Terbinafine-vertex 250 mg 10 pcs. Vertex ao tablets

Compound

Terbinafine tablets contain the active substance terbinafine hydrochloride , as well as additional components: MCC, lactose monohydrate, potato starch, talc, primellose, aerosil, magnesium stearate.
Terbinafine cream contains the active component terbinafine hydrochloride , as well as additional components: benzyl alcohol, stearic acid, distilled glycerol, petrolatum, emulsifier, water, triethanolamine.

The ointment contains the active component terbinafine hydrochloride , as well as additional components: methyl parahydroxybenzoate, carbomer , petroleum jelly, polysorbate, sodium hydroxide, propylene glycol, water.

Terbinafine spray contains the active component terbinafine hydrochloride , as well as additional components: macrogol 400 , water, propylene glycol, ethyl alcohol.

Components of Terbinafine

The instructions indicate the following ingredients of the medication:

1. Tablets - presented with terbinafine hydrochloride, lactose monohydrate, potato starch, talc, aerosil, magnesium stearate, MCC;
2. Ointment - terbinafine hydrochloride, carbomer, vaseline oil, polysorbate, sodium hydroxide, water, propylene glycol, methyl parahydroxybenzoate.

Terbinafine is produced not only in ointments and tablets, but also in cream and spray. The choice of the appropriate form to combat fungal infection is the responsibility of the attending physician. External forms are used for mild lesions, oral forms for systemic infection.

pharmachologic effect

Terbinafine is a fungicidal, antifungal drug. Demonstrates activity against almost all types of fungi that can infect the human body. In small concentrations it exhibits a fungicidal effect against molds, dermatophytes, and some types of dimorphic fungi. Both fungicidal and fungistatic effects are possible on yeast fungi.

Its therapeutic effect is determined by its destructive effect on the fungal cell membrane, as well as due to the specific inhibition of squalene epoxidase (an enzyme important for the normal function of the fungal cell membrane).

Under the influence of Terbinafine, the production of ergosterol , due to the lack of which the amount of squalene in the fungal cell increases. As a result, all enzyme systems are inactivated, and the cell dies.

The active component does not affect the cytochrome P450 system, therefore, does not affect the metabolism of hormones or other drugs.

Pharmacokinetics and pharmacodynamics

When taking the medicine orally, the active substance is rapidly absorbed from the digestive tract. Its partial metabolism occurs in the liver, as a result, its bioavailability decreases to 40%. The bioavailability of the drug is only slightly affected by food intake, so there is no need to adjust the dose.

The highest concentration of the drug in the blood is observed 2 hours after the 250 mg tablet was taken. 99% of the active substance in the blood binds to plasma proteins.

The drug is noted to be onycho- and epidermotropic, that is, its largest amount (concentrations optimal for a therapeutic effect) accumulates in the hair, skin, nails, and also in the subcutaneous tissue.

In the body, terbinafine hydrochloride is biotransformed into metabolites that do not demonstrate antifungal activity. Most of them are excreted in the urine. The half-life is 17 hours.

There is no accumulation of Terbinafine when taken. Its effectiveness is the same for all patients, regardless of the person’s age. In the presence of pathological changes in the liver and kidneys, the biotransformation of the drug may slow down. As a result, its concentration in biological fluids increases and the period of circulation of the drug in the blood increases.

When using Terbinafine topically, no more than 5% of the active component enters the blood.

Indications for use

The instructions for the use of Terbinafine indicate that all forms of the drug are used for diseases that were caused by yeast-like , molds , and dermatophytes .

The drug in tablets is indicated for use in diseases of fungal origin that were caused by dermatophytes of the genus Trichophyton (T. Mentagrophytes, T. verrucosum, T. Violaceum, T. Rubrum, T. tonsurans), Microsporum canis, Epidermophyton floccosum, as well as fungi of the genus Candida. Tablets are prescribed for trichophytosis , microsporia , onychomycosis , epidermophytosis , candidiasis .

As a rule, Terbinafine tablets are prescribed for widespread and severe symptoms. At the same time, treating lichen versicolor with tablets is ineffective.

What the cream, ointment and spray are for, and whether these local remedies should be used, should be determined by a specialist.

As a rule, the cream should be used for fungal diseases caused by Candida, Microsporum canis, Trichophyton, Pityriasis, Epidermophyton floccosum fungi.

Also, ointment and cream are used for candidiasis, skin lesions caused by dermatophytes, and lichen versicolor.

