Terbinafin pills 250mg, 10pcs

Composition

1 tablet contains:  

Active ingredient:

terbinafine hydrochloride 250 mg;

Auxiliary substances:

microcrystalline cellulose,

hyprolose (hydroxypropylcellulose),

croscarmellose sodium,

colloidal silicon dioxide,

calcium stearate,

lactose monohydrate

Pharmacological action

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

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

In low concentrations, terbinafine has a fungicidal effect against dermatophytes, mold and some dimorphic fungi. Activity against yeast fungi, depending on their type, can 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 ergosterol deficiency and intracellular squalene accumulation, which causes fungal cell death. The action of terbinafine is carried out by inhibiting the enzyme squalene oxidase in the cell membrane of the fungus. This enzyme does not belong to the cytochrome P450 system. Terbinafine does not significantly affect the metabolism of hormones or other medications.

Indications

• Mycoses of the scalp (trichophytosis, microsporia).
• Fungal diseases of the skin and nails (onychomycosis) caused by Trychophyton (T. rubrum, T. mentagrophytes, T. verrucosum, T. violaccum), Microsporum (M. sapis, M. gypseum) and Epidermophyton floccosum.
• Severe, widespread dermatomycosis of smooth skin of the trunk and limbs, requiring systemic treatment.
• Candidiasis of the skin and mucous membranes.

Contraindications

Hypersensitivity, severe hepatic-cellular and renal insufficiency, blood diseases, tumors, metabolic diseases, vascular pathology of the extremities, pregnancy, breast-feeding, children (up to 2 years).

Side effects

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

Interaction

Inhibits the CYP2P6 isoenzyme and interferes with 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-type inhibitors (for example, selegiline) and antipsychotics (for example, chlorpromazine, haloperidol) means. Drugs that are inducers of cytochrome P450 isoenzymes (for example, rifampicin) can accelerate the 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. Terbinafine dosage adjustment may be required when these drugs are used concomitantly. Menstrual disorders may occur when taking terbinafine and oral contraceptives at the same time. Terbinafine reduces the clearance of caffeine by 21% and prolongs its half-life by 31%. It does not affect the clearance of phenazone, digoxin, or warfarin. When combined with ethanol or drugs that have a hepatoxic effect, 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 disease.

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

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

Skin infections:

Recommended duration of treatment:

• dermatomycosis of the feet (interdigital, plantar, or sock-like): 2-6 weeks;
• dermatomycosis of the trunk, limbs, and lower legs: 2-4 weeks;
• skin candidiasis: 2-4 weeks.

Complete disappearance of infection symptoms and complaints associated with it may occur only a few weeks after mycological treatment.

Infections of the hair and scalp:

Recommended duration of treatment:

• mycosis of the scalp: 4 weeks.

Mycoses of the scalp are observed mainly in children.

Onychomycosis:

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

Use of terbinafine in the elderly: There is no reason to assume that the elderly 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 liver or kidney dysfunction should be taken into account.

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 maintenance therapy.

Special instructions

If during treatment with Terbinafine, the patient has phenomena that suggest liver function disorders, such as unexplained persistent nausea, vomiting, lack of appetite, fatigue, jaundice, pain in the right hypochondrium, dark urine or discolored feces, in this case, the liver origin of these symptoms should be confirmed (determination of serum concentrations of ALT, ACT) and treatment with Terbinafine should be discontinued. The patient should be warned about the need to consult a doctor in case of similar symptoms.

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

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Terbinafine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, Children over 3 years of age, Children as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Nail Fungus, Toenail Fungus, Scalp Fungus, Thrush