Expiration date: 02/2025

The composition and form of issue: 

Cream for external use, 1 g contains active substance: 

naftifine hydrochloride 10 mg

excipients: sodium hydroxide benzyl alcohol servicestart cetylpalmitate alcohol cetyl alcohol stearyl Polysorbate 60 methyl ethyl ketone purified water 

in the aluminium tubes to 15 or 30 grams in a cardboard bundle 1 tuba.

The topical solution, 1 ml contains active substance: 

naftifine hydrochloride 10 mg

excipients: propylene glycol ethanol purified water 

in dark glass bottles of 10 ml in a cardboard pack 1 bottle.

Description pharmaceutical form:

The topical cream: white, homogenous or slightly storegenie, shiny, with a faint characteristic odor.

The topical solution: clear, colorless or slightly yellow, with the smell of ethanol.

Pharmacokinetics:

Cream

When applied topically it penetrates into the various layers of the skin sufficient for antifungal activity concentrations. After application on the skin cream systemic absorption was only 6% of active substance. The absorbed amount partially metabolized and excreted by the kidneys and bile. T1/2 of the drug is 2-3 days.

Description pharmacological action:

Drug Exoderil — antifungal agent belonging to the class of allylamines. Its active ingredient is naftifine. The mechanism of action is associated with inhibition of synthesis of ergosterol.

Naftifin active against dermatophytes such as Trichophyton, Epidermophyton and Microsporum, yeast (Candida), molds (Aspergillus) and other fungi (e.g. Sporothrix schenckii). Against dermatophytes and Aspergillus naftifin the acts fungicidal in vitro. Against yeast fungi, the drug has fungicidal and fungistatic activity, depending on the strain of microorganism. Naftifin has antibacterial activity against gram-positive and gram-negative microorganisms.

In clinical settings it was found that naftifine has anti-inflammatory action that contributes to the rapid disappearance of the symptoms of inflammation, particularly itching.

Because drug Exoderil quickly penetrates the skin, creating a sustainable antifungal concentrations in its various layers, it may have local application only once a day.

Indications:

For both dosage forms

• fungal infections of the skin and skin folds (tinea corporis, tinea inquinalis)
  
• interdigital mycoses (tinea manum, tinea pedum)
  
• fungal infections of the nails (onychomycosis)
  
• cutaneous candidiasis
  
• pityriasis versicolor
  
• inflammatory dermatomycoses (with an accompanying itching or not).
  
• For mortar for external use additionally
  
• mycosis of the external auditory canal.
  

Contraindications:

Hypersensitivity to naftifine or other components of the drug (benzyl alcohol for dosage forms cream or propylene glycol (pharmaceutical form solution).

The drug should not be applied to the wound surface.

With caution: pregnancy, lactation, children's age.

Side effects:

In some cases, there may occur local reactions: dry skin, redness and burning.

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

Drug interactions:

There were no interactions with other drugs.

Method of application and dose:

Cream for external use

Externally. Drug Exoderil should be applied on the affected surface of the skin and surrounding areas once a day after thorough cleaning and drying, capturing about 1 cm of healthy skin around the edges of the affected area. Duration of treatment: for ringworm — 2-4 weeks (if necessary — to 8 weeks), with candidiasis — 4 weeks, with infections of nails should be used 2 times a day duration of therapy to 6 months. To prevent relapse of infection should continue the drug for at least 2 weeks after clinical recovery.

The solution for external use

Externally. Drug Exoderil should be applied on the affected surface of the skin and surrounding areas once a day after thorough cleaning and drying, capturing about 1 cm of healthy skin around the edges of the affected area. When lesions nail before the first application of a solution should be possible to remove the affected part of the nail scissors and nail file. Duration of treatment: for ringworm — 2-4 weeks (if necessary — to 8 weeks), with candidiasis — 4 weeks, with the defeat of nails should be used 2 times a day duration of therapy to 6 months. To prevent relapse of infection should continue to use the drug for at least 2 weeks after clinical cure.

When mycosis of the external auditory canal treatment solution must be conducted no less than 14 days. Local treatment is carried out by insertion in the ear with a cotton turundae, soaked with a solution of the drug, for 5-8 minutes 1-2 times a day.

Special instructions:

Can be made into cream and topical solution drug Exoderil eyes and open wounds.