EXO-TIFIN

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

Composition:

Active substance: naftifine;

1 ml of the preparation contains 10 mg of naftifine hydrochloride;

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

Pharmaceutical form. Topical spray solution.

Main physicochemical properties: clear solution ranging from colorless to light yellow, with the odor of ethanol.

Pharmacotherapeutic group. Antifungal agents for dermatological use. ATC code D01A E22.

Pharmacological Properties.

Pharmacodynamics.

An antifungal agent of the allylamine class. Its active ingredient 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 against yeasts (Candida), molds (Aspergillus), and other fungi (e.g., Sporothrix schenckii). Against dermatophytes and Aspergillus species, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it exhibits either fungicidal or fungistatic activity depending on the microbial strain.

The drug also demonstrates antibacterial activity against both gram-positive and gram-negative microorganisms that may cause secondary bacterial infections accompanying fungal lesions.

In addition, the preparation possesses potent anti-inflammatory properties.

Pharmacokinetics.

Naftifine hydrochloride is rapidly absorbed and forms stable antifungal concentrations in various layers of the skin. Approximately 4% of the applied dose is absorbed through the skin, so systemic exposure to the active substance is very low. 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 nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without pruritus.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any other component 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.

Apply the medication 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 lacking or limited. Animal studies do not indicate any direct or indirect harmful effects of the drug on reproductive function. The medication may be used during pregnancy or breastfeeding only if absolutely necessary and after careful assessment of the benefit-risk ratio as determined by a physician.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Dosage and Administration.

The spray is intended for external use only.

The medication should be applied to the affected skin area and adjacent areas once daily after thorough cleaning and drying of the skin, covering approximately 1 cm of healthy skin around the periphery of the affected area.

Duration of treatment and frequency of application should be determined according to the indication:

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 affected portion of the nail should be trimmed as much as possible using nail clippers or a nail file (to facilitate this procedure, nails may be softened with a special softening agent as advised by a physician).

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

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 has not been observed with topical application.

Systemic intoxication following external application is unlikely due to minimal absorption of the active substance through the skin.

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

Side effects.

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 of suspected adverse reactions after registration 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, should report all cases of 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.

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

Keep out of reach of children.

Packaging. 8 ml or 15 ml in a bottle with a spray nozzle and protective cap, packed in a cardboard box.

Availability category. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity. 22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.