Thermicon pills 250 mg 14 pcs
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Active ingredients
Terbinafin
Release form
Pills
Composition
1 tablet contains: Active substance: terbinafine hydrochloride in terms of terbinafine - 250 mg. Excipients: sodium carboxymethyl starch (sodium starch glycolate), microcrystalline cellulose, lactose (milk sugar), hypromellose (hydroxypropylmethyl cellulose), magnesium stearate for the pharmaceutical industry, colloidal silicon dioxide (aerosil).
Pharmacological effect
Terbinafine belongs to the group of allylamines, has a broad spectrum of antifungal action. In low concentrations, it has a fungicidal effect on the Trychophyton dermatophytes (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (eg Aspergillus, Cladosporium, Scopulariopsisvivryvibusum, mold fungi (eg Aspergillus, Cladosporium, Scopulariopsisvivryvibusum, fungi (eg Aspergillus, Cladosporium, Scopulariopsisvivryvibusi, mold fungi (eg Aspergillus, Cladosporium, Scopulariopsisvivryvibusi, mold fungi) (eg. Aspergillus, Cladosporium, Scopulariopsisvivryvibusum, mold fungi (eg Aspergillus, Cladosporium, Scopulariopsisvivryvibusum, fungi) yeast fungi, mainly Candida albicans, and some dimorphic fungi. Depending on the type of fungus, Candida fungi and its mycelial forms have a fungicidal or fungistatic effect. Terbinafine violates the early stage of the biosynthesis of the main component of the cell membrane of the fungus ergosterol by inhibiting the enzyme squalene epoxidase. Peroral use is not effective in the treatment of the varicolored lichen caused by Malassezia shof.
Pharmacokinetics
When taken orally, it is well absorbed, after 0.8 hours half the dose taken is absorbed; after 4.6 hours, half of the dose taken is distributed in the body. 1-2 hours after ingestion of a single 250 mg dose, the maximum concentration of the drug in the blood plasma reaches 0.97 mg / ml. Bioavailability 80%. Meal does not affect the bioavailability of terbinafine. Terbinafine is intensively bound to plasma proteins (99%), spreads rapidly in tissues, penetrates into the dermal layer of the skin and nail plates. It penetrates the secret of the sebaceous glands and accumulates in high concentrations in the hair follicles, hair, skin and subcutaneous tissue. The half-life is 16-18 hours, the half-life of the terminal phase is 200-400 hours. It biotransformed in the liver to inactive metabolites; 80% of the dose taken is excreted in the urine as metabolites, the rest (22%) - with feces. Not cumulated in the body. Patient age does not affect the pharmacokinetics of terbinafine, however, elimination may decrease with kidney or liver damage, leading to high concentrations of terbinafine in the blood. Provided with breast milk.
Indications
Mycoses of the scalp (trichophytia, microsporia). Skin and nail mycoses due to Trychophyton (T.rubrum, mentagrophytes, verrucosum, violaceum), Microsporum (M. canis, M.gypseum) and Epidermophyton floccosum. Onychomycosis. Severe, common dermatomycoses of smooth skin of the trunk and extremities, requiring systemic treatment. Candidiasis of the skin and mucous membranes.
Contraindications
Hypersensitivity to any component of the drug; children's age up to 3 years and with body weight up to 20 kg (for this dosage form), the period of breastfeeding.
Precautionary measures
With caution: hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the limbs.
Use during pregnancy and lactation
Acceptance of terbinafine during pregnancy is contraindicated due to the lack of sufficient data on its safety during pregnancy. Terbinafine is excreted in breast milk, so its use is contraindicated during breastfeeding.
Dosage and administration
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. Adults: Usual dose: 250 mg (1 tablet) 1 time per day. Onychomycosis: the duration of therapy is about 6-12 weeks. If the nails of the fingers of the hands and feet are affected (except for the big toe), or when the patient is young, the duration of treatment may be less than 12 weeks. With an infection of the big toe, a 3-month course of treatment is usually sufficient. In rare cases, with a slower growth rate of nails, it may be necessary to have a longer treatment for up to 6 months or more. Fungal infections of the skin: the duration of treatment for interdigital, plantar or socks-like localization of the infection is 2-6 weeks, for mycoses of other body parts: legs - 2-4 weeks., torso - 4 weeks .; with mycosis caused by Candida, 2-4 weeks; with mycosis of the head caused by Microsporum canis - more than 4 weeks. Children: usually prescribed 125 mg (1/2 tablet). The duration of treatment of mycosis of the scalp is about 4 weeks, while infection with Microsporum canis can be longer. With a mass of from 20 to 40 kg-125 mg 1 time per day. With a mass of more than 40 kg -250 mg 1 time per day. For older patients, the drug is prescribed in the same doses as adults.
