NAFTIDERIL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAFTIDERIL (NAFTIDERILE)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains 10 mg of naftifine hydrochloride;

Excipients: propylene glycol, ethanol 96%, 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: D01A E22.

Pharmacological properties.

Pharmacodynamics.

Naftiderm is an antifungal agent of the allylamine class, whose mechanism of action is associated with inhibition of ergosterol synthesis.

Naftiderm 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 either fungicidal or fungistatic activity depending on the microbial strain.

In addition, Naftiderm exhibits antibacterial activity against both gram-positive and gram-negative microorganisms that may cause secondary bacterial infections alongside fungal lesions.

Furthermore, Naftiderm has anti-inflammatory properties and promotes rapid relief from inflammatory symptoms and itching.

Pharmacokinetics.

Due to the rapid skin penetration of the drug and the formation of sustained antifungal concentrations in various skin layers, Naftiderm can be administered once daily.

Clinical characteristics.

Indications.

Local 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 itching.

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.

Interaction studies have not been performed.

Special precautions for use.

Apply Naftyderil externally only for nail and skin disorders!

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

Ability to influence reaction rate when driving vehicles or operating machinery.

No influence.

Method of Administration and Dosage.

Apply the Naftideril solution once daily to the affected area of skin after thoroughly cleaning and drying it, covering approximately 1 cm of surrounding healthy skin around the affected site.

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 should 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 recommended by a physician).

To prevent relapses, treatment 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 Naftideril in children; therefore, the use of Naftideril is not recommended in this age group.

Overdose.

Symptoms of overdose: intensification of adverse effects.

Treatment is symptomatic.

Side effects.

Skin and subcutaneous tissue disorders: Frequency unknown — contact dermatitis and erythema.

General disorders: In isolated cases, local reactions may occur: dry skin, redness and burning sensation, itching, local irritation.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

10 ml in a bottle. 1 bottle per carton.

Pharmaceutical category. Over-the-counter.

Manufacturer.

JSC "Tekhnolog".

Manufacturer's address and place of business.

8 Stara Prorizhna Street, Uman, Cherkasy region, Ukraine, 20300.