Universal reference book for medicines
Product name: EXODERIL ® (EXODERIL ® )

Active substance: naftifine

Type: Antifungal medication for external use

Manufacturer: SANDOZ (Austria) manufactured by MERCK (Austria)
Composition, form of production and packaging

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Cream for external use in white, uniform or slightly granular, shiny, with a weak characteristic odor.
1 g

naftifin hydrochloride 10 mg

Excipients: sodium hydroxide 1.2 mg, benzyl alcohol 10 mg, sorbitan stearate 19 mg cetyl palmitate 20 mg cetyl alcohol 40 mg stearyl alcohol 40 mg polysorbate 60 61 mg, isopropyl myristate 80 mg water purified - 718.8 mg.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Antifungal drug for external use from the group of allylamines.
The mechanism of action is associated with inhibition of the synthesis 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.
The drug is active against dermatophytes Trichophyton, Epidermophyton, Microsporum, yeast (Candida spp., Pityrosporum), mold fungi (Aspergillus spp.) And other fungi (Sporotrix schenckii).
With respect to dermatophytes and aspergillus, naphthyfine acts fungicidally. With regard to yeast fungi shows fungicidal or fungistatic activity, depending on the strain of the microorganism. The drug has antibacterial action against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections.
The drug has an anti-inflammatory effect that contributes to the rapid disappearance of symptoms of inflammation, especially itching.

PHARMACOKINETICS

Suction and distribution

With external application, naphthyfine penetrates well into various layers of the skin, reaching concentrations sufficient for antifungal action.

After application, less than 6% of the active substance is exposed to the skin of the systemic absorption cream.

Metabolism and excretion

The absorbed amount is partially metabolized and excreted by the kidneys and through the intestine.
T 1/2 is 2-3 days.
INDICATIONS

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

- Candidiasis of the skin;

- pityriasis vulgaris;

- dermatomycosis (with or without accompanying itching).

DOSING MODE

Exoderyl ® should be applied to the affected skin and adjacent areas 1 time / day, after thorough cleaning and drying, taking approximately 1 cm of healthy skin at the edges of the affected area.

Duration of treatment for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.

With onychomycosis, before the first use of the cream, it is necessary to remove the affected part of the nail as much as possible with scissors and a nail file.
The drug should be applied 2 times / day, the duration of treatment - up to 6 months.
To prevent recurrence of infection , therapy should be given for at least 2 weeks after the disappearance of clinical symptoms.

SIDE EFFECT

Local reactions: in some cases - dry skin, hyperemia, burning.

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

CONTRAINDICATIONS

- Pregnancy (safety and efficacy not determined);

- lactation period (safety and efficacy not determined);

- Hypersensitivity to naphthyfine, benzyl alcohol or other components of the drug.

With caution: child age (experience in clinical use is limited).

PREGNANCY AND LACTATION

Contraindicated in the use of Exozderyl ® during pregnancy and lactation (safety and efficacy not determined).

APPLICATION FOR CHILDREN

With caution : child age (experience in clinical use is limited).

SPECIAL INSTRUCTIONS

The drug is not intended for use in ophthalmology.
Avoid contact with the eyes.
No special measures are required to destroy the drug.

Impact on the ability to drive vehicles and manage mechanisms

The drug does not adversely affect the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

OVERDOSE

No cases of overdose have been reported.

DRUG INTERACTION

There was no drug interaction between the drug Exoderyl ® and other drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

RU1608519479

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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