Terbizil
Terbizil: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. For violations of liver function
- 10. Use in the elderly
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Terbisil
ATX code: D01AE15
Active ingredient: terbinafine (terbinafine)
Producer: Gedeon Richter (Hungary)
Description and photo update: 2019-13-08
Prices in pharmacies: from 240 rubles.
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Terbizil is an antifungal drug.
Release form and composition
Terbizil dosage forms:
- tablets: round biconvex, almost white or white, on one side - dividing risk, on the other - engraving "250" (14 pcs. in a blister, in a cardboard box 1 or 2 blisters);
- cream for external use 1%: almost white or white mass with a slight smell of almonds (15 g each in an aluminum tube, in a cardboard box 1 tube).
1 tablet contains:
- active substance: terbinafine hydrochloride - 281.25 mg, which corresponds to 250 mg of terbinafine;
- auxiliary components: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, sodium carboxymethyl starch (type A), magnesium stearate.
1 g of cream contains:
- active substance: terbinafine hydrochloride - 10 mg, which corresponds to 8.8 mg of terbinafine;
- auxiliary components: polysorbate 60, benzyl alcohol, sorbitan monostearate, sodium hydroxide, cetyl alcohol, cetostearyl alcohol [cetyl alcohol (60%) and stearyl alcohol (40%)], cetyl palmitate, isopropyl myristate, purified water.
Pharmacological properties
Pharmacodynamics
Terbizil is an antifungal drug for external use. It is characterized by a wide range of antifungal activity. Terbinafine has a fungicidal effect against molds and certain dimorphic fungi (Pityrosporum orbiculare) and dermatophytes (Epidermophyton floccosum, Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton vercosum. In relation to yeast-like fungi (mainly Candida albicans), the substance exhibits fungicidal or fungistatic activity, which is determined by their type.
Terbinafine is characterized by the specific nature of changes in the early stage of sterol biosynthesis in fungi. This leads to intracellular accumulation of squalene and a lack of ergosterol, which leads to the death of fungal cells. The latter becomes possible by inhibiting the enzyme squalene epoxidase.
Oral administration of terbinafine is an ineffective way to combat versicolor versicolor caused by Malassezia furfur, Pityrosporum orbiculare, Pityrosporum ovale.
Terbinafine does not affect the cytochrome P 450 system in humans and does not alter the metabolism of hormones or other drugs.
Pharmacokinetics
When taken orally, terbinafine is well absorbed - more than 70%. Its absolute bioavailability, due to the "first pass" effect, reaches approximately 50%. After a single oral administration of the drug at a dose of 250 mg, the maximum concentration of terbinafine is 1.3 μg / ml. This value is reached in approximately 1.5 hours.
The area under the concentration-time curve (AUC) is 4.56 μg · h / ml. When terbinafine is taken orally with food, there is an increase in AUC by 20%. Long-term administration of the drug leads to an increase in the maximum concentration of terbinafine by 25%, and the AUC increases by 2.3 times. The effective half-life is approximately 30 hours, and the terminal half-life reaches 200-400 hours, which indicates long-term elimination of terbinafine from adipose tissue and skin. The equilibrium concentration of a substance in plasma is not determined by the age and sex of the patient.
Terbinafine binds to plasma proteins by 99%, while being rapidly distributed throughout the tissues and penetrating into the nail plates and the dermal layer of the skin. The active component of Terbizil is also contained in the secretion of the sebaceous glands and is accumulated in high concentrations in the skin and subcutaneous tissue, hair and hair follicles.
Terbinafine is actively involved in metabolic processes with the formation of metabolites, for which antifungal activity is uncharacteristic. 70% of the dose taken is excreted in the urine. The substance does not accumulate in the body and passes into breast milk. The pharmacokinetics of terbinafine does not depend on the patient's age, however, the rate of its elimination may decrease in renal and hepatic dysfunctions, causing a high level of the compound in the blood. When terbinafine is used externally, absorption is less than 5%, and the systemic effect on the body is insignificant.
Indications for use
Pills
- onychomycosis caused by dermatophytes;
- skin mycosis caused by anthropophilic fungus (Epidermophyton floccosum), trichophytes (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) or microspores (including M. gypseum, M. canis);
- dermatomycosis of smooth skin of the trunk, legs, feet in a severe widespread form that requires systemic treatment;
- mycoses of the scalp (trichophytosis, microsporia);
- candidiasis of the skin.
