Trimetazidine-Teva tab p / 20 mg of the film 60 pc

Description

Composition
Active substance:
trimetazidine dihydrochloride 20.0 mg
Excipients:
Microcrystalline cellulose 20.0 mg Mannitol 44.5 mg, kopolividon 4.0 mg colloidal silicon dioxide 0.5 mg Magnesium stearate 1.0 mg; shell tablets: 2.3 mg hypromellose, macrogol 6000 (polyethylene glycol) 0.23 mg, dye – iron oxide red (E 172) 0.1 mg titanium dioxide (E 171) 0.49 mg.
Description:
Round, biconvex tablets, film-coated red-brown.
Product form:
Tablets, film-coated, 20 mg.
10 tablets in a blister made of PVC / Al-foil.
6 blisters with instruction for use in a cardboard box.
Contraindications
– hypersensitivity to any component of the drug;
– Parkinson’s disease, parkinsonism, tremor, a syndrome of “restless legs” and other related movement disorders.
– severe renal impairment (creatinine clearance (CC) below 30
ml / min).;
– pregnancy;
– the period of breast-feeding;
– the age of 18 years (effectiveness and safety have been established).
Carefully
Patients with severe hepatic impairment, moderate renal impairment (creatinine clearance of 30-60 ml / min), elderly patients older than 75 years (trimetazidine may increase exposure).
Dosage
20 mg
Indications
Long-term therapy of coronary heart disease: prevention of angina attacks (monotherapy or in combination therapy).
Interaction with other drugs
Cases of drug interactions are not described.
Trimetazidine can be used in conjunction with heparin, low molecular weight heparin, anticoagulants indirect action, drugs used in violation of lipid metabolism, acetylsalicylic acid, beta-blockers, blockers “slow” calcium channel blockers, cardiac glycosides.
Overdose
No cases of overdose have been reported. In the case of an overdose should be symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antihypoxanth means.
Pharmacodynamics:
Trimetazidine in ischemia and hypoxia prevents decrease intracellular adenosine triphosphatase activity (ATP), maintaining energy metabolism and homeostasis providing cells by ensuring the normal functioning of ionic channels and cell membranes natriykalievogo transmembrane flux. It inhibits beta-oxidation of fatty acids, selectively blocking the enzyme 3-ketoacyl-CoA thiolase, which increases glucose oxidation.
Cells are able to generate energy ischemia during glucose oxidation requires less oxygen than at the beta-oxidation of fatty acids.
Switching the energy metabolism of cells with fatty acid oxidation to glucose oxidation is based on the pharmacological effects of trimetazidine. Under experimental conditions, it is shown that the drug:
– supports the energy metabolism of the heart and neurosensory tissue ischemia;
– reduces the severity of intracellular acidosis and transmembrane ion flux changes occurring during ischemia;
– reduces the migration and infiltration of polynuclear neutrophils in ischemic heart tissue and reperfuziruemyh;
– reduces the size of myocardial injury;
In patients with coronary artery disease trimetazidine heart acts as a metabolic agent, maintaining adequate myocardial intracellular activity of high-energy phosphates. Anti-ischemic effect is achieved without affecting hemodynamics.
In patients with angina, trimetazidine:
– increases coronary flow reserve, thereby delaying the onset of ischemia, exercise-induced, starting from the 15th day of treatment;
– restricts blood pressure oscillations caused by physical activity, without significant changes in heart rate;
– reduces the frequency of angina attacks and need for nitroglycerin short-acting;
– improve the contractile function of the left ventricle in patients with coronary dysfunction.
Pharmacokinetics:
When administered trimetazidine is rapidly absorbed from the gastrointestinal tract, maximum plasma concentration (Cmax) is achieved after less than 2 hour and 55 ng / mL after single dose of 20 mg. Repeated application of the equilibrium state concentration of drug in the blood is achieved after 24-36 hours, and remains stable until the end of therapy.
