Active substanceTerbinafineTerbinafine
Similar drugsTo uncover
  • Atifin®
    cream externally 
  • Atifin®
    pills inwards 
  • Binafin
    cream externally 
  • Binafin
    pills inwards 
  • Lamisil®
    pills inwards 
    Novartis Pharma AG     Switzerland
  • Lamisil®
    cream externally 
  • Lamisil
    spray externally 
  • Lamisil® Dermgel
    gel externally 
  • Lamizil® Uno
    solution externally 
  • Lameler
    spray externally 
  • Lamifungin®
    gel externally 
  • Myconorm
    cream externally 
  • Tebicur®
    cream externally 
  • Tebicur®
    pills inwards 
  • Terbized-Ajio
    cream externally 
  • Terbisil®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Terbisil®
    externally 
    GEDEON RICHTER, OJSC     Hungary
  • Terbix®
    cream externally 
    ALTAYVITAMINS, CJSC     Russia
  • Terbix®
    spray externally 
    ALTAYVITAMINS, CJSC     Russia
  • Terbinafine
    pills inwards 
    MEDISORB, CJSC     Russia
  • Terbinafine
    pills inwards 
    Pfizer Inc.     USA
  • Terbinafine
    pills inwards 
  • Terbinafine
    spray externally 
    Firm VIPS-MED, LLC     Russia
  • Terbinafine
    cream externally 
    BIOSINTEZ, PAO     Russia
  • Terbinafine
    pills inwards 
    BIOKOM, CJSC     Russia
  • Terbinafine
    pills inwards 
    VERTEKS, AO     Russia
  • Terbinafine
    cream externally 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Terbinafine
    pills inwards 
  • Terbinafine
    cream externally 
    VERTEKS, AO     Russia
  • Terbinafine
    pills inwards 
    ATOLL, LLC     Russia
  • Terbinafine Sandoz®
    pills inwards 
    Sandoz d.     Slovenia
  • Terbinafine-OBL
    pills inwards 
  • Terbinafine-MFF
    pills inwards 
  • Terbinafine-MFF
    ointment externally 
  • Terbinafine-Sar®
    pills inwards 
    BIOCHEMIST, OJSC     Russia
  • Terbinafine-Teva
    pills inwards 
  • Terbinox®
    cream externally 
  • Terbifin®
    pills inwards 
    Cipla Ltd.     India
  • Terbifin®
    cream externally 
    Cipla Ltd.     India
  • Terbifin®
    spray externally 
    Cipla Ltd.     India
  • Thermicon®
    cream externally 
    OTISIFARM, OJSC     Russia
  • Thermicon®
    pills inwards 
  • Thermicon®
    spray externally 
    OTISIFARM, OJSC     Russia
  • Tigal-Sanovel
    pills inwards 
  • UNGUSAN®
    cream externally 
    GRINDEX, JSC     Latvia
  • Fungoterbin®
    spray externally 
  • Fungoterbin®
    cream externally 
  • Fungoterbin®
    pills inwards 
    NIZHFARM, JSC     Russia
  • Exeter
    cream externally 
    ATOLL, LLC     Russia
  • Exeter
    pills inwards 
    OZONE, LLC     Russia
  • Exifin®
    cream externally 
  • Exifin®
    pills inwards 
  • Exifin®
    gel externally 
  • Dosage form: & nbspTabletki.
    Composition:

    For 1 tablet:

    Active substance: terbinafine hydrochloride 281.0 mg, in terms of terbinafine, 250.0 mg.

    Excipients: lactose monohydrate (sugar milk) - 102.8 mg, sodium carboxymethyl starch type A - 25.8 mg, hypromellose - 12.9 mg, silicon dioxide colloid - 3.2 mg, magnesium stearate - 4.3 mg.

    Description:Round, flat-cylindrical tablets of white or almost white color, with a risk on one side and with a facet on both sides.
    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    D.01.A.E.15   Terbinafine

    Pharmacodynamics:

    Terbinafine is an allylamine that has a broad spectrum of action against fungi that cause skin, hair and nail diseases, including dermatophytes such as Trichophyton (eg, Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans), Microsporum (eg, Microsporum canis), Epidermophyton floccosum, as well as yeast fungi of the genus Candida (eg, FROM. albicans) and Malassezia.

