Thermicon tablets 250mg, No. 14

• Mycoses of the scalp (trichophytosis, microsporia);

• mycoses of the skin and nails due to Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum;

• onychomycosis;

• severe common dermatomycosis of the smooth skin of the trunk and extremities, requiring systemic treatment;

• candidiasis of the skin and mucous membranes.

The duration of the course of treatment and the dosage regimen is set individually and depends on the localization of the process and the severity of the disease.

Inside, the drug is prescribed for adults at 250 mg 1 time / day (after meals).

With onychomycosis, the duration of treatment is about 6-12 weeks.

With onychomycosis of the hands and feet (except for the big toe), or in young patients, the duration of treatment may be less than 12 weeks.

For a big toe infection, a 3-month course of treatment is usually sufficient.

In rare cases, with a slower growth rate of nails, a longer treatment may be required - up to 6 months or more.

With dermatomycosis of the feet (interdigital, plantar or sock-like), the duration of treatment is from 2 to 6 weeks; with dermatomycosis of the legs - from 2 to 4 weeks; with dermatomycosis of the trunk - 4 weeks; with candidiasis of the skin and mucous membranes from 2 to 4 weeks.

In case of mycosis of the scalp caused by Microsporum canis, the recommended duration of treatment is more than 4 weeks. For children weighing from 20 to 40 kg, the drug is prescribed in a dose of 125 mg (1/2 tab.) 1 time / day, with a body weight of more than 40 mg - 250 mg 1 time / day.

The duration of treatment for mycoses of the scalp is about 4 weeks. In cases where the pathogen is Microsporum canis, treatment may be longer.

Elderly patients are prescribed the drug in the same doses as for adults. In case of severe renal failure (CC <50 ml / min or serum creatinine content> 300 ?mol / L), in case of impaired renal function, the dose of the drug should be reduced by 2 times, for adults - 125 mg 1 time / day.

Tablets are white or white with a yellowish sheen, flat-cylindrical, with a chamfer and a score.

1 tab.

terbinafine hydrochloride 281.25 mg,

which corresponds to the content of terbinafine 250 mg

Excipients: croscarmellose sodium - 48 mg, microcrystalline cellulose - 35.2 mg, lactose monohydrate - 23.95 mg, hypromellose (hydroxypropyl methylcellulose) - 6.2 mg, magnesium stearate (for the pharmaceutical industry) - 4 mg, colloidal silicon dioxide (aerosil) - 1.4 mg.

• Pregnancy;

• breastfeeding period;

• children under 3 years of age and children weighing up to 20 kg;

• hypersensitivity to the components of the drug.

The drug should be used with caution in case of renal and / or hepatic insufficiency, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

pharmachologic effect

Antifungal drug, allylamine. Possesses a wide spectrum of antifungal action. Active against dermatophytes: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum. In low concentrations, it has a fungicidal effect on dermatophytes, molds (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 type, the drug has a fungicidal or fungistatic effect. ThermikonЃ disrupts the early stage of biosynthesis of the main component of the cell membrane of the fungus ergosterol by inhibiting the enzyme squalene epoxidase.This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine works by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. Ingestion is not effective in the treatment of pityriasis versicolor caused by Pityrosporum orbiculare (Malassezia furfur).

Pharmacokinetics

Suction

After oral administration, the drug is well absorbed from the gastrointestinal tract. After 0.8 hours, half of the dose taken is absorbed. After a single dose of 250 mg, Cmax of terbinafine in blood plasma is reached after 1-2 hours and is 0.97 ?g / ml. Bioavailability is 80%. Food intake does not affect the bioavailability of terbinafine.

Distribution

Plasma protein binding - 99%. After 4.6 hours after administration, half of the dose taken is distributed in the body. The drug quickly penetrates into the dermal layer of the skin and nail plates. Penetrates into the secretion of the sebaceous glands, accumulates in high concentrations in hair follicles, hair, skin and subcutaneous tissue. Does not accumulate in the body. Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver with the formation of inactive metabolites. Excretion In the form of metabolites, about 80% of the dose taken is excreted in the urine, the rest - with feces (22%). Pharmacokinetics in special clinical situations The age of patients does not affect the pharmacokinetics of terbinafine, however, excretion of the drug may decrease in renal or hepatic lesions, leading to high concentrations of terbinafine in the blood. T1 / 2 is 16-18 hours. T1 / 2 in the terminal phase is 200-400 hours.

