Mizol^® Evalar (Solution) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

Evalar, CJSC (Russia)

ATC Code

D01AE22 (Naftifine)

Active Substance

Naftifine (Rec.INN registered by WHO)

Dosage Form

Mizol® Evalar

Solution for external use 1%: bottle 10 ml, 20 ml or 50 ml

Dosage Form, Packaging, and Composition

Solution for external use transparent, colorless or almost colorless, with the smell of ethanol.

Excipients: propylene glycol, ethanol (ethyl alcohol) 95%, purified water.

10 ml – glass bottles (1) with a dropper cap – cardboard packs.
20 ml – glass bottles (1) with a dropper cap – cardboard packs.
50 ml – glass bottles (1) with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

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

Pharmacological Action

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, which is part of the fungal cell wall.

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

Naftifine acts fungicidally against dermatophytes and aspergilli. Against yeasts, the drug 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 quickly penetrates the skin, creating stable antifungal concentrations in its various layers, which makes it possible to use it once a day.

Indications

• Fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis);
• Interdigital mycoses (tinea manum, tinea pedum);
• Fungal nail infections (onychomycosis);
• Skin candidiasis;
• Pityriasis versicolor;
• Dermatomycoses (with or without accompanying itching).

ICD codes

Dosage Regimen

Externally.

For skin lesions

Mizol^® Evalar is applied once a day to the affected skin surface and adjacent areas (approximately 1 cm of healthy skin around the edges of the lesion) after thorough cleaning and drying.

The duration of therapy for dermatomycoses is 2-4 weeks (if necessary – up to 8 weeks), for candidiasis – 4 weeks.

For nail lesions

Mizol^® Evalar is applied twice a day to the affected nail. Before the first application of the drug, the affected part of the nail should be removed as much as possible with scissors or a nail file.

The duration of therapy for onychomycosis is up to 6 months. To prevent relapse, treatment should be continued for at least 2 weeks after the clinical symptoms disappear.

The drug should be used only in the manner and at the doses indicated above.

Children

It is impossible to give recommendations on the dosage regimen due to the limited experience of clinical use (see the “Special Precautions” section).

Adverse Reactions

Local reactions in some cases – dry skin, skin hyperemia and burning.

Side effects are reversible and do not require discontinuation of treatment.

Contraindications

• Hypersensitivity to naftifine, propylene glycol or to any of the excipients included in the drug;
• Pregnancy;
• Breastfeeding period;
• Application of the drug to the wound surface.

With caution

Children (experience of clinical use is limited).

Use in Pregnancy and Lactation

Pregnancy

The use of Mizol^® Evalar during pregnancy is contraindicated (the safety and efficacy of naftifine in this category of patients have not been studied).

Breastfeeding

The use of Mizol^® Evalar during breastfeeding is contraindicated (the safety and efficacy of naftifine in this category of patients have not been studied).

Fertility

No data available.

Pediatric Use

It is impossible to give recommendations on the dosage regimen due to the limited experience of clinical use.

Special Precautions

Mizol^® Evalar is not intended for use in ophthalmology. Avoid contact of the drug with the eyes.

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

Mizol^® Evalar is effective in the treatment of mycoses affecting areas of the skin with hyperkeratosis, as well as in hair growth areas.

Excipients

Propylene glycol, which is part of the solution, may cause skin irritation.

Effect on the ability to drive vehicles and mechanisms

Mizol^® Evalar does not affect the performance of potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Overdose is unlikely when using the drug in accordance with the dosage regimen indicated above.

Treatment in case of accidental ingestion: gastric lavage, symptomatic therapy.

Drug Interactions

Interaction with other drugs has not been studied.

Storage Conditions

The drug should be stored out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 5 years.

After opening the bottle, use within 6 months.

Dispensing Status

The drug is available without a prescription.

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.