EXIK

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

Composition:

Active substance: naftifine hydrochloride;

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

Excipients: benzyl alcohol, sorbitan stearate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, cetyl palmitate, sodium hydroxide, purified water.

Pharmaceutical form. Cream.

Main physico-chemical properties: white cream with a weak specific odor.

Pharmacotherapeutic group.

Antifungal agents for dermatological use. ATC code D01A E22.

Pharmacological Properties

Pharmacodynamics

Exik 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.

Exik 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 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 have no 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 infections of the nails;
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without itching.

Contraindications.

Hypersensitivity to naftifine 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.

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

The product contains cetyl alcohol and stearyl 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 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 the physician.

Breastfeeding mothers should avoid contact of the medicinal product with the infant's skin or gastrointestinal tract.

Ability to affect reaction speed when driving or operating machinery.

Has no effect.

Method of Administration and Dosage

Apply Exoderil cream to the affected skin area and adjacent regions once daily after thoroughly cleansing and drying 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 drug 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 with scissors or a nail file. (To facilitate this procedure, nails may be softened 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 main symptoms of the disease have disappeared.

Children

There is insufficient data on the efficacy and safety of Exoderil in children; therefore, the drug 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, 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 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 drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare 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. Do not freeze. Keep out of reach and sight of children.

Packaging.

15 g in a tube; 1 tube per carton.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of manufacturing activities.

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