Compound
Contains the active ingredient terbinafine in the form of terbinafine hydrochloride.
1 tablet of Terbizil contains 125 or 250 mg of this substance, as well as auxiliary components: hypromellose, silicon dioxide, sodium carboxymethyl starch, magnesium stearate, microcrystalline cellulose.
1 gram of Terbizil cream contains 8.8 mg of the active ingredient, as well as isopropyl myristate, sodium hydroxide, benzyl alcohol, cetyl alcohol, cetostearyl alcohol, sorbitan stearate, cetyl palmitate, polysorbate, and pure water.
Terbizil 250 mg No. 28 tablets
Terbizil ( TERBIZIL )
Terbizil cream ( TERBIZIL cream )
Compound
Pills
- 250 mg of terbinafine in each tablet.
Cream
— 10 mg of terbinafine hydrochloride per 1 g of cream.
Pharmacotherapeutic group: Antifungal agents for systemic and local use.
Pharmacological properties
Pharmacodynamics
Terbinafine is an allylamine derivative with a broad spectrum of antifungal activity and is effective in the treatment of dermatophytosis of the skin, hair and nails. Active against the following fungi: Trichophyton (for example, T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum (for example, M. canis), Epidermophyton floccosum, Candida and Pityrosporium from the group of yeast-like fungi (eg Candida albicans).
In low concentrations, terbinafine has a fungicidal effect against dermatophytes, yeast-like fungi and some dimorphic fungi. In relation to yeast-like fungi, for example the genus Candida, it can exhibit a fungicidal or fungistatic effect, depending on the microorganism.
Terbinafine affects the early stage of sterol biosynthesis by inhibiting squalene epoxidase, which leads to ergosterol deficiency and intracellular accumulation of squalene, which leads to fungal cell death.
Terbinafine inhibits the enzyme squalene epoxidase, located on the cell membrane of the fungus. The enzyme squalene epoxidase does not belong to the cytochrome P450 system.
Pharmacodynamic properties
When taken orally, the drug accumulates in the skin, nail plates and hair in concentrations that provide a fungicidal effect.
Pharmacokinetics
Pills
After oral administration, terbinafine is well absorbed (>70%), the absolute bioavailability of terbinafine as a result of first-pass metabolism is approximately 50%. Terbinafine is highly bound to plasma proteins (99%). It quickly penetrates the skin and is concentrated in the lipophilic stratum corneum. Terbinafine is also secreted with sebum, resulting in its high concentration in hair follicles, hair and sebum-rich skin. Terbinafine also penetrates the nail plate during the first few weeks after the start of treatment.
Terbinafine is rapidly and intensively metabolized by at least seven isoenzymes of the CYP system, with CYP2C9, CYP1A2, CYP3A4, CYP2C8 and CYP2C19 playing a particularly important role. Biotransformation of terbinafine leads to the formation of metabolites that do not have antifungal activity.
Metabolites are excreted primarily in the urine.
The half-life, calculated based on the increase in plasma AUC, is approximately 30 hours. The terminal half-life is approximately 16.5 days.
Indications
Onychomycosis caused by a dermatophyte fungus (fungal infection of the nails).
Fungal infections of smooth skin, nails and scalp caused by fungi of the genus Trichophyton (for example T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans T. violaceum), M. canis and Epidermophyton floccosum.
Systemic treatment of severe widespread mycosis of the skin (dermatomycosis of the smooth skin of the trunk), mycosis of the groin area (tinea groin), mycosis of the feet (tinea pedis) and skin infections caused by fungi of the genus Candida.
Fungal infection of the scalp (ringworm).
Note: Unlike topical treatment with Terbizil cream, Terbizil tablets are not effective in treating pityriasis versicolor (varicose) caused by the fungus Pityrosporum orbiculare (also known as Malessezia furfur).
Method of administration and dose
Pills
The tablets are swallowed without chewing, washed down with a small amount of water. It is advisable to take the tablets at the same time every day. The tablets can be taken on an empty stomach or after meals.
Adults:
For the treatment of adult patients, it is recommended to take one 250 mg tablet daily.
Duration of treatment
The duration of treatment depends on the clinical indications and the severity of the infection.
Onychomycosis:
In the case of fungal infection of the fingernails, 6 weeks of treatment is usually sufficient.
Fungal infections of the toenails, especially the first toe nail, require treatment for 12 weeks.
The maximum clinical effect can be observed several months after mycological cure. This may be due to the length of time it takes for a healthy nail to grow back.
