Composition, form of production and packaging
? Cream for external use 1% white or almost white, with a slight odor of almonds.
1 g
terbinafine hydrochloride 10 mg,
which corresponds to the content of terbinafine 8.8 mg
[PRING] sodium hydroxide 1.2 mg, benzyl alcohol 10 mg, sorbitan monostearate 19 mg, cetyl palmitate 20 mg, cetyl alcohol 40 mg, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) 40 mg, polysorbate 60 - 61 mg, isopropyl myristate - 80 mg, purified water - 718.8 mg.
15 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Terbinafine belongs to the group of allylamines, it has a wide spectrum of antifungal action. It is active against Tryphophyton , Microsporum and Epidermophytondermatophytes, as well as yeast fungi, mainly Candida albicans , and also against Pityrosporum ovale , the causative agent of the colored lichen (Pityriasis versicolor). Depending on the type of fungus, fungi of the genus Sanendida and their mycelial forms render fungicidal or fungistatic action.
Inhibits squalene-epoxidase in mushrooms and disrupts the early stage of sterol biosynthesis, leading to ergosterol deficiency, accumulation of squalene in the cell, and cell death. Fungicidal action is observed already at low concentrations of the drug and is manifested in the effect on the synthesis and formation of the fungal membrane.
Squalene-epoxidase does not belong to the cytochrome P450 (CYP450) system, so terbinafine does not affect the metabolism of hormones and drugs whose metabolism is associated with CYP450.
PHARMACOKINETICS
With topical application of the cream, less than 5% of the dose is absorbed, the systemic effect is minimal. Quickly penetrates through the skin accumulates in the sebaceous glands. High concentrations are created in the hair follicles and hair, after a few weeks of application penetrates into the nail plates; accumulates in the stratum corneum and in the nails in concentrations that provide fungicidal action. Not cumulated. Penetrates into breast milk.
INDICATIONS
- fungal skin infections caused by Trichophyton dermatophytes ( T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. interdigitale, T. tonsurans), Microsporum canis and gypseum, Epidermophyton floccosum;
- skin infections caused by yeast-like fungi, mainly Candida (eg, Candida albicans);
- multi-colored (pityriasis) lichen Pityriasis versicolor, caused by Pityrosporum orbiculare (Malassezia furfur).
DOSING MODE
For external use.
The duration of treatment depends on the nature and severity of the disease.
Adults and children : after preliminary cleansing and drying of the affected surface, a thin layer of medical cream is applied to it 1-2 times / day, lightly rubbing it into the affected and adjacent healthy areas of the skin. Places of physiological folds of the skin (areas under the mammary glands, interdigital spaces, interannual and inguinal areas) it is desirable to cover with gauze after applying the cream, in particular, overnight.
With dermatomycosis of the trunk and lower legs: the cream is applied 1-2 times / day; treatment duration 1-2 weeks.
With dermatomycosis, stop : apply 1-2 times / day; duration of treatment 2-4 weeks.
With candidiasis skin cream can be applied up to 2 times / day; treatment duration 1-2 weeks.
With multicolored lichen, the cream can be applied up to 2 times / day; course of treatment 2 weeks.
For elderly patients, the drug is prescribed in the same regimen.
Treatment of children is carried out after an estimation of a parity of prospective advantage and potential harm.
In pregnancy, the drug can be used only if the intended benefit to the mother exceeds the potential risk to the fetus.
If necessary, treatment with Terbizil during lactation should resolve the issue of stopping breastfeeding.
SIDE EFFECT
In rare cases, the place of application of the cream causes reddening of the skin, itching or burning sensation, requiring the cessation of treatment.
CONTRAINDICATIONS
- the period of breastfeeding;
- Hypersensitivity to any of the components of the drug.
With caution : during pregnancy, in childhood (due to lack of sufficient clinical experience).
PREGNANCY AND LACTATION
In pregnancy, the drug can be used only if the intended benefit to the mother exceeds the potential risk to the fetus.
Contraindicated during breastfeeding. If necessary, treatment with Terbizil during lactation should resolve the issue of stopping breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Data on the use of terbizil in patients with impaired renal function are not provided.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Data on the use of terbizil in patients with impaired liver function are not provided.
APPLICATION FOR CHILDREN
Use with caution in childhood (due to lack of sufficient clinical experience).
APPLICATION IN ELDERLY PATIENTS
The administration of the drug to elderly patients does not require dosage adjustment.
SPECIAL INSTRUCTIONS
Avoid contact with the cream on the mucous membrane of the eyes, nose, mouth. In case of contact with eyes, rinse them with plenty of water and, if necessary, consult a doctor.
During treatment, general hygiene rules should be followed to avoid re-infection through linens and shoes.
Clinical effect is usually observed from the first days of treatment.
Irregular application or premature termination of treatment leads to a relapse of the disease. In the case when there is no improvement after 2 weeks of treatment, the diagnosis and sensitivity of the pathogen to the drug should be checked.
OVERDOSE
To date, cases of terbizyl overdose have not been reported.
If you accidentally get the cream inside, you may experience nausea, loss of appetite, pain in the upper abdomen, diarrhea.
Treatment: activated charcoal, if necessary, perform symptomatic therapy.
DRUG INTERACTION
The interaction of Terbisil cream with other medications is unknown.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Storage conditions:
Store at 15-30 В° C in a place inaccessible to children.
Shelf life:
5 years.
Do not use after the expiration date printed on the package.