Composition, form of production and packaging
? Cream for external use 1% white or almost white, homogeneous.
1 g
terbinafine hydrochloride 10 mg
[PRING] cetostearyl alcohol, cetomacrogol 1000, glyceryl monostearate, dimethicone, poloxamer, paraffin liquid, benzyl alcohol, paraffin, disodium edetate, propylene glycol, trolamine, purified water.
10 g - aluminum tubes (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Terbifin В® - an antifungal agent for topical use, is an allylamine and has a broad spectrum of antifungal action, Terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity with respect to yeast-like fungi, depending on their type, may be fungicidal or fungistatic.
Terbinafine disrupts the biosynthesis of ergosterol in the fungi in the early stages. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.This enzyme does not belong to the cytochrome P450 system. Terbinafine В® does not affect the metabolism of hormones or other medications.
PHARMACOKINETICS
When topical application of the cream is absorbed less than 5% of the dose, so the systemic effect of the drug is minimal.
INDICATIONS
- fungal skin infections caused by dermatophytes such as Trichophyton (eg, T. rubrum, T.mentagrophytes, T.verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum;
- yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans);
- Multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
DOSING MODE
Adults and children 12 years and older:
The drug is applied to the skin once or twice a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied a thin layer on the affected skin and adjacent areas and lightly rubbed.
In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night.
Average duration of treatment:
Dermatomycosis of trunk, drumsticks: 1 week 1 time per day
Dermatomycosis of the feet: 1 week 1 time per day
Candidiasis of the skin: 1-2 weeks 1 or 2 times a day
Multicolored lichen: 2 weeks 1 or 2 times a day
Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. In the event that after two weeks of treatment there are no signs of improvement, the diagnosis should be verified.
The use of the drug in the elderly
There is no reason to assume that for elderly people it is required to change the dosage of the drug or that they have side effects that differ from those in younger patients.
Use of the drug in children
Do not use this drug for children under 12 years.
SIDE EFFECT
In the place of application of the drug in rare cases, redness, an itching or burning sensation at the site of application of the cream was noted, but these phenomena rarely led to the need to stop treatment. These above symptoms should be distinguished from allergic reactions, for example, urticaria, which occur rarely, however, when they appear, you must stop treatment.
CONTRAINDICATIONS
- Hypersensitivity to terbinafine or to any other component that is part of the cream.
PREGNANCY AND LACTATION
In experimental studies of teratogenic, the terbinafine property was not identified. To date, no developmental deficiencies have been reported with the use of Terbifin.However, since the clinical experience of using Terbifin in pregnant women is very limited, it should be used only on strict indications.
Terbinafine is excreted in breast milk. However, when a nursing mother uses terbifin cream, a small amount of active substance is absorbed through the skin, so it is unlikely that the baby will be adversely affected.
APPLICATION FOR CHILDREN
Do not use this drug for children under 12 years.
APPLICATION IN ELDERLY PATIENTS
There is no reason to assume that for elderly people it is required to change the dosage of the drug or that they have side effects that differ from those in younger patients.
SPECIAL INSTRUCTIONS
The cream is for external use only. Avoid contact with the eyes.
OVERDOSE
No cases of drug overdose have been reported. If the drug is accidentally taken internally, the same side effects can be expected, as in the case of an overdose of terbifin tablets: nausea, anorexia, upper abdominal pain, diarrhea.
Treatment: activated charcoal, if necessary - symptomatic maintenance therapy.
DRUG INTERACTION
Currently, drug interactions are not known.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