Skin infections:
In the case of mycosis of the feet (interdigital, plantar, “moccasin” type), the duration of taking the drug orally is from 2 to 6 weeks; in the case of mycosis of the smooth skin of the trunk and mycosis of the groin area, the duration of taking the drug orally is from 2 to 4 weeks. For cutaneous candidiasis, the duration of treatment is from 2 to 4 weeks.
Complete disappearance of clinical symptoms of infection can only be observed several weeks after mycological cure.
Infections of the scalp:
For infections of the scalp (ringworm), the duration of treatment is about 4 weeks. Ringworm usually occurs in children.
Additional information on special patient populations
Patients with liver dysfunction
It is not recommended to prescribe terbinafine tablets to patients with chronic or acute liver disease.
Patients with impaired renal function
The use of octerbinafine tablets in patients with impaired renal function has not been sufficiently studied and is therefore not recommended for the treatment of this group of patients.
Elderly patients
There is no evidence that elderly patients require different dosages from those indicated for younger patients or that they experience more side effects from the drug. When prescribing octerbinafine tablets to patients in this age group, it is necessary to take into account the likelihood that they have impaired liver or kidney function.
Application in children
Treatment with terbinafine tablets in children over 2 years of age is well tolerated.
There is no clinical experience with terbinafine in children under 2 years of age (or weighing less than 12 kg).
Children with a body weight of 20 kg - 40 kg: 1/2 tablet of the drug Terbizil (125 mg) once a day. Children with a body weight of more than 40 kg: 1 tablet of the drug Terbizil (250 mg) once a day.
Cream
Apply the cream to the affected area and surrounding area in a thin layer, rubbing lightly.
To prevent infection from spreading to other parts of the body or infecting another person, you should always wash your hands after use.
If there are infectious lesions in the area of skin folds, healing is facilitated by applying a gauze bandage to the area where the cream is applied, especially at night. In this case, gauze dressings must be changed before each use.
The infected area of skin should be cleaned regularly and gently dried. Despite the itching, you should not scratch the affected area of skin, as this can damage the skin and thereby slow down the healing process or cause the infection to spread.
Contraindications
Known hypersensitivity to terbinafine or any excipients of Terbizil tablets.
Side effects
Very common (> 1/10) – loss of appetite, headache, gastrointestinal disorders (bloating, abdominal pain, dyspepsia, nausea, diarrhea), rash, urticaria, arthralgia, myalgia
Often (>1/100 -
Uncommon (>1/1000 -
Special instructions and precautions for use
Liver function
It is not recommended to prescribe Terbizil to patients with chronic or acute liver disease. Patients taking oral terbinafine preparations should be cautioned to immediately report any signs and symptoms, such as unexplained persistent nausea, decreased appetite, fatigue, vomiting, pain in the right upper abdomen, dark-colored urine or light-colored stool. If such symptoms occur, oral terbinafine should be discontinued and biochemical liver function tests should be checked.
Dermatological effects
Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have very rarely been observed in patients taking terbinafine tablets. If a progressive skin rash appears, treatment with terbinafine tablets should be discontinued.
Hematological effects
Cases of blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been very rarely reported in patients receiving terbinafine tablets.
Kidney function
In patients with impaired renal function (creatinine clearance less than 50 ml/min or serum creatinine content more than 300 µmol/l), the use of octerbinafine tablets has not been sufficiently studied, and therefore cannot be recommended.
Age
The use of this drug in children under 2 years of age is not recommended due to lack of clinical experience.
Interaction with other drugs and other forms of interaction
Effects of other medicines: narterbinafine
Plasma clearance of sterile binafine can be accelerated by drugs that induce its metabolism and slowed down by drugs that suppress cytochrome P450. If it is necessary to prescribe such drugs simultaneously, an appropriate adjustment of the dose of Terbizil is possible.
The following drugs may enhance the effect of terbinafine or increase its concentration in the blood plasma:
Cimetidine reduces the clearance of terbinafine by 33%.
Fluconazole, due to its inhibitory effect on the enzymes CYP2C9 and CYP3A4, increases the Cmax and AUC of terbinafine by 52% and 69%, respectively. A similar increase in terbinafine concentrations may occur when drugs that inhibit CYP2C9 and CYP3A4, such as ketoconazole and amiodarone, are co-administered with terbinafine.
The following drugs may decrease the effect of terbinafine or reduce its plasma concentration:
Rifampicin increases the clearance of terbinafine by 100%.
