Erkaderyl (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 ).

Naftifine acts fungicidally against dermatophytes and aspergillus.

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 that 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 of naftifine is less than 6%. It is partially metabolized. It is excreted by the kidneys and through the intestines.

Indications

• Fungal infections of the skin and nails caused by susceptible organisms.
• Treat dermatophytoses including tinea pedis, tinea cruris, and tinea corporis.
• Manage onychomycosis affecting the nail plates.
• Use for cutaneous candidiasis and pityriasis versicolor.
• Apply for mycotic infections complicated by secondary bacterial involvement.

Refer to the ICD code tables for specific diagnosis correlations.

ICD codes

Dosage Regimen

Apply the preparation externally to the affected skin areas and the immediately surrounding skin once daily.

For cutaneous infections, the typical treatment duration is two to four weeks. For onychomycosis, apply the preparation daily until the nail has completely regrown and is clinically healthy, which may take several months.

Thoroughly cleanse and dry the affected area before application. Wash hands after application unless the hands are the treated area.

Adverse Reactions

Adverse reactions are typically localized to the site of application.

Common reactions include dryness of the skin, erythema, itching, and a burning or stinging sensation.

These effects are usually mild and transient. Discontinue use if a severe local reaction or signs of a systemic allergic reaction occur.

Contraindications

• Do not use in patients with a known hypersensitivity to naftifine or to any of the excipients in the formulation.
• Contraindicated for use during pregnancy and lactation due to a lack of safety data.
• Avoid application to open wounds, broken skin, or mucous membranes.

Use with caution in the pediatric population as clinical experience is limited.

Drug Interactions

Formal studies of drug interactions for topically applied naftifine have not been conducted.

Due to low systemic absorption (<6%), clinically significant drug interactions are not anticipated.

No specific interactions with other topical preparations have been reported. Avoid concurrent use of other topical preparations on the same area unless directed by a physician.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption.

Excessive topical application may lead to intensified local adverse reactions such as severe erythema, itching, or burning.

In case of accidental ingestion, institute supportive measures and seek medical attention. There is no specific antidote.

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 30°C (86°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.