Cream for external use
- fungal infections of the skin caused by dermatophytes Trichophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum, T. interdigitale, T. tonsurans), Microsporum canis and gypseum, Epidermophyton floccosum;
- skin infections caused by yeast-like fungi, mainly Candida (including Candida albicans);
- pityriasis versicolor Pityriasis versicolor caused by Pityrosporum orbiculare (Malassezia furfur).
Contraindications
- period of breastfeeding;
- hypersensitivity to the components of the drug.
According to the instructions, Terbizil should be prescribed with caution during pregnancy.
The use of terbinafine during pregnancy is possible only if the expected effect of therapy for the mother, in the opinion of the doctor, exceeds the potential threat to the fetus.
In addition, additional contraindications for the use of tablets:
- age up to 2 years;
- severe liver dysfunction.
Carefully:
- tablets: renal failure, inhibition of bone marrow hematopoiesis, metabolic diseases, tumors, occlusive pathologies of the vessels of the extremities, alcoholism;
- cream: children's age.
Instructions for the use of Terbizil: method and dosage
Pills
Terbizil tablets are taken orally 1 time per day, after meals.
Recommended dosage:
- adults and children weighing more than 40 kg: 1 tablet (250 mg);
- children weighing 12–20 kg: 1/4 tablet (62.5 mg);
- children weighing 20-40 kg: 1/2 tablet.
Treatment of mycosis of the scalp in children is carried out at a dose of 250 mg per day.
The period of use depends on the clinical indications and the severity of the disease:
- onychomycosis: fingernails approximately 6 weeks, toenails approximately 12 weeks. The duration of therapy depends on the patient's age, the condition of the nails at the beginning of treatment, and the presence of concomitant diseases. The clinical effect usually occurs 8–12 weeks after a negative mycological examination, it depends on the individual rate of regrowth of a healthy nail;
- mycoses of smooth skin: trunk and lower legs - 2–4 weeks, candidiasis of the skin - 2–4 weeks, interdigital, plantar or sock-like localization of infection - 2–6 weeks;
- scalp candidiasis: 4 weeks, M. canis infections - more than 4 weeks.
In renal failure (creatinine clearance less than 50 ml / min or blood creatinine more than 300 μmol / l), adult patients should be prescribed 1/2 tablet.
Cream for external use
Terbizil cream is applied by applying a thin layer and lightly rubbing it into the skin of the body area affected by the fungus, capturing the adjacent healthy surface. Before applying, the skin of the problem area must be thoroughly cleaned and dried.
After applying the cream in places of physiological folds of the skin (groin and intergluteal region, interdigital spaces, areas under the mammary glands), it is advisable to use gauze dressings, especially at night.
The procedure should be carried out 1-2 times a day.
The duration of therapy depends on the clinical indications and the severity of the disease:
- dermatomycosis of the trunk and legs: 1-2 weeks;
- dermatomycosis of the feet: 2-4 weeks;
- candidiasis of the skin: 1-2 weeks;
- versicolor versicolor: 2 weeks.
When treating elderly patients, no dosage adjustment is required.
In the absence of a therapeutic effect after two weeks of using the cream, it is necessary to clarify the diagnosis and check the sensitivity of the pathogen to terbinafine.
Side effects
Pills
- digestive system: sometimes - mild pain in the lower abdomen, nausea, feeling of a full stomach, loss of appetite, diarrhea; rarely - a transient violation or loss of gustatory perception; extremely rare - severe liver dysfunction (jaundice, cholestasis, hepatitis);
- hematopoietic system: very rarely - thrombocytopenia, agranulocytosis, neutropenia;
- nervous system: dizziness, slight headache;
- immune system: sometimes - skin rash, urticaria, exanthema, myalgia, edema, arthralgia; rarely, erythema multiforme; very rarely - severe forms of skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis); very rarely - severe anaphylactoid reactions;
- others: intense hair loss.
When using Terbizil cream, in rare cases, local reactions occur in the form of skin redness, itching or burning in the area of application of the cream, which require discontinuation of the drug.
Overdose
Signs of an overdose of Terbizil when taken orally include frequent urination, headache, dizziness, nausea, vomiting, pain in the epigastric region and lower abdomen.