Effect of terbinafine on other drugs
Terbinafine may enhance the effect or increase the plasma concentration of the following drugs:
Substances predominantly metabolized by CYP2D6 (tricyclic antidepressants (TCAs), beta blockers, selective serotonin reuptake inhibitors (SSRIs), antiarrhythmics (including class 1A, 1B and 1C antiarrhythmics) and MAO-B inhibitors).
Terbinafine reduces the clearance of desipramine by 82%.
Caffeine
Terbinafine reduces the clearance of caffeine after intravenous administration by 19%.
Terbinafine may reduce the effect or plasma concentrations of the following drugs:
Terbinafine increases the clearance of cyclosporine by 15%.
The influence of food intake on the effect of the drug
Food intake has a moderate effect on the bioavailability of terbinafine (increases AUC by at least 20%), but there is no need for dose adjustment.
Pregnancy and lactation, fertility
Terbinafine tablets should be used during pregnancy only if the woman's condition requires it and the expected benefit to the mother outweighs the possible risk to the fetus.
Lactation:
Terbinafine passes into breast milk, so women taking terbinafine by mouth should stop breastfeeding.
Impact on the ability to drive vehicles and operate machinery
Patients experiencing dizziness during therapy should avoid driving or operating machinery.
Overdose
Symptoms: headache, nausea, epigastric pain and dizziness.
Treatment: Recommended treatment in case of overdose includes measures to remove the drug, primarily by administering activated charcoal, and, if necessary, the use of symptomatic supportive therapy.
Package
Pills
14 tablets in an AL/PVC blister.
1 or 2 blisters in a cardboard box with attached instructions for use.
Cream
15 g of cream in a sealed aluminum tube with a white polyethylene cap with a perforation punch.
One tube in a cardboard box with attached instructions for use.
Pharmacodynamics and pharmacokinetics
Terbizil is a broad-spectrum antimycotic and belongs to the group of allylamines. The active ingredient is terbinafine .
In low concentrations, the main substance exhibits a fungicidal effect, to which fungi (Microsporum canis, Trychophyton rubrum, Epidermophyton floccosum, etc.), mold fungi, as well as fungi of the genus dimorphic (Pityrosporum orbiculare) are susceptible.
Terbizil has both a fungicidal and fungistatic effect against yeast fungi.
The fungicidal effect is achieved by suppressing sterol synthesis in cells, which leads to inhibition of ergosterol , and this in turn causes the death of the microorganism.
Additionally, Terbizil causes inhibition of the enzyme squalene epoxidase . Squalene epoxidase is located in the cell membrane, and disruption of its work leads to the accumulation of squalene in the cell and the death of the fungus.
For humans, Terbizil is not at all dangerous, since terbinafine does not have a similar effect in the cells of the human body.
Indications for use
Mycotic infections of the skin and nail plate, diseases of the skin and hair of the head of a fungal nature ( onychomycosis , microsporia , trichophytosis , epidermophytosis , cutaneous candidiasis, rubrophytosis, mucosal candidiasis); lichen versicolor (only forms for local use are used).
Contraindications
There are no absolute contraindications for the use of Terbizil cream and tablets; the only possible one is hypersensitivity to terbinafine.
Relative (Terbizil should be prescribed with caution) contraindications: pathology of the hepatic system and kidneys, accompanied by impaired organ function and failure.
You should be careful if the patient has diseases of the hematopoietic organs and endocrine diseases, vascular and oncological pathologies .
There is no experimental evidence of the safety of terbinafine in pediatric practice; before reaching the age of two, the drug is used according to strict indications.
Terbizil should not be prescribed during breastfeeding or pregnancy.
Instructions for use TERBISIL®
Terbizil® cream is for external use only. It should not be applied to the mucous membrane of the eyes. If the cream gets into your eyes, rinse them with plenty of water and, if necessary, consult an ophthalmologist.
Terbizil® cream 10 mg/g is not recommended for the treatment of hyperkeratotic, chronic, plantar (moccasin type) dermatophytosis of the feet.
If an allergic reaction occurs, wash off the cream and stop treatment.
The cream contains cetostearyl alcohol and cetyl alcohol, which may cause local skin reactions (eg contact dermatitis).
Impact on the ability to drive vehicles and operate machinery
Terbizil® in the form of a cream does not affect the ability to drive vehicles or operate complex machinery.
