Terbinafin-Teva - Instructions For Use Of Tablets 250 Mg, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Terbinafin-Teva

Terbinafin-Teva: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Terbinafine-Teva

ATX code: D01BA02

Active ingredient: terbinafine (Terbinafine)

Manufacturer: Teva Pharmaceutical Enterprises, Ltd. (Teva Pharmaceutical Industries, Ltd.) (Israel)

Description and photo update: 2020-06-02

Prices in pharmacies: from 380 rubles.

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Terbinafine-Teva is an antifungal agent.

Release form and composition

Dosage form - tablets: capsule-shaped, biconvex, almost white or white, with a dividing line on one side and engraving "T" on both sides of the risks (in a cardboard box 1, 2 or 4 blisters containing 7 tablets each, and instructions for the use of Terbinafina-Teva).

The composition of the drug for 1 tablet:

• active substance: terbinafine (in the form of hydrochloride) - 250 mg;
• auxiliary components: colloidal silicon dioxide, sodium carboxymethyl starch (type A), magnesium stearate, hypromellose, microcrystalline cellulose.

Pharmacological properties

Pharmacodynamics

Terbinafine is a drug from the group of allylamines (synthetic antifungal agents) with a wide spectrum of action.

In low concentrations, the drug has fungicidal activity against yeast (mainly Candida albicans) and dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton rubrum, Trichophyton violaceum).

On yeast fungi, terbinafine can have a fungicidal or fungistatic effect, depending on the type of mycoses.

The mechanism of action of Terbinafine-Teva is due to its ability to inhibit the squalene epoxidase enzyme and, as a result, to disrupt the early stage of ergosterol biosynthesis (the main component of the fungal cell membrane).

In oral dosage forms, terbinafine is ineffective for pityriasis versicolor caused by Pityrosporum ovale and Pityrosporum orbiculare (Malassezia furfur).

Pharmacokinetics

After oral administration, terbinafine is absorbed in large volumes (> 70%). It is subject to first pass metabolism (it has the effect of the first passage through the liver), due to which the absolute bioavailability is reduced by 40%. After a single dose of 250 mg, the maximum concentration (C _max) is reached within 2 hours and is 1 μg / ml. The AUC (area under the concentration-time curve) is 4.56 μg × h / ml, increases by 20% in the case of simultaneous food intake.

With long-term treatment, the time to reach C _max increases by 25%, AUC - 2.5 times.

The equilibrium concentration of the drug does not depend on the age and sex of the patient.

The effective half-life (T _1/2) is approximately 36 hours, the terminal one is 200-400 hours.

At least 99% of the drug binds to plasma proteins. Terbinafine is well distributed in tissues, penetrates into the nail plates and the dermal layer of the skin, into the secretion of the sebaceous glands. In high concentrations, it accumulates in hair follicles, subcutaneous tissue.

Terbinafine undergoes significant metabolism, but the resulting metabolites do not exhibit antifungal activity.

Approximately 70% of the drug is excreted by the kidneys. Terbinafine does not accumulate in the body.

In the elderly, the pharmacokinetics of Terbinafine-Teva does not change. With impaired liver and kidney function, the excretion of terbinafine decreases, due to which its concentration in the blood increases significantly.

The drug passes into breast milk.

Indications for use

Terbinafin-Teva 250 mg tablets are prescribed in the following cases:

• candidiasis of the skin;
• fungal diseases of the skin and nails (onychomycosis) caused by Epidermophyton floccosum, Microsporum spp., Trichophyton spp.;
• mycoses of the scalp (microsporia, trichophytosis);
• severe widespread dermatomycosis of smooth skin of the limbs and trunk, requiring systemic treatment.

Contraindications

Absolute:

• chronic renal failure [creatinine clearance (CC) <50 ml / min];
• chronic and active liver diseases;
• children up to 3 years old and body weight up to 20 kg;
• period of pregnancy and lactation;
• hypersensitivity to any component of Terbinafina-Teva.

Relative:

• oppression of bone marrow hematopoiesis;
• occlusive vascular disease of the extremities;
• diseases accompanied by metabolic disorders;
• oncological diseases;
• alcoholism;
• chronic renal failure (CC> 50 ml / min).

