The instruction for medical use
of Ekzifin® medicine
the Trade name
the International unlicensed
name Terbinafin Lekarstvennaya a form
of 1 g of drug contains
active agent – a terbinafin a hydrochloride of 10 mg
excipients: cetyl alcohol, stearyl alcohol, cetyl palmitate, benzyl alcohol, sorbitan monostearate, isopropyl myristate, sodium hydroxide, polysorbate 60, water purified.
Cream from almost white till yellowish color, uniform consistence.
Other antifungal drugs for topical administration. Terbinafin.
The ATX D 01AE15 code
Pharmacokinetics At properties topical administration of Ekzifin® cream is soaked up less than 5% of a dose and presence of a terbinafin at system blood circulation minimum. Terbinafin gets into a thermal layer of skin and collects in a lipophilic corneal layer. If duration of treatment lasts from 1 to 7 days, elimination half-life of a terbinafin from a corneal layer raises by 3 times.
of Ekzifin® – antifungal drug, derivative allylamine. In low concentration has fungicide effect concerning dermatophytes, mold mushrooms and some dimorphous mushrooms. Action on barmy mushrooms can be fungistatic or fungicidal, depending on a species of a mushroom.
Drug specifically suppresses an early stage of biosynthesis of sterols in a mushroom cell. Экзифин® inhibits a skvalenepoksidaza in a cellular membrane of a mushroom, it results in deficiency of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Enzyme of a skvalenepoksidaz does not belong to a system P450 cytochrome therefore Ekzifin does not influence metabolism of hormones or other medicines.
At external use of Ekzifin® it is active concerning causative agents of dermatomycoses: Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis, Epidermophyton floccosum, yeast-like mushrooms of the sort Candida (in the main Candida albicans). At external use of Ekzifin® it is active also concerning Pityrosporum orbiculare (Malassezia furfur) – multi-colored (scaly) depriving of the activator.
– an onychomycosis
– candidiases of skin, mucous membranes
– scaly (multi-colored) deprive dermatomycoses (an epidermophitia of skin and nail plates, rubromikoza, trichophytias, microsporias).
The route of administration and doses
apply Cream 1-2 times a day. Before putting cream it is necessary to clean and dry up the struck areas. Cream is applied to the affected skin and by adjacent areas a thin layer and slightly rub. In case of the infections which are followed by an intertrigo (under mammary glands, between fingers, in buttock and inguinal folds), the site of application of cream can be covered with a gauze (especially for the night).
Treatment duration in dermatomycoses of skin of a trunk, shins is 1 – 2 weeks, in dermatomycoses of feet – 1 week (2 times a day), 2 weeks (once a day), in skin candidiasis – 1 – 2 weeks, in multi-colored herpes – 2 weeks.
Reduction or disappearance of clinical symptoms is usually observed in several days of use of cream. However in order to avoid a disease recurrence, it is necessary to treat completely.
To patients of advanced age of Ekzifin® appoint in the same doses, as the adult.
Not to apply under occlusive bandages.
– reddening, feeling of an itching or burning
– skin rash, an itching, a small tortoiseshell, in rare instances – Stephens-Johnson’s syndrome, a toxic epidermal necrolysis.
– hypersensitivity to a terbinafin or to other components of drug
– pregnancy and the period of a lactation
– children’s age up to 12 years
At simultaneous use of Ekzifin® cream with other drugs of clinically significant medicinal interaction it is not established.
instructions Ekzifin® Cream it is intended only for external use. It is necessary to avoid hit of cream in eyes, a nose, a mouth.
With care in a liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, a tumor, a metabolism disease, occlusal diseases of vessels of extremities.
Use for patients from the liver broken by function and kidneys
Patients with the profound abnormal liver functions and/or kidneys (clearance of creatinine less than 50 ml/min. or concentration of creatinine in serum more than 300 µmol/l) should appoint a half of a usual dose of Ekzifina®. Before an initiation of treatment it is necessary to estimate initial indicators of function of a liver and to provide their monitoring in the course of treatment. If at the patient the phenomena indicating presence of an abnormal liver function, such as inexplicable persistent nausea, lack of appetite, fatigue, jaundice, dark urine or decoloured by kcal are noted, it is necessary to cancel treatment terbinafiny.
At long use of drug the blood monitoring is recommended.
If in 2 weeks of treatment the improvement of a state is not noted, it is necessary to define repeatedly an infestant and its sensitivity to drug.
At treatment of Ekzifinom® it is necessary to follow the general rules of hygiene for prevention of a possibility of repeated infection (through linen, socks, footwear).
At external use – is improbable.
Symptoms at accidental intake: a headache, nausea, a gastralgia, dizziness, the speeded-up urination, rash.
Treatment: gastric lavage with the subsequent prescribing of activated carbon. If necessary carry out symptomatic therapy.
A form of release and packing
Cream of 1% in tubas on 10 grams. On 1 tuba together with the instruction for use it is placed in cardboard packing. 12 packs are placed in 1 external cardboard box.
In the dry place protected from light at a temperature not over 25 of 0C.
To store out of children’s reach!
A period of storage
After an expiration date not to apply
Prescription status. Without prescription
Producer Dr. of Reddi’s Laboratoris Ltd
Site No. 41, Nasiger,
KIADB, Malur – 563,130
Area Kodar Range, India
the Owner of the registration certificate
Dr. of Reddi’s Laboratoris Ltd, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality a produktsiipredstavitelstvo of the Dr. of Reddi’s Laboratoris Limited company in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45, ph. 8 (727) 3941688, fax: 8 (727) 3941294