Experimental results
In long-term studies (up to 1 year) in rats and dogs, no significant toxic effects were observed in any animal species when terbinafine was administered orally at a dose of about 10 mg/kg/day. When administered orally in high doses, possible target organs include the liver and kidneys.
In a two-year carcinogenicity study in mice, no neoplasms or other pathological changes associated with the drug were found at doses up to 130 mg/kg/day (males) and 156 mg/kg/day (females). In a 2-year oral carcinogenicity study in rats, an increase in the incidence of liver tumors was observed in males at the highest dose of 69 mg/kg/day. At this dose, systemic exposure is similar to that observed in clinical settings. The mechanism of tumor development and its clinical significance are unknown. Changes possibly related to peroxisome proliferation appeared to be species specific because they were not detected in carcinogenicity studies in mice, dogs, or monkeys.
In studies in monkeys using high doses, refractive inhomogeneities were found in the retina (non-toxic level 50 mg/kg). These irregularities were associated with the presence of a terbinafine metabolite in the eyeball tissue and disappeared after discontinuation of the drug. There were no changes at the histological level.
Using a standard battery of in vitro and in vivo genotoxic tests, there was no evidence of mutagenic or clastogenic potential.
Side effects
With a frequency of up to 10%, disorders of the digestive tract are possible: loss of appetite, nausea, diarrhea, pain in the epigastric zone.
Terbizil can cause allergic skin reactions (urticaria, rash). There have been cases where pain in the joints and muscles appeared while taking the drug.
The nervous system may react to taking the drug with dizziness. Possible headache.
Extremely rare, but still not excluded, are taste disturbances, up to its complete loss, congestion in the hepato-pancreatic-duodenal region ( cholestatic jaundice ), polymorphic exudative erythema, bullous dermatitis up to toxic epidermal necrolysis ( Lyell's syndrome ).
Signs of inhibition of the function of hematopoietic organs may be observed: agranulocytosis and thrombocytopenia , lymphopenia or neutropenia.
hyperemia may occur at the site of application .
Terbizil tablets 250 mg No. 14x2
Name
Terbizil tablet 250 mg in blister pack. in pack No. 14x2
Main active ingredient
Terbinafine
Release form
pills
Compound
Active ingredient: 250 mg of terbinafine (as 281.25 mg of terbinafine hydrochloride) in each tablet. Excipients: colloidal anhydrous silicon dioxide, magnesium stearate, hypromellose, microcrystalline cellulose, sodium carboxymethyl starch (type A).
Description
White or off-white, round, biconvex tablets, about 11 mm in diameter, scored on one side and engraved “250” on the other.
Dosage
250 mg
Indications for use
The active ingredient of Terbizil tablets is terbinafine. It belongs to the group of antifungal drugs. Terbisil tablets are used to treat fungal infections of the fingernails and toenails, some fungal infections of the skin of the legs (athlete's foot), trunk and groin area, as well as infections caused by yeast, and some fungal infections of the scalp (called lichen). . When taken orally, a significant portion of the terbinafine dose reaches the affected area, killing fungi or inhibiting their spread. What you need to know before you start taking Terbizil tablets are available only with a doctor's prescription. Follow your doctor's instructions exactly, even if they differ from what is written in this leaflet.
Contraindications
If you are allergic (hypersensitive) to terbinafine or any other part of this drug (listed in section 6). If you think you may have an allergic reaction, talk to your doctor and don't take the pills until then!
Use during pregnancy and lactation
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this drug. Your doctor will discuss the risks of terbinafine therapy with you during pregnancy. If you think you are pregnant, tell your doctor. During pregnancy, you can take terbinafine only on the recommendation of a doctor. When taking Terbizil tablets, the active substance passes into breast milk, so this drug should not be taken during breastfeeding. If necessary, a woman should stop breastfeeding. Animal studies have not demonstrated any negative effects on fertility.
