cream 1 % Сreme Terbinafini 1%
international nonproprietary name
Antifungal preparations for treatment of skin diseases. Antifungal preparations for external use.
Composition of the preparation
Active agent – terbinafine (counted as per 100 % substance) 1 g,
Auxiliary agents – emulsion wax, distillated glycerine, sunflower oil, glycerine monostearate, carbamide, sodium benzoate, propylene glycol, triethanolamide, purified water.
Terbinafineisasyntheticantifungalpreparationofallylaminecategory. It has a wide range of action. Inhibiting squalene epoxidase in the fungi cell membrane it suppresses the early phase of sterol synthesis in the fungi cell that leads to the deficit of ergosterine, intracellular accumulation of squalene and death of the cell.
It has an effect on dermatophytes, yeastlike and mold fungi. In low concentrations it has a fungicide activity towards dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), mold fungi (comprising Aspergillus, Cladosporium, Scopulariopsis brevicaulis). On local application terminafine is active towards Pityrosporum orbiculare. The action on the yeastlike fungi ofCandida type can be fungicide or fungistatic depending on the fungi type.
Terbinafine in contrast to azole derivaties is insignificantly limits the function of cytochrome Р450 and metabolism of steroid hormones and other medications.
On external application the preparation penetrates rapidly through the skin dermal layer and is accumulated in the corneal layer, mails and hair. On single application of 100 mkl of ointment onto the skin surface of 30 sqm, 3,5-5 % of the dose of the preparation is observed in the urine therefore a systemic action is minimal. On external use a potential possibility of the preparation penetration into breast milk is not excluded.
The preparation is prescribed to adults on dystrophic retina diseases (comprising inherited retinal abiotrophy), cornea dystrophy, senile cataract, trauma cataract, irradiation cataract and other types of cataracts, as well as on cornea trauma (as a stimulator of reparation processes).
Irregular application of the preparation and a preliminary termination of the treatment can lead to recidivation development.
On application of the cream personal hygiene shall be observed to prevent a repeated infection through the underclothes or shoes. In the process and in the end of the treatment it is necessary to carry out antifungial treatment of the shoes, socks and underwear.
Dosage and method of administration
The cream is applied with a thick layer slightly rubbing into the damaged skin that was purified and dried before, as well as into the damaged areas around 1-2 times a day.
On infections accompanied by intertrigo (under the mammary gland, in the interdigitalis pedum, between the buttocks, in the inguinal region), the place of the application can be covered by gauze napkin.
The average duration of treatment on dermatomycosis of the body, legs, feet is about a week, on skin candidosis — 1-2 weeks, on petyriasis versicolor – 2 weeks.
Cases of the preparation overdosing have not been reported.
Terbinafine cream is only for external use.
Ingress into the mucous membrane of the eyes, nose and mouth shall be prevented. On penetration of the preparation into the eyes, the eyes shall be washed down with a big amount of water and, in case of a persistent irritation, consult the physician.
Skinallergicreactions, burning, reddeninganditchingintheplaceoftheapplication.
Hypersensitivity to preparation components, pregnancy, lactation period (lactation shall be suspended for the period of treatment).
Interactions with other medicinal preparations
Interaction with other medications have not been specified.
The form of release
In tubes of 15 g. Each tube with the instruction for use is placed in a carton.