Composition, form of production and packaging
? Spray for external use 1% in the form of a transparent, colorless or light yellow liquid with a characteristic smell of ethyl alcohol.
1 ml
terbinafine hydrochloride 10 mg
[PRING] ethanol, rectified, propylene glycol, poloxamer (proxanol 268), purified water.
30 g - polypropylene bottles (1) with metering pump, nozzle and protective cap - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Antifungal drug, allylamine. 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. At low concentrations, it has a fungicidal effect on dermatophytes, mold fungi (including Aspergillus, Cladosporium, Scopulariopsis brevicaulis) and some dimorphic fungi. On yeast fungi of the genus Candida (mainly Candida albicans) and their mycelial forms, depending on the species, the preparation has a fungicidal or fungistatic effect.
Thermicone В® disrupts the early stage of biosynthesis of the main component of the cellular membrane of the ergosterol fungus by inhibiting the enzyme squalene epoxidase. 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.
PHARMACOKINETICS
With external application of the spray, less than 5% of the dose is absorbed, so the systemic effect of the drug is minimal.
INDICATIONS
- prevention and treatment of fungal infections of the skin, incl. mycosis of the feet, inguinal epidermophytia (tinea cruris), fungal lesions of the smooth skin of the body (tinea corporis) caused by such dermatophytes as Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis and Epidermophyton floccosum;
- Multicolored lichen caused by Pityrosporum orbiculare (Malassezia furfur).
DOSING MODE
The duration of the course of treatment and the dosage regimen is determined individually and depends on the localization of the process and the severity of the disease.
Outwardly the drug is prescribed to adults 1-2 times / day, depending on the indications. Before applying the drug, it is necessary to clean and dry the affected areas.The drug is sprayed on the affected skin and adjacent areas in an amount sufficient to moisturize them, and, in addition, applied to adjacent areas of intact skin.
Indications Duration of treatment Multiplicity of drug use
Dermatomycosis of the trunk, drumsticks 1 week 1 time / day
Dermatomycosis stop 1 week 1 time / day
Multicolored lichen 1 week 2 times / day
The dosing regimen for elderly patients is the same as for older adults.
SIDE EFFECT
Local reactions: possible - redness, itching or burning sensation.
Allergic reactions are possible .
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
Precautions should be taken with renal and / or hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, in children under 12 years of age.
PREGNANCY AND LACTATION
Thermicone В® should be used according to strict indications and if the intended benefit to the mother exceeds the potential risk to the fetus.
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 teratogenicity of terbinafine was not revealed. To date, no developmental deficiencies have been reported with terbinafine.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with renal insufficiency inside are prescribed 125 mg once a day.
With caution should prescribe the drug externally with renal failure
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Caution should be given to the drug inside and outwardly with hepatic insufficiency.
APPLICATION FOR CHILDREN
With caution should be used in children under 12 years.
APPLICATION IN ELDERLY PATIENTS
The dosing regimen for elderly patients is the same as for older adults.
SPECIAL INSTRUCTIONS
It should be borne in mind that irregular use or early termination of treatment increases the risk of relapse.
If after 1 week of treatment with Termicon there is no improvement, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug.
When treating the drug, you should follow the general rules of hygiene to prevent the possibility of re-infection through the underwear and shoes. In the process (after 2 weeks) and at the end of treatment it is necessary to produce antifungal treatment of shoes, socks and stockings.
Thermicone В® is intended for external use only. Avoid contact with the eye, as it can cause irritation. In case of accidental contact, the eye should be rinsed with running water, and in case of persistent irritation the patient should consult a doctor. In case of accidental ingestion of the drug in the respiratory tract, in case of any symptoms, especially if they are preserved, the patient should also consult a doctor. Care should be taken when applying Thermicon to damaged areas of the skin, since alcohol, which is part of its composition, can cause irritation.
When developing allergic reactions, the drug should be discarded.
Use in Pediatrics
The experience of applying Thermicon in the form of a spray in children under the age of 12 is limited.
Impact on the ability to drive vehicles and manage mechanisms
Terbinafine does not affect the ability to drive vehicles and perform work that requires an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
No cases of an overdose of Thermicone in the form of a spray for external use have been reported. If you randomly take the drug inside, you should expect the development of the same side effects as when taking Thermicon in the form of tablets (nausea, vomiting, pain in the lower abdomen and epigastric region, dizziness).The content of the ethanol preparation should also be considered.
Treatment: activated charcoal, if necessary - symptomatic maintenance therapy.
DRUG INTERACTION
Currently, the medicinal interaction of Termicon is unknown.
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; Do not freeze. Shelf life - 2 years.