Instructions

The ointment is used strictly externally. Recommended for use by adults and children over 12 years of age. Before applying the product, it is necessary to remove all contaminants from the surface of the skin and dry it. A small amount of cream is rubbed into the lesion, covering a small area beyond the edges of the inflammation. Repeat the procedure in the morning and evening.

The course of treatment depends on the degree of damage and the type of fungal infection:

• smooth skin, including areas on the back, abdomen and lower legs, require 1 week of treatment;
• foot fungus goes away within 8-9 days of using Terbinafine ointment;
• treatment of candidiasis can last up to 2 weeks;
• It also takes 10 to 14 days to get rid of tinea versicolor.

If the use of the ointment does not give the desired effect over time, or during treatment there is a clear progression of the disease, accompanied by growth of the affected area, it is necessary to contact a specialist to prescribe systemic antifungal agents or to change the treatment regimen with local agents.

Contraindications

The use of medication in tablet form is contraindicated for the following diseases and conditions:

• liver disease in chronic or active form;
• chronic renal failure (creatinine clearance less than 50 ml/min);
• the patient’s age is up to three years and his weight is up to 20 kg;
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• lactation;
• high sensitivity to the components of the product.

Caution Terbinafine tablets should be prescribed to people with chronic renal failure (with glomerular filtration more than 50 ml/min based on the Rehberg test), hematopoietic disorders, alcoholism , endocrine diseases, psoriasis , vasoconstriction of the extremities, tumors, systemic and cutaneous lupus erythematosus.

When taking Terbinafine, the condition of the liver and kidneys should be closely monitored. Terbinafine or Terbinafine Teva tablets should be discontinued immediately if the following symptoms occur:

• abdominal pain;
• nausea;
• loss of appetite;
• jaundice;
• weakness;
• darkening of urine;
• light cal.

Forms of the drug for topical use should not be used in case of hypersensitivity or allergies.

Relative contraindications to the use of such drugs are:

• tumors;
• alcoholism;
• liver and kidney failure;
• endocrine diseases;
• narrowing of the lumen of blood vessels;
• hematopoietic disorder;
• The patient's age is up to 12 years.

Terbinafine

The drug is generally well tolerated. Side effects are usually mild or moderate and transient.

When assessing the frequency of side effects, the following gradations were used: “very often” (≥ 1/10), “often” (≥1/100 <1/10), “infrequently” (≥1/1000 <1/100), “ rarely" (≥1/10000 <1/1000), "very rarely" (<1/10000), including isolated reports.

Disorders of the hematopoietic 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).

Nervous system disorders

: very often - headache; often - dizziness, disturbances in taste, up to their loss (usually recovery occurs within a few weeks after stopping treatment); infrequently - paresthesia, hypoesthesia. There are isolated reports of cases of long-term disturbances in taste. In some cases, while taking the drug, exhaustion was noted.

Mental disorders

: often - depression; infrequently - anxiety.

Visual disorders

: uncommon - visual impairment.

Hearing and labyrinth disorders

: uncommon - tinnitus.

Disorders of the liver and biliary tract

: rarely - hepatobiliary dysfunction (mainly of cholestatic nature), incl. liver failure, including very rare cases of severe liver failure (some fatal or requiring liver transplantation; in most cases where liver failure developed, the patients had serious underlying systemic diseases and the causal relationship of liver failure to terbinafine was questionable), hepatitis, jaundice, cholestasis, increased activity of liver enzymes.

Digestive system disorders

: very often - bloating, loss of appetite, dyspepsia, nausea, mild abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders

: very often - rash, urticaria, infrequently - photosensitivity reactions; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis, bullous dermatitis, psoriasis-like skin rashes or exacerbations of psoriasis, alopecia.

Musculoskeletal and connective tissue disorders

: very often - arthralgia, myalgia.

General disorders

: often - feeling tired; infrequently - increased body temperature.

Laboratory and instrumental data

: infrequently - weight loss (secondary to a disturbance in the sense of taste).

Based on spontaneous reports received during the post-registration period and literature data, the following adverse events were identified, the frequency of which, due to the inaccurate number of patients, cannot be established:

Immune system disorders

: anaphylactic reactions, serum sickness-like syndrome.

Visual disorders

: blurred vision, decreased visual acuity.

Skin and subcutaneous tissue disorders

: drug rash with eosinophilia and systemic symptoms (rash, swelling, fever, and swollen lymph nodes).

