Exoderil®

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

Composition:

Active substance: naftifine hydrochloride;

1 g of cream contains 10 mg of naftifine hydrochloride;

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

Pharmaceutical form. Cream.

Main physicochemical characteristics: white, soft or slightly syrupy, shiny cream with a slight characteristic odor.

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, 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 accompanying mycotic lesions.

In addition, Exoderil® has 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, 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 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 (onychomycosis);
• cutaneous candidiasis;
• pityriasis versicolor;
• inflammatory dermatomycoses, with or without itching.

Contraindications.

Hypersensitivity to naftifine or to any of the excipients. The product must not be applied to wound surfaces. Do not use for eye treatment.

Interaction with other medicinal products and other types of interactions.

Interaction studies have not been conducted.

Special precautions for use.

Apply the medication topically only for skin and nail disorders!

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 absolutely necessary and after careful assessment of the benefit-risk ratio determined by a physician.

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

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Dosage and Administration

Apply Exoderil® cream once daily to the affected skin area and adjacent surrounding areas after thoroughly cleaning and drying the skin, extending approximately 1 cm beyond the edge of the affected area onto healthy skin.

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 infected 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 advised by a physician).

To prevent relapses, treatment with the drug should be continued for at least 2 weeks after the main symptoms have disappeared.

Children

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

Overdose

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

Systemic intoxication following topical application is unlikely due to minimal absorption of the active ingredient 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 (≥ 1/10,000, < 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, erythema, pruritus, local irritation.

Shelf life. 3 years.

The product is stable for 4 weeks at 25 °C after first opening.

Storage conditions.

Store at temperatures not exceeding 30 °C.

Keep out of reach of children.

Packaging.

15 g or 30 g of cream in a tube; 1 tube per cardboard box.

Classification by prescription.

Over-the-counter (without prescription).

Manufacturer.

Sandoz GmbH – TechOps (batch release).

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

Biochemiestrasse 10, 6250 Kundl, Austria.

or

Manufacturer.

SALUTAS Pharma GmbH (bulk manufacturer, primary and secondary packaging, control, batch release).

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

Production site in Osterweddingen, Lange Herren 3, Sülzetal, OT Osterweddingen, Saxony-Anhalt, 39171, Germany.