Terbinafine description. Terbinafine tablets: composition, interaction with other drugs and side effects

In this article, you can read the instructions for using the drug Terbinafine. Reviews of site visitors - consumers are presented this medicine, as well as the opinions of medical specialists on the use of Terbinafine in their practice. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Terbinafine analogues in the presence of existing structural analogues. Use for the treatment of skin and nail fungus in adults, children, as well as during pregnancy and lactation. The composition of the drug.

Terbinafine- is an allylamine, which has a wide spectrum of action against fungi, disease-causing 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 (e.g. Aspergillus, Cladosporium, Scopulariopsis brevicaulis), yeasts, mainly Candida albicans. At 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 a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out 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.

At oral administration not effective in the treatment of versicolor caused by Pityrosporum ovale, Pityrosporum orbiculare (Malassezia furfur).

Compound

Terbinafine hydrochloride + excipients.

Pharmacokinetics

When taken simultaneously with food, dose adjustment of the drug is not required. Terbinafine rapidly penetrates the skin and accumulates in sebaceous glands. High concentrations are created in the hair follicles and hair, after a few weeks of use it penetrates into the nail plates. It 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 (diffusion rate exceeds the growth rate of the nail) at concentrations that provide a fungicidal effect. Terbinafine is metabolized in the liver to inactive metabolites. Excreted mainly by the kidneys (70%) as metabolites, as well as through the skin. There is no evidence of accumulation of the drug in the body. Stands out from breast milk. There were no changes in the steady state plasma concentration of terbinafine depending on age, but in patients with impaired renal or hepatic function, there may be a slow rate of elimination of the drug, which leads to higher blood concentrations of terbinafine.

When applied topically, absorption is 5%, it has a slight systemic effect.

Indications

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;
mycosis of the scalp (trichophytosis, microsporia);
severe, widespread dermatomycosis of the smooth skin of the trunk and extremities, requiring systemic treatment;
Pityriasis versicolor, caused by Pityrosporum orbiculare (also known as Malassezia furfur).
candidiasis of the skin and mucous membranes.

Release forms

Cream for external use 1% (sometimes mistakenly called an ointment or gel).

Tablets 125 mg and 250 mg.

Spray for external use 1% (under the brand name Fungoterbin).

Instructions for use and method of use

Tablets

Adults

Inside, after eating. Usual dose: 250 mg once a day.

Children over 3 years old

With a body weight of 20 to 40 kg - 125 mg 1 time per day.

With a body weight of more than 40 kg - 250 mg 1 time per day.

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

Onychomycosis: The duration of therapy is on average 6-12 weeks. If the nails of the fingers and toes are affected (with the exception of thumb feet), or at a young age of the patient, 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 with reduced nail growth may require a longer treatment period.

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

The duration of treatment of fungal infections of the scalp is about 4 weeks, in case of infection with Microsporum canis, it can be longer.

For elderly patients, the drug is prescribed in the same doses as for adults.

Patients with hepatic or kidney failure- 125 mg 1 time per day.

Cream

Adults and children from 12 years old

Before applying the cream, clean and dry the affected areas. The cream is applied once or twice a day with a thin layer on the affected skin and adjacent areas and lightly rubbed. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region), the places where the cream is applied can be covered with gauze, especially at night. With extensive fungal infections of the body, it is recommended to use the cream in tubes of 30 g.

The average duration of treatment: ringworm of the trunk, legs - 1 week 1 time per day; tinea pedis - 1 week 1 time per day; skin candidiasis - 1-2 weeks 1 or 2 times a day; versicolor versicolor: 2 weeks 1 or 2 times a day.

Decrease in severity clinical manifestations usually observed in the first days of treatment. In case of irregular treatment or its premature termination, there is a risk of recurrence of the infection. If after one to two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

The dosage regimen of the drug in the elderly does not differ from that described above.

Side effect

feeling of fullness in the stomach;
loss of appetite;
dyspepsia;
nausea;
diarrhea;
neutropenia, agranulocytosis, thrombocytopenia, pancytopenia;
anaphylactoid reactions (including angioedema);
headache;
taste disorder;
skin reactions (including rash, urticaria);
Stevens-Johnson syndrome;
toxic epidermal necrolysis;
psoriasis-like rash;
exacerbation of existing psoriasis;
alopecia;
arthralgia;
myalgia;
fatigue;
cutaneous lupus erythematosus, SLE or their exacerbation.

Contraindications

chronic or active liver disease;
chronic renal failure (CC less than 50 ml / min);
childhood(up to 3 years) and with a body weight of up to 20 kg (for this tablet) and up to 12 years for the cream;
lactation period;
lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
hypersensitivity to terbinafine or other components of the drug.

