Exolic

INSTRUCTION FOR MEDICINAL USE OF THE MEDICINAL PRODUCT EXOLIK (EXOLIK)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains: naftifine hydrochloride 10 mg;

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

Pharmaceutical form. Topical solution.

Main physicochemical characteristics: clear liquid, colorless to pale yellow, with a characteristic odor.

Pharmacotherapeutic group. Antifungal agents for dermatological use.

ATC code D01A E22.

Pharmacological Properties

Pharmacodynamics

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

Exolic also demonstrates antibacterial activity against gram-positive and gram-negative microorganisms that may cause secondary bacterial infections associated with fungal lesions.

In addition, Exolic possesses potent anti-inflammatory properties.

Pharmacokinetics

Naftifine hydrochloride is rapidly absorbed and achieves sustained antifungal concentrations in various layers of the skin. 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 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 mycoses;
• fungal infections of nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses that may be accompanied by itching.

Contraindications.

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

Interaction studies have not been conducted.

Special precautions for use.

The medicinal product should be used only externally for nail and skin disorders!

The preparation contains ethanol, therefore 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 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 influence reaction rate when driving vehicles or operating machinery.

Does not influence.

Administration and Dosage.

Exolic solution should be applied to the affected skin area and adjacent regions once daily after thorough cleansing and drying of the skin, covering approximately 1 cm of healthy skin surrounding 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 medicinal product 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 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 disappearance of the main symptoms of the disease.

Children.

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

Overdose.

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

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

In case of accidental ingestion of the medicinal product, 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: frequency not known – contact dermatitis and erythema.

Reporting suspected adverse reactions after authorization of the medicinal product 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 via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Keep out of reach of children.

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

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

Do not use after the expiry date.

Packaging.

10 ml in bottles, 1 in a pack.

20 ml in bottles, 1 in a pack.

Supply category. Over-the-counter.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address and place of business.

1, Gordienkovskaya Street, Kharkiv, Kharkiv Oblast, 61010, Ukraine.