Hearing and labyrinth disorders

: hearing loss, hearing impairment.

Vascular disorders

: vasculitis.

Nervous system disorder

: loss of smell, including for a long period of time, decreased sense of smell.

Digestive system disorders

: pancreatitis.

Disorder of the musculoskeletal and connective tissue side

: rhabdomyolysis.

General disorders

: flu-like syndrome.

Blood and lymphatic system disorders

: anemia.

Laboratory and instrumental data

: increased activity of creatine phosphokinase in blood plasma.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Side effects

When taking pills, patients may experience the following side effects:

• feeling of pain and weakness in the epigastric region;
• loss of appetite;
• cholestasis;
• taste disturbance;
• allergic reactions;
• nausea;
• diarrhea;
• decreased levels of platelets and neutrophils in the blood.

When applied topically, itching, burning and hyperemia may occur in the areas where the product was applied. Allergic manifestations may develop in rare cases.

Instructions for use of Terbinafine (Method and dosage)

Terbinafine tablets, instructions for use

The duration of taking the tablets should be determined by the doctor, taking into account the severity of the disease. Children should take the product after meals, this should be done once a day. When determining a single dose of medication, it is necessary to take into account the child’s body weight.

Children weighing less than 20 kg receive 62.5 mg of the drug, children weighing from 20 to 40 kg - 125 mg, children weighing over 40 kg - 250 mg.

Adult patients receive 250 mg Terbinafine Teva or Terbinafine tablets once daily or 125 mg twice daily.

The duration of treatment depends on the disease. For tinea pedis, you need to take the tablets for 2 to 6 weeks.

For candidiasis of the skin, dermatomycosis of the extremities, trunk, legs, treatment lasts from 2 to 4 weeks.

For infections of the scalp, treatment lasts 4 weeks.

For onychomycosis, effective treatment of the disease is possible if the drug is taken for 6 to 12 weeks. Sometimes, if the patient has a reduced rate of nail growth, treatment may take longer. The effect will be observed several months after completion of the course of treatment.

Terbinafine ointment, instructions for use

Ointment or cream is applied to the affected areas 1-2 times a day. Before applying the product, you need to very thoroughly clean and dry the affected skin. Apply a thin layer of the product to the affected areas and surrounding areas and rub in lightly. If during the development of the infection the patient experiences diaper rash , these areas can be covered with gauze after applying the product. It is advisable to do this if the ointment or cream is applied at night.

The duration of treatment depends on the disease. For candidiasis of the skin, dermatomycosis of the extremities, torso, and legs, the product should be applied for 1-2 weeks.

When treating lichen versicolor – 2 weeks.

Treatment of tinea pedis lasts 2-4 weeks.

For mycosis of the nail plates, the product is applied for 3-6 months.

As a rule, clinical manifestations decrease after the first days of using the medicine. It should be borne in mind that if the product is not applied regularly or therapy is stopped prematurely, the infection may recur. Provided that after two weeks of regular use of Terbinafine the manifestations of the disease do not decrease, you should consult a doctor and clarify the diagnosis.

The spray is used externally, it should be used 1-2 times a day.

Terbinafine tablets

Registration number: R No. LSR-008787/10

Trade name of the drug: Terbinafine-MFF.

International nonproprietary name: Terbinafine.

Dosage form: Tablets.

Composition per tablet: Active substance:

• Terbinafine hydrochloride 281 mg (corresponding to 250 mg terbinafine base).

Excipients (to obtain a tablet weighing 0.390 g):

• Colloidal silicon dioxide – 2 mg
• Calcium stearate monohydrate (calcium stearate 1-water) – 2 mg
• Potato starch - 29 mg
• Microcrystalline cellulose (MCC-200) – 47 mg
• Lactose monohydrate – 8 mg
• Crospovidone (polyplasdone XL-10) – 8 mg
• Crospovidone (polyplasdon XL) – 8 mg
• Povidone K 90 (plasdon K-90) - 5 mg

Description: Tablets are white or almost white, with a slight specific odor, flat-cylindrical in shape with a chamfer and a score.

Pharmacotherapeutic group: Antifungal agent.