Side effects
Dyspeptic disorders (loss of appetite, nausea, diarrhea, feeling of fullness in the stomach, abdominal pain); allergic skin reactions (urticaria, rash); musculoskeletal reactions (arthralgia, myalgia),aggravation of systemic lupus erythematosus. Disorders of taste, including their loss (recovery occurs within a few weeks after stopping treatment). Extremely rare: hepatobiliary disorders (cholestatic jaundice), malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (syndrome) Lyell), anaphylactoid reactions, agranulocytosis or thrombocytopenia, neutropenia, lymphopenia.
Overdose
Symptoms: nausea, vomiting, pain in the lower abdomen, in the epigastric region. Treatment: gastric lavage followed by the appointment of activated carbon and / or symptomatic therapy.
Interaction with other drugs
Inhibits CYP2D6 isoenzyme and interferes with the metabolism of drugs such as tricyclic antidepressants and selective serotonin uptake blockers (for example, Desipramine, fluvoxamine), β1-blockers (metoprolol, propolol), atopolydemic medication (a), and man-atopropylic acid. and antipsychotics (for example, chlorpromazine, haloperidol). Medications - inducers of CYP450 enzymes (eg rifampicin) can accelerate the excretion of terbinafine from the body. Medications - inhibitors of CYP450 (eg cimetidine) can t slow down the metabolism and excretion of terbinafine from the body. With the simultaneous use of these drugs, you may need to adjust the dose of terbinafine. It is possible that the menstrual cycle is disturbed while taking terbinafine and oral contraceptives at the same time. Reduces caffeine clearance by 21% and prolongs its half-life by 31%. It does not affect the clearance of phenazone, digoxin, warfarin. When used together with ethanol or drugs with a hepatotoxic effect, there is a risk of developing drug damage to the liver.
special instructions
Irregular use of terbinafine or premature cessation of treatment lead to a relapse of the disease. Factors such as the presence of concomitant diseases, nail conditions at the beginning of the course of treatment can affect the duration of therapy. If the condition is not improved after 2 weeks of treatment, the causative agent must be redetermined and sensitivity to the drug. Systemic use in onychomycosis is justified only in the case of total damage to most nails, the presence of pronounced subungual gi perkeratosis,the ineffectiveness of previous local therapy. When treating onychomycosis, the clinical response is usually observed several months after mycological cure and discontinuation of the course of treatment due to the speed of regrowth of a healthy nail. Removal of nail plates in the treatment of onychomycosis of the hands for 3 weeks and onychomycosis of the feet for 6 weeks is not required. In the presence of severe renal failure (creatinine clearance less than 50 ml / min or creatinine in the blood more than 300 µmol / l), in violation of liver function dose terbinafine should be halved. In the presence of liver disease, the clearance of terbinafine can be reduced. With reduced liver function, half of the adult dose is prescribed. During treatment, it is necessary to control the level of liver transaminases in the serum. In rare cases, after 3 months of treatment, cholestasis and hepatitis occur. If there are signs of abnormal liver function (weakness, persistent nausea, loss of appetite, abdominal pain, jaundice, dark urine or colorless stools), the drug should be discontinued. The appointment of terbinafine to patients with psoriasis requires increased caution, because in very rare cases, terbinafine can provoke an outbreak of psoriasis. When treating with terbinafine, the general rules of hygiene should be followed to prevent the possibility of re-infection through underwear and shoes. In the process of treatment (after 2 weeks) and at the end it is necessary to produce antifungal treatment of shoes, socks and stockings. Influence on the ability to drive and work mechanisms: terbinafine does not affect the ability to drive and perform work that requires increased concentration of attention.