Terbinafine - instructions for use, analogs, reviews and release forms (cream or ointment 1%, tablets 125 mg and 250 mg, spray) drugs for the treatment of skin and nail fungus in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Terbinafine. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Terbinafine in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of terbinafine in the presence of existing structural analogs. Use to treat skin and nail fungus in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Terbinafine - is allylamine, which has a wide range of action against fungi that cause skin, hair and nail diseases, including dermatophytes. At low concentrations, it has a fungicidal effect on the Tryphophyton spp. Dermatophytes. (T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum canis, Epidermophyton floccosum, fungi (e.g., Aspergillus, Cladosporium, Scopulariopsis brevicaulis), yeasts, primarily Candida albicans. At low concentrations terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.

Terbinafine specifically suppresses the early stage of biosynthesis of sterols in the fungal cell. This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes 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 medications.

When taking terbinafine inside the skin, hair and nails are created concentrations of the drug, providing fungicidal effect.

When administered orally, it is not effective in treating multicolored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare (Malassezia furfur).

Composition

Terbinafine hydrochloride + excipients.

Pharmacokinetics

With a simultaneous admission with food, dose adjustment is not required. Terbinafine rapidly penetrates the skin and accumulates in the sebaceous glands. High concentrations are created in the hair follicles and hair, after a few weeks of application penetrates the nail plates. It accumulates in the stratum corneum (the concentration increases 10 times on day 2 after taking 250 mg, 70 times on day 12) and nails (the diffusion rate exceeds the nail growth rate) at concentrations that provide fungicidal action. Terbinafine is metabolized in the liver with the formation of inactive metabolites. It is excreted mainly by the kidneys (70%) in the form of metabolites, and also through the skin. There is no evidence of cumulation of the drug in the body. Excreted in breast milk. There were no changes in the equilibrium concentration of terbinafine in the plasma, depending on the age, but patients with impaired renal or hepatic function may have a delayed release rate, which leads to higher concentrations of terbinafine in the blood.

With topical application, absorption - 5%, has an insignificant 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;
• mycoses of the scalp (trichophytosis, microsporia);
• severe, common dermatomycosis of the smooth skin of the trunk and extremities that require systemic treatment;
• a multicolored lichen (Pityriasis versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
• candidiasis skin and mucous membranes.

Forms of release

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

Tablets 125 mg and 250 mg.

Spray for external use 1% (under the trade name Fungoterbine).

Instructions for use and how to use them

Pills

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 once a day.

With a body weight of more than 40 kg, 250 mg once a 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 an average of 6-12 weeks. If the fingers and toes of the hands and feet (with the exception of the thumb of the foot) are affected,or at a young age of the patient, the duration of treatment may be less than 12 weeks. If infection of the thumb of the foot is usually enough 3-month course of treatment.

Some patients who have a reduced rate of nail growth may need a longer period of treatment.

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

The duration of treatment of mycosis of the scalp is about 4 weeks, with infection of Microsporum canis - may be more prolonged.

Older patients prescribe the drug in the same doses as adults.

Patients with hepatic or renal insufficiency - 125 mg once a day.

Cream

Outwardly.

Adults and children from the age of 12

Before applying the cream, it is necessary to 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.In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night. In case of extensive fungal lesions of the body, it is recommended to use a cream in tubes of 30 g.

Average duration of treatment: dermatomycosis of the trunk, shins - 1 week 1 time per day; dermatomycosis stop - 1 week 1 time per day; Candidiasis of the skin - 1-2 weeks 1 or 2 times a day; multi-colored lichen: 2 weeks 1 or 2 times a day.

Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. In the event that after one or two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

Dosage regimen in elderly people does not differ from the above.

The use of this drug in children under 12 years is not recommended.

Side effect

• feeling of overflow of the stomach;
• decreased appetite;
• dyspepsia;
• nausea;
• diarrhea;
• neutropenia, agranulocytosis, thrombocytopenia, pancytopenia;
• anaphylactoid reactions (including angioedema);
• headache;
• a 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);
• children's age (up to 3 years) and with a body weight of up to 20 kg (for this pill) and up to 12 years for cream;
• lactation period;
• deficiency of lactase, lactose intolerance, glucosogalactose malabsorption;
• hypersensitivity to terbinafine or other components of the drug.

Application in pregnancy and lactation

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

Terbinafine is excreted in breast milk, therefore its purpose is contraindicated in the period of breastfeeding.

Use in children

Contraindicated for children under 3 years old and with a body weight of up to 20 kg for tablets and children up to 12 years for cream.

special instructions

Irregular application 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 for a skin infection there is no improvement, it is necessary to repeatedly identify the pathogen and its sensitivity to the drug.

Systemic use in onychomycosis is justified only in case of total defeat of most nails, the presence of pronounced subungual hyperkeratosis, ineffectiveness of previous local therapy.

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

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

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

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

The administration of terbinafine to psoriasis patients requires caution. In very rare cases, terbinafine can provoke an exacerbation of psoriasis.

When treating terbinafine, general hygiene rules should be followed to prevent the possibility of re-infection through linens and shoes. In the process of treatment (after 2 weeks) and at the end of it, it is necessary to produce antifungal treatment of shoes, socks and stockings.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

It 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), antiarrhythmics (flecainide, propafenone), monoamine oxidase B inhibitors (eg selegiline), and antipsychotics (for example, chlorpromazine, haloperidol).

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

Possible violation of the menstrual cycle with the simultaneous administration of 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 damage to the liver.

Analogues of Terbinafine

Structural analogs for the active substance:

• Atitis;
• Binafin;
• Lamisyl;
• Lamizil Dermgel;
• Lamizil Uno;
• Lamican;
• Lamella;
• Myconorm;
• Mycoterbine;
• Onihon;
• Tebicur;
• Terbized Agio;
• Terbisyl;
• Terbiks;
• Terbinafine Hexal;
• Terbinafine Pfizer;
• Terbinafine MFF;
• Terbinafine Sar;
• Terbinafine Teva;
• Terbinafine hydrochloride;
• Terbinox;
• Terbifin;
• Thermic;
• Tigal is a sanovel;
• Ungusan;
• Fungoterbine;
• Cidokan;
• Exeter;
• Exifin.

Similar medicines:

Other medicines: