Exic

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

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains naftifine hydrochloride (calculated as 100 % dry substance) 10 mg;

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

Exoderil 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.

Exoderil also exhibits antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections alongside mycotic 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; 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 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 nails;
• 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 open wounds. Do not use for treatment of the eyes.

Interaction with other medicinal products and other forms of interaction.

No studies on interactions have been conducted.

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 determined by the physician.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Administration and Dosage

Exoderil solution should be applied once daily to the affected skin area and adjacent regions after thorough cleansing and drying of the skin, extending approximately 1 cm onto healthy skin surrounding 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 medication 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 medication should be continued for at least 2 weeks after the main symptoms have disappeared.

Children

There is insufficient data regarding the efficacy and safety of Exoderil in children; therefore, the medication is not recommended for use in this age group.

Overdose

Acute overdose with topical naftifine has not been reported.

Systemic intoxication following external application of the medication is unlikely due to minimal absorption of the active substance through the skin.

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

Adverse reactions.

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).

Disorders of the skin and subcutaneous tissue: frequency not known: contact dermatitis, erythema.

General disorders and administration site conditions: frequency not known: skin dryness, redness and burning sensation, itching, local irritation.

Reporting of adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

After opening the bottle, store the solution for up to 6 months at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging.

20 ml in a bottle; 1 bottle in a carton.

Availability.

Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of its business activity.

4 Korolova St., Stanyshivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.