Directions for use and doses
How to take Always use the drug strictly in accordance with your doctor's recommendations. If in doubt, consult your doctor or pharmacist. Do not exceed the recommended dose! If you think that the effect of Terbizil is too strong or too weak, tell your doctor or pharmacist. Recommended dose: Adults are recommended to take one tablet per day (250 mg). Duration of treatment The duration of treatment depends on the type and severity of the infection, as well as the location of the affected areas. It is recommended to take the drug for the entire treatment period prescribed by the doctor, since premature cessation of treatment may lead to relapse of the disease. Unless otherwise prescribed by a doctor, the duration of treatment is usually: In the case of a fungal infection of the skin - for the treatment of a fungal infection of the foot (athlete's foot), usually from 2 to 6 weeks - for the treatment of ringworm or candidiasis of the skin of the trunk and groin area, usually from 2 to 4 weeks. In case of infection of the scalp, the duration of treatment is about 4 weeks. In case of fungal nail infection - the duration of treatment is usually longer than for other fungal infections, usually it is from 6 to 12 weeks - in case of fungal infection of fingernails, in most cases the duration of treatment should be 6 weeks - in case of involvement of fingernails feet, the duration of treatment should be 12 weeks - in case of damage to the toenails with slow regrowth of a healthy nail, longer treatment may be required. The specific duration of treatment will be determined by your attending physician. Directions for use The tablets are swallowed without chewing and washed down with a small amount of water. The tablets can be taken regardless of meals. Taking Terbizil at the same time every day will help you adhere to your treatment regimen. Other Treatment Considerations Talk to your doctor about how to avoid re-infection. In addition to taking the tablets, you can help cure or prevent re-infection by keeping the infected area clean, changing bandages covering the infected area daily, disinfecting shoes, and wearing appropriate socks/stockings and underwear. It is also important to keep the infected area from getting wet. Use in children There are no data on the use of Terbizil tablets in children under 2 years of age (usually weighing less than 12 kg), therefore the use of Terbizil tablets in children under 2 years of age is not recommended. Unless the doctor prescribes a different dose, the standard dose for children over 2 years of age is: Children weighing less than 20 kg (usually under 5 years): since there is insufficient experience with this category of patients, use is possible only in cases where there is no other therapeutic alternative, and the benefits of using the drug outweigh the possible risks. For body weight from 20 to 40 kg (from 5 to 12 years): 1/2 tablet of Terbizil (125 mg) once a day. For body weight over 40 kg (usually over 12 years): 1 tablet of Terbizil (250 mg) once a day. Terbizil tablets can be divided into equal doses. Elderly patients (65 years and older) The dose of Terbizil for people aged 65 years and older is the same as for younger adult patients. If you take more than the prescribed amount If you take more Terbizil tablets than prescribed, contact your doctor immediately. In case of overdose, seek medical attention at your nearest hospital emergency room. Take your medication package with you. The same should be done if someone else besides you accidentally took your pills. Symptoms of overdose: headache, nausea, stomach pain and dizziness. If you forget to take it It is most practical to take the tablet at the same time every day. If you forget to take a pill and there are more than 4 hours left before taking the next pill, you can take the missed pill. If you have less than 4 hours until your next tablet is taken, take the next tablet at your usual time. Do not take a double dose to make up for a missed tablet! If you stop taking it, it is recommended to take the drug for the entire treatment period prescribed by your doctor. Premature cessation of treatment may lead to relapse of the disease. If you have any further questions about using this drug, ask your doctor or pharmacist.
Side effect
Like all medicines, Terbizil tablets can cause side effects, although not all patients get them. The following are serious side effects that are very rare or their frequency is unknown. Terbizil tablets may rarely cause liver dysfunction. In very rare cases, this disorder can be serious. Terbizil may cause severe allergic reactions (hypersensitivity), changes in the number of certain blood cells, systemic lupus erythematosus (an autoimmune disease), severe skin reactions (such as erythema multiforme and Stevens-Johnson syndrome), inflammation of the blood vessels and pancreas, and degeneration muscle tissue. Tell your doctor right away if you have any of the following symptoms: - unexplained persistent cough, stomach problems, loss of appetite, unusual tiredness and weakness (you may have liver problems); yellow skin or whites of the eyes (jaundice); sometimes dark urine or light-colored stools (you may have liver dysfunction); - current presence of infectious diseases with fever, chills, sore throat or ulcers on the oral mucosa, or an increase in the frequency of infectious diseases (you may have a disease associated with a change in the number of blood cells); - any skin reactions, for example, rash, redness of the skin, blisters on the lips, mucous membranes of the eyes or mouth, possibly fever (severe skin reactions); - unusual bruising, bleeding in the mucous membranes of the eyes or bleeding (this may be a sign of a disease associated with changes in the number of certain types of blood cells); - difficulty breathing, dizziness, swelling (mainly of the face or throat), redness of the skin, stomach cramps or loss of consciousness (can be