Exoderil, cream 1% 30 g

Antifungal agent

ATX code: D01AE22

Pharmacodynamics

Naftifine is a topical antifungal agent belonging to the class of allilamines. Its mechanism of action is related to inhibition of squalene-2,3-epoxidase, which results in reduction of formation of ergosterol, a component of the cell wall of the fungus. It is active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, molds (Aspergillus spp.), yeasts (Candida spp., Pityrosporum) and other fungi (such as Sporothrix schenckii).

With respect to dermatophytes and aspergillus naphthifin acts fungicidal. Against yeast fungi the drug has 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 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 on the skin less than 6% of naphthifin is absorbed systemically. Absorbed amount is partially metabolized and excreted by kidneys and intestine. Half-life period of the drug is 2 – 3 days.

Indications

– fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), incl. interdigital mycoses (tinea manum, tinea pedum);

– fungal infections of nails (onychomycosis);

– skin candidiasis;

– pityriasis versicolor;

– ringworm (with or without accompanying itching).

Pharmacological effect

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

Naftifine has a fungicidal effect against dermatophytes and aspergillus. Against 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 symptoms of inflammation, especially itching. Pharmacokinetics

When used 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 subject to systemic absorption. The absorbed amount is partially metabolized and excreted by the kidneys and intestines. The half-life of the drug is 2 – 3 days.

Special instructions

Precautions for use:

Exoderil® is not intended for use in ophthalmology. The drug should not come into contact with the eyes.

Effect on the ability to drive vehicles and other mechanisms: Exoderil® does not have a negative effect on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

Active ingredient

Naftifin

Composition

1 g of cream contains:

active substance:

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.

Pregnancy

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

Contraindications

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

With caution

Children’s age (experience of clinical use is limited).

Side Effects

In some cases, local reactions may be observed: dry skin, skin hyperemia and burning.

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

Interaction

There were no drug interactions between Exoderil® and other drugs.

Overdose

No cases of overdose have been reported.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

5 years

Manufacturer

Salutas Pharma GmbH, Germany