Mizol Evalar 1% Solution for External Use 50 ml

Indications

• fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis);
• interdigital mycoses (tinea manum, tinea pedum);
• fungal infections of the nails (onychomycosis);
• candidiasis of the skin;
• pityriasis (tinea versicolor);
• dermatomycoses (with or without accompanying itching).

Application method and doses

For external use.
Mizol® Evalar is applied once a day to the affected skin surface and adjacent areas (approximately 1 cm of healthy skin at the edges of the affected area) after thorough cleansing and drying. The duration of therapy for dermatomycoses is 2-4 weeks (if necessary, up to 8 weeks), and for candidiasis - 4 weeks.
For nail infections, 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 maximally removed with scissors or a nail file. The duration of therapy for onychomycosis is up to 6 months.
To prevent recurrence, treatment should be continued for at least 2 weeks after the clinical symptoms have disappeared.
If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the method of application and in the doses specified in the instructions. If necessary, please consult a doctor before using the medication.

Section: Composition

1 ml of solution contains
Active ingredient: naftifine hydrochloride - 10.00 mg
Excipients: propylene glycol - 50.00 mg; ethanol (ethyl alcohol) 95% - 400.00 mg; purified water - 475.00 mg.

Transparent colorless or almost colorless solution with the smell of ethanol.

Contraindications

Hyper-sensitivity to naftifine or propylene glycol.
Pregnancy and breastfeeding period (safety and efficacy of use have not been established).
Application of the drug on a wound surface is contraindicated.
With caution
Child age (clinical experience is limited).
Use during pregnancy and breastfeeding
The use of the Mizol® Evalar drug during pregnancy and breastfeeding is contraindicated (the safety and efficacy of naftifine in this category of patients have not been studied).

Special Instructions

The drug Mizol® Evalar is not intended for use in ophthalmology. The preparation should not come into contact with the eyes.
To achieve a therapeutic effect, a course of treatment is required.
Mizol® Evalar is effective in the treatment of mycoses affecting areas of skin with hyperkeratosis, as well as in hair growth areas.
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.
Effect on the ability to drive vehicles and operate machinery
Mizol® Evalar does not affect the performance of potentially dangerous activities that require increased attention and quick psychomotor reactions.

Section: Side Effects

In some cases, local reactions may occur: skin dryness, skin hyperemia, and burning. The side effects are reversible and do not require discontinuation of treatment. If you experience side effects listed in the instructions or if they worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.

Section: Overdose

English translation:
When using the drug according to the instructions for use, overdose is unlikely. In case of accidental ingestion, gastric lavage and symptomatic therapy are indicated.

Interaction with other medicinal products has not been studied.

Pharmacodynamics

Naftifine is an antifungal agent for external use, belonging to the class of allylamines. Its mechanism of action is associated with the inhibition of squalene-2,3-epoxidase, leading to a decrease in the formation of ergosterol, which is a component of the fungal cell wall. It is active against dermatophytes such as Trichophyton, Epidermophyton, and Microsporum, molds (Aspergillus spp.), yeast fungi (Candida spp., Pityrosporum), and other fungi (e.g., Sporothrix schenckii). Naftifine acts fungicidally against dermatophytes and Aspergillus. For yeast fungi, the drug exhibits either 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 possesses anti-inflammatory effects that contribute to the rapid resolution of inflammation symptoms, especially itching.

Pharmacokinetics

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