    In low concentrations terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistagic.

    Terbinafine, by inhibiting squalene epoxidase in the cell membrane of the fungus (not belonging to the cytochrome P450 system), specifically inhibits the early stage of sterol biosynthesis in the fungal cell, leading to ergosgerin deficiency, intracellular squalene accumulation, and fungal cell death.

    When the drug is used inside the skin, hair and nails, the drug concentrations are created to ensure fungicidal action.

    Pharmacokinetics:

    After oral administration terbinafine is well absorbed (> 70%), absolute bioavailability is about 50% ("first pass" effect). After a single administration of terbinafine inwards at a dose of 250 mg, the maximum concentration in the plasma (Cmax) - 1.3 μg / ml, the time to reach the maximum concentration (TCmax) - 1.5 h. With the constant intake of terbinafine, its Cmax on average increased by 25%, compared with a single admission; the area under the concentration-time curve (AUC) increased by 2.3 times. Based on the increase in AUC, it is possible to calculate the effective half-life (30 hours). Food intake moderately affects the bioavailability of the drug (AUC increases by less than 20%), but dose adjustment Terbinafine with simultaneous intake with food is not required.

    The connection with plasma proteins is 99%. Terbinafine quickly penetrates the dermal layer of the skin and concentrates in the lipophilic stratum corneum. Terbinafine also penetrates into the secretion of the sebaceous glands, which leads to the creation of high concentrations in the hair follicles, hair and in the skin, rich in sebaceous glands. It is also shown that terbinafine penetrates the nail plate in the first few weeks after the initiation of therapy.

    Terbinafine is metabolized rapidly and to a significant extent with the participation of at least seven isoenzymes of cytochrome P450, with the main role being played by the isozymes CYP2C9, CYP1A2, CYP3A4, CYP2C8, CYP2C19. As a result of the biotransformation of terbinafine, metabolites are formed that do not possess antifungal activity and are excreted mainly by the kidneys. Multiple application of terbinafine, leading to an increase in its concentration in the blood plasma, is accompanied by a three-phase excretion with a finite half-life of about 16.5 days. There were no changes in the equilibrium concentration of terbinafine in plasma, depending on age. In pharmacokinetic studies, patients with concomitant renal impairment (creatinine clearance <50 mL / min) and liver disease have been shown to reduce the clearance of the drug by 50%.

    Indications:

    - Onychomycosis caused by mushrooms dermatophytes.

    - Mycosis of the scalp.

    - Fungal skin infections - treatment of dermatomycosis of the trunk, shins, feet, and yeast infections of the skin caused by fungi of the genus Candida (eg, Candida albicans) - In those cases where the localization, severity or prevalence of infection determines the advisability of oral therapy.

    Contraindications:

    Hypersensitivity to terbinafine or any other component of the drug; the period of breastfeeding; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; children under 3 years old, with a body weight of up to 20 kg for a given dosage; chronic or active liver disease; impaired renal function (creatinine clearance less than 50 ml / min or creatinine concentration in the blood plasma more than 300 μmol / l), since the use of the drug in this category of patients is not sufficiently studied.

    Carefully:

    Oppression of bone marrow hemopoiesis, cutaneous lupus erythematosus or systemic lupus erythematosus, psoriasis.

    Pregnancy and lactation:

    The data of experimental studies do not give grounds to assume the presence of undesirable phenomena with respect to fertility and toxic effects on the fetus. Because the clinical experience with terbinafine in pregnant women is very limited, the drug should not be used during pregnancy, except when the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

    Terbinafine is excreted in breast milk, so women who receive the drug Terbinafine inside, should not continue breastfeeding.

    Dosing and Administration:

    The drug is administered orally, regardless of food intake, with water. It is advisable to apply the drug at the same time. The duration of treatment depends on the indication and severity of the course of the disease.

    Adults

    250 mg once a day.

