ESTESIFIN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESTESIFIN® (ESTESIFIN)

Composition:

Active substance: naftifine hydrochloride;

1 ml of spray contains naftifine hydrochloride equivalent to 100% dry substance 10 mg;

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

Pharmaceutical form. Topical spray.

Main physico-chemical characteristics: clear solution, colorless to light yellow, with a characteristic alcoholic odor.

Pharmacotherapeutic group. Antifungal agents for dermatological use.

ATC code: D01AE22.

Pharmacological Properties

Pharmacodynamics

Estefin® 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.

Estefin® 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 species, naftifine exerts a fungicidal effect in vitro; against yeast fungi, it demonstrates either fungicidal or fungistatic activity depending on the microbial strain.

Estefin® also exhibits antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections accompanying fungal lesions.

In addition, Estefin® 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 to 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 mycosis;
• fungal nail infections (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 the medicinal product externally only for nail and skin disorders!

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

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

No effect.

Method of Administration and Dosage

Estesifin® solution should be applied once daily to the affected area of skin and the adjacent surrounding areas after thorough cleansing and drying of the skin, 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. Before 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 treated with a special softening agent as recommended by a physician.)

To prevent relapses, treatment with the drug 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 drug in children; therefore, Estesifin® is not recommended for use in this age group.

Overdose

Acute overdose with topical application of naftifine has not been reported.

Systemic intoxication following external application of the drug is unlikely due to the minimal amount of active substance absorbed 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 (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

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

Skin and subcutaneous tissue disorders with frequency "not known": contact dermatitis and erythema.

Shelf life. 2 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.

15 ml or 20 ml in a bottle. 1 bottle per carton.

Availability category. Over-the-counter.

Manufacturer.

JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.