Exoderil, cream 1%, 30g

Composition

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of 1 g of cream contains:

Active ingredient:

Naftifine hydrochloride – 10.0 mg

. excipients:

sodium hydroxide-1.2 mg,

benzyl alcohol-10.0 mg,

sorbitan stearate-19.0 mg,

cetyl palmitate-20.0 mg,

cetyl alcohol-40.0 mg,

stearyl alcohol-40.0 mg,

polysorbate 60-61.0 mg,

isopropyl myristate-80.0 mg,

purified water-718.8 mg

Pharmacological action

antifungal agent

ATX Code: D01AE22

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 micro-organisms 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, it penetrates well into various layers of the skin, creating stable antifungal concentrations in its various layers. After application to the skin, less than 6% of Naftifine is absorbed by the system. The absorbed amount is partially metabolized and excreted by the kidneys and through the intestines. The half-life of the drug is 2-3 days.

Indications

-fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), including interdigital mycoses (tinea manum, tinea pedum);

– fungal infections of the nails (onycho – mycoses);

– candidiasis of the skin;

– pityriasis;

– dermatomycosis (with or without concomitant itching).

Use during pregnancy and lactation

The use of Exoderil® is contraindicated during pregnancy and lactation (safety and efficacy have not been determined).

Contraindications

Hypersensitivity to Naftifine, benzyl alcohol or other components of the drug; pregnancy and lactation (safety and efficacy of the drug have not been determined).

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.

Interaction

There was no drug interaction of Exoderil with other drugs.

How to take, course of use and dosage

Externally.

In case of skin damage, Exoderyl® 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.

If the nails are affected, Exoderyl® 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.

Overdose

No overdose cases have been reported.

Special instructions

Precautions for use:

Exoderil® is not intended for use in ophthalmology. Do not allow the drug to get into the eyes.

Influence on the ability to drive vehicles and other mechanisms: Exoderyl® does not adversely affect the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.

Product form

white, uniform or slightly grainy, shiny cream with a faint characteristic smell.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

5 years

Active ingredient

Naftifine

Dosage form

cream

Description

For adults, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Fungus, Skin Fungus, Nail Fungus