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), including. interfinger mycoses (tinea manum, tinea pedum);

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

– Candidiasis of the skin;

– chancroid;

– dermatomycoses (with or without associated itching).

Active ingredient

Composition

1 g of cream contains:

the active ingredient:

naphthyphine 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.

How to take, the dosage

Externally.

In case of skin lesions Exoderil® is applied once a day to the affected skin surface and its neighboring areas (about 1 cm of healthy skin at the edges of the affected area) after their thorough cleaning and drying. Duration of therapy in dermatomycosis – 2-4 weeks (if necessary – up to 8 weeks), in candidiasis – 4 weeks.

When the nails are affected, Exoderil® is applied 2 times a day on the affected nail. Before the first use of the drug, remove the affected part of the nail with scissors or a nail file as much as possible. 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 disappearance of clinical symptoms.

Interaction

No drug interactions of Exoderil® with other drugs were noted.

Special Instructions

Precautions for use:

The drug Exoderil® is not intended for use in ophthalmology. Avoid contact of the drug with the eyes.

Impact on the ability to drive vehicles and other mechanisms: Exoderil® has no adverse effect on the ability to drive vehicles and perform other activities requiring concentration and quick psychomotor reactions.

Contraindications

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

With caution

Paediatric age (experience with clinical use is limited).

Side effects

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

The side effects are reversible and do not require treatment withdrawal.

Overdose

No cases of overdose have been reported.

Pregnancy use

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

Similarities