NAFTIFINE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NAFTIFINE (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. Topical solution.

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

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, yeasts (Candida), molds (Aspergillus), and other fungi (e.g., Sporothrix schenckii). Against dermatophytes and Aspergillus, naftifine exerts a fungicidal effect in vitro, while against yeast fungi it demonstrates either fungicidal or fungistatic activity depending on the microbial strain.

Furthermore, naftifine 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 detectable in blood plasma and urine. The active substance is almost completely metabolized; metabolites lack antifungal activity and are excreted via 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 pruritus.

Contraindications.

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

Studies on interactions have not been performed.

Special precautions for use.

The medicinal product is intended for topical use only in skin and nail disorders.

The preparation contains ethanol; therefore, care should be taken to avoid contact with eyes and open wounds. The preparation contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

Data on the use of naftifine in pregnant women are limited. Animal studies do not indicate any direct or indirect harmful effects of the drug on reproductive function. The medicinal product should be used during pregnancy or breastfeeding only if clearly necessary, after careful assessment of the benefit-risk ratio determined by the physician.

Ability to affect reaction speed when driving vehicles or operating machinery.

No effect.

Method of Administration and Dosage

The medicinal product 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 edges 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 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 treated 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 of the disease have disappeared.

Children. There is insufficient data on the efficacy and safety of naftifine use in children; therefore, the drug is not recommended for patients in this age group.

Overdose.

Acute overdose with topical naftifine has not been observed. Systemic intoxication is unlikely following external application, as only a small amount of the active substance is absorbed through the skin.

In case of accidental ingestion of the solution, 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).

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

Shelf life.

2 years from the date of manufacture of the drug in the in bulk packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging. 20 ml of the drug in a bottle closed with a dropper cap and fitted with a screw cap, in a box.

Supply category. Over-the-counter.

Manufacturer. Limited liability company "Pharmaceutical company "Vertex".

Manufacturer's address and location of its business operations.

Ukraine, 61085, Kharkiv region, city of Kharkiv, Astronomichna Street, building 33, letter "V-1".