Terbinafine
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 45 rubles.
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Terbinafine is an antifungal drug for systemic and external use, a wide range of antimycotic activity.
Release form and composition
- tablets: chamfered and scored, from white to white with a yellowish or cream shade of color (7 or 10 pcs. in blister strip packs, in a cardboard box 1-5 or 10 packs; 14, 28, 50 or 100 pcs. in polymer cans, in a pack of cardboard 1 can);
- cream for external use 1%: from white to white with a yellowish or cream shade, a homogeneous mass with a weak specific odor (10, 15 or 30 g each in aluminum tubes; in a cardboard box 1 tube);
- spray for external use: transparent, colorless or light yellow solution, possibly slightly opalescent, with a characteristic smell of ethanol (10 or 20 g each in neutral glass vials, sealed with a crimp microsprayer, complete with a spray nozzle and a protective cap; 1 set in pack of cardboard).
Composition of 1 tablet:
- active substance: terbinafine (in the form of hydrochloride) - 125 or 250 mg;
- auxiliary components: microcrystalline cellulose, calcium stearate, hydroxypropyl cellulose (hyprolose), croscarmellose sodium, lactose monohydrate, colloidal silicon dioxide.
Composition of 1 g of cream:
- active substance: terbinafine (in the form of hydrochloride) - 10 mg;
- auxiliary components: polysorbate 60 (tween 60), sorbitan monostearate, cetyl palmitate, isopropyl myristate, sodium hydroxide, benzyl alcohol, cetyl alcohol, purified water.
Composition of 1 g spray:
- active substance: terbinafine (in the form of hydrochloride) - 10 mg;
- auxiliary components: propylene glycol, povidone-K17, macrogol-400, macrogol glyceryl hydroxystearate, ethanol 95%, purified water.
Indications for use
- all forms of release: treatment and prevention of fungal skin lesions caused by infection with Trychophyton spp. (T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violacium), Epidermophyton floccosum, Microsporum spp. (M. canis, M. gypseum): epidermophytosis inguinal, mycoses of feet and smooth skin of the body, etc.
- tablets: mycoses of nails (onychomycosis) and scalp (microsporia, trichophytosis), as well as severe widespread dermatomycosis of smooth skin of the trunk and extremities, requiring systemic treatment;
- tablets and cream: yeast infections of the skin caused by Candida; in particular, intertrigo of the skin (cream) and candidiasis of the mucous membranes (tablets);
- cream and spray (topical products): Pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).
Contraindications
Pills
Absolute:
- active liver disease or chronic;
- chronic renal failure with creatinine clearance (CC) ≤ 50 ml / min;
- children under 3 years old;
- body weight up to 20 kg;
- pregnancy (the teratogenic safety profile has not been studied);
- lactation / breastfeeding period (terbinafine is excreted in breast milk);
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- increased individual sensitivity to terbinafine or excipients.
Relative (take with caution):
- renal failure with CC> 50 ml / min;
- liver failure;
- alcoholism;
- oppression of bone marrow hematopoiesis;
- tumors;
- metabolic diseases;
- limb vascular occlusion;
- cutaneous or systemic lupus erythematosus.
Cream and spray for external use
Absolute:
- children under 12 years old;
- increased individual sensitivity to terbinafine or excipients of the drug.
Relative (use with caution): renal and / or hepatic failure, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusion of limb vessels, pregnancy and breastfeeding, children over 12 years of age (insufficient clinical experience), alcoholism.
Method of administration and dosage
Pills
The tablets are taken orally, after a meal.
Standard dose, provided that it is taken once a day:
- children over 3 years old weighing 20-40 kg - 125 mg;
- children over 3 years of age weighing> 40 kg and adults - 250 mg.
The duration of the course of therapy and the dosage regimen is determined by the doctor individually, depending on the localization of the infectious process and the severity of the course of the disease.
The average duration of therapy for various types of mycoses:
- onychomycosis: 6-12 weeks; in case of damage to the nail plates of the fingers and toes (except for the big toe) or in young patients, the duration of therapy may be reduced <12 weeks; big toe treatment usually lasts 3 months; with a reduced rate of nail growth, the duration of treatment may increase;
- fungal infections of the skin: 2-4 weeks or more; interdigital, plantar or sock-type infection - 2–6 weeks; legs, trunk - 2–4 weeks; candidiasis (mycoses caused by fungi of the genus Candida) - 2–4 weeks; mycoses of the scalp caused by fungi of the genus Microsporum - more than 4 weeks.
In hepatic or renal failure, the dose is reduced to 125 mg once a day.