Use during pregnancy and lactation

Since studies on the safety of Terbinafine in pregnant women have not been conducted, the drug should not be administered during pregnancy.

Terbinafine is excreted in breast milk, so its administration is contraindicated during breastfeeding.

Use in children

Contraindicated in children under 3 years of age and weighing up to 20 kg for tablets and children under 12 years of age for cream.

special instructions

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

The duration of therapy can also 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 in onychomycosis is justified only in the case of total damage to most nails, the presence of pronounced subungual hyperkeratosis, and the ineffectiveness of previous local therapy.

In the treatment of onychomycosis, a laboratory-confirmed clinical response is usually observed a few months after mycological cure and discontinuation of treatment, which is due to the rate of growth of a healthy nail.

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

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

The appointment of terbinafine in patients with psoriasis requires caution, because. in very rare cases, terbinafine can provoke an exacerbation of psoriasis.

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

Influence on the ability to drive vehicles and control mechanisms

There is no data on the effect of Terbinafine on the ability to manage vehicles and mechanisms.

drug interaction

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

Medications-inducers of cytochrome P450 isoenzymes (for example, rifampicin) can accelerate the metabolism and excretion of terbinafine from the body. Drugs - inhibitors of cytochrome P450 isoenzymes (for example, cimetidine) can slow down the metabolism and excretion of terbinafine from the body. With the simultaneous use of these drugs, dose adjustment of terbinafine may be required.

Possible violation menstrual cycle while taking terbinafine and oral contraceptives.

Terbinafine reduces caffeine clearance by 21% and prolongs its half-life by 31%. Does not affect the clearance of phenazone, digoxin, warfarin.

When combined with ethanol (alcohol) or drugs that have a hepatotoxic effect, there is a risk of developing drug-induced liver damage.

Analogues of the drug Terbinafine

Structural analogues for the active substance:

Atifin;
Binafin;
Lamisil;
Lamisil Dermgel;
Lamisil Uno;
Lamikan;
Lamitel;
Mikonorm;
Mycoterbin;
Onikhon;
Tebikur;
Thurbized Agio;
Terbizil;
Terbix;
Terbinafine Geksal;
Terbinafine Pfizer;
Terbinafine MFF;
Terbinafine Sar;
Terbinafine Teva;
Terbinafine hydrochloride;
Terbinox;
Terbifin;
Thermikon;
Tigal sanovel;
Ungusan;
Fungoterbin;
Tsidokan;
Exiter;
Exifin.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Content

Common areas, household items, handshakes carry the risk of contracting a fungal infection. The immune system cannot always cope with the introduced pathogens on its own. The right decision is the extermination of infection with Terbinafine - antifungal drug for external or systemic treatment.

Composition and form of release

Many types of fungi living on the surface of the skin and inside the body led to the creation of several dosage forms of the drug. Tablets, cream (ointment) and spray have a different composition and form of release:

Tablets white-yellowish or white color, are packaged in 10 or 7 pieces in cellular, contour packs, which are placed in cardboard packages of 1,2,3,4,5 or 10 units.
Cream or ointment 1%, intended for external use, white-yellowish or white (sometimes a cream shade is present), with a slight odor, uniform consistency. The cream is presented in aluminum tubes of 10, 15 and 30 g, which are placed in cardboard packaging.
Spray (solution) is a clear, yellowish or colorless liquid. It goes on sale in glass bottles of 20 and 10 mg, which are equipped with a spray nozzle and a cap. The solution can be sold without a sprayer.

Each form contains an identical active ingredient - terbinafine hydrochloride. The composition of auxiliary components is indicated in the instructions:

	Weight, mg for tablets	Weight, mg for cream (ointment)	Weight, mg for spray (solution)
Terbinafine
Auxiliary components:	croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose, colloidal silicon dioxide, calcium stearate, lactose monohydrate	cetyl palmitate, sodium hydroxide, benzyl alcohol, polysorbate 60, sorbitan monostearate, cetyl alcohol, isopropyl myristate, purified water	macrogol-400, povidone-K17, propylene glycol, ethanol 95%, macrogol glyceryl hydroxystearate, purified water

Pharmacodynamics and pharmacokinetics

Instructions for use Terbinafine includes basic information about the action and properties of the drug. An antifungal medicine is designed for topical or oral use. Small concentrations of the active substance exhibit a fungicidal or fungistatic effect against Trychophyton rubrum, mentagrophytes, verrucosum, violaceum, tonsurans, Microsporum canis, Epidermophyton floccosum, Candida albicans, Pityrosporum orbiculare, pedis trichophyton.