    Infections of the skin

    Recommended duration of treatment:

    Dermatomycosis of the foot (interdigital, plantar or by the type of socks): 2-6 weeks.

    Dermatomycosis of the trunk, drumsticks: 2-4 weeks.

    Candidiasis of the skin: 2-4 weeks.

    Complete disappearance of manifestations of infection and complaints associated with it can occur no earlier than a few weeks after mycological cure.

    Hair and scalp infections

    Recommended duration of treatment:

    Mycosis of the scalp: 4 weeks.

    Mycoses of the scalp are mainly seen in children.

    Onychomycosis

    Duration of treatment is in most patients from 6 to 12 weeks.

    When onychomycosis of brushes in most cases, 6 weeks of treatment is sufficient.

    When onychomycosis of the feet in most cases, 12 weeks of treatment are sufficient.

    Some patients who have a reduced rate of nail growth may require longer treatment. The optimal clinical effect is observed several months after mycological cure and discontinuation of therapy. This is determined by the time period that is necessary for the growth of a healthy nail.

    Use in children

    In children older than 3 years and weighing more than 20 kg, the drug is used once a day.

    Single dose depends on the body weight and is: for children weighing from 20 to 40 kg - 125 mg (1/2 tablet 250 mg); more than 40 kg - 250 mg.

    Application in the elderly

    There is no reason to assume that for elderly people, it is required to change the dosage regimen of the drug or that they have side effects that differ from those in younger patients. In case of application in this age the group of drug in tablets should take into account the possibility of concomitant liver or kidney dysfunction.

    Side effects:

    The drug as a whole is well tolerated. Side effects are usually mild or moderate and are transient.

    When assessing the incidence of side effects, the following grades are used: "Often" (≥ 1/10), "often" (≥1/100 <1/10), "infrequently" (≥1/1000 <1/100), "rarely" (≥1/10000 <1/1000), "rarely" (<1/10000), including individual messages.

    Disorders from the hematopoiesis system: infrequently - anemia, very rarely - neutropenia, agranulocytosis, thrombocytopenia, pancytopenia.

    Immune system disorders: very rarely - anaphylactoid reactions (including angioedema), cutaneous and systemic lupus erythematosus (or their exacerbation).

    Disturbances from the nervous system: very often - headache; often - dizziness, flaws, up to their loss (usually recovery occurs within a few weeks after cessation of treatment); infrequently - paresthesia, hypoesthesia. There are separate reports of cases of long-term disturbances of taste sensations. In some cases, when taking the drug, depletion was noted.

    Disorders of the psyche: often - Depression; infrequently anxiety.

    Disturbances on the part of the organ of sight: infrequently - impaired vision.

    Hearing disorders and labyrinthine disorders: infrequent - noise in the ears.

    Disturbances from the liver and bile ducts: rarely - hepatobiliary dysfunction (mostly of the cholestatic nature), incl.hepatic failure, including very rare cases of serious liver failure (some with fatal outcome or requiring liver transplantation, in most cases, when developed liver failure, patients had serious concomitant systemic disease and the causal link of liver failure with taking terbinafine was doubtful) hepatitis, jaundice, cholestasis, increased activity of "liver" enzymes.

    Disorders from the digestive system: very often - bloating, decreased appetite, indigestion, nausea, mild abdominal pain, diarrhea.

    Disturbances from the skin and subcutaneous tissues: Very often - rash, urticaria, rarely - photosensitivity reactions; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis, bullous dermatitis, psoriasiform skin rash or exacerbation of psoriasis, alopecia.

    Disturbances from musculoskeletal and connective tissue: Often - arthralgia, myalgia.

    General disorders: often - a feeling of fatigue; infrequent - an increase in body temperature.

    Laboratory and instrumental data: infrequently - a decrease in body weight (secondary to the violation of taste sensations).

    Based on the spontaneous messages received during the post-registration period and the literature data, the following undesirable phenomena were identified, the frequency of which due to an inaccurate number of patients can not be established:

    Immune system disorders: anaphylactic reactions, a syndrome similar to serum sickness.

    Disturbances on the part of the organ of sight: blurred vision, reduced visual acuity.

