EXODERIL®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EKZODERIL® (EXODERIL®)

Composition:

Active substance: naftifine hydrochloride;

1 ml of solution contains 10 mg of naftifine hydrochloride;

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

Pharmaceutical form. Topical solution.

Main physicochemical characteristics: clear, colorless to pale 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, while 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 fungal lesions.

In addition, Exoderil® possesses potent anti-inflammatory properties.

Pharmacokinetics

Naftifine hydrochloride is rapidly absorbed and achieves sustained antifungal concentrations in various skin layers. 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 detectable in blood plasma and urine. The active substance is almost completely metabolized; metabolites lack antifungal activity and are excreted via 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, propylene glycol, or to any of the excipients 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 medicinal product 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 medicinal product may be used during pregnancy or breastfeeding only if clearly necessary, following careful assessment of the benefit-risk ratio as determined by a physician.

Ability to influence reaction rate when driving or operating machinery.

Does not influence.

Method of administration and dosage.

Exoderil® solution should be applied once daily to the affected skin area and adjacent regions after thorough cleaning and drying of the skin, extending approximately 1 cm into the surrounding 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.

In fungal nail infections, the drug is recommended to be applied twice daily. Before 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 advised 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, 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 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

Frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), 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, erythema, itching, local irritation.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

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

Keep out of the reach of children.

Packaging.

10 ml or 20 ml of solution in a bottle; 1 bottle per cardboard box.

Classification of supply.

Over-the-counter (without prescription).

Manufacturer.

Sandoz GmbH – Manufacturing Division Anti-Infectives GLZ and Chemical Operations Kundl (AIHO GLZ Kundl) (responsible for batch release).

Manufacturer's location and address of its place of business.

Biochemiestrasse 10, 6250 Kundl, Austria.

Or

Manufacturer.

Lek Pharmaceuticals d.d., Slovenia (responsible for batch release).

Manufacturer's location and address of its place of business.

Verovškova 57, 1526 Ljubljana, Slovenia.