Naftifine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAFTIFINE

Composition:

Active substance: naftifine;

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

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

Pharmaceutical form. Cutaneous spray, solution.

Main physicochemical properties: clear solution ranging from colorless to pale 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. The active ingredient of the medicinal product 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 demonstrates either 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 associated with fungal lesions.

In addition, the preparation has 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, 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 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 the nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without accompanying pruritus.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any of the excipients. 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.

Studies on interactions have not been conducted.

Instructions for use.

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

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

The medicinal 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 a direct or indirect harmful effect of the medicinal product on reproductive function. The medicinal product should be used during pregnancy or breastfeeding only if clearly necessary, following careful assessment of the benefit-risk ratio as determined by the physician.

Ability to influence reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

The spray is intended for external use only.

The medicinal product should be applied to the affected skin area and adjacent regions once daily after thorough cleansing and drying of the skin, including 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 product 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 scissors 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 product 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 medicinal product in children; therefore, its use is not recommended in this age group.

Overdose.

Acute overdose with topical application has not been reported.

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 calculated from available data).

General disorders: frequency not known – local reactions may occur in isolated cases: dry skin, redness and burning sensation, erythema, itching, local irritation.

Reporting of adverse reactions

Reporting of adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years from the date of manufacture of the product in bulk packaging.

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 15 ml of the medicinal product in a bottle equipped with a pump, spray nozzle, and protective cap, in a cardboard box.

Category of supply. Over-the-counter (without prescription).

Manufacturer. Limited Liability Company "Pharmaceutical Company "Vertex".

Manufacturer's address.
Ukraine, 61085, Kharkiv region, city of Kharkiv, Astronomichna Street, building 33, lit. "V-1".