Terbinafin-Teva, instructions for use: method and dosage

Terbinafin-Teva tablets should be taken orally, after meals.

Recommended doses:

• adults and elderly patients - 250 mg (1 tablet) 1 time per day;
• children over 3 years old weighing more than 40 kg - 250 mg once a day;
• children over 3 years old weighing 20-40 kg - 125 mg (½ tablet) 1 time per day.

In chronic renal failure (CC> 50 ml / min), a decrease in the daily dose to 125 mg is required.

The duration of therapy is determined individually, depending on the type of disease and the severity of its course.

The standard duration of the course, depending on the location and type of mushrooms:

• mycoses of the legs, trunk and mycoses caused by Candida - 2–4 weeks;
• plantar and interdigital fungal diseases, as well as infections of the "sock" type - 2-6 weeks;
• mycoses of the scalp - 4 weeks;
• mycoses caused by Microsporum cams - more than 4 weeks;
• onychomycosis - 6-12 weeks.

If the big toe is affected, a 12-week course of therapy is often sufficient. At a young age, as well as with the defeat of the nails on the hands and feet (with the exception of the big toe), the duration of treatment can be less than 12 weeks. In some patients, the rate of nail growth is reduced, so an increase in the course of therapy is required.

Side effects

• from the digestive system: very often (at least 10%) - a feeling of fullness in the stomach, abdominal pain, dyspepsia, diarrhea, decreased appetite, nausea; infrequently (at least 0.1%) - violation or loss of taste (this phenomenon disappears within a few weeks after stopping the administration of Terbinafine-Teva), increased activity of hepatic transaminases; rarely (more than 0.01%, but less than 0.1%) - jaundice, cholestasis, hepatitis; very rarely (less than 0.01%) - long-term disorders of gustatory sensations, which leads to refusal to eat and a significant decrease in body weight, liver failure;
• from the central and peripheral nervous system: often (more than 1%, but less than 10%) - headache; rarely - dizziness, hypoesthesia, paresthesia; very rarely - anxiety, depression;
• on the part of the musculoskeletal system: very often - myalgia, arthralgia;
• on the part of the organ of hearing and labyrinthine disorders: very rarely - vertigo;
• on the part of the blood and lymphatic system: very rarely - agranulocytosis, thrombocytopenia, lymphocytopenia, neutropenia; very rarely - pancytopenia;
• on the part of the skin: very rarely - acute generalized pustular exanthema, psoriasis-like rash, exacerbation of psoriasis;
• allergic reactions: very often - skin rashes, urticaria; very rarely - anaphylactoid reactions, angioedema, toxic epidermal necrolysis, malignant epidermal erythema;
• others: rarely - a feeling of malaise, weakness; very rarely - systemic lupus erythematosus.

Overdose

If the dose of Terbinafine-Teva is excessively exceeded, the following symptoms may develop: skin rash, dizziness, headache, frequent urination, nausea, vomiting, gastralgia.

It is recommended to rinse the stomach and take activated charcoal as soon as possible. Overdose treatment is symptomatic.

special instructions

With premature termination of treatment or irregular intake of the drug, a relapse of the disease is possible. If, after 2 weeks of taking Terbinafine-Teva, there is no improvement in the condition, it is necessary to re-determine the type of pathogen and its sensitivity to the antifungal agent.

In case of onychomycosis, systemic therapy is advisable if previous local therapy was ineffective, most of the nails are affected, or there is pronounced subungual hyperkeratosis.

A confirmed laboratory clinical response to the treatment of onychomycosis is usually observed several months after the end of the course of therapy and depends on the growth rate of a healthy nail.

Removal of nail plates during treatment with Terbinafin-Teva is not required.

In rare cases, the drug can exacerbate psoriasis, therefore, with this disease, terbinafine should be used with caution.

In order to avoid re-infection through shoes and underwear during treatment, patients should follow general hygiene rules. Antifungal treatment of socks, stockings and shoes should be done 2 weeks after the start of therapy and after it ends.

