Thermicon tablets 250 mg, 28 pcs. (Terbinafine)

release form

Tablets

Packing

28 pcs

Pharmacological action

Thermicon - antifungal drug, allylamine. It has a wide range of antifungal effects.

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 drug has a fungicidal or fungistatic effect.

Thermicon disrupts the early stage of biosynthesis of the main component of the cell membrane of the ergosterol fungus by inhibiting the squalene epoxidase enzyme. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the 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

Absorption

After oral administration, the drug is well absorbed from the digestive tract. After 0.8 h, half of the dose taken is absorbed.

After a single dose of 250 mg of Cmax terbinafine in plasma is achieved after 1-2 hours and is 0.97 mcg / ml. Bioavailability is 80%. Eating does not affect the bioavailability of terbinafine.

Distribution of

Plasma Protein Binding - 99%.

4.6 hours after ingestion, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm Eating does not affect the bioavailability of terbinafine.

Distribution of

Plasma Protein Binding - 99%.

4.6 hours after ingestion, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm Eating does not affect the bioavailability of terbinafine.

Distribution of

Plasma Protein Binding - 99%.

4.6 hours after ingestion, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm

Distribution of

Plasma Protein Binding - 99%.

4.6 hours after ingestion, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm

Distribution of

Plasma Protein Binding - 99%.

4.6 hours after ingestion, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm 6 hours after administration, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm 6 hours after administration, half the dose taken is distributed in the body. The drug quickly penetrates the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands, accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farm skin and subcutaneous tissue. Does not cumulate in the body.

Terbinafine is excreted in breast milk.

Metabolism

Biotransformed in the liver to form inactive metabolites.

Excretion of

About 80% of the accepted dose is excreted in the form of metabolites in the urine, the rest with feces (22%).

Pharmacokinetics in special clinical cases

Patient age does not affect farmakokinetics of terbinafine, however, the excretion of the drug may decrease with damage to the kidneys or liver, 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.

Indications of

mycosis of the scalp (trichophytosis, microsporia)

mycoses of the skin and nails due to Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum Microsporum fromycophymis canis torso and extremities requiring systemic treatment of

candidiasis of the skin and mucous membranes.

Contraindications

pregnancy

breastfeeding period

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

hypersensitivity to the components of the drug.

With caution, the drug should be used orally for renal and / or liver failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, and occlusive diseases of the limb vessels.

Special instructions

Irregular use or early termination of treatment increases the risk of relapse.

If after 2 weeks of treatment no improvement is noted, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug.

Caution should be exercised when administering Thermicon inward to patients with impaired liver and / or kidney function. When identifying symptoms suggesting impaired liver function (lack of appetite, fatigue, persistent nausea, jaundice, dark urine), it is necessary to cancel the drug.

Patients with chronic impaired liver and kidney function should be given half the usual recommended dose of the drug and monitor liver and kidney function during treatment. Unlike Thermicon for topical use, Thermicon tablets are not effective for multi-colored lichen.

In the process and at the end of treatment it is necessary to produce antifungal treatment of shoes, socks and stockings.

Composition

1 tablet contains: srdlp Active ingredient:

terbinafine 250 mg

Excipients:

sodium starch glycolate,

hydroxypropyl methylcellulose,

microcrystalline cellulose,

milk sugar,

aerosil,

magnesium stearate.

Dosage and administration

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 adults, the drug is prescribed 250 mg 1 time per day (after eating).

With onychomycosis, the duration of treatment is about 6-12 weeks. With onychomycosis of the hands and feet (with the exception of the big toe), or in young patients, the duration of treatment may be less than 12 weeks. With a big toe infection, a treatment course of 3 months is usually sufficient. In rare cases, with a slowed nail growth rate, longer treatment may be required - up to 6 months or more.

With dermatomycosis of the feet (interdigital, plantar or by type of socks), 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.

For scalp mycosis caused by Microsporum canis, the recommended treatment duration is more than 4 weeks.

For children with a body weight of 20 to 40 kg, the drug is prescribed at a dose of 125 mg (1/2 tab.) 1 time per day, with a body weight of more than 40 mg - 250 mg 1 time per day. The duration of treatment for mycosis of the scalp is about 4 weeks. In cases if the causative agent is Microsporum canis, treatment may be longer.

In elderly patients, the drug is prescribed in the same doses as adults.

With renal failuresevere accuracy (KK300 µmol / l), in case of impaired renal function, the dose should be reduced by 2 times, for adults - 125 mg once a day.

Side effects of the digestive system: dyspepsia, loss of appetite, nausea, diarrhea, fullness of the stomach, abdominal pain, disturbances in taste, including their loss (recovery occurs within a few weeks after discontinuation of treatment) very rarely - hepatobiliary disorders (cholestatic jaundice).

From the musculoskeletal system: arthralgia, myalgia.

From the hemopoietic system: agranulocytosis, thrombocytopenia, neutropenia.

Allergic reactions: urticaria, rash very rarely - toxic epidermal necrolysis (Lyell's syndrome), anaphylactoid reactions, malignant exudative erythema (Stevens-Johnson syndrome).

Drug interaction

Terbinafine inhibits the CYP2D6 isoenzyme and slows down the metabolism of drugs such as tricyclic antidepressants and selective serotonin reuptake blockers (e.g., desipramine, fluvoxamine), beta1-adrenoblocker, propololifen, propylene, propylene, propylene, propylene, propylene, antioxidants type B (for example, selegiline) and antipsychotic drugs (for example, chlorpromazine, haloperidol).

Inductors of isoenzymes of the cytochrome P450 system (for example, rifampicin) can accelerate the excretion of terbinafine from the body, inhibitors of isoenzymes of the cytochrome P450 system (such as cimetidine) can slow it down. With simultaneous use with such drugs, dose adjustment of tebinafine may be required.

With the simultaneous administration of terbinafine and oral contraceptives, a menstrual cycle is possible.

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 together with Thermicon, increase the risk of hepatotoxicity.

Overdose

Symptoms: nausea, vomiting, lower abdominal and epigastric pain, dizziness.

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

Storage Conditions

Keep in a dry, dark place away from children.

shelf life

2 years

Deystvuyushtee substance

Terbinafine

prescription drugstore

Dosage PMA



Possible product names

TERMIKON 0.25 N28 TABLE

TERMIKON 250MG. No. 28 TAB.

Thermicon tab 250mg N28 (cfn box N7x4) ind pack

Thermicon tab 250mg N28 (cnc unit N7x4) ind pack *

TERMIKON TAB. 250MG №28

Pharmstandard-Leksredstva, Russia



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