Cream for external use
The cream is applied externally, in a thin layer, on the affected and adjacent areas of the skin, after cleaning and drying them, and rubbing lightly.
When treating infections accompanied by diaper rash (in the interdigital spaces, under the breast, in the groin area, between the buttocks), you can cover the places where the cream is applied with gauze, especially at night.
Recommended dosage regimen:
- dermatomycosis of the trunk, legs and feet: 1 time per day for 1 week;
- candidiasis of the skin: 1-2 times a day for 1-2 weeks;
- tinea versicolor: 1-2 times a day for 2 weeks.
Spray for external use
The spray is applied externally to the affected and adjacent areas of the skin, having previously cleaned and dried them, in a volume sufficient for thorough moisturizing.
Recommended dosage regimen:
- dermatomycosis of the trunk, legs and feet: 1 time per day for 1 week;
- tinea versicolor: 2 times a day for 1 week.
Elderly patients do not need to adjust the dosage regimen of terbinafine in any form of release.
Side effects
Pills
- digestive system: very often - decreased appetite, a feeling of fullness in the stomach, abdominal pain, dyspepsia, nausea, diarrhea; rarely - liver dysfunction; very rarely - extreme hepatic failure, including death;
- hematopoietic organs: very rarely - pancytopenia, agranulocytosis, neutropenia, thrombocytopenia;
- musculoskeletal system: very often - myalgia, arthralgia;
- nervous system: often - headache; infrequently - distortion of taste (including ageusia);
- skin: very often - skin reactions (rash, itching, urticaria); very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, exacerbation of existing psoriasis, psoriasis-like rash, alopecia;
- hypersensitivity reactions: very rarely - anaphylactoid reactions (including angioedema);
- other reactions: very rarely - fatigue; cutaneous or systemic lupus erythematosus, or their exacerbation.
Symptoms of an overdose of tablets are rash, dizziness, headache, epigastric pain, nausea, vomiting, and frequent urination. For the treatment of the condition, it is recommended to carry out measures to remove the drug from the body: taking activated charcoal, gastric lavage. If necessary, supportive symptomatic therapy is carried out.
Cream and spray for external use
- cream and spray (at the application site): redness, itching or burning sensation, pain and irritation, worsening of the current disease;
- spray: rarely - eye irritation.
In the presence of hypersensitivity to terbinafine, in isolated cases, the following allergic reactions may develop: widespread urticaria, rash, itching, bullous rashes. These conditions require immediate discontinuation of the drug.
Due to low systemic absorption, overdose of topical agents is extremely unlikely. But if you accidentally take a cream or spray inside, the same side effects are possible as with an overdose of tablets (dizziness, headache, epigastric pain, nausea, etc.). For the treatment of the condition, it is recommended to take activated carbon; if necessary, supportive symptomatic treatment is carried out.
special instructions
If terbinafine is used irregularly or if treatment is stopped prematurely, there is a risk of re-infection.
Usually, a decrease in the severity of clinical manifestations is observed in the first days of therapy. But if after 7-14 days there is no improvement, it is required to verify the diagnosis by re-determining the causative agent of the disease and the degree of its sensitivity to the drug.
The duration of the course of therapy can be influenced by concomitant diseases, and with onychomycosis, by the condition of the nails at the beginning of treatment.
Taking Terbinafine tablets for the treatment of onychomycosis is justified only with total damage to most of the nails, the presence of pronounced subungual hyperkeratosis and the ineffectiveness of previous local therapy.
A laboratory-confirmed clinical response to the treatment of onychomycosis can usually be obtained several months after the completion of the course and mycological cure. This is due to the rate of complete renewal of the nail plate.
It is not required to remove the nail plates during the treatment of onychomycosis of the hands - 21 days and onychomycosis of the feet - 42 days.
With liver disease, a decrease in terbinafine clearance is possible. It is necessary to monitor the indicators of the level of hepatic transaminases in the blood serum in order to timely correct the doses of the drug.
As a result of systemic use, in rare cases, three months after the start of therapy, cholestasis and hepatitis may occur. The appearance of signs of liver failure, such as persistent nausea, weakness, decreased appetite, severe abdominal pain, dark urine or discolored stools, jaundice, require immediate withdrawal of the tablets.
It is necessary to use terbinafine with caution in psoriasis, because, in very rare cases, an antifungal agent can provoke its exacerbation.
Terbinafine Cream and Spray are for external use only. Avoid getting the cream and spray in the eyes to avoid irritation. If this happens, the eyes must be rinsed immediately with plenty of running water, and if persistent irritation develops, consult a doctor.