signs of severe allergic reactions), as well as joint pain, joint stiffness, skin rash, fever and swollen lymph nodes ; - rash, fever, itching, fatigue or red spots on the skin (this may be a symptom of inflammation of the blood vessels) - severe pain in the stomach or back (this may be a symptom of inflammation of the pancreas); unexplained muscle weakness or muscle pain, or dark (red-brown) urine (symptoms of muscle degeneration). The following side effects have been reported while taking this drug: Very common side effects (occurring in more than 1 in 10 people taking the drug): Headache, nausea, mild abdominal pain, abdominal discomfort after eating, diarrhea, bloating abdominal pain (feeling of fullness), loss of appetite, skin rash, hives (including itching), joint pain and muscle pain. Common side effects (occurring in approximately 1 in 10 patients taking the drug): Mood changes (depression), distortion or loss of taste, dizziness, blurred vision and fatigue. Uncommon side effects (occurring in approximately 1 in 100 patients taking the drug): Unusual paleness of the skin, mucous membranes, or nails, unusual fatigue, weakness, or difficulty breathing during exercise (symptoms of low red blood cell count), restlessness, trembling, or numbness in the extremities with decreased skin sensitivity, increased skin sensitivity to sunlight (with skin inflammation and mild rashes), ringing in the ears, fever and weight loss. Rare side effects (occurred in approximately 1 in 1000 patients taking the drug): Yellowing of the skin and mucous membranes of the eyes (which may be symptoms of liver dysfunction), changes in biochemical indicators of liver function, inflammation of the liver, yellowing of the skin, bile stagnation, malaise. Very rare side effects (occurring in about 1 in 10,000 patients taking the drug): Decreased number of some types of blood cells, dizziness, systemic lupus erythematosus (an autoimmune disease), severe skin reactions, swelling of the face, neck and upper chest, rash , resembling a psoriasis rash (silver rash), worsening of psoriasis, rash with peeling and baldness. Side effects, the frequency of which is unknown (the frequency of their development cannot be estimated from the available data): Severe allergic reactions, inflammation of the blood vessels, impaired sense of smell, loss of smell, decreased sense of smell, blurred vision, blurred vision, impaired hearing, inflammation of the pancreas, drug rash with an increase in the content of certain types of white blood cells, degeneration of muscle tissue, flu-like symptoms (for example, fatigue, chills, sore throat, joint or muscle pain), an increase in the level of certain isoenzymes (creatine phosphokinase) in the blood.
Overdose
headache, nausea, stomach pain and dizziness.
Interaction with other drugs
If you have recently taken, are taking, or will take any other medications, including herbal products, contraceptives, and over-the-counter medications, tell your doctor or pharmacist. When taking Terbizil tablets and certain other medicines at the same time, their effects may interfere with each other, especially when taking the following medicines: - some antibiotics prescribed to treat certain infections (for example, rifampicin), - some medicines taken to treat stomach ulcers ( for example, cimetidine), - some drugs prescribed to treat fungal infections (for example, fluconazole, ketoconazole), - caffeine, - drugs that normalize heart rhythm (antiarrhythmics of groups IA, 1B and 1C, for example, propafenone and amiodarone), - drugs, those that lower blood pressure (some beta blockers, such as metoprolol), certain antitussives (such as dextromethorphan), certain drugs used to treat mental disorders (such as antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase type B, desipramine), cyclosporine and other drugs that act on the immune system (for example, used to prevent the development of transplant rejection). Food and liquid intake Terbizil can be taken on an empty stomach or after meals.
Precautionary measures
Check with your doctor or pharmacist before taking Terbizil tablets: -If you are taking other drugs (see “Interactions with other drugs”) Call your doctor if you have one of the conditions listed below before or during treatment with Terbizil: - If you suffer from any liver disease or have had it previously. - If you suffer from kidney disease. - Please note that if symptoms such as itching, recurring nausea, loss of appetite, weakness, vomiting, yellowing of the skin or whites of the eyes (jaundice), dark urine or light-colored stool, pain in the upper abdomen on the right, appear during treatment, contact your doctor immediately. If these symptoms appear, you should immediately stop taking the drug. Your doctor may order tests to evaluate your liver function tests. - If you experience skin symptoms such as a rash, redness around the eyes or swollen lips, peeling skin, fever (this may be a sign of a serious skin reaction), rash combined with an increase in the number of a certain type of white blood cell. - If you have psoriasis (thick red/silver patches on the skin), cutaneous or generalized systemic lupus erythematosus (face rash, joint and muscle pain, fever), or have similar symptoms. - If you are worried about weakness, unusual bleeding, bruising or frequent infections (these may be symptoms of a blood disorder). — If you are taking any other drugs that are listed in the “Interactions with other drugs” section. Before and during treatment with Terbizil tablets, your doctor may order regular blood tests to monitor your liver function. Deviations of results from the norm may cause discontinuation of the drug Terbizil. Children and adolescents (aged 2 to 17 years): Terbizil tablets can be prescribed to adolescents and children aged 2 years and older. There are no data on the use of Terbizil tablets in children under 2 years of age, so the use of the drug in this age group is not recommended.
