of ergosterol synthesis.

Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton, and Microsporum, as well as yeasts (Candida), molds (Aspergillus), and other fungi (e.g., Sporothrix schenckii). Against dermatophytes and Aspergillus, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it demonstrates fungicidal or fungistatic activity depending on the microbial strain.

The drug also exhibits antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections alongside mycotic lesions.

In addition, the drug has potent anti-inflammatory properties.

Pharmacokinetics.

Naftifine hydrochloride is rapidly absorbed and achieves sustained antifungal concentrations in various skin layers. Approximately 4% of the applied dose is absorbed through the skin, resulting in very low systemic exposure to the active substance. Only trace amounts of naftifine are detected in blood plasma and urine. The active substance is almost completely metabolized; metabolites have no antifungal activity and are excreted in feces and urine. The elimination half-life is 2–4 days.

Clinical characteristics.

Indications.

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

• fungal infections of the skin and skin folds;
• interdigital mycoses;
• fungal infections of the nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without itching.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any of the other components of the medicinal product. The product must not be applied to wound surfaces. Do not use for treatment of the eyes.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

The medicinal product should be used externally only for nail and skin disorders!

The product contains ethanol; therefore, avoid contact of the solution with eyes and open wounds.

The product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Data on the use of naftifine in pregnant women are limited. Animal studies do not indicate a direct or indirect harmful effect of the medicinal product on reproductive function. The product may be used during pregnancy or breastfeeding only if absolutely necessary, after careful assessment of the benefit/ risk ratio determined by the physician.

Ability to influence reaction rate when driving or operating machinery.

Does not influence.

Dosage and Administration

The medication should be applied to the affected skin area and adjacent regions once daily after thorough cleansing and drying of the skin, extending approximately 1 cm onto healthy skin surrounding 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 infections, the medication is recommended to be applied twice daily. Prior to the first application, the infected portion of the nail should be trimmed as much as possible using scissors or a nail file (to facilitate this procedure, nails may be softened with a special softening agent as directed by a physician).

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

Children

There is insufficient data on the efficacy and safety of the medication in children; therefore, its use is not recommended in this age group.

Overdose

Acute overdose with topical application of naftifine has not been reported. Systemic intoxication is unlikely with external use, as only a minimal amount of the active substance is absorbed through the skin.

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

Adverse reactions.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated from the available data).

General disorders

Frequency not known: in isolated cases, local reactions may occur – dry skin, redness and burning sensation, contact dermatitis, erythema, itching, local irritation.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

After opening the bottle, store the solution for up to 6 months at a temperature not exceeding 25 °C.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 8 ml or 20 ml of the preparation in a bottle closed with a dropper stopper and sealed with a cap; 1 bottle per cardboard box.

Supply category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business. 22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.