The spray contains ethyl alcohol (33% by weight), which can cause irritation when applied to damaged skin. The propylene glycol in the spray may irritate the skin.
If during inhalation the spray was accidentally injected into the respiratory tract, if any symptoms appear, especially if they persist, you need to contact a medical institution.
In the event of allergic reactions, the drug must be canceled.
Terbinafine therapy is carried out in accordance with general hygiene rules in order to prevent the possibility of re-infection through underwear and shoes. During treatment, after 14 days from the beginning and at the end, it is necessary to perform antifungal treatment of shoes, stockings and socks.
There are no data on the effect of terbinafine use on concentration and psychomotor speed.
Drug interactions
For systemic use (tablets):
- tricyclic antidepressants and selective serotonin reuptake inhibitors (fluvoxamine, desipramine), β-adrenergic blockers (propranolol, metoprolol), monoamine oxidase B inhibitors (selegiline), antiarrhythmics (propafenone, flecainide), chloropromycin YP, chloramphenamine, antipsychotics, disrupts the metabolism of the above drugs;
- rifampicin and other inducers of cytochrome P450 isoenzymes: may increase the rate of excretion of terbinafine, increasing its metabolism; dose adjustment of terbinafine may be required;
- cimetidine and other inhibitors of cytochrome P450 isoenzymes: may decrease the rate of excretion of terbinafine, weakening its metabolism; dose adjustment of terbinafine may be required;
- oral contraceptives: terbinafine may cause menstrual irregularities;
- caffeine: clearance decreases by 21%, half-life increases by 31%;
- phenazone, digoxin, warfarin: terbinafine has no effect on their clearance;
- ethanol, drugs with a hepatotoxic effect: there is a risk of drug damage to the liver.
Information about the drug interaction of the external forms of Terbinafine (spray and cream) is unknown. But since no compatibility studies have been conducted, it is not recommended to use drugs in conjunction with other drugs for topical and external use.
Analogs
Analogs of Terbinafine tablets are: Binafin, Onykhon, Lamikan, Terbizil, Miconorm, Exifin, etc.
Analogs of Terbinafine preparations for external use (cream and spray) are: Lamisil Uno, Terbizil, Thermikon, Terbinox, Lamitel, Miconorm, etc.
Terms and conditions of storage
Store in a place protected from moisture and light, out of the reach of children, tablets and cream at a temperature not exceeding 25 ° C, spray - from 2 to 20 ° C.
Shelf life: tablets - 3 years; cream and spray - 2 years.
Terms of dispensing from pharmacies
The tablets are available with a prescription.
Terbinafine cream and spray are available without a prescription.
Terbinafine: prices in online pharmacies
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Drug name Price Pharmacy |
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Terbinafine 1% cream for external use 15 g 1 pc. RUB 45 Buy |
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Terbinafine 1% cream for external use 15 g 1 pc. RUB 47 Buy |
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Terbinafine cream d / nar. approx. 1% tube 15g RUB 68 Buy |
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Terbinafine 1% cream for external use 15 g 1 pc. RUB 90 Buy |
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Terbinafine Canon 250 mg tablets 10 pcs. 108 RUB Buy |
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Terbinafine cream 1% 15g Vertex 124 RUB Buy |
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Terbinafine 250 mg tablets 10 pcs. 129 RUB Buy |
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Terbinafine Canon 250mg tablets 10 pcs. 130 RUB Buy |
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Terbinafine 250 mg tablets 10 pcs. 141 r Buy |
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Terbinafine 1% spray for external use 20 g 1 pc. 149 r Buy |
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Terbinafine Canon gel for external use approx. 1% tube 15g 171 r Buy |
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Terbinafine 1% cream for external use 30 g 1 pc. 171 r Buy |
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Terbinafine Canon 1% gel for external use 15 g 1 pc. 171 r Buy |
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Terbinafine 250 mg tablets 14 pcs. RUB 180 Buy |
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Terbinafine tablets 250mg 10 pcs. 188 r Buy |
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Terbinafine Canon 250 mg tablets 14 pcs. 209 RUB Buy |
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Terbinafine tablets 250mg 14 pcs. 215 RUB Buy |
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Terbinafine tablets 250mg 14 pcs. 227 r Buy |
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Terbinafine cream 1% 30g 240 RUB Buy |
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Terbinafine 250 mg tablets 28 pcs. 328 RUB Buy |
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Terbinafine tablets 250mg 28 pcs. 338 r Buy |
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Terbinafine 250 mg tablets 30 pcs. RUB 539 Buy |
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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