In some cases, 3 months after the end of antifungal therapy, cholestasis and hepatitis may develop. Terbinafin-Teva should be immediately canceled if the following symptoms of a functional liver disorder appear: discolored feces, dark urine, excessive abdominal pain, decreased appetite, persistent nausea, jaundice, weakness. For the same reason, during the period of therapy, it is recommended to regularly monitor the indicators of the activity of liver enzymes in the blood serum.

Influence on the ability to drive vehicles and complex mechanisms

Terbinafine-Teva does not adversely affect the reaction rate and ability to concentrate. However, some patients experience dizziness during therapy, so it is recommended to be careful when driving a car and performing potentially hazardous types of work.

Application during pregnancy and lactation

Due to the lack of sufficient data on the safety of terbinafine during pregnancy, it is contraindicated to take the drug during gestation.

The drug passes into breast milk, therefore, Terbinafin-Teva is not prescribed for breastfeeding women.

Pediatric use

Antifungal drug is not used to treat children under 3 years of age and weighing less than 20 kg.

With impaired renal function

• CC <50 ml / min: Terbinafine-Teva is contraindicated;
• CC> 50 ml / min: the drug should be used with extreme caution.

For violations of liver function

In liver diseases (both active and chronic), a decrease in the clearance of terbinafine is possible, therefore Terbinafine-Teva is contraindicated.

Drug interactions

With the joint appointment of inducers or inhibitors of cytochrome P450 isoenzymes, which can accelerate or slow down the elimination of terbinafine from the body, its dose must be adjusted. For example, rifampicin increases the rate of elimination of terbinafine by 100%, cimetidine decreases by 30%.

Terbinafine does not affect the rate of excretion of digoxin and antipyrine.

In vivo and in vitro studies, it was found that, due to inhibition of the isoenzyme CYP2P6, terbinafine disrupts the metabolism of the following drugs: antipsychotic drugs (haloperidol, chlorpromazine), beta-blockers (metoprolol, propranolol), selective serotonin reuptake inhibitors, inhibitors of serotonin (fluvoxamine) monoamine oxidase B (selegiline), antiarrhythmics (propafenone, flecainide), tricyclic antidepressants. Terbinafine has no significant effect on the rate of elimination of oral contraceptives, terfenadine, tolbutamide, triazolam and other drugs metabolized with the participation of other cytochrome P450 isoenzymes (with the exception of the CYP2P6 isoenzyme).

When treating with terbinafine while taking oral contraceptives, menstrual irregularities may be disturbed.

In the case of simultaneous use with cyclosporine, terbinafine reduces its concentration in blood plasma (by about 15%) and, as a result, reduces the therapeutic effect.

Terbinafine, when taken in conjunction with warfarin, can affect the prothrombin test (international normalized ratio and blood clotting time).

Terbinafine reduces the rate of elimination of caffeine from the body by 21%, which leads to an increase in its concentration in blood plasma and an increase in the effect.

When desipramine is taken, its elimination rate is reduced by 82%.

With the simultaneous use of ethanol or drugs with a hepatotoxic effect, drug damage to the liver is possible.

Analogs

The analogues of Terbinafin-Teva are Atifin, Binafin, Vero-Fluconazole, Voriconazole, Diflucan, Itraconazole, Cancidas, Medoflucon, Noxafil, Orunit, Procanazole, Rumikoz, Terbinafin, Termikon, Flucoscis and others, Erakan,

Terms and conditions of storage

Keep out of reach of children at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Terbinafine-Teva

Reviews about Terbinafine-Teva are mostly positive. Patients note that this drug is effective in treating fungal diseases and is well tolerated. Moreover, it costs an order of magnitude cheaper than many similar medicines. Of the shortcomings, they indicate a negative effect of the drug on the liver.

In rare reports, there are complaints about the lack of effect of antifungal therapy.

Price for Terbinafin-Teva in pharmacies

The approximate price for Terbinafine-Teva 250 mg is 449 rubles. per pack of 14 tablets.

Terbinafin-Teva: prices in online pharmacies

Drug name Price Pharmacy

Terbinafine-Teva 250 mg tablets 14 pcs. RUB 380 Buy

Terbinafine-Teva 250 mg tablets 28 pcs. 389 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!