The agent changes the early stage of sterol synthesis in fungal cells, which leads to a deficiency of squalene epoxidase, ergosterol and intracellular accumulation of squalene. This leads to the death of the pathogen. The drug does not affect the system of cytochrome isoenzymes, the metabolism of hormones or other drugs. When ingested, the substance accumulates in the skin, nails and hair. Oral use of the drug is powerless with multi-colored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur.

Terbinafine reaches its maximum plasma concentration two hours after oral administration, when applied topically it is absorbed by 5% without affecting the systemic circulation. The substance binds to plasma proteins by 99%, is metabolized in the liver. The half-life is 17 hours, the terminal phase is 300 hours. The remainder of the dose is excreted by the kidneys and through the skin. The drug is excreted in breast milk.

Indications for use

The use of one or the other dosage form Terbinafine is indicated in the presence of a fungal infection. The use of tablets, spray and cream has both general indications, and individual, specified in the instructions:

tablets, cream (ointment), spray: prevention and treatment of infection with fungi (mycosis of the skin of the body and feet, inguinal epidermophytosis);
tablets: severe dermatomycosis of the smooth epidermis of the body, which requires systemic treatment; mycosis of the scalp (trichophytosis and microsporia), onychomycosis (mycosis of the nails);
cream and tablets: infection of the skin with yeast microorganisms of the genus Candida, candidiasis of the mucous epithelium (tablets), skin diaper rash (cream);
spray and cream: ringworm versicolor caused by dermatophytes.

Method of application and dosage

The manufacturer provides instructions for use for each form of the drug. The treatment regimen should be developed by a dermatologist, who takes into account the results of the tests and the degree of the disease. A common mistake of patients is to refuse to continue treatment in case of disappearance visible symptoms infections. This leads to a relapse of the disease. Therefore, it is very important to complete the course of therapy completely.

Ointment Terbinafine

The application of the ointment is carried out both directly on the areas of the skin infected with microorganisms, and on the areas adjacent to them. Before the procedure, it is required to dry and clean the affected surface in order for the treatment to be as effective as possible. With dermatomycosis of the body, feet and legs, the ointment is applied once a day, the duration is 7 days. With multi-colored lichen, a daily double use of the remedy is prescribed for two weeks. According to the instructions, skin candidiasis is treated for 7 days, with application once a day.

Cream

Before applying the cream, it is necessary to dry and clean the areas of the skin affected by the fungus. The agent is applied in a thin layer to the affected area and adjacent areas. If a feature of the disease is the presence of diaper rash (in the groin, between the fingers, between the buttocks, under the breast), then it is recommended to cover (especially at night) the surface treated with cream with gauze.

Terbinafine tablets

The standard instruction for the use of tablets provides for taking the drug orally, once a day, after meals, in the following dosages: children from 3 years old, weighing 20-40 kg - 125 mg; children weighing more than 40 kg, as well as adult patients - 250 mg. The duration of therapy is determined by the doctor after assessing the severity of the infection. Worked out next dates treatment depending on individual circumstances:

When diagnosing onychomycosis, treatment should continue for 6-12 weeks. In case of infection of the nails of the hands and feet (except for the big toes) or in young patients, shorter periods are prescribed. The destruction of the infection that struck the big toe lasts at least three months.
With fungal skin lesions, therapy continues for 2-4 weeks (sometimes more).
Treatment of interdigital, plantar infection lasts 2-6 weeks.
Infection of the surface of the trunk and legs - 2-4 weeks.
Candidiasis 2-4 weeks.
Mycoses of the scalp - more than 4 weeks.

Spray Terbinafine

According to the instructions, Terbinafine spray from nail fungus is applied externally. It can be used on the nail plates or skin 1-2 times a day for 1-2 weeks (this time is enough to eliminate the pronounced signs of a fungal disease). The spray is sprayed onto the affected skin with healthy areas affected, not rubbed in, left until completely absorbed.

Solution

For exclusively external use, a solution is intended that copes with fungal diseases of the skin, nails and hair. According to the instructions, they treat the affected skin if the area of damage is extensive. The surface of the integument is irrigated with a solution, rubbed lightly, the procedure is repeated 1-2 times a day, the course of treatment lasts until the symptoms of the disease disappear completely.

special instructions

Using Terbinafine tablets, spray, solution or cream, patients notice a decrease in the pronounced clinical manifestations of the fungus already in the first days of therapy. If treatment is irregular or interrupted prematurely, there is a risk of relapse. Other special instructions from the instructions:

