Composition, form of production and packaging
? Cream for external use 1% white, homogeneous, with a weak specific odor.
1 g
terbinafine hydrochloride 10 mg
[PRING] benzyl alcohol, cetyl palmitate, sodium hydroxide, sorbitan stearate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water.
15 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Antifungal agent for topical use. Has a wide range of antifungal action.
It is active against dermatophytes: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum. In small concentrations, in addition to dermatophytes, terbinafine has a fungicidal effect against molds, yeast (mainly Candida albicans) and certain dimorphic fungi (Pityrospomm orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.
Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergosterol and 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.
Thermicone В® does not affect the isoenzymes of the cytochrome P450 system in humans and, accordingly, the metabolism of hormones or other medications.
PHARMACOKINETICS
With topical application, absorption - less than 5%, has a minor systemic effect.
INDICATIONS
- prevention and treatment of fungal infections of the skin, incl. mycosis of the feet (tinea pedis), inguinal epidermophyte (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis) caused by dermatophytes;
- yeast infections of the skin (mainly caused by Candida albicans), in particular, diaper rash;
- Multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare.
DOSING MODE
Thermicone В® is prescribed externally to adults and children over 12 years of age.
Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied 1-2 times / day with a thin layer on the affected skin and adjacent areas, 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.
The average duration of treatment for dermatomycosis of the trunk, legs, feet - 1 time / day for 1 week; at a candidiasis of a skin - 1-2 times / sut within 1-2 weeks;with multi-colored lichen - 1-2 times / day for 2 weeks.
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 there are no signs of improvement after 1-2 weeks of treatment, the diagnosis should be verified.
Dosage regimen for elderly patients is the same as for patients of other age groups.
SIDE EFFECT
Local reactions: in places of application of a cream redness, sensation of an itch or a burning sensation, allergic reactions are possible.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
With caution , the drug should be used for hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive disease of the extremities, in children under 12 years of age (lack of sufficient clinical experience).
PREGNANCY AND LACTATION
Until now, there have been no reports of any developmental defects in the use of Thermicon. However, since the clinical experience of using Termicon in pregnancy is very limited, it should be used only on strict indications.
Terbinafine is excreted in breast milk. In the case of the use of a nourishing mother Thermicone, a small amount of active substance is absorbed through the skin, so it is unlikely that the baby will be adversely affected.
In experimental studies teratogenic properties of terbinafine were not revealed.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply the drug for kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution apply the drug in case of liver failure.
APPLICATION FOR CHILDREN
Caution should be used in children under 12 years of age (lack of sufficient clinical experience).
APPLICATION IN ELDERLY PATIENTS
Dosage regimen for elderly patients is the same as for patients of other age groups.
SPECIAL INSTRUCTIONS
Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or premature termination, there is a risk of recurrence of the infection.
Thermicone В® is intended for external use only.
Avoid contact with eyes, as it can cause irritation. In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a physician.
When developing allergic reactions, it is necessary to cancel the drug.
OVERDOSE
No cases of drug overdose have been reported. If Termicon В® is accidentally ingested, the same symptoms can be expected as with an overdose of tablets: headache, nausea, epigastric pain and dizziness.
Treatment: activated charcoal, if necessary - symptomatic maintenance therapy.
DRUG INTERACTION
There are no data on the medicinal interaction of Thermicon.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 2 years. Do not use after the expiration date.
