Exoderil® (Naftifine) 1%, 10 ml solution (external application)

The instruction for medical use

of Ekzoderil Torgovoye medicine a name

Ekzoderil

Mezhdunarodnoye the unlicensed



name Naftifin Lekarstvennaya a form

of 1% solution for external use

Structure

of 1 ml of solution contains

active agent - a naftifin a hydrochloride of 0.01 g,

excipients: propylene glycol, ethanol, water purified.

The description

Transparent, from colourless till slightly yellowish color liquid with an ethanol smell.

Pharmacotherapeutic group

Other antifungal drugs for external use. Naftifin

the ATX D01AE22 Code

the Pharmacological



Ekzoderil Pharmacokinetics properties solution is soaked up in skin through a corneal layer (transdermalny way) and well gets into all layers of a nail, is long being present at various layers of skin and at nail plates in anti-mycotic concentration. Researches showed that after single topical administration of Ekzoderil solution, concentration in a nail plate exceeded by 3-5 times the minimum inhibiting concentration for trikhofit within 2 days.

Drug does not come to a system blood stream.

The pharmacodynamics

Ekzoderil solution 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 in the conditions of in vitro. 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.

Indications

- 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

need to be caused on 2-3 drops of solution by means of the special dropper located on a cap or by means of a cotton plug. Solution needs to be applied 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 Solution once a day on affected areas of skin which before it have to be cleaned and dried carefully up.

Treatment duration:

- 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 Solution 2 times a day 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 solution under an air-permeable bandage (plaster, bandage etc.), but it is not necessary to apply under an occlusive bandage.



Side effects

In some cases can be noted signs of local inflammation, such as xeroderma, reddening and burning. Side effects always have reversible character and do not demand treatment cancellation.



Contraindications

- hypersensitivity to a naftifin or propylene glycol

- an open wound surface



Medicinal interactions

are not established



Special

instructions Ekzoderil solution is intended only for external use. It cannot be applied in ophthalmologic practice and also to apply on open wounds. In the latter case it is necessary to apply Ekzoderil in the form of cream which does not contain ethanol.

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. 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. Children's age it is necessary to Apply Ekzoderil solution at children up to 18 years with care and only in emergency cases. 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





the Overdose does not influence





the Form of release and packing

On 10 or 20 ml of drug is not revealed place in bottles of dark glass with a polyethylene dropper and the polyethylene screwing-up cover of white color with control of the first opening.

On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.





To Store storage conditions in the place protected from light 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.



Prescription status

Without prescription



the Producer/packer

Pharmatsoytishe Produktyons's Globopharm und Handels GmbH, Austria

Breitenfurter Strasse, 251, 1230, Wien, 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
e-mail: kzsdz.drugsafety@sandoz.com