ATX code: D01BA02

Pharmacodynamics: Terbinafine belongs to the group of allylamines and has a wide spectrum of antifungal action. In low concentrations it has a fungicidal effect on dermatophytes Trichophyton spp. (T. rubrum, T. mentagrophytes, Ttonsurans, T. verrucosum, Tviolaceum), Microsporum canis, Epidermophyton floccosum, molds (for example, Scopulariopsis brevicaulis), yeasts, mainly Candida albicans. For fungi Candida spp. and their mycelial forms have a fungicidal or fungistatic effect, depending on the type of fungus. Terbinafine disrupts the early stage of biosynthesis of the main component of the fungal cell membrane (ergosterol) by inhibiting the enzyme squalene epoxidase. When administered orally, it is not effective in the treatment of pityriasis versicolor caused by Pityrosporum ovale, Pityrosporum orbiculare (Malassezia furfur).

Pharmacokinetics: When taken orally, more than 70% is well absorbed; absolute bioavailability due to the “first pass” effect is reduced by 40%. After a single oral dose of 250 mg, the time to reach maximum concentration (TCmax) is about 2 hours; maximum concentration (dmax) - 1 μg/ml. The area under the curve of the infection localization is 2 - 6 weeks; for mycoses of other parts of the body, legs or torso: 2 - 4 weeks; for mycoses caused by fungi of the genus Candida: 2 - 4 weeks; for mycoses of the scalp caused by fungi of the genus Microsporum: more than 4 weeks.

Children: With body weight from 20 to 40 kg: 125 mg 1 time per day. For body weight more than 40 kg: 250 mg once a day. The duration of treatment for mycoses of the scalp is about 4 weeks; for infection with Microsporum canis it can be longer.

Elderly patients are prescribed the drug in the same doses as adults. For patients with hepatic and renal insufficiency, terbinafine is prescribed at a dose of 125 mg once a day.

Side effect:

• Dyspeptic disorders (decreased appetite, nausea, diarrhea, feeling of fullness in the stomach, abdominal pain)
• Allergic skin reactions (urticaria, rash)
• Musculoskeletal reactions (arthralgia, myalgia), aggravation of systemic lupus erythematosus

Disorders of taste, including their loss (recovery occurs within several weeks after cessation of treatment).

Rarely (with a frequency of 0.01 - 0.1%) a hepatotoxic effect is observed (increased activity of “liver” transaminases, liver failure). Malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), psoriasis-like skin rashes, exacerbation of psoriasis, anaphylactoid reactions, agranulocytosis or thrombocytopenia, neutropenia, lymphopenia.

Overdose: Symptoms: Nausea, vomiting, headache, dizziness, pain in the lower abdomen, in the epigastric region, frequent urination.

Treatment: Gastric lavage followed by the use of activated charcoal and/or symptomatic therapy.

Interaction with other drugs: Inhibits the CYP2D6 isoenzyme and disrupts the metabolism of drugs such as tricyclic antidepressants and selective serotonin reuptake inhibitors (for example, desipramine, fluvoxamine), beta-blockers (metoprolol, propranolol), antiarrhythmics (flecainide, propafenone), inhibitors monoamine oxidase B (eg, selegiline) and antipsychotic (eg, chlorpromazine, haloperidol) agents. Drugs that induce cytochrome P450 isoenzymes (for example, rifampicin) can accelerate the metabolism and elimination of terbinafine from the body. Drugs that inhibit cytochrome P450 isoenzymes (for example, cimetidine) can slow down the metabolism and elimination of terbinafine from the body. If these drugs are used concomitantly, a dose adjustment of terbinafine may be required. Menstrual irregularities are possible when taking terbinafine and oral contraceptives simultaneously. Terbinafine reduces the clearance of caffeine by 21% and prolongs its half-life by 31%. Does not affect the clearance of phenazone, digoxin, warfarin. When used together with ethanol or drugs that have hepatoxic effects, there is a risk of developing drug-induced liver damage.

Special instructions: Irregular use of terbinafine or premature cessation of treatment may lead to relapse of the disease. The duration of therapy can be influenced by factors such as the presence of concomitant diseases, the condition of the nails with onychomycosis at the beginning of the course of treatment. If after 2 weeks of treatment of a skin infection there is no improvement in the condition, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug. Systemic use for onychomycosis is justified only in the case of total damage to most nails, the presence of severe subungual hyperkeratosis, and the ineffectiveness of previous local therapy. When treating onychomycosis, a laboratory-confirmed clinical response is usually observed several months after mycological cure and cessation of treatment, which is due to the rate of regrowth of a healthy nail. Removal of nail plates is not required when treating onychomycosis of the hands for 3 weeks and onychomycosis of the feet for 6 weeks. In the presence of liver disease, the clearance of terbinafine may be reduced. During treatment, it is necessary to monitor the activity of “liver” transaminases in the blood serum. In rare cases, cholestasis and hepatitis occur after 3 months of treatment. If signs of liver dysfunction occur (weakness, persistent nausea, decreased appetite, excessive abdominal pain, jaundice, dark urine or discolored stools), the drug should be discontinued. Prescribing terbinafine to patients with psoriasis requires caution, because in very rare cases, terbinafine can cause an exacerbation of psoriasis. When treating with terbinafine, general hygiene rules should be observed to prevent the possibility of re-infection through underwear and shoes. During treatment (after 2 weeks) and at the end it is necessary to carry out antifungal treatment of shoes, socks and stockings.