Storage conditions
At temperatures from +15 °C to + 30 °C, in a place protected from light. Keep out of the reach of children.
Instructions for use of Terbizil (Method and dosage)
The duration of therapy is largely determined by the nature of the disease and its severity.
Terbizil tablets, instructions for use
In pediatrics, in the treatment of children, starting from the third year of life, a dosage of 125 mg is used, prescribed once (per day).
For adults, a dosage of 250 mg should be used; it is recommended to take this amount of Terbizil in one dose.
For onychomycosis, the duration of an effective course of treatment is from six to twelve weeks, determined by the growth rate of a healthy nail plate.
The duration of treatment may be determined by other factors: age, presence of concomitant pathology.
Terbizil is used in the treatment of dermatomycosis of the feet (plantar, interdigital or sock-type) - the treatment period is from two to six weeks; for dermatomycosis of other areas of the skin, the course of therapy lasts from two to four weeks; for head diseases of mycotic etiology - 4 weeks.
Instructions for Terbizil cream (ointment)
The cream is applied 1-2 times a day. It is necessary to clean and dry the lesions before applying Terbizil. The cream is distributed in a thin layer, covering not only the lesion, but also the adjacent areas of healthy skin.
For fungal infections accompanied by diaper rash, it is recommended to cover the cream with a bandage.
Instructions for use TERBISIL® tablets
Unlike topical treatment with Terbizil® cream, Terbizil® tablets are ineffective in treating tinea versicolor caused by Malassezia furfur. Terbizil is ineffective against vaginal candidiasis.
Terbizil® for oral administration is prescribed when it is not possible to use a dosage form for topical use (for example, localization, severity, size of the fungal lesion).
When prescribing terbinafine orally, the presence of liver disease should be taken into account. Pharmacokinetic studies in patients with liver disease have shown that the clearance of terbinafine in these patients may be reduced by 50%. Patients receiving terbinafine by mouth should be instructed to immediately report any signs or symptoms suggestive of liver dysfunction, such as persistent unexplained nausea, lack of appetite or weakness, vomiting, upper right abdominal pain, jaundice, dark urine, light feces. Patients with such symptoms should stop taking Terbizil tablets. Monitoring of liver function indicators is necessary.
Terbizil® should be used with caution in patients with psoriasis; in very rare cases, exacerbation of psoriasis is possible.
Laboratory studies have shown that terbinafine inhibits CYP2D6-mediated metabolism. Therefore, caution is required when coadministering drugs that are primarily metabolized by this enzyme (eg, tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, MAO type B inhibitors and class IC antiarrhythmics). Dosage adjustments may be required.
Impact on the ability to drive vehicles and operate machinery
There is no evidence that terbinafine affects the ability to drive vehicles.
Experimental results
In long-term studies (up to 1 year) in rats and dogs, no significant toxic effects were observed in either species up to a dose of 100 mg/kg/day. At high oral doses, the liver and possibly the kidneys have been identified as target organs.
In a two-year carcinogenicity study in mice receiving terbinafine doses of 130 (male) and 156 (female) mg/kg/day, no tumors occurred. In a 2-year oral carcinogenicity study in rats, an increase in the incidence of liver neoplasms was observed in males at the maximum dose level of 69 mg/kg/day. At this dose level, systemic exposure was close to clinical. The mechanism of tumor development or its clinical significance is unknown.
Changes that may be associated with peroxisome proliferation have shown to be species dependent as they were not observed in carcinogenicity studies in mice, dogs, or monkeys.
In a high-dose study in monkeys, retinal abnormalities were observed at the highest doses (non-toxic exposure level of 50 mg/kg). These disorders were associated with the presence of terbinafine metabolites in the ocular tissues; they disappeared after discontinuation of the drug. No histological changes were noted.
A standard battery of in vitro tests and in vitro genotoxicity tests revealed no evidence of mutagenic or clastogenic potential.
