Naftifine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAFTIFINE (NAFTIFIN)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains 10 mg of naftifine hydrochloride;

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

Pharmaceutical form. Topical solution.

Main physicochemical properties: clear solution ranging from colorless to pale yellow with an ethanol odor.

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

Pharmacological properties.

Pharmacodynamics.

NAFTIFINE 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 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.

Furthermore, NAFTIFINE 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 forms stable antifungal concentrations in various skin layers. Approximately 4% of the applied dose is absorbed through the skin, resulting in very low systemic exposure to the active substance. 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 elimination period 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 itching.

Contraindications.

Hypersensitivity to naftifine, propylene glycol, or to any of the other components of the 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.

No interaction studies have been performed.

Special precautions for use.

The medication should be used externally only for the treatment of nail and skin disorders!

The medication contains ethanol; therefore, care should be taken to 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 and after careful assessment of the benefit-risk ratio as determined by the physician.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of Administration and Dosage

NAFTIFINE solution should be applied once daily to the affected skin area and adjacent surrounding areas after thorough cleansing and drying, covering approximately 1 cm of 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 drug 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 drug 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 drug in children; therefore, NAFTIFINE is not recommended for use in this age group.

Overdose

Acute overdose with topical naftifine has not been reported.

Systemic intoxication is unlikely with external application of the drug 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 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.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

After opening the bottle, the solution can be stored for 6 months at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

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

Supply category.

Over-the-counter (without prescription).

Manufacturer.

TOV "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business.

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