Exostat 1% Solution for External Use 10 ml Bottle

• fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis);

• interdigital mycoses (tinea manuum, tinea pedum);

• fungal infections of the nails (onychomycoses);

• cutaneous candidiasis;

• pityriasis versicolor;

• dermatomycoses (with or without accompanying itching).

Method of application and doses

Topically.

In case of skin lesions

The Exostat® preparation is applied once a day to the affected skin surface and the adjacent areas (approximately 1 cm of healthy skin around the edges of the affected area) after thorough cleansing and drying.

Duration of therapy for dermatomycoses - 2-4 weeks (if necessary, up to 8 weeks), for candidiasis - 4 weeks.

In case of nail lesions

The Exostat® preparation is applied twice a day to the affected nail. Before the first application of the preparation, the affected part of the nail should be maximally removed with scissors or a nail file.

Duration of therapy for onychomycosis - up to 6 months.

To prevent recurrence, treatment should be continued for at least 2 weeks after the clinical symptoms have disappeared.

Composition

1 ml of the solution contains:
active ingredient: naftifine hydrochloride - 10.0 mg;
excipients: propylene glycol - 50.0 mg; ethanol 95% (ethyl alcohol 95%) - 400.0 mg; purified water - up to 1 ml.

Description of the dosage form

Transparent colorless or light yellow solution with the smell of ethanol.

• hypersensitivity to naftifine or other components of the drug;

• pregnancy and breastfeeding period (safety and efficacy have not been established);

• application to a wound surface.

With caution

• child age (clinical experience is limited).

Special instructions

To achieve a therapeutic effect, a course of treatment is required. The drug Exostat® is not intended for use in ophthalmology. The drug should not come into contact with the eyes. Exostat® is effective in treating mycoses affecting areas of skin with hyperkeratosis, as well as in areas of hair growth. Propylene glycol, which is part of the solution, may cause skin irritation; if side effects occur, the use of the drug should be discontinued and a doctor should be consulted. Use in pediatrics: The drug Exostat® should be used with caution in children under 18 years of age (the efficacy and safety of the drug have not been proven).

Section: Side Effects

In some cases, local reactions may occur: skin dryness, skin hyperemia (redness), and burning. The side effects are reversible and do not require discontinuation of treatment. If any of the side effects listed in the instructions worsen, or if any other side effects not mentioned in the instructions are observed, this should be reported to a doctor immediately.

Overdose

There have been no reports of overdose cases.

Interaction with other medicinal products has not been studied.

Pharmacodynamics

Naftifine is an antifungal agent for external use, belonging to the class of allylamines. The mechanism of action is associated with the inhibition of squalene-2,3-epoxidase, which leads to a decrease in the formation of ergosterol, a component of the fungal cell wall. It is active against dermatophytes such as Trichophyton, Epidermophyton, Microsporum, mold fungi (Aspergillus spp.), yeast fungi (Candida spp., Pityrosporum), and other fungi (e.g., Sporothrix schenckii). Naftifine acts fungicidally against dermatophytes and aspergilli. Against yeast fungi, naftifine exhibits fungicidal or fungistatic activity depending on the strain of the microorganism. It has antibacterial activity against gram-positive and gram-negative microorganisms that can cause secondary bacterial infections. It has anti-inflammatory effects that contribute to the rapid resolution of inflammation symptoms, especially itching.

Pharmacokinetics

When applied externally, naftifine penetrates well into the skin, creating sustained antifungal concentrations in its various layers, which allows for the use of the drug once a day.