Interaction
Terbizil affects the clearance of drugs whose metabolism occurs through the cytochrome P450 (tolbutamide, cycloserine , oral contraceptives), and terbinafine can both accelerate and slow down the metabolism of these drugs.
The metabolism of Terbizil itself can be accelerated by substances that enhance the activity of microsomal enzymes of liver cells ( rifampicin ).
Drugs that inhibit the activity of the cytochrome P450 enzyme slow down the elimination of terbinafine, which requires adjustment of the dose of the latter.
Analogs
Level 4 ATX code matches:
Mikonorm
Undecin
Gentian violet
Zinkundan
Exoderil
Exiter
Batrafen
Lotseril
Lamisil Dermgel
Lamisil Uno
Lamisil
Salicylic acid
Salicylic ointment
Keto Plus
Exifin
Fungoterbin
Mycoseptin
Thermikon
Nitrofungin
Sulsena
Analogues include the following drugs: Atifan , Binafin , Lamisil , Lamikon , Lamifast , Lamifen , Mikonorm , Mikofin , Terbinafine , Terbinox , Terbinorm , Fungoterbin , Exifin .
Terbizil price, where to buy
The price of Terbizil ointment is about 350 rubles.
The price of Terbizil in tablets of 250 mg is in the range of 890-1300 rubles per pack of 14 pieces.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Terbizil cream 1% 15g JSC Gedeon Richter
RUB 301 order
Pharmacy Dialogue
- Terbizil cream (tube 1% 15g)Gedeon-Richter
RUB 288 order
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Pharmacy24
- Terbizil 1% 15g cream VAT "Gedeon Richter", Ugorshchina
157 UAH. order
PaniPharmacy
- Terbizil cream Terbizil cream 1% 15g Hungary, Gedeon Richter
164 UAH order
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Instructions for use TERBISIL
The duration of therapy is determined by the nature and severity of the disease. Irregular use or premature cessation of treatment leads to relapse of the disease.
For adults
prescribed 250 mg 1 time/day.
For onychomycosis
The duration of effective treatment is 6-12 weeks and is determined by the growth rate of a healthy nail. In some cases (with slow nail growth), the course of treatment may be longer. The duration of therapy may depend on other factors:
- the age of the patient, the presence of a concomitant disease, the condition of the nails at the beginning of the course of treatment. The optimal clinical effect is observed several months after mycological cure and cessation of therapy. This is determined by the period of time required for a healthy nail to grow back.
Recommended duration of treatment for mycoses of the feet
(interdigital, plantar or sock-type) - 2-6 weeks;
for mycosis of the trunk, legs
- 2-4 weeks;
for mycoses of the scalp
- 4 weeks (but with infection with Microsporum canis it may be longer);
for skin candidiasis
- 2-4 weeks.
It must be remembered that treatment should be long enough, because shortening the duration of therapy and/or irregular use of the drug can lead to relapse of the disease, so a control mycological study should be carried out. Clinical recovery is often observed several weeks after mycological cure.
In children over 2 years old
For
the treatment of mycoses of the scalp,
125 mg tablets are usually used.
data on the use of the drug in children under 2 years of age
(or children weighing less than 12 kg).
The drug is prescribed 1 time/day. A single dose depends on the child’s body weight.
| Body mass | Dose |
| 12 -20 kg | 62.5 mg (1/2 tablet of 125 mg) |
| 20-40 kg | 125 mg (1 tablet of 125 mg) |
| more than 40 kg | 250 mg (2 tablets of 125 mg or 1 tablet of 250 mg) |
Terbizil in the form of a cream is used 1-2 times a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied in a thin layer to the affected skin and surrounding areas and rubbed in lightly. For infections accompanied by diaper rash (under the mammary glands, in the spaces between the fingers, between the buttocks, in the groin area), the cream can be applied under a bandage. The source of infection must be removed.
Average duration of use of the cream for mycosis of the trunk and legs
- 1 Week;
for mycosis of the feet
- 1 week;
for skin candidiasis
- 1 week;
for tinea versicolor
- 2 weeks.
Clinical symptoms of mycoses, confirmed by mycological examination, usually improve within a few days after the start of use. Irregular use or premature cessation of treatment leads to relapse of the disease.
Elderly patients
Terbizil is prescribed in the same doses as for adults.
Patients with severe liver or kidney dysfunction
(CrCl < 50 ml/min or serum creatinine concentration more than 300 µmol/l), the dose of the drug should be halved.