Easily it passes through the blood-tissue barriers. Binding to plasma proteins is low (about 16% in vitro).
Excreted mainly by the kidneys (60%) unaltered. The half-life (T1 / 2) was 5-6 hours. Trimetazidine total renal clearance correlates with creatinine clearance (CC), hepatic clearance decreases with age.
Patients older than 75 years
Patients trimetazidina increase exposure in the blood plasma can be observed over 75 years as a result of age-related decline in renal function. No features regarding the safety of the drug was found in patients older than 75 years compared with the general population.
Patients with impaired renal function
Exposure trimetazidine plasma was increased by an average 2.4-fold in patients with impaired renal function moderate severity (CC 30-60 ml / min) and an average of 4-fold – in patients with impaired renal function, severe (CC less than 30 ml / min) compared with healthy volunteers with normal renal function.
It did not show any peculiarities about the safety of the drug in patients with impaired renal function compared with the general population.
Use in children and adolescents
Trimetazidine Pharmacokinetics in children and adolescents under 18 years of age has not been studied.
Pregnancy and breast-feeding
Data on the use of trimetazidine absent in pregnant women.
Animal studies have not revealed the presence of drug teratogenicity.
The potential risk of its use in pregnant women is unknown. A drug
Trimetazidine-Teva is contraindicated during pregnancy.
It is unknown whether trimetazidine breast milk is released, so if necessary, use during lactation should stop breastfeeding.
In reproductive toxicity studies in animals have not determined the influence of trimetazidine fertility.
Conditions of supply of pharmacies
Prescription.
side effects
The frequency of adverse events classified according to the recommendations of the World
Health Organization: very common (> 1/10); often (> 1/100 and
special instructions
Trimetazidine not intended for relief of angina attacks and is not indicated for the initial treatment of unstable angina or myocardial infarction in the prehospital phase and during the first days of hospitalization.
In the case of angina attack should review and adapt the treatment (drug therapy, and possibly revascularisation).
Trimetazidine can cause or worsen the symptoms of parkinsonism (tremor, akinesia, increased muscle tone), so should be regulyarnoenablyudenie patients, particularly the elderly. In doubtful cases, patients should be counseled by a neurologist.
In case of other movement disorders, such as the “precariousness” of gait, the syndrome of “restless legs” of the patient must be referred to a neurologist for appropriate examination.
The frequency of motor disorders of the low and the symptoms usually disappear after discontinuation of therapy, most patients within 4 months after discontinuation of the drug. If symptoms persist for more than 4 months of parkinsonism after discontinuation of the drug should consult a neurologist.
In applying the drug may occur cases fall associated with the “unsteadiness” gait or hypotension, especially in patients taking antihypertensive drugs (see. The section “Side effect”).
It should be used with caution in trimetazidine patients who may increase its exposure:
– with moderate renal dysfunction (see sections “Dosage and Administration”.).
– in patients older than 75 years (. See section “Dosage and administration”).
– in severe hepatic dysfunction (see “Precautions”.).
Effect on the ability to drive mechanisms and
In connection with the possible development of dizziness and other side effects should be careful when driving and occupation of other activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 degrees.
Keep out of the reach of children!
Dosing and Administration
Inside, 1 tablet 2-3 times a day at meal time.
Tablets should be taken whole, without chewing, washing down with water.
The daily dose is 40-60 mg.
The duration of therapy is determined individually, depending on the clinical situation.
Patients with impaired moderate renal function (creatinine clearance of 30-60 ml / min)
The recommended dose of 20 mg (1 tablet), 2 times a day (morning and evening).
Patients older than 75 years
In patients older than 75 years may experience increased exposure trimetazidina because age-related decrease in renal function. Patients with impaired moderate renal function (creatinine clearance of 30-60 ml / min) – the recommended dose of 20 mg (1 tablet), 2 times a day (morning and evening). Dose selection for patients over the age of 75 years should take place with care (see. Section “Special Instructions”).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist