Exo-tifin

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

Composition:

Active substance: naftifine;

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

Excipients: cetyl stearyl alcohol, isopropyl myristate, polysorbate 60, cetyl palmitate, sorbitan sesquioleate, benzyl alcohol, sodium hydroxide, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white, soft or slightly syrupy, lustrous cream. A slight characteristic odor is permissible.

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 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 gram-positive and gram-negative microorganisms that may cause secondary bacterial infections alongside mycotic lesions.

In addition, the preparation has 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; therefore, 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 lack antifungal activity and are excreted in feces and urine. The 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 (onychomycosis);
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without pruritus.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Studies on interactions have not been conducted.

Special precautions for use.

Apply the medicinal product externally only for nail and skin disorders!

The medicinal product contains cetyl stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

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 product may be used during pregnancy or breastfeeding only if clearly necessary, following careful assessment of the benefit-risk ratio determined by the physician.

Breastfeeding mothers should avoid contact of the drug with the infant's skin and gastrointestinal tract.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

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 around the periphery 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 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 main symptoms 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 with topical application of naftifine has not been reported.

Systemic intoxication following external application of the medication 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 (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

General disorders

Frequency not known: local reactions may occur in isolated cases – 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 continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

The product is stable for 4 weeks at 25 °C after first opening.

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

Keep out of reach and sight of children.

Packaging. 15 g in a tube; 1 tube in a cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.