Terbinafin-Teva, pills 250mg 14pcs

Composition

Active ingredient:

terbinafine hydrochloride 250 mg;

auxiliary substances:

microcrystalline cellulose,

hyprolose (hydroxypropyl cellulose),

sodium croscarmellose,

silicon dioxide colloidal,

calcium stearate,

lactose monohydrate

Pharmacological action

Terbinafine belongs to the group of allylamines, has a wide spectrum of antifungal action. In low concentrations, it has a fungicidal effect on Trychophyton dermatophytes (T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, T. violaceum), Microsporum canis, Epidermophyton floccosum, mold fungi (e. g. Scopulariopsis brevicaulis), yeast fungi, mainly Candida albicans. On Candida spp mushrooms. 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 cell membrane of the fungus ergosterol by inhibiting the enzyme squalene oxidase.

When administered orally, it is not effective in the treatment of multicolored lichen caused by Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur.

pHarmacokinetics

When taken orally, it is well absorbed, after 0.8 hours half of the dose is absorbed; after 4.6 hours, half of the dose is distributed in the body. 1-2 hours after ingestion of a single dose of 250 mg, the maximum concentration of the drug in blood plasma reaches 0.97 micrograms / ml. The bioavailability of The Structure Is 80%. Food intake does not affect the bioavailability of terbinafine.

Terbinafine binds intensively to plasma proteins (99%), is rapidly distributed in tissues, penetrates into the dermal layer of the skin and nail plates. Penetrates into the secret of the sebaceous glands and accumulates in high concentrations in hair follicles, in hair, skin and subcutaneous tissue.

The half-life of the Structure is 16-18 hours, the half-life of the terminal phase is 200-400 hours.

Biotransformed in the liver to inactive metabolites. 80% of the dose is excreted by the kidneys in the form of metabolites, the rest (20%) is excreted through the intestine.

It does not accumulate in the body. The age of patients does not affect the pharmacokinetics of terbinafine, however, elimination may decrease with kidney or liver damage, leading to high concentrations of terbinafine in the blood. It is excreted in breast milk.

Indications

• Mycoses of the scalp (trichophytia, microsporia).
• Fungal lesions of the skin and mucous membranes.
• 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 diseases,
• chronic renal failure (creatinine clearance (CC) less than 50 ml/min),
• children under 3 years of age and with a body weight of up to 20 kg (for this dosage form),
• lactation period,
• pregnancy.

With caution: chronic renal failure (CC more than 50 ml/min), alcoholism, suppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

Side effects

Feeling of heaviness and pain in the epigastric region, taste disorders, decreased appetite, nausea, diarrhea, cholestasis, neutropenia, thrombocytopenia, skin allergic reactions; burning sensation, redness of the skin and itching in the area of application of the cream.

Interaction

Correction of the dose of terbinafine is required when used simultaneously with inhibitors and inducers of cytochrome P 450 isoenzymes, which can slow down and accelerate the excretion of terbinafine from the body. Cimetidine reduces the rate of excretion of terbinafine by 30%, and rifampicin increases the rate of excretion of terbinafine by 100%.

In vitro and in vivo studies have shown that terbinafine, by inhibiting the CYP2P6 isoenzyme, disrupts the metabolism of tricyclic antidepressants, selective serotonin reuptake inhibitors (desipramine, fluvoxamine), beta-blockers (metoprolol, propranolol), antiarrhythmic agents (flecainide, propafenone), monoamine oxidase B inhibitors (selegiline) and antipsychotic drugs (chlorpromazine, haloperidol).

Terbinafine does not significantly affect the rate of elimination of tolbutamine, terfinadine, triazolam, oral contraceptives, which are metabolized by other cytochrome P 450 isoenzymes (with the exception of the CYP2P6 isoenzyme). Terbinafine does not affect the rate of elimination of antipyrine and digoxin.

With simultaneous use of terbinafine and oral contraceptives, menstrual cycle disorders may develop. Terbinafine can enhance the effectiveness of caffeine by increasing its concentration in plasma and reducing the rate of excretion from the body by 21%. Terbinafine can reduce the rate of excretion of desipramine from the body by 82%. Terbinafine can reduce the effectiveness of cyclosporine by reducing its plasma concentration by 15%.

When used simultaneously with warfarin, it can affect the parameters of the prothrombin test: blood clotting time and the international normalized ratio.

When used in combination with ethanol or drugs with hepatoxic effects, there is a risk of developing drug-induced liver damage.

How to take, course of use and dosage

The duration of treatment depends on the indication and severity of the course of the disease.  

Children: Inside, after eating, they are prescribed once a day. A single dose depends on body weight and Structure: for children with a body weight of less than 20 kg – 62.5 mg (half a 125 mg tablet); from 20 to 40 kg – 125 mg (one 125 mg tablet); more than 40 kg – 250 mg (two 125 mg tablets).  

Adults: 250 mg once a day in the evening or 2 times a day for 125 mg.

Infections of the skin:

Recommended duration of treatment:

• dermatomycosis of the feet (interdigital, plantar or by type of socks): 2-6 weeks;
• dermatomycosis of the trunk, limbs, shins: 2-4 weeks;
• candidiasis of the skin: 2-4 weeks.  

Complete disappearance of manifestations of infection and complaints related to it, it may occur only a few weeks after the mycological cure.  

Infections of the hair and scalp:

Recommended duration of treatment:

• scalp mycosis: 4 weeks.  

Mycoses of the scalp are observed mainly in children.  

Onychomycosis:

The duration of effective treatment of Structure lasts from 6 to 12 weeks in most patients. With onychomycosis of the hands, in most cases,6 weeks of treatment is sufficient. In most cases,12 weeks of treatment is sufficient for onychomycosis of the feet. Some patients who have a reduced rate of nail growth may require longer treatment. The optimal clinical effect is observed several months after mycological cure and discontinuation of therapy. This is determined by the period of time that is necessary for the regrowth of a healthy nail.  

The use of terbinafine in the elderly: There is no reason to assume that elderly people need to change the dosage of the drug or that they have side effects that differ from those in younger patients. If the drug is used in tablets in this age group, the possibility of concomitant impairment of liver or kidney function should be taken into account.  

Overdose

Symptoms: nausea, vomiting, headache, dizziness, gastralgia, frequent urination, rash.  

Treatment: gastric lavage followed by the use of activated charcoal. If necessary, symptomatic therapy is performed.

Special instructions

Irregular use of terbinafine or premature discontinuation of treatment can lead to a relapse of the disease. 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 damage to the majority of nails, the presence of pronounced subcutaneous hyperkeratosis, the ineffectiveness of previous local therapy.

In the treatment of onychomycosis, a laboratory-confirmed clinical response is usually observed several months after mycological cure and discontinuation of the course of treatment, due to the rate of regrowth 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 “hepatic” transaminases in the blood serum.

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

The use of terbinafine to 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. During the treatment (after 2 weeks) and at the end of it, it is necessary to perform antifungal treatment of shoes, socks and stockings.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 25°C

Shelf life

3 years

Active ingredient

tErbinafine

Conditions of release from pharmacies

By prescription

Dosage form

tablets

Purpose

For adults as directed by your doctor

Indications

Scalp Fungus, Nail Fungus, Fungus, Skin Fungus