Terbinafin-Vertex, tablets 250 mg 10 pcs

Terbinafine is an antifungal agent. It has a broad spectrum of action against fungi that cause skin, hair and nail diseases, including:

• dermatophytes such as Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum (e.g., M. canis), Epidermophyton floccosum;
• degenerative fungi of the genus Candida (e.g., C. albicans) and Pityrosporum.

In low concentrations terbinafine has fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity against yeast fungi, depending on their species, may be fungicidal or fungistatic.

The mechanism of action is associated with specific suppression of the early stage of sterol biosynthesis in the fungal cell. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes cell death of the fungus. The action of terbinafine is performed by inhibiting the enzyme squaleneepoxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Terbinafine has no significant effect on the metabolism of hormones or other drugs.

Indications

Fungus, thrush (candida), Nail fungus, Scalp fungus

• Mycoses of the scalp (Trichophytosis, Microsporia).
• Fungal skin and nail diseases (onychomycosis) caused by Trychophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaccum), Microsporum (M. caries, M. gypseum) and Epidermophyton floccosum.
• Severe, widespread dermatomycoses of smooth skin of the trunk and extremities that require systemic treatment.
• Candidoses of the skin and mucous membranes.

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Active ingredient

Terbinafine

Composition

1 tablet contains:

The active ingredient:

terbinafine hydrochloride 250 mg;

Excipients:

microcrystalline cellulose,

hyprolose (hydroxypropyl cellulose),

croscarmellose sodium,

colloidal silica,

calcium stearate,

lactose monohydrate

How to take, the dosage

Duration of treatment depends on the indication and the severity of the disease.

In children: Orally, after meals, once a day. The single dose depends on body weight and is as follows: for children with body weight less than 20 kg – 62.5 mg (half tablet of 125 mg); from 20 to 40 kg – 125 mg (one tablet of 125 mg); over 40 kg – 250 mg (two tablets of 125 mg).

Adults: 250 mg once a day in the evening or twice a day of 125 mg.

Skin infections:

Recommended duration of treatment:

• dermatomycosis of the feet (interfinger, plantar, or sock type): 2-6 weeks;
• dermatomycosis of trunk, limbs, shins: 2-4 weeks;
• candidosis of the skin: 2-4 weeks.

The complete disappearance of manifestations of the infection and the complaints associated with it may occur only a few weeks after mycological cure.

Hair and scalp infections:

Recommended duration of treatment:

• scalp mycosis: 4 weeks.

Mycoses of the scalp are predominantly seen in children.

Onychomycosis:

The duration of effective treatment is 6 to 12 weeks in most patients. For onychomycosis of the hands, 6 weeks of treatment is sufficient in most cases. For onychomycosis of the feet, 12 weeks of treatment are sufficient in most cases. Some patients who have a reduced nail growth rate may require longer treatment. The optimal clinical effect is seen several months after mycological cure and discontinuation of therapy. This is determined by the period of time required for healthy nail growth.

The use of terbinafine in the elderly:
There is no reason to believe that the dosage of the drug needs to be changed for the elderly or that they experience side effects different from those in younger patients. The possibility of concomitant hepatic or renal dysfunction should be considered if the drug is used in this age group in tablets.

Interaction

Inhibits CYP2P6 isoenzyme and inhibits metabolism of drugs such as tricyclic antidepressants and selective serotonin reuptake inhibitors (e.g., desipramine, fluvoxamine), beta-adrenoblockers (metoprolol, propranolol), antiarrhythmic agents (flecainide, propafenone), type B monoamine oxidase inhibitors (e.g., selegiline) and antipsychotic agents (e.g., chlorpromazine, haloperidol).

Drugs – cytochrome Р450 isoenzyme inducers (e.g., rifampicin) may accelerate excretion of terbinafine from the body.

Drugs – cytochrome Р450 isoenzyme inhibitors (e.g., cimetidine) may slow down the metabolism and excretion
of terbinafine from the body. With concomitant use of these drugs a dose adjustment of terbinafine may be required.

Menstrual cycle disorders may occur with concomitant use of terbinafine and oral contraceptives.

Terbinafine reduces caffeine clearance by 21% and prolongs its half-life by 31%. It does not affect the clearance of phenazone, digoxin, warfarin.
When used together with ethanol or drugs with hepatoxic effect, there is a risk of drug-induced liver damage.

Special Instructions

If during treatment with Terbinafine the patient experiences phenomena suggestive of liver dysfunction, such as unexplained persistent nausea, vomiting, lack of appetite, fatigue, jaundice, pain in the right subcavity, dark urine or discolored stool, in this case the liver origin of these symptoms should be confirmed (determination of serum ALT, ACT) and Terbinafine treatment should be stopped. The patient should be warned about the need to consult a physician in case of similar symptoms.

Patients with impaired renal function (creatinine clearance less than 50 ml/min or serum creatinine level greater than 300 µmol/L) should receive half the usual dose of the drug.

Contraindications

Hypersensitivity, marked hepatic and renal insufficiency, blood diseases, tumors, metabolic diseases, vascular pathology of the extremities, pregnancy, lactation, children (under 2 years).

Side effects

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

Overdose

Symptoms: headache, dizziness, nausea, vomiting, pain in the epigastric region, rapid urination, rash.

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

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Similarities

Terbinafin-Teva, Exifin, Lamisil, Fungoterbin, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin, Terbix