Release form: Tablets 250 mg. 10 or 14 tablets in a blister pack made of polyvinyl chloride film and aluminum foil with thermovarnish. One or two blister packs along with instructions for use are placed in a cardboard pack.

Shelf life: 2 years. Do not use after expiration date.

Storage conditions: In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Conditions for dispensing from pharmacies: By prescription.

Overdose

If an overdose of Terbinafine in tablet form occurs, the patient may experience a rash , nausea , headache , vomiting , dizziness , epigastric pain, and frequent urination. It is important to perform gastric lavage; they also practice taking activated carbon and symptomatic treatment.

There is no data on an overdose of the drug in the form of external agents. If accidentally ingested as an ointment or cream, nausea, headache, dizziness, and epigastric pain may occur. In this case, symptomatic treatment is carried out; the use of activated carbon is indicated.

Composition of Terbinafine ointment

The main component is terbinafine hydrochloride. In one tube it is contained in the amount of 1g per 100g of composition. As additional substances, it contains rare cross-linked polyacrylic acid in the amount of 1.5 g, as well as 10 g of propylene glycol, 5 g of petroleum jelly, 0.4 g of sodium hydroxide. A large share of the volume is purified water - here it is 81g.

Terbinafine is available both as an ointment and as a gel or cream. The product for topical use is packaged in aluminum tubes, which are placed in cardboard packages, 1 piece each.

Interaction

When using Terbinafine, there may be an effect on the clearance of drugs whose metabolism involves the cytochrome P450 . These are Tolbutamide , Cyclosporine , oral contraceptives .

Increases the concentration of H2-histamine blockers in the blood plasma.

Slows down the excretion of Rifampicin , in turn, Rifampicin doubles its clearance.

Women who use oral contraceptives may experience menstrual irregularities.

Terfenadine inhibits the CYP2P6 isoenzyme, which leads to an obstruction of the metabolism of tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, antiarrhythmic drugs, type B monoamine oxidase inhibitors, and antipsychotic drugs.

Under the influence of Terbinafine, the clearance of caffeine decreases by 21%, while its half-life increases by 31%.

Has no effect on the clearance of Digoxin , Phenazone , Warfarin .

When taken simultaneously with ethanol or with drugs that have a hepatotoxic effect, the likelihood of drug-induced liver damage increases.

Interaction with other drugs

Combination with foreign drugs provokes:

• influence on the clearance of drugs - Cyclosporine, oral contraceptives, Tolbutamide;
• increased concentration of histamine blockers in the blood;
• slowing down the excretion of Rifampicin;
• changes in the menstrual cycle - when combined with oral contraceptives.

Drug-induced liver damage occurs when taken with hepatotoxic drugs or ethanol.

special instructions

When treating onychomycosis for six weeks, it is not necessary to remove the affected nail plates.

It is important to consider that if the medication is not used regularly and its use is stopped prematurely, a relapse of the disease may occur.

The duration of treatment with Terbinafine may be affected by the presence of other diseases in the patient.

Systemic use of the drug in patients with onychomycosis is advisable only in cases of total damage to most nails, in the presence of subungual hyperkeratosis , and also in the absence of effect after local treatment.

People with liver disease may have reduced clearance of terbinafine.

During treatment, liver transaminase activity in the blood should be monitored.

Hepatitis and cholestasis may occur three months after starting treatment, but this occurs only in rare cases. If the patient develops signs indicating liver dysfunction, the medication is discontinued.

The drug should be prescribed with caution to patients suffering from psoriasis , as the medicine can provoke an exacerbation of this disease.

It is necessary to carefully observe all the rules of personal hygiene during the treatment process to prevent re-infection. After completion of treatment and during its process (two weeks after the start), you need to practice antifungal treatment of socks, stockings, and shoes.