Avoid accidental contact of the cream with the eyes due to the risk of irritation. If the drug gets on the mucous membranes, it should be washed off with water, and if persistent irritation occurs, consult a doctor.
With the development allergic reactions the drug is cancelled.
The duration of therapy can be affected by the presence of diseases, the condition of the nails with onychomycosis at the beginning of treatment.
If after two weeks of using Terbinafine the condition does not improve, it is necessary to make sure once again that the causative agent of the infection is identified correctly and to make sure of its sensitivity to the drug.
With onychomycosis, the use of local agents is more often indicated. But with a total lesion of the nails, the ineffectiveness of local therapy, tablets are prescribed.
Terbinafine clearance is reduced in liver disease.
Three months after the start of treatment, patients in very rare cases may experience cholestasis and hepatitis. With the appearance of weakness, nausea, loss of appetite, abdominal pain, jaundice, dark urine and discolored stools, the drug is canceled.
Patients with psoriasis should be cautiously prescribed drug therapy, because this can lead to an exacerbation of the disease.
Two weeks after the start of therapy and at its end, antifungal treatment of socks, shoes, and stockings is required.
It is not known whether the use of Terbinafine affects the ability to drive vehicles.

During pregnancy

To date, no teratogenic properties of the drug have been identified. It is also unknown about cases of fetal malformations when using Terbinafine in pregnant women. According to the instructions, the drug can be used for limited indications and under the supervision of a doctor. The active substance of the tablets is excreted in breast milk, so it should not be used when breastfeeding. Breastfeeding mothers can use the cream.

Terbinafine and alcohol

Doctors do not recommend combining terbinafine hydrochloride tablets with alcohol, because this increases the load on the liver and reduces the effectiveness of the drug. The simultaneous use of ethyl alcohol is allowed only in conjunction with the use of a cream, spray or solution, because they do not enter the systemic circulation.

drug interaction

unknown about drug interaction cream, spray and solution with other means. For tablets, the instruction highlights combinations and consequences:

The drug disrupts the metabolism of tricyclic antidepressants, Fluvoxamine, Desipramine, beta-blockers Metoprolol and Propranolol, antipsychotics Haloperidol and Chlorpromazine, antiarrhythmic drugs Propafenone and Flecainide, monoamine oxidase inhibitors Selegiline, Dextromethorphan, Dextrorphan, Zidovudine, Ketoconazole, Co-trimoxazole, Sulfametholinaoxol.
Rifampicin can speed up the metabolism of the drug, cimetidine can slow it down. In all cases, dose adjustment of the drug is required.
Simultaneous administration of the drug with oral contraceptives disrupts the menstrual cycle.
The agent reduces the clearance of caffeine, but does not affect the performance of Digoxin, Warfarin, Phenazone.
Co-administration of the drug with ethanol or drugs with a hepatotoxic effect leads to the risk of drug-induced liver damage.

Side effects

During therapy, manifestations are possible adverse reactions. These include:

allergy;
feeling of a full stomach, loss of appetite, abdominal pain, nausea;
arthralgia;
fatal liver failure;
hyperkeratosis;
increased activity of liver isoenzymes, impaired creatinine clearance;
fever;
paresthesia;
hepatotoxicity;
bloating, diarrhea, pancreatitis;
visual impairment;
mental disorders;
pancytopenia, neutropenia, thrombocytopenia, agranulocytosis, eosinophilia, anemia;
anaphylactoid reactions, angioedema;
ageusia, taste disturbances;
alopecia, skin reactions, exacerbation of psoriasis, rash, urticaria, psoriasis-like or bullous rash, dermatitis, pustulosis, skin pigmentation, peeling, eczema, erythema.

Possible signs of an overdose of tablets or if the cream is accidentally taken orally are headache, nausea, dizziness, epigastric pain, rash, frequent urination. Treatment for overdosing consists of taking activated carbon, gastric lavage, conducting symptomatic specialized therapy if necessary.

Contraindications

The drug can be used with caution in alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, blood vessels of the extremities, under the age of 12 years. The instruction highlights contraindications:

chronic or acute liver disease, lack of isoenzymes;
vasculitis;
kidney failure;
children's age up to three years and weight up to 20 kg (for tablets);
lactation, pregnancy;
lupus erythematosus;
lactose intolerance, lactase deficiency, malabsorption of glucose-galactose;
hypersensitivity to components.

Terms of sale and storage

Terbinafine tablets are a prescription drug. Cream, spray and solution are available without a prescription. All forms of the drug are stored at temperatures up to 25 degrees for three years in places inaccessible to children.

Analogues

To replace Terbinafine, you can choose products with the same active ingredient or a similar therapeutic effect. These include:

Atifin - cream based on terbinafine hydrochloride;
Binafin - tablets, cream with a similar composition;
Terbizil - cream, tablets with the same component in the composition;
Lamikon - a cream with a similar substance;
FungoTerbin - spray, cream with the same composition;
Mycofin - tablets, spray, cream based on the same substance;
Exifin - tablets, cream with the same composition;
Exiter is a tableted product based on the same component;
Terbinafine Teva is a direct analogue of the product, produced by an Israeli company.

