The instruction for medical use
of Ekzoderil Torgovoye medicine a name
of the drug Ekzoderil Mezhdunarodnoye the unlicensed
name Naftifin Lekarstvennaya a form
Cream of 1%
of 1 g of cream contains
active agent – a naftifin a hydrochloride of 10 mg,
excipients: benzyl alcohol, sorbitan stearate, sodium hydroxide, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, water purified.
White, uniform or slightly stvorozhenny, brilliant cream with a slight specific smell.
Antifungal drugs for treatment of diseases of skin.
Other antifungal drugs for topical administration. Naftifin.
The ATX D01AE22 code
Ekzoderil Pharmacokinetics properties cream quickly gets into various layers of skin, creating steady antifungal concentration in its various layers therefore its topical administration only once in day is possible.
After applique on skin of 1% of cream of system absorption from 4.2 to 6% of active ingredient are exposed. The soaked-up quantity partially
is metabolized and removed by kidneys and with bile. Elimination half-life makes 2-3 days.
Ekzoderil cream is the antifungal allylamine drug intended for external use. Its active ingredient is naftifin.
Naftifin has activity concerning barmy fungi (type of Candida, Pityriasis versicolor), mold fungi (type of Aspergillus) and other fungi (for example, Sporothrix Schenckii).
For dermatophytes and a fungus of Aspergillus naftifin works fungicidally. Concerning barmy fungi drug shows fungicide and fungistatic activity depending on a strain of a microorganism.
Action mechanism: naftifin, suppressing skvalenepoksidaza enzyme, inhibits synthesis of ergosterol which is necessary for growth of a fungal cell therefore the fungistatic effect is shown. Besides, suppression of a skvalenepoksidaza leads to accumulation of squalene in membranes of a fungal cell and damage of its wall therefore the fungicide effect is shown.
Except antifungal action, naftifin has antibacterial activity concerning a number of gram-positive and gram-negative pathogenic microorganisms who often meet in a combination fungal infections: golden staphylococcus, pyocyanic stick, colibacillus, proteas.
In clinical conditions it was established what naftifin possesses anti-inflammatory action which promotes fast disappearance of symptoms of inflammation, especially the nagger.
– the fungal infections of skin and skin folds caused by activators Tinea corporis, Tinea inguinalis
– the interdigital mycoses of hands and feet caused by activators Tinea manum, Tinea pedum
– fungal infections of nails on hands and legs (onychomycoses)
– the skin candidiases caused by Candida
– the chromophytosis caused by the Pityriasis versicolor activator
– inflammatory dermatomycoses (with the accompanying itching or without it)
the Route of administration
Cream need to be caused not only on affected areas of a skin/nail, but also on the adjoining sites for prevention of spread of an infection.
Fungal infections of skin
apply Cream with a thin layer once a day, accurately rubbing, on affected areas of skin which before it have to be cleaned and dried carefully up.
– fungal infections of skin and skin folds up to 4 weeks,
– interdigital mycoses of hands and feet from 4th to 8 weeks,
– skin candidiases 4 weeks,
– a chromophytosis up to 2 weeks
– inflammatory dermatomycoses 2-4 weeks,
After manifestation of clinical effect, namely disappearance of an itching and burning, for prevention of returnable infection treatment it is necessary to continue within not less than 2 weeks.
Fungal infections of nails on hands and legs (onychomycoses)
apply Cream 2 times a day with a thin layer, accurately rubbing on the struck surface of nail plates which before it have to be cleaned, dried carefully up and as much as possible obstrizhena. Duration of treatment is defined by the speed of growth of nail plates and can be from 3rd to 6 months until the new nail completely grows.
Ekzoderil is recommended to apply cream under an air-permeable bandage (plaster, bandage etc.), but it is not necessary to apply under an occlusive bandage.
– xeroderma, a dermahemia
– burning, irritation
of the Contraindication
– hypersensitivity to a naftifin or benzyl alcohol
are not established
it is not necessary to allow hits of drug in eyes. Ekzoderil cream contains cetyl alcohol and can cause local side reactions on skin (for example, contact dermatitis).
For elimination of a fungal infection (mycosis), it is recommended to adhere to the following precautionary measures:
1. Fungi can get on the clothes and/or socks coming into contact with the area struck a skin/nail therefore the clothes and/or socks should be changed every day, and regularly to process footwear.
2. Maintenance of the struck surface of a skin/nail in a dry state provides good protection against spread of a fungal infection. It is not recommended to cover an affected area with dense fabric or accessories which limit or interfere with ventilation (for example, the stockings made of synthetic fibers, close footwear). The affected area of a skin/nail should be dried carefully after washing. Also it is necessary to change daily the towels, clothes and/or socks adjoining to the struck surface.
3. In case of a fungus disease of feet, it is not necessary to go barefoot at home or in public places to prevent repeated infection or distribution of pathogenic activators.
4. Saunas or steam baths can be visited only after full disposal of a fungal infection.
Safety and efficiency of use for children is not established.
Pregnancy and a lactation
on condition of the correct use the impact of drug on a fruit or the newborn child is improbable.
Features of influence of drug on ability to run transport and potentially dangerous mechanisms
of Data on overdose or clinical signs does not influence there is no poisoning.
In case of overdose, symptomatic treatment.
The form of release and packing
On 15 or 30 g of drug place in tubas aluminum with internal varnish coating.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at
a temperature not higher than 30 S. Hranit out of children’s reach!
Not to use a period of storage of 5 years after the expiry date specified on packing.
Merk of KGaA und To, Austria
Hoesslgasse 20, A-9800 Spittal/Drau, Austria
the Owner of the registration certificate
of Sandoz GmbH, Austria
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of JSC Sandoz Pharmasyyutikals of of in Republic of Kazakhstan, Almaty, Luganskogo St. 96
ph. +7 (727) 2581048 Fax: +7 (727) 2581047
8 800 080 0066 free number of dialing across Kazakhstan