EXIFUT

INSTRUCTIONS for medical use of the medicinal product EXIFOOT (EXIFOOT)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains naftifine hydrochloride (calculated as 100% dry substance) 10 mg;

Excipients: propylene glycol, ethanol 96% (calculated as anhydrous ethanol), purified water.

Pharmaceutical form. Topical solution.

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

Pharmacotherapeutic group.
Antifungal agents for dermatological use. ATC code D01AE22.

Pharmacological Properties

Pharmacodynamics

Exifut is 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 species, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it demonstrates either fungicidal or fungistatic activity depending on the microbial strain.

Exifut also exhibits antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections associated with fungal lesions.

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

Pharmacokinetics

Naftifine hydrochloride is rapidly absorbed and achieves sustained antifungal concentrations in various layers of the skin. Approximately 4% of the applied dose is absorbed through the skin, resulting in very low systemic exposure. Only trace amounts of naftifine are detected in blood plasma and urine. The active substance is almost completely metabolized; metabolites lack 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 itching.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any of the excipients. The product must not be applied to open wounds. Do not use for treatment of the eyes.

Interaction with other medicinal products and other forms of interaction.

No interaction studies have 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 solution 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 clearly needed, 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.

Method of Administration and Dosage

Exifut solution should be applied once daily to the affected skin area and adjacent regions after thorough cleaning 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 drug is recommended to be applied twice daily. Before 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 directed by a physician).

To prevent relapses, treatment with the drug 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 Exifut in children; therefore, the drug is not recommended for use in this age group.

Overdose

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

Systemic intoxication following external application of the drug is unlikely due to minimal absorption of the active ingredient 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).

Skin and subcutaneous tissue disorders: frequency not known – contact dermatitis, erythema.

General disorders and administration site conditions: frequency not known – skin dryness, redness and burning sensation, itching, local irritation.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients are encouraged to report any suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life: 5 years.

Storage conditions:

Store at a temperature not exceeding 30 °C.

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

Keep out of reach and sight of children.

Packaging:

20 ml in a bottle; 1 bottle with dropper cap in a carton.

Pharmaceutical supply category:

Available without a prescription.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business:

4, Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.

Marketing Authorization Holder: Limited Liability Company "Representation Baum Pharm GmbH".

Address of the Marketing Authorization Holder:

66, Shyrokа St., Lviv, 79052, Ukraine.