    Disturbances from the skin and subcutaneous tissues: a drug rash with eosinophilia and systemic symptoms (rash, swelling, fever, and enlarged lymph nodes).

    Hearing disorders and labyrinthine disorders: hearing loss, hearing impairment.

    Violation of the vessels: vasculitis.

    Violation of the nervous system: loss of smell, including for a long period of time, a decrease in the sense of smell.

    Disorders from the digestive system: pancreatitis.

    Disturbance of the side of the musculoskeletal and connective tissue: rhabdomyolysis.

    General disorders: flu-like syndrome.

    Violations of the blood and lymphatic system: anemia.

    Laboratory and instrumental data: increased activity creatine phosphokinase in blood plasma.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    There are reports of several cases of overdose (the accepted dose of terbinafine was up to 5 g), with headache, dizziness, nausea, pain in the epigastric region, frequent urination, rash.

    Recommended in case of an overdose treatment includes measures to remove the drug, primarily by prescribing activated charcoal and washing the stomach; if necessary, conduct symptomatic and supportive therapy.

    Interaction:

    The effect of other drugs on terbinafine

    The plasma clearance of terbinafine can be accelerated under the influence of drugs-inducers of metabolism, and suppressed under the influence of inhibitors of cytochrome P450.If it is necessary to simultaneously apply the above drugs and the preparation Terbinafine it may be necessary to correct the dosage regimen of the latter.

    Cimetidine can enhance the action of terbinafine or increase its concentration in the plasma. Cimetidine reduces terbinafine clearance by 33%.

    Fluconazole increases the Stach and AUC terbinafine by 52% and 69%, respectively, due to the inhibition of isoenzymes CYP2C9 and CYP3A4. This increase in terbinafine exposure may occur with the use of other isozyme inhibitory drugs CYP2C9 and CYP3A4, for example, ketokoisazole and amiodarone.

    Rifampicin can reduce the effect of terbinafine or reduce its concentration in the plasma. Rifampicin increases the terbinafine clearance by 100%.

    The effect of terbinafine on other drugs

    In studies in vivo and in vitro it was shown that terbinafine suppresses metabolism mediated by isoenzyme 2D6 (CYP2D6). These data may be clinically significant for those drugs that are metabolized primarily by this isoenzyme: tricyclic antidepressants, beta-blockers (metoprolol, propranolol), selective serotonin reuptake inhibitors, antiarrhythmic drugs of class (IA, IB, IC class), antipsychotic drugs (chlorpromazine, haloperidol) and monoamine oxidase B type inhibitors (seleginin) - if the concomitant drug has a small range of therapeutic concentration.

    Terbinafine reduces clearance desipramine on 82%.

    In studies on healthy volunteers with active metabolism dextromethorphan (antitussive and substrate CYP2D6) terbinafine increased the metabolic coefficient of dextromethorphan / dextrorphan in urine 16-97 times. In this way, terbinafine in persons with high isoenzyme activity CYP2D6 can reduce the activity of the latter.

    Terbinafine reduces clearance caffeine when administered intravenously by 19%.

    With simultaneous use with warfarin, rare cases of changes in INR and / or prothrombin time have been noted.

    Drug Interactions, not rendering or having an insignificant influence

    The results of studies conducted in vitro and in healthy volunteers, show that terbinafine has little potential for suppressing or enhancing the clearance of most drugs that are metabolized by the cytochrome P450 system (for example,terfenadine, triazolam, tolbutamide or oral contraceptives), except for those that are metabolized with CYP2D6. Terbinafine does not affect the ground clearance phenazone or digoxin.

    Terbinafine does not significantly affect the pharmacokinetics fluconazole.

    There were no clinically significant interactions between terbinafine and components co-trimoxazole (trimethoprim and sulfamethoxazole), zidovudine or theophylline.

    There are reports of several cases of menstrual cycle disorders in patients taking the drug with oral contraceptives, although the frequency of these disorders does not exceed the average frequency of such disorders in patients taking only oral contraceptives.

    Terbinafine can reduce the concentration in the blood plasma or the severity of the clinical effects of the following drugs.