Lamisil or Terbinafine - which is better

Like Terbinafine, Lamisil is an antifungal agent with the same active ingredient, but is produced by a Swiss company and is the original. Terbinafine is a generic, that is, a drug that is cheaper, but has the same active base. Lamisil is more expensive, but its effectiveness is about the same. It is up to the attending physician to decide which is better.

Terbinafine price

You can buy the product at prices depending on the form of release, the volume of the pack and the price policy of the seller. In Moscow, the cost will be:

Video

Terbinafine tablets are used for complex treatment fungal infections of the skin, upper nails and lower extremities. Terbinafine is highly active against all known human pathogens that cause mycosis.

The therapeutic effect on the fungal cell is to inhibit the enzymatic intracellular metabolism of svalene oxidase, which leads to the destruction of the cell membrane of the pathogen.

The drug is used for the following pathogens:

dermatophytes (Tr.rubrum, Tr.tonsurans, Tr.mentagrophytes, Tr.verrucosum, Tr.violaceum, Tr.mentagrophytes);
yeast fungi (Candida albicans, Cryptococcus neoformans);
microspores (Microsporum canis);
lichen (Malassezia furfur, Pityrosporum orbiculare, Pit.ovale);
mold fungi (Scopulariopsis brevicaulis, Epidermophyton floccosum, Aspergillus niger, Cladosporium).

The antimycotic activity of Terbinafine tablets in relation to pathogenic flora is fungicidal or fungistatic, depending on the therapeutic concentration in the lesion. Unlike other drugs and analogues, this remedy used for infection with dimorphic fungi resistant to conventional drugs.

The form of release most widely used in the treatment of fungal infections is Terbinafine tablets, the high effectiveness of which has been proven by numerous clinical trials.

In addition to the main tablet form, the drug is available in external forms:

solution;
ointment;
cream;
spray;
gel.

Oral administration is preferable to external use due to the rapid achievement of therapeutic concentrations, a pronounced fungicidal effect that suppresses the growth of fungal cells. Terbinafine tablets prevents relapse after therapy, reduces the risk of developing complications of fungal infection.

The composition of Terbinafine includes the active substance Terbinafine, which is presented in the form of terbinafine hydrochloride. The active substance is a synthetically obtained derivative of allylamine, widely used in medical practice for the treatment of superficial and deep onychomitosis, dermatophytosis.

Terbinafine at a dose of 250 mg is sold as yellowish-white tablets with a chamfer of 7, 10, 14 pieces per pack. The tablets are biconvex, debossed with a "T" on both sides. It is sold in pharmacies strictly on prescription, for use in a child, consultation and appointment of a pediatrician is required.

The pharmacology of the drug is described in detail in the instructions for use of the drug. Terbinafine tablets inhibit the synthesis of sterols by fungal cells, which leads to a deficiency of ergosterol, accumulation of squalene in the cytoplasm, followed by rupture of the cell membrane and its death. The active substance selectively blocks the production of the enzyme squalene epoxidase, which is located in the cell membrane of the fungus.

The fungistatic effect of the drug leads to the cessation of the growth of fungal cells, the biosynthesis of intracellular enzymes, and the deposition of new microspores. Pathogenic cell loses its activity, phagocytosed immune cells organism. Inhibition of fungal reproduction prevents the development of a repeated exacerbation of the disease after a course of treatment.

After oral administration, the therapeutic concentration of the drug is reached within two hours. A high content of terbinafine is found in hair, hair follicles, skin and nail plates. Metabolism in the liver cells to inactive metabolites takes from 14 to 18 hours, after which the drug is excreted in the urine.

Side effects of Terbinafine tablets are relatively rare, the drug has gone through multi-stage clinical researches, has a proven level of safety.

During the use of the drug in medical practice, single side effects were identified:

Gastrointestinal tract (dyspepsia, nausea, vomiting, heartburn);
immunity ( anaphylactic shock, angioedema, urticaria);
hematopoietic organs (agranulocytosis, neutropenia, pancytopenia);
CNS (headache, taste disorders);
skin (rash, itching, peeling, toxic necrolysis, Stevens-Johnson syndrome).

In severe systemic diseases, such as rheumatism, systemic lupus erythematosus, in rare cases, the development of an exacerbation of the underlying pathology is diagnosed. For psoriasis or other degenerative diseases skin episodes of exacerbation of symptoms were noted.

Interaction with other drugs of the drug is limited, due to rapid absorption in the intestine, targeted action, weak chemical reaction with the active substances of other drugs.

It is contraindicated to use against the background of taking selective serotonin reuptake inhibitors, tricyclic antidepressants due to the enhancement of their effects due to the metabolic block, prolonged circulation in the blood.