Irritation can be caused by Terbinafine cream or ointment, which is why you should not allow these products to come into contact with your eyes. If the product gets into your eyes, rinse them immediately with clean water. If symptoms of irritation persist, you should consult your doctor.

In case of allergic manifestations, the medicine is discontinued.

Terbinafine-vertex 250 mg 10 pcs. Vertex ao tablets

pharmachologic effect

Terbinafine is an allylamine that has a broad spectrum of activity against fungi that cause diseases of the skin, hair and nails, including dermatophytes.
At low concentrations it has a fungicidal effect on dermatophytes Trychophyton spp. (T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum canis, Epidermophyton floccosum, molds (for example, Aspergillus, Cladosporium, Scopulariopsis brevicaulis), yeasts, mainly Candida albicans. In low concentrations, terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic. Terbinafine specifically inhibits the early stage of sterol biosynthesis in the fungal cell. This leads to ergosterol deficiency and intracellular accumulation of squalene, which causes the death of the fungal cell. Terbinafine works by inhibiting the enzyme squalene epoxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not affect the metabolism of hormones or other drugs.

When Terbinafine is taken orally, concentrations of the drug are created in the skin, hair and nails, providing a fungicidal effect.

When administered orally, it is not effective in the treatment of pityriasis versicolor caused by Pityrosporum ovale, Pityrosporum orbiculare (Malassezia furfur).

Composition and release form Terbinafine-vertex 250 mg 10 pcs. Vertex ao tablets

Tablets - 1 tablet:

• Active ingredients: terbinafine (in the form of hydrochloride) - 250 mg;
• Excipients: microcrystalline cellulose 0.08 g, hyprolose (hydroxypropylcellulose) 0.025 g, croscarmellose sodium 0.08 g, colloidal silicon dioxide 0.01 g, calcium stearate 0.005 g, lactose monohydrate to obtain a tablet weighing 0.5 g.

Description of the dosage form

Tablets of white or white with a yellowish tint with a chamfer and a score.

Directions for use and doses

For adults:

Inside, after eating. Usual dose: 250 mg 1 time per day.

Children over 3 years old:

For body weight from 20 to 40 kg - 125 mg 1 time per day.

For body weight more than 40 kg - 250 mg 1 time per day.

The duration of the course of treatment and dosage regimen are established individually and depend on the localization of the process and the severity of the disease.

Onychomycosis: duration of therapy is on average 6-12 weeks. If the nails of the fingers and toes are affected (with the exception of the big toe), or if the patient is young, the duration of treatment may be less than 12 weeks. For a big toe infection, a 3-month course of treatment is usually sufficient.

Some patients whose nail growth rate is reduced may require a longer treatment period.

Fungal skin infections: the duration of treatment for interdigital, plantar or “sock” localization of infection is 2-6 weeks; for mycoses of other parts of the body: legs - 2-4 weeks, torso - 2-4 weeks; for mycoses caused by fungi of the genus Candida - 2-4 weeks; for mycoses of the scalp caused by fungi of the genus Microsporum - more than 4 weeks.

The duration of treatment for mycoses of the scalp is about 4 weeks; for infection with Microsporum canis, it may be longer.

Elderly patients are prescribed the drug in the same doses as adults.

For patients with liver or kidney failure - 125 mg 1 time per day.

Pharmacokinetics

After a single oral dose of terbinafine at a dose of 250 mg, its Cmax in plasma is reached after 2 hours and is 0.97 mcg/ml. The half-life of absorption is 0.8 hours, the half-life of distribution is 4.6 hours. Communication with blood plasma proteins - 99%. When taken simultaneously with food, no dose adjustment is required.

Terbinafine quickly penetrates the skin and accumulates in the sebaceous glands. High concentrations are created in the hair follicles and hair; after a few weeks of use it penetrates into the nail plates. Accumulates in the stratum corneum of the skin (the concentration increases 10 times on day 2 after taking 250 mg, 70 times on day 12) and nails (the diffusion rate exceeds the rate of nail growth) in concentrations that provide a fungicidal effect.

Terbinafine is metabolized in the liver to form inactive metabolites. T1/2 is 16-18 hours. T1/2 of the terminal phase is 200-400 hours. It is excreted mainly by the kidneys (70%) in the form of metabolites, as well as through the skin. There is no evidence of drug accumulation in the body. Excreted in breast milk. There have been no changes in steady-state plasma concentrations of terbinafine with age, but patients with impaired renal or hepatic function may have a slower rate of elimination of the drug, resulting in higher blood concentrations of terbinafine.

