Epideril^® (Solution) Instructions for Use

Marketing Authorization Holder

Interpharma, LLC (Russia)

Manufactured By

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

D01AE22 (Naftifine)

Active Substance

Naftifine (Rec.INN registered by WHO)

Dosage Form

Epideril®

Solution for topical application 1%: fl. or dropper bottle 10 ml or 20 ml

Dosage Form, Packaging, and Composition

Solution for topical application transparent, colorless or slightly yellowish in color, with an odor of ethanol.

Excipients : propylene glycol – 50 mg, ethanol 96% – 400 mg, purified water – up to 1 ml.

10 ml – dropper bottles – cardboard packs.
10 ml – bottles – cardboard packs.
20 ml – dropper bottles – cardboard packs.
20 ml – bottles – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal agent for topical use, belongs to the 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, which is part of the fungal cell wall.

Active against dermatophytes, such as Trichophyton, Epidermophyton, Microsporum , molds ( Aspergillus spp .), yeasts ( Candida spp., Pityrosporum ) and other fungi (for example, Sporothrix schenckii ).

Naftifine acts fungicidally against dermatophytes and aspergillus.

Against yeasts, Naftifine exhibits fungicidal or fungistatic activity depending on the microorganism strain.

Has antibacterial activity against gram-positive and gram-negative microorganisms that can cause secondary bacterial infections.

Has an anti-inflammatory effect that contributes to the rapid disappearance of inflammation symptoms, especially itching.

Pharmacokinetics

When applied topically, Naftifine penetrates the skin well, creating stable antifungal concentrations in its various layers. Systemic absorption is less than 6% of naftifine. Partially metabolized. Excreted by the kidneys and through the intestines.

Indications

Onychomycosis, pityriasis versicolor, epidermophytosis of large skin folds and feet, rubromycosis, trichophytosis, microsporia, skin candidiasis, mycoses with secondary bacterial infection.

ICD codes

Dosage Regimen

Apply the solution topically to the affected and surrounding skin areas once daily.

Prior to application, thoroughly cleanse and dry the affected area. Apply a sufficient amount of the solution to cover the entire affected area.

For skin infections such as tinea pedis, tinea cruris, or tinea corporis, the typical treatment duration is two to four weeks.

For pityriasis versicolor, the typical treatment duration is two weeks.

For onychomycosis (nail fungus), apply the solution to the affected nail(s) twice daily. Treatment must be continued until the nail has completely regrown and is clinically healthy.

Treatment for onychomycosis typically requires six months for fingernails and nine to twelve months for toenails.

Ensure the solution is allowed to dry completely after application. Wash hands after use, unless the hands are the treated area.

Avoid contact with eyes, mucous membranes, and open wounds. Do not apply occlusive dressings unless directed by a physician.

Continue use for the full prescribed duration, even if symptoms improve, to prevent recurrence. If no clinical improvement is observed after the expected treatment period, re-evaluate the diagnosis.

Adverse Reactions

In some cases at the application site: dryness and redness of the skin, burning sensation.

Contraindications

Hypersensitivity to naftifine; pregnancy, breastfeeding period (safety and efficacy of use have not been established); application to a wound surface.

With caution in children.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated. The safety and efficacy of naftifine in this category of patients have not been studied.

Pediatric Use

Use in children is not recommended (clinical experience is limited).

Special Precautions

A course of treatment is required to achieve a therapeutic effect.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.