Terbinafine is prescribed with caution when taking antiarrhythmic drugs, beta-blockers, in the treatment of drugs used in psychiatric practice. Under the supervision of a physician, Terbinafine is used while taking oral contraceptives, hormonal drugs. Diuretics speed up elimination active substance affect the effectiveness of treatment.

The manufacturers of the drug are companies in Russia - Vertex, MFF (Moscow Pharmaceutical Factory), Canonpharma. The drug is the most accessible among antifungal agents, is presented in pharmacies under the name "Lamisil", the cost of which is much lower than foreign representatives.

More cheap analogue Terbinafine-Teva is manufactured in India and pharmacological effect does not differ from the original. The price differs in the network of pharmacies, the choice of the drug and the manufacturer is best done under the supervision of the attending physician. You can buy medicine in a pharmacy, an online store with home delivery in Russia, Ukraine. Reviews after application on the forums help in choosing a manufacturer.

How to take Terbinafine: indications and contraindications, dosage and analogues

Recommendations on how to take Terbinafine are detailed in the instructions for use. Before you start taking the drug, you need to consult a doctor general practice or a dermatologist to determine the indications and contraindications for the use of this medication.

Indications for the use of Terbinafine are:

superficial mycoses of the skin varying degrees gravity;
deep mycoses;
dermophytosis;
trichophytosis;
microsporia;
candidiasis;
inguinal epidermophytosis;
multi-colored lichen;
diaper rash in adults.

A wide spectrum of antimycotic action makes it possible to take Terbinafine for the treatment of almost all human fungal diseases. The duration and frequency of treatment depends on the extent and extent of the lesion.

Contraindications to the use of Terbinafine include pathology from the organs in which the drug is metabolized. Acute or chronic hepatocellular insufficiency, renal insufficiency lead to an increase in the toxicity of the active substance due to prolonged circulation in the bloodstream.

Inflammatory diseases of the gastrointestinal tract lead to malabsorption of terbinafine, a longer onset therapeutic effect. Pregnancy, lactation are contraindications to the use of Terbinafine due to the lack of clinical trials of safety among pregnant and lactating women.

The duration of the course and the frequency of admission during the day are assigned individually. The drug is taken after a meal, washed down with a sufficient amount of pure non-carbonated water. After the appointment of an individual treatment regimen, it is necessary to follow the schedule for taking the drug.

Spontaneous discontinuation of Terbinafine against the background of elimination of unpleasant symptoms of the disease can cause recurrence and resistance of the fungus to ongoing therapy, which is due to an incomplete fungicidal effect. The frequency of daily intake should be monitored to avoid the risk of overdose and the development of side effects.

The dosage of Terbinafine depends on the prevalence of fungal infection, the depth of penetration of the infection. Children are prescribed a single dose with a dosage calculation by weight: up to 20 kg - 62.5 g, from 20 kg to 40 kg - 125 g, above 40 kg - 250 g per day. Adults are prescribed 250 mg once or twice a day.

The drug is prescribed for a period of 6 to 12 weeks with generalized onychomycosis.

The duration of the course is up to 6 weeks with:

extensive damage to the feet;
interdigital dermatomycosis;
plantar dermatomycosis;
dermatomycosis by type of socks.

During treatment, the specialist laboratory tests reflecting the activity of pathogenic flora, which allows you to adjust the dosage and duration of treatment.

With caution, Terbinafine is prescribed for:

liver diseases (hepatitis, cirrhosis, compression of the inferior vena cava);
kidney pathology (glomerulonephritis, pyelonephritis, renal artery stenosis);
menstrual disorders (amenorrhea, early menopause, polycystic ovary syndrome);
taking medications (antiarrhythmics, contraceptives, antidepressants).

By special instructions as prescribed by the attending physician drug therapy Terbinafine is prescribed during pregnancy, during lactation. Terbinafine is produced in breast milk; during treatment, a pediatrician's control over the child's health is required.

With a persistent course of a fungal infection, doctors prescribe courses of Terbinafine as preventive treatment. Treatment is carried out from one to two times a year to prevent relapses and exacerbations of the disease.

Terbinafine analogs are represented by the following drugs:

Atifin;
Terbinafine-Teva;
Thermikon;
Exifin;
Fungoterbin.

Analogues have various forms release, in the form of ointments, creams, gels, tablets. They differ in manufacturers, price category, pharmacological mechanism. Before starting use, a doctor's consultation is required; it is not recommended to choose antimycotic drugs on your own.

Prices for Terbinafine tablets range from 290 to 520 rubles., which is a relatively low cost compared to antifungal drugs with other active substances. Prices for ointments and other forms for external use are below 180 rubles, but they are prescribed as maintenance therapy while taking Terbinafine tablets.

