Mizol Evalar solution for external use 1%, 50ml

Composition

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1 ml of the 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

Pharmacological action

Pharmacological group: antifungal agent

ATX Code: D01AE22

Pharmacological properties

Pharmacodynamics

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 cell wall of the fungus. It is active against dermatophytes, such as trichophyton, epidermophyton and microsporum, molds (Aspergillus spp. ), yeast fungi (Candida spp., Pityrosporum) and other fungi (for example, Sporothrix schenckii). Naftifine acts as a fungicide against dermatophytes and aspergillus. In relation to yeast fungi, the drug exhibits 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 has an anti-inflammatory effect, which contributes to the rapid disappearance of inflammatory 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 infections of the nails (onychomycosis);
• candidiasis of the skin;
• multi-colored (pityriasis) lichen;
• dermatomycosis (with or without concomitant itching).

Use during pregnancy and lactation

Application of the drug Mizol® Evalar is contraindicated during pregnancy and lactation (the safety and efficacy of Naftifine in this category of patients has not been studied).

Contraindications

Hypersensitivity to naphthifine or propylene glycol.

Pregnancy and lactation (safety and efficacy have not been established).

Application of the drug to the wound surface is contraindicated.

With caution

Children’s age (limited clinical experience).

Side effects

In some cases, local reactions may occur: dry skin, hyperemia of the skin and burning. Side effects are reversible and do not require discontinuation of treatment.

If you experience any of the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Interactions with other drugs have not been studied.

How to take, course of use and dosage

Externally.

Mizol® Evalar is applied once a day to the affected skin surface and adjacent areas (approximately 1 cm of healthy skin along the edges of the affected area) after thorough cleaning and drying. The duration of therapy for dermatomycosis is 2-4 weeks (if necessary-up to 8 weeks), for candidiasis-4 weeks.

In case of nail damage Mizol® Evalar is applied 2 times a day to the affected nail. Before the first application of the drug, the affected part of the nail is 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.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor. Use the drug only according to the method of use and in the doses indicated in the instructions. If necessary, please consult your doctor before using the medicine.

Overdose

When using the drug in accordance with the instructions for use, overdose is unlikely. In case of accidental ingestion, gastric lavage and symptomatic therapy are indicated.

Description

Transparent colorless or almost colorless solution with an ethanol smell.

Special instructions

The drug Mizol® Evalar is not intended for use in ophthalmology. Do not allow the drug to get into 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 the skin with hyperkeratosis, as well as in areas of hair growth. Propylene glycol, which is part of the solution, can cause skin irritation; if side effects occur, stop using the drug and consult a doctor. Effect on the ability to drive vehicles, mechanismim Izole® Evalar does not affect the performance of potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Solution for external use 1%.10,20 ml in bottles-droppers made of brown or orange glass for medicines, capped with dropper stoppers and lids screwed on with the control of the first opening. 50 ml each in bottles made of brown or orange glass for medicinal products, capped with dropper stoppers and screw-on lids with the control of the first opening. Each dropper bottle or bottle together with the instructions for use is placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. After opening, use for 6 months. Do not use after the expiration date.

Active ingredient

Naftifine

Dosage form

solution for external use