NAFTIFINE

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

Composition:

Active ingredient: 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, shiny cream. A slight characteristic odor is permissible.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. ATC code D01A E22.

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 activity.

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, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it exhibits fungicidal or fungistatic activity depending on the microbial strain.

Naftifine also demonstrates antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections accompanying mycotic lesions.

In addition, the drug 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 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 nail infections (onychomycoses);
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without pruritus.

Contraindications.

Hypersensitivity to naftifine or to any of the excipients of the medicinal product. Do not apply 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.

Special precautions for use.

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

The medicine contains cetylstearyl 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 medicine on reproductive function. The medicine may be used during pregnancy or breastfeeding only if clearly necessary, after careful assessment of the benefit-risk ratio determined by the physician.

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

Ability to influence reaction rate when driving or operating machinery.

No influence.

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 beyond the borders of the affected area to include healthy skin.

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 relapses, 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, as only a minimal amount of the active substance is absorbed through the skin.

In case of accidental ingestion of the cream, symptomatic treatment should be initiated.

Side effects.

The frequency of side effects 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 bulk packaging.

Storage conditions.

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

Keep out of the reach of children.

Packaging. 15 g in a tube, in a box.

Prescription status. Over-the-counter.

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

Manufacturer's address and place of business.

33, Astronomichna Street, lit. V-1, Kharkiv, Kharkiv region, 61085, Ukraine.