Ointment from nail fungus terbinafine is a fungicidal agent that is active against fungal microorganisms. This drug is used to treat fungal infections of the skin and nails. It is also effective in case of damage to the scalp. The medicine does an excellent job with mold, yeast and other types of infections. It is important to consider that the attending physician should prescribe this remedy, taking into account individual features organism.

On microorganisms Candida spp. the agent has a fungicidal effect. This means that the use of the drug allows you to stop the growth and development of pathogenic flora. Active ingredient ointment terbinafine hydrochloride leads to disruption of the initial stage of biosynthesis of the main component of the cell membrane of fungi. The drug in no way affects the cytochrome P450 system. This means that the drug does not affect the metabolism of hormonal substances or medications.

What helps Terbinafine?

Terbinafine ointment helps with the following disorders in the body:

skin and nail fungus associated with Trychophyton, Microsporum, Epidermophyton floccosum infection;
severe dermatomycosis of the skin of the body and extremities requiring systemic therapy;
versicolor versicolor associated with Pityrosporum orbiculare activity;
fungal infections of the scalp;
candidiasis of the skin and mucous membranes.

Instructions for use Terbinafine

This medicine is only suitable for local application. Moreover, it is permissible to use it only after 12 years. Instructions for use of terbinafine ointment indicate that before applying the drug substance, the affected areas should be cleaned and dried well. The tool is recommended to be used 1-2 times a day. To do this, it is applied in a thin layer to the damaged areas and nearby areas, after which it is gently rubbed.

At infectious diseases accompanied by diaper rash, the place of application of the ointment should be covered with gauze. It is especially important to do this before bed. These areas include the spaces between the fingers, the groin, buttocks, and the area under the breasts.

On average, the duration of therapy depends on the area of the lesion and the form of the disease:

With dermatomycosis of the body and legs, the agent is applied 1 time per day. The course of therapy should last 7 days.
With dermatomycosis of the feet, the drug is used for 7 days once a day.
Candidiasis of the skin requires the application of ointment 1-2 times a day. The duration of treatment depends on the severity of the pathology - it usually lasts 1-2 weeks.
When multi-colored lichen appears, the ointment is applied 1-2 times a day. You need to do this for 14 days.

The use of the drug allows you to improve the condition on the first day of therapy. With irregular treatment or premature discontinuation of the use of the drug, there is a risk of recurrence of the pathology. If after 2 weeks of therapy the person's condition does not improve, it becomes necessary to consult a doctor again.

Terbinafine ointment contraindications

Given medicine has many contraindications. These include the following:

High sensitivity to active substance and other components present in the composition of the drug.
Chronic or active liver pathology.
Chronic form of renal failure.
Age less than 12 years.

With great care you need to prescribe this drug in such cases:

kidney or liver failure;
tumor formations;
violations of metabolic processes;
occlusion of the vessels of the extremities;
oppression of bone marrow hematopoiesis;
alcohol addiction.

In some cases, the drug provokes side effects. After its application, skin hyperemia, itching or burning sensation sometimes appears. In some situations, people develop allergic reactions.

Pregnancy and breastfeeding

Experimental studies have not revealed teratogenic characteristics of terbinafine. Currently, there is no information regarding the occurrence of malformations with the use of this substance. However, the lack of full-fledged clinical experience with the use of the drug in pregnant women indicates that it is permissible to use it only under strict indications.

The active ingredient of the drug passes into breast milk. However, when using the ointment by a nursing woman, only a small amount of the active substance penetrates the body through the skin. Therefore, the drug does not adversely affect the child.

Overdose

Cases of drug overdose have not been recorded. If you accidentally take the ointment inside, there is a risk of the same side effects, as with excessive use of tablets. People have a headache, nausea, discomfort in the epigastric region, dizziness.

special instructions

In order for the treatment to bring the desired results, it is necessary to take into account the following features of the use of the drug:

In the first days of therapy, the severity of overt clinical symptoms usually decreases.
With irregular use of the drug or premature termination of therapy, there is a risk of recurrence of the disease.
The medicine in the form of an ointment is used only externally.
It is necessary to avoid getting the medicine on the mucous membrane of the eyes, as it can cause irritation. If this does happen, the eyes should be rinsed with water.
If allergy symptoms appear, it is better to refuse the use of the drug.

Ointment from the fungus terbinafine is a very effective drug. With its help, it will be possible to cope with this disease in a short time. However, it is very important to take into account contraindications to the use of the medication and strictly adhere to the recommendations of the attending physician.

antifungal drug

Active substance

Terbinafine (as hydrochloride) (terbinafine)

Release form, composition and packaging

Tablets white or white with a yellowish tint with a bevel and a risk.

Excipients: microcrystalline cellulose 0.08 g, hyprolose (hydroxypropyl cellulose) 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.

