Project Description

Terbinafine

cream 1 % Сreme Terbinafini 1%

international nonproprietary name

Terbinafine.

Ref

BP-0142

Pharmacotherapeutic group

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.

Pharmacological action

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.

Pharmacokinetics

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.

Indications 

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).

special indication

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.

special warning

Not established

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.

overdosage

Cases of the preparation overdosing have not been reported.

safety measures

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.

Side effects

Skinallergicreactions, burning, reddeninganditchingintheplaceoftheapplication.

Contraindications

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.