Application during pregnancy and lactation

The experience of using the TermikonЃ drug during pregnancy is limited, therefore its appointment during pregnancy is contraindicated. Terbinafine is excreted in breast milk, therefore, if it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be decided. In experimental studies, the teratogenic effect of terbinafine has not been identified. To date, no malformations have been reported with terbinafine.

Application for violations of liver function

With caution, the drug should be prescribed internally and externally in liver failure.

Application for impaired renal function

Patients with renal insufficiency are prescribed by mouth 125 mg 1 time / day. With caution, the drug should be prescribed externally for renal failure.

Application in children

Contraindicated: children under 3 years of age and children weighing up to 20 kg.

Use in elderly patients

Elderly patients are prescribed the drug in the same doses as for adults.

special instructions

It should be borne in mind that irregular use or early termination of treatment increases the risk of relapse. The duration of therapy can be determined by the presence of concomitant diseases, the condition of the nails at the beginning of the course of treatment. If after 2 weeks of treatment with Thermikon there is no improvement in the condition, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug. Systemic use in onychomycosis is justified only in the case of total damage to most of the nails, the presence of pronounced subungual hyperkeratosis, and the ineffectiveness of previous local therapy. In the treatment of onychomycosis, the clinical response is usually observed several months after the mycological cure and discontinuation of the course of treatment, which is due to the rate of regrowth of a healthy nail.Removal of nail plates in the treatment of onychomycosis of the hands within 3 weeks and onychomycosis of the feet within 6 weeks is not required. During treatment, the activity of hepatic transaminases in the blood serum should be monitored. In rare cases, after 3 months of treatment, cholestasis and hepatitis develop. If symptoms of liver dysfunction are detected (weakness, persistent nausea, lack of appetite, abdominal pain, jaundice, dark urine or colorless feces), the drug should be discontinued. With extreme caution, the drug should be prescribed to patients with psoriasis, since in very rare cases terbinafine can provoke an exacerbation of psoriasis. When treating with the drug, general hygiene rules should be observed to prevent the possibility of re-infection through underwear and shoes. In the process (after 2 weeks.) and at the end of the treatment it is necessary to carry out antifungal treatment of shoes, socks and stockings. With the development of allergic reactions, the drug should be canceled. Use in pediatrics ThermikonЃ is contraindicated for use in children under 3 years of age and children weighing up to 20 kg.

Influence on the ability to drive vehicles and use mechanisms

Terbinafine does not affect the ability to drive vehicles and perform work that requires increased concentration of attention and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, pain in the lower abdomen and epigastric region, dizziness.

Treatment: gastric lavage followed by the appointment of activated charcoal and / or symptomatic therapy.

Drug interactions

Terbinafine inhibits the CYP2D6 isoenzyme and slows down the metabolism of drugs such as tricyclic antidepressants and selective serotonin reuptake blockers (eg desipramine, fluvoxamine), beta1-blockers (metoprolol, propranolol), antiarrhythmics (flecainide), such as propafitores selegiline) and antipsychotic drugs (eg, chlorpromazine, haloperidol). Inducers of isoenzymes of the cytochrome P450 system (for example, rifampicin) can accelerate the elimination of terbinafine from the body, inhibitors of isoenzymes of the cytochrome P450 system (for example, cimetidine) can slow it down. When used simultaneously with such drugs, a dose adjustment of tebinafine may be required. With the simultaneous administration of terbinafine and oral contraceptives, menstrual irregularities may be disturbed.Terbinafine reduces caffeine clearance by 20% and increases its T1 / 2 by 31%. Terbinafine does not affect the clearance of antipyrine, digoxin, warfarin. Ethanol and other hepatotoxic drugs, when used simultaneously with Thermicon, increase the risk of developing hepatotoxicity.