7 pcs. - cellular contour packings (1) - packs of cardboard.
7 pcs. - cellular contour packings (2) - packs of cardboard.
7 pcs. - cellular contour packings (4) - packs of cardboard.
10 pieces. - cellular contour packings (1) - packs of cardboard.
10 pieces. - cellular contour packings (2) - packs of cardboard.
10 pieces. - cellular contour packings (3) - packs of cardboard.

pharmachologic effect

Terbinafine is an allylamine that has a broad spectrum of activity against fungi that cause 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 (e.g. Aspergillus, Cladosporium, Scopulariopsis brevicaulis), yeasts, mainly Candida albicans. At 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.

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

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

Pharmacokinetics

After a single dose of terbinafine orally at a dose of 250 mg, its Cmax is reached after 2 hours and is 0.97 μg / ml. The half-life is 0.8 hours, the half-life is 4.6 hours. Communication with blood plasma proteins - 99%. When taken simultaneously with food, dose adjustment of the drug is not 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. It 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 (diffusion rate exceeds the growth rate of the nail) at concentrations that provide a fungicidal effect.

Terbinafine is metabolized in the liver to inactive metabolites. T 1/2 is 16-18 hours. T 1/2 of the terminal phase is 200-400 hours. It is excreted mainly by the kidneys (70%) as metabolites, and also through the skin. There is no evidence of accumulation of the drug in the body. It is allocated with breast milk. There were no changes in the steady state plasma concentration of terbinafine depending on age, but in patients with impaired renal or hepatic function, there may be a slow rate of elimination of the drug, which leads to higher blood concentrations of terbinafine.

Indications

- 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 (trichophytosis, microsporia);

- severe, widespread dermatomycosis of the smooth skin of the trunk and extremities, requiring systemic treatment;

- candidiasis of the skin and mucous membranes.

Contraindications

- chronic or active liver disease;

- chronic (CC 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.

Should be respected caution at:

- renal failure (with CC more than 50 ml / min);

- alcoholism;

- oppression of bone marrow hematopoiesis;

- tumors;

- metabolic diseases;

- occlusive diseases of the vessels of the extremities;

- Cutaneous lupus erythematosus or systemic lupus erythematosus.

Dosage

Adults:

Inside, after eating. Usual dose: 250 mg once a day.

Children over 3 years of age:

With a body weight of 20 to 40 kg- 125 mg 1 time per day.

With a body weight of more than 40 kg- 250 mg 1 time per day.

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

Onychomycosis: The 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 with reduced nail growth may require a longer treatment period.

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

The duration of treatment of fungal infections of the scalp is about 4 weeks, in case of infection with Microsporum canis, it can be longer.

Elderly patients the drug is prescribed in the same doses as for adults.

Patients with hepatic or renal insufficiency- 125 mg 1 time per day.

Side effects

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 than 1/10000, including individual cases.

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

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

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

From the side nervous system: often - headache; infrequently - a violation of taste, including ageusia.

From the side of 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.

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

Overdose

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

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

drug interaction

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

Drugs that induce cytochrome P450 isoenzymes (for example,) can accelerate the metabolism and excretion of terbinafine from the body. Drugs - inhibitors of cytochrome P450 isoenzymes (for example, cimetidine) can slow down the metabolism and excretion of terbinafine from the body. With the simultaneous use of these preparations, dose adjustment of terbinafine may be required.

Possible violation of the menstrual cycle while taking terbinafine and oral contraceptives.
Terbinafine reduces caffeine clearance by 21% and prolongs its half-life by 31%. Does not affect the clearance of phenazone, digoxin, warfarin.

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

special instructions

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

The duration of therapy can also 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 in onychomycosis is justified only in the case of total damage to most nails, the presence of pronounced subungual hyperkeratosis, and the ineffectiveness of previous local therapy.

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

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, after 3 months of treatment, cholestasis and hepatitis occur. If there are signs of impaired liver function (weakness, persistent nausea, decreased appetite, excessive, jaundice, dark urine or discolored stools), the drug should be discontinued.

The appointment of terbinafine in patients with psoriasis requires caution, because. in very rare cases, terbinafine can provoke 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. In the process of treatment (after 2 weeks) and at the end of it, it is necessary to carry out antifungal treatment of shoes, socks and stockings.

Influence on the ability to drive vehicles and control mechanisms

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

Pregnancy and lactation

Since studies on the safety of Terbinafine in pregnant women have not been conducted, the drug should not be administered during pregnancy.

Terbinafine is excreted in breast milk, so its administration is contraindicated during breastfeeding.

Application in childhood

Contraindicated in children under 3 years of age and weighing up to 20 kg.

For impaired renal function

Terms and conditions of storage

In a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life - 3 years.