Indications for use Terbinafine-vertex 250 mg 10 pcs. Vertex ao tablets

• fungal diseases of the skin and nails (onychomycosis) caused by Trychophyton spp. (T. rubrum, T. mentagrophytes, T.
• verrucosum, T. tonsurans, T. violacium), Microsporum spp. (M. canis, M. gypseum) and Epidermophyton floccosum;
• mycoses of the scalp (trichophytia, microsporia);
• severe, widespread dermatomycosis of smooth skin of the trunk and extremities, requiring systemic treatment;
• candidiasis of the skin and mucous membranes.

Contraindications

• chronic or active liver disease;
• chronic renal failure (creatinine clearance less than 50 ml/min);
• children's age (up to 3 years) and with a body weight of up to 20 kg (for this dosage form);
• lactation period;
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• hypersensitivity to terbinafine or other components of the drug.

Caution should be used when:

• renal failure (with CC more than 50 ml/min);
• alcoholism;
• inhibition of bone marrow hematopoiesis;
• tumors;
• metabolic diseases;
• occlusive diseases of the vessels of the extremities;
• cutaneous lupus erythematosus or systemic lupus erythematosus.

Application Terbinafine-vertex 250 mg 10 pcs. Vertex AO tablets during pregnancy and breastfeeding

Since no studies have been conducted on the safety of Terbinafine in pregnant women, the drug should not be prescribed during pregnancy. Terbinafine is excreted in breast milk, so its use is contraindicated during breastfeeding. Contraindicated in children under 3 years of age and weighing up to 20 kg.

special instructions

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

The duration of therapy can be influenced by factors such as the presence of concomitant diseases, the condition of the nails with onychomycosis at the beginning of the course of treatment.

If after 2 weeks of treatment of a skin infection there is no improvement in the condition, it is necessary to re-determine the causative agent of the disease and its sensitivity to the drug.

Systemic use for onychomycosis is justified only in the case of total damage to most nails, the presence of severe subungual hyperkeratosis, and the ineffectiveness of previous local therapy.

When treating onychomycosis, a laboratory-confirmed clinical response is usually observed several months after mycological cure and cessation of treatment, which is due to the rate of regrowth of a healthy nail.

Removal of nail plates is not required when treating onychomycosis of the hands for 3 weeks and onychomycosis of the feet for 6 weeks.

In the presence of liver disease, the clearance of terbinafine may be reduced. During treatment, it is necessary to monitor the activity of “liver” transaminases in the blood serum.

In rare cases, cholestasis and hepatitis occur after 3 months of treatment. If signs of liver dysfunction occur (weakness, persistent nausea, decreased appetite, excessive abdominal pain, jaundice, dark urine or discolored stools), the drug should be discontinued.

Prescribing terbinafine to patients with psoriasis requires caution, because in very rare cases, terbinafine can cause an exacerbation of psoriasis.

When treating with terbinafine, general hygiene rules should be observed to prevent the possibility of re-infection through underwear and shoes. During treatment (after 2 weeks) and at the end it is necessary to carry out antifungal treatment of shoes, socks and stockings.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of Terbinafine on the ability to drive vehicles and machines.

Overdose

Symptoms: headache, dizziness, nausea, vomiting, epigastric pain, frequent urination, rash.

Treatment: measures to eliminate the drug (gastric lavage, taking activated charcoal); if necessary, symptomatic maintenance therapy.

Side effects Terbinafine-vertex 250 mg 10 pcs. Vertex ao tablets

Frequency: very often - more than 1/10, often - more than 1/100 and less than 1/10, infrequently - more than 1/1000 and less than 1/100, rarely - more than 1/10000 and less than 1/1000, very rarely - less 1/10000, including individual cases.

From the digestive system: very often - a feeling of fullness in the stomach, loss of appetite, dyspepsia, nausea, abdominal pain, diarrhea; rarely - liver dysfunction; very rarely - liver failure, even death.

From the hematopoietic organs: very rarely - neutropenia, agranulocytosis, thrombocytopenia, pancytopenia.

Allergic reactions: very rarely - anaphylactoid reactions (including angioedema).

From the nervous system: often - headache; Uncommon: taste disturbance, including ageusia.

From the skin: very often - skin reactions (including rash, urticaria); very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, psoriasis-like rash, exacerbation of existing psoriasis, alopecia.

