Terbinafine tablets 250 mg 10 pcs. (Terbinafine)

Packing

10 tablets.

Pharmacological action

Terbinafine is an antifungal agent. It has a wide spectrum of action against fungi that cause skin diseases, 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 of the genus Candida (e.g. C. albicans) and Pityrosporum.

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

The mechanism of action is associated with a specific suppression of 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 significantly affect the metabolism of hormones or other drugs.

Indications

Mycosis 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. canis, M. gypseum) and Epidermophyton floccosum.

Severe, common dermatomycosis of smooth skin of the trunk and extremities, requiring systemic treatment.

Candidiasis of the skin and mucous membranes.

Contraindications

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

Use during pregnancy and lactation

In experimental studies, teratogenic properties of terbinafine were not detected.

The use of the drug during pregnancy is possible in cases where the intended benefits to the mother outweigh the possible risk to the fetus. Terbinafine is excreted in breast milk.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Composition

1 tablet contains:

Active substance:

terbinafine hydrochloride 250 mg

Excipients:

microcrystalline cellulose,

giproloza (hydroxypropylcellulose),

croscarmellose sodium,

colloidal silicon dioxide,

calcium stearate,

lactose monohydrate

Dosage and administration of

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

Children: Inside, after food, appoint once a day. A single dose depends on body weight and is: for children with body weight 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 125 mg tablets).

Adults: 250 mg once daily in the evening or 2 times daily 125 mg.

Skin infections:

Recommended treatment duration:

dermatomycosis of the feet (interdigital, plantar or sock type): 2-6 weeks

dermatomycosis of the trunk, limbs, lower legs: 2-4 weeks

candidiasis of the skin: 2-4 weeks.

Complete disappearance of the manifestations of infection and complaints associated with it can occur only a few weeks after mycological cure.

Infections of the hair and scalp:

Recommended treatment duration:

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

The use of terbinafine in the elderly: There is no reason to assume that for the elderly it is necessary to change the dosage of the drug or that they have side effects that are different from those in younger patients. In the case of the use of the drug in tablets in this age group, the possibility of concomitant impaired liver or kidney function should be considered.

Side effects

Sensation of heaviness and pain in the epigastric region, taste disturbance, loss of appetite, nausea, diarrhea, cholestasis, neutropenia, thrombocytopenia, skin allergic reactions, burning sensation, skin redness and itching in the area of ​​application of the cream.

Drug Interaction

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

Medications - Inductors of cytochrome P450 isoenzymes (eg, rifampicin) can accelerate the elimination of terbinafine from the body.

Drugs - inhibitors of cytochrome P450 isoenzymes (eg, cimetidine) can slow down the metabolism and elimination of

terbinafine from the body. With these drugs, a dose adjustment of terbinafine may be required.

Menstrual irregularities may occur with concomitant 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 used together with ethanol or hepatotoxic drugs, there is a risk of developing a drug for liver damage.

Overdose

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

Treatment: measures for removal of the drug (gastric lavage, activated charcoal intake), if necessary - symptomatic supportive therapy.

Storage conditions

In a dry place, at a temperature not exceeding 25 ° С

The Expiration of

is 3 years.

Deystvuyuschee substances

Terbinafine

pharmacy outlets p176 pharmacy s17

Prescription

Dosage

form Dosage form

tablets

Vertex, Russia



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