Exohelp (Solution, Cream) Instructions for Use

ATC Code

D01AE22 (Naftifine)

Active Substance

Naftifine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

Pharmacological Action

Antifungal agent for external 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.

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

Against dermatophytes and aspergillus, Naftifine acts fungicidally.

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

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

It has an anti-inflammatory effect, which contributes to the rapid disappearance of inflammation symptoms, especially itching.

Pharmacokinetics

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

Indications

• Fungal nail infections (Onychomycosis).
• Superficial skin mycoses including tinea corporis, tinea cruris, and tinea pedis caused by dermatophytes.
• Cutaneous candidiasis.
• Pityriasis versicolor.
• Mycoses complicated by secondary bacterial infections.

Apply the preparation to the affected skin areas and surrounding healthy skin once or twice daily, depending on the severity of the infection.

For cream, apply and rub in gently. For solution, apply a sufficient amount to cover the affected area. Continue treatment for the prescribed duration, typically for 2 to 4 weeks, and for at least 2 weeks after clinical symptoms have resolved to prevent relapse.

ICD codes

Dosage Regimen

Apply the preparation to the affected skin areas and surrounding healthy skin once or twice daily, depending on the severity of the infection.

For cream, apply and rub in gently. For solution, apply a sufficient amount to cover the affected area.

Continue treatment for the prescribed duration, typically for 2 to 4 weeks, and for at least 2 weeks after clinical symptoms have resolved to prevent relapse.

Solution, Cream

Apply externally. The dosage regimen is set individually, depending on the indications and the dosage form used.

Adverse Reactions

Adverse reactions are typically localized to the site of application and are usually mild and transient.

Common reactions include skin dryness, erythema, burning, and itching.

Discontinue use if signs of severe local irritation or contact dermatitis develop. Systemic reactions are unlikely due to low percutaneous absorption.

Drug Interactions

No specific drug interactions have been reported. The potential for systemic interactions is considered low due to minimal systemic absorption following topical application.

Concomitant use with other topical preparations on the same area is not recommended as it may cause irritation or dilute the effect.

Avoid applying occlusive dressings over the treated area unless directed by a physician.

Contraindications

• Hypersensitivity to naftifine or any of the excipients in the formulation.
• Application to open wounds or severely broken skin.

Use during pregnancy and lactation is contraindicated due to lack of safety data. Use with caution in the pediatric population as clinical experience is limited.

Overdose

Topical overdose is unlikely to lead to systemic effects due to low absorption. Excessive topical application may result in increased local adverse reactions such as severe redness, irritation, or burning.

In case of accidental ingestion, seek medical attention immediately. Symptoms of ingestion may include gastrointestinal irritation. Provide symptomatic and supportive care.

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

Course 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.