In this case, immediate gastric lavage is recommended, followed by the intake of activated carbon and / or symptomatic therapy. With external use of Terbizil, cases of overdose have not been registered, and inadvertent intake of the cream inside leads to the appearance of the same symptoms as in the case of tablets.
special instructions
Unlike cream, Terbizil tablets should not be prescribed to treat versicolor versicolor caused by Malassezia furfur.
With onychomycosis, the use of tablets is justified only with total damage to most nails, pronounced subungual hyperkeratosis and lack of effect after previous local therapy.
Oral administration of terbinafine should be based on liver function tests, which should be repeated frequently and regularly during treatment.
When confirming the effect of tablets on the development of side effects of hepatic etiology, the drug should be canceled.
Cancellation of Terbizil is required in case of severe skin or anaphylactic reactions.
Side effects from the use of tablets, as a rule, are mild and short-term.
Irregular use of Terbizil or premature discontinuation of therapy leads to a relapse of the pathology.
Since terbinafine tends to accumulate in the skin and nail plates, the clinical effect often occurs after several weeks of using the tablets.
Treatment should be carried out strictly following the rules of personal hygiene, this will prevent re-infection through underwear and shoes. After three weeks of therapy and at the end of treatment, antifungal treatment of shoes, socks or stockings is required.
Do not allow the cream to come into contact with the mucous membranes of the mouth, nose or eyes. In case of accidental contact with eyes, they should be rinsed with copious amounts of water and, if necessary, seek medical advice.
The clinical effect usually appears from the first days of applying the cream.
The appointment of Terbizil in children should be made after a careful assessment of the ratio of the expected benefits of therapy and potential harm.
The effect of tablets on the patient's ability to drive vehicles and mechanisms has not been established.
For violations of liver function
In severe liver dysfunctions, the use of Terbizil is contraindicated. When using the drug in patients with liver dysfunctions, the elimination of terbinafine worsens, which is accompanied by a subsequent increase in the content of the active component of the drug in the blood.
Use in the elderly
The pharmacokinetics of terbinafine does not depend on the patient's age.
Drug interactions
With the simultaneous use of Terbizil in tablet form:
- inducers of CYP450 enzymes (including rifampicin) can accelerate the elimination of terbinafine;
- cimetidine and other CYP450 inhibitors may delay the elimination of terbinafine;
- tricyclic antidepressants, beta 1 -blockers, MAO-B blockers, selective serotonin uptake blockers slow down their metabolism;
- cyclosporine, terfenadine, triazolam, tolbutamide, oral contraceptives and other drugs metabolized with the participation of cytochrome P 450 practically do not violate their clearance;
- caffeine reduces its clearance by 20%;
- ethanol and other hepatotoxic agents increase the risk of developing a hepatotoxic effect.
The interaction of the cream when combined with other drugs has not been established.
Analogs
Terbizil's analogs are: Atifan, Exifin, Fungoterbin, Binafin, Terbinorm, Lamisil, Terbinox, Lamikon, Terbinafin, Lamifast, Mikofin, Mikonorm, Lamifen.
Terms and conditions of storage
Keep out of the reach of children.
Store at 15-30 ° C, tablets in a dark place.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Terbizil tablets are a prescription drug. No prescription is needed to purchase a topical cream.
Reviews about Terbizil
According to reviews, Terbizil is a highly effective and high-quality product from a reliable manufacturer. If the instructions for use are followed, most patients experience an improvement. Some patients speak negatively about the drug, but this is mainly due to the incorrect use of Terbizil or its use not according to indications.
Price for Terbizil in pharmacies
The approximate price for Terbizil in the form of tablets is about 924–983 rubles (the package includes 14 pcs.) Or 1601–2278 rubles (the package includes 28 pcs.). You can buy 1% cream for external use for 265-294 rubles (for a tube of 15 g).
Terbizil: prices in online pharmacies
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Drug name Price Pharmacy |
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Terbizil 1% cream for external use 15 g 1 pc. 240 RUB Buy |
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Terbizil cream 1% 15g 247 r Buy |
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Terbizil 250 mg tablets 14 pcs. 884 r Buy |
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Terbizil 250 mg tablets 28 pcs. 1678 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!