    Terbinafine increases clearance cyclosporine by 15%.

    Interaction with food and beverages

    Food has a slight effect on the bioavailability of terbinafine (an increase AUC<20%), which does not require a change in the dose of the drug.

    Special instructions:

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

    If after 2 weeks of treatment there is no improvement, it is necessary to repeatedly identify the pathogen and its sensitivity to terbinafine.

    Prior to the use of the drug Terbinafine in tablets, it is necessary to monitor liver function. Hepatotoxicity can occur both in patients with previous liver diseases, and without them. During therapy, a periodic study of liver function is recommended (4-6 weeks after the start of treatment). Treatment with drug Terbinafine should be immediately stopped in case of increased activity of "liver" samples. Patients who are prescribed a drug Terbinafine, should be warned that it is necessary to immediately inform the attending physician of the appearance of such symptoms as persistent nausea, loss of appetite, a feeling of fatigue, vomiting, pain in the right hypochondrium, jaundice, dark urine or light feces when taking the drug. If such symptoms appear, stop taking the drug immediately and perform a liver function test.

    Care should be taken when using the drug in patients with oppression of bone marrow hematopoiesis, cutaneous lupus erythematosus or systemic lupus erythematosus.

    Serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms) were extremely rare when terbinafine was used.

    When terbinafine was used, extremely rare cases of changes in the cellular composition of the blood (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) were noted. In the case of qualitative or quantitative changes in the blood constituents, the cause of the impairment should be established and the question of reducing the dose of the drug or, if necessary, discontinuing the therapy with the drug Terbinafine.

    Since the use of the drug in patients with impaired renal function (creatinine clearance less than 50 ml / min or creatinine concentration in the blood plasma more than 300 μmol / l) is insufficiently studied, the drug Terbinafine is not recommended for this category of patients.

    If a patient has a history of psoriasis, caution should be taken with the drug Terbinafine, since there are data on cases of exacerbation of the disease.

    Systemic use in onychomycosis is justified only in case of total defeat of most nails, the presence of pronounced subungual hyperkeratosis, ineffectiveness of previous local therapy.

    In the treatment of onychomycosis, the clinical response is usually observed a few months after mycological cure and discontinuation of treatment, which is due to the rate of regrowth of a healthy nail. Removal of nail plates in the treatment of onychomycosis of brushes for 3 weeks and onychomycosis of the feet for 6 weeks is not required.

    It was shown that terbinafine suppresses metabolism mediated by isoenzyme 2D6 (CYP2D6). Therefore, continuous monitoring of patients receiving concomitantly metabolized with terbinafine with this isoenzyme (tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, antiarrhythmic drugs of class (IA, IB, IC class), antipsychotic drugs and monoamine oxidase B type inhibitors) in the case where the concomitant drug has a small range of therapeutic concentration.

    When treating terbinafine, general hygiene rules should be followed to prevent the possibility of re-infection through linens 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.

    Effect on the ability to drive transp. cf. and fur:

    The influence of terbinafine on the ability to drive vehicles and work with mechanisms has not been studied. With the development of dizziness against the background of drug therapy, patients should not drive vehicles and / or work with mechanisms.

    Form release / dosage:

    Tablets, 250 mg.

    Packaging:

    By 3, 4, 5, 7, 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    10, 20, 21, 28, 30, 40, 50, 56 or 100 tablets in cans of polyethylene terephthalate for medicinal products sealed with caps screwed with a first opening control or a "push-rotate" system of polypropylene or polyethylene or polypropylene cans for medicinal products means sealed with caps tightened with the control of the first opening from polyethylene or cans of polypropylene for medicinal products sealed with caps tightened with the control of the first opening of high pressure polyethylene.

    One jar or 1, 2, 3, 4, 5, 6, 7, 8 or 10 contour squares, together with instructions for use, are placed in a cardboard package.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003952
    Date of registration:09.11.2016
    Expiration Date:09.11.2021
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspOZON PHARM, LLCOZON PHARM, LLC
    Information update date: & nbsp11.12.2016
    Illustrated instructions
      Instructions
      Up