Terbinafin
Producer: LLC Pharmtekhnologiya Republic of Belarus
Code of automatic telephone exchange: D01AE15
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
Active ingredient: 10 mg of a terbinafin of a hydrochloride in 1 g of cream.
Excipients: propylene glycol, paraffin soft white, cetostearyl alcohol, a makrogolglitserin hydroxystearate, a macrogoal cetostearyl ether, glycerin, a dimethyl sulfoxide, isopropyl myristate, stearic acid, diethanol amide, methylparahydroxybenzoate, пропилпарагидроксибензоат, citric acid monohydrate, the water purified.
Antifungal medicine of local use with a wide range of antifungal action.
Pharmacological properties:
Pharmacodynamics. Antifungal medicine, allylamine. Possesses a wide range of antifungal action. Terbinafin has fungicidal effect concerning dermatophytes, mold and some dimorphous mushrooms. Activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic.
Terbinafin breaks the biosynthesis of ergosterol happening in mushrooms at early stages. It leads to deficit of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Action of a terbinafin is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom. This enzyme does not belong to system of P450 cytochrome therefore тербинафин does not exert impact on metabolism of hormones or other medicines.
Terbinafin is effective concerning dermatophytes of the sorts Trichophyton, Microsporum, Epidermophyton, drozhzhepodobny mushrooms of mushrooms of the sort Candida, Pityrosporum orbiculare – scaly (multi-colored) depriving of the activator.
Pharmacokinetics. At external use of medicine less than 5% of a dose of cream therefore absorption of a terbinafin in a system blood stream is extremely insignificant are soaked up.
Indications to use:
- the fungus diseases of skin caused by dermatophytes such as Trichophyton (including T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis and Epidermopyton floccosum;
- the barmy infections of skin mainly caused by Candida (including Candida albicans);
- multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare (also known under the name Malassezia furfur).
Route of administration and doses:
To adults and children 12 years are more senior: Terbinafin, cream is applied by 1-2 times/days. Before putting cream it is necessary to clear and dry affected areas. Medicine is imposed a thin layer on the affected skin and by adjacent sites and slightly rub. Medicine is recommended to be applied both on the defeat center, and on the site of healthy skin around it.
The average duration of use of medicine at a dermatomycosis of a trunk, shins, skin candidiasis – 1 week, mycosis of feet – 2-4 weeks, multi-colored herpes – 2 weeks.
At medicine use reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination there is a risk of a recurrence of an infection. If in a week of treatment improvement signs are not noted, it is necessary to verify the diagnosis.
Use of medicine for children. Safety and efficiency at children aged up to 12 years was not tested on a systematic basis. Children up to 5 years should not appoint Terbinafin due to the lack of clinical experience.
Features of use:
Medicine is intended only for external use.
At accidental hit of cream in eyes, they should be washed out immediately flowing water.
At treatment it is necessary to follow the general rules of hygiene for prevention of a possibility of repeated infection (through linen, footwear).
Pregnancy and lactation. Use of medicine at pregnancy and in the period of a lactation perhaps only according to strict testimonies of the attending physician.
Side effects:
Local reactions: seldom – reddening, feeling of an itch or burning.
Allergic reactions: seldom – skin rash, an itch. At their emergence it is necessary to stop treatment.
Interaction with other medicines:
Interaction with other medicines is unknown.
Contraindications:
- hypersensitivity to the terbinafin or other ingredients which are a part of medicine.
In connection with the small number of data on safety of use of cream for children, it is only necessary to appoint it when the expected positive effect exceeds potential risk.
Overdose:
At external use of medicine the overdose is improbable. At accidental intake the following symptoms are possible: a headache, nausea, pains in epigastriums and dizziness.
Treatment: gastric lavage, administration of absorbent carbon and/or symptomatic therapy.
Storage conditions:
To store at a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity 2 years.
Issue conditions:
Without recipe
Packaging:
On 7,0 g, 20, 0 g, 30,0 g and 50,0 g in the tubas placed together with a leaf insert in packs from a cardboard.