From the musculoskeletal system: very often - arthralgia, myalgia.

Other: very rarely - fatigue; cutaneous lupus erythematosus, SLE or their exacerbation.

Drug interactions

Inhibits the CYP2D6 isoenzyme and disrupts the metabolism of drugs such as tricyclic antidepressants and selective serotonin reuptake inhibitors (for example, desipramine, fluvoxamine), beta-blockers (metoprolol, propranolol), antiarrhythmics (flecainide, propafenone), monoamine oxidase B inhibitors (for example, selegiline ) and antipsychotic (eg, chlorpromazine, haloperidol) agents.

Drugs that induce cytochrome P450 isoenzymes (for example, rifampicin) can accelerate the metabolism and elimination of terbinafine from the body. Medicines that are inhibitors of cytochrome P450 isoenzymes (for example, cimetidine) can slow down the metabolism and elimination of terbinafine from the body. If these drugs are used concomitantly, a dose adjustment of terbinafine may be required.

Menstrual irregularities are possible when taking terbinafine and oral contraceptives simultaneously. Terbinafine reduces the clearance of caffeine by 21% and prolongs its half-life by 31%. Does not affect the clearance of phenazone, digoxin, warfarin.

When used together with ethanol or drugs that have hepatotoxic effects, there is a risk of developing drug-induced liver damage.

Analogs

Level 4 ATX code matches:
Atifin

Binafin

Lamican

Griseofulvin

Analogues in tablets are the drugs Lamican , Onychon , Terbizil , Binafin , Exifin , Myconorm , Terbinafine hydrochloride , etc.

Analogues of Terbinafine for external use are the drugs Termicon , Lamisil Uno , Terbinox , Terbizil , Mikonorm , Lamitel , Terbinafine-MFF , etc.

Reviews of Terbinafine

Both reviews of Terbinafine tablets and reviews of cream and ointment appear online in most cases, positive. Patients write about the quick effect after starting to take Terbinafine and Terbinafine Teva tablets. With their help, it was possible to get rid of fungal diseases and restore the structure of the nails.

Those who have used Terbinafine ointment also leave positive reviews, noting that the product is inexpensive, but at the same time it allows you to completely cure fungal diseases and get rid of diaper rash in a few weeks. However, side effects develop very rarely.

Terbinafine cream - instructions

Unlike ointment, cream does not penetrate so deeply into the skin. Part of the applied layer is often rubbed off on clothing and surfaces with which the affected area of ​​the body comes into contact. Therefore, the use of cream can be increased up to 3 times a day.

The advantage of the cream is its effectiveness even on moderately wet surfaces, which is especially important for fungal skin infections. If it is not possible to dry the surface due to the constant release of liquid, it is better to buy a cream, since the ointment in this case will be ineffective.

Terbinafine price, where to buy

The price of Terbinafine in tablets is from 210 rubles for 10 pieces. Terbinafine Teva tablets can be bought for an average of 130 rubles. (pack of 7 pcs.). The average price of Terbinafine cream is 80 rubles. per pack 15 g. The price of Terbinafine spray is from 300 rubles. for 30 ml.

Price of Terbinafine ointment in UAH. (Ukraine) – from 100 UAH. You can purchase the product in Dnepropetrovsk and other cities by order.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• Terbinafine cream 1% 15g VertexVertex AO RUB
  147 order
• Terbinafine cream 1% 30gVertex AO

  260 rub. order

• Terbinafine-vertex tab. 250 mg 10 pcs. Vertex AO

  RUB 332 order

• Terbinafine-vertex tab. 250 mg 30 pcs. Vertex JSC

  RUR 716 order

• Terbinafine Canon tablets 250 mg 10 pcs. JSC Canonpharma Production

  RUB 161 order

Pharmacy Dialogue

• Terbinafine tablets 250 mg No. 10Vertex

  RUB 298 order

• Terbinafine-Canon tablets 250 mg No. 14Canonpharma Production

  RUB 246 order

• Terbinafine (cream 15g)Vertex

  119 RUR order

• Terbinafine-Canon (tab. 250 mg No. 14)Canonpharma Production

  RUB 252 order

• Terbinafine-Teva (250 mg tablet No. 28) Teva

  RUR 711 order

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Pharmacy24

• Terbinafine-KV 250 mg No. 14 tablets PAT "Kiev Vitamin Plant", Kiev, Ukraine
  80 UAH. order