Trimetazidine MB-Teva Tab n / a film about prolong. 35mg 60 pc

Description

Composition
Active substance:
trimetazidine dihydrochloride 35.00 mg
Excipients:
90.00 mg of Hypromellose, calcium hydrogen phosphate dihydrate 141.00 mg Magnesium stearate 3.00 mg colloidal silica 1.00 mg; adjuvants (shell): pink aqueous gloss * 7.00 mg.
* – Hypromellose 60.00%, 5.00% stearic acid, macrogol 6000 3.00%, glycerol 5.00%, 26.75% titanium dioxide, iron oxide red dye 0.25%.
Description:
Round biconvex tablets, film-coated pink. On the cross-section of a tablet – core white or nearly white.
Product form:
Prolonged action tablets, film-coated, 35 mg.
10 tablets in blister PVC / PVDC / Al-foil.
6 blisters with instructions for use in a cardboard box.
Contraindications
– hypersensitivity to any component of the drug;
– severe renal impairment (creatinine clearance less than 30 mL / min);
– Parkinson’s disease, parkinsonism, tremor, a syndrome of “restless legs” and other symptoms associated with movement disorders;
– pregnancy;
– the period of breast-feeding;
– Children up to age 18 years (effectiveness and safety have been established).
Carefully
Patients with severe hepatic impairment, moderate renal impairment and elderly patients older than 75 years (trimetazidine may increase exposure).
Dosage
35 mg
Indications
Long-term therapy of coronary heart disease: prevention of attacks of stable angina pectoris as 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 heparins, indirect anticoagulant agents, 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 of cell membranes and the sodium-potassium transmembrane flux. It inhibits beta-oxidation of fatty acids, selectively blocking the enzyme 3-ketoatsilKoA-thiolase, which increases glucose oxidation. Cells are able to generate energy ischemia during glucose oxidation requires less oxygen than in 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;
– no adverse effect on hemodynamic parameters.
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:
If ingestion Trimetazidine is rapidly absorbed from the gastrointestinal tract (GIT), its maximum concentration in plasma is reached after an average of 5 hours.
Over 24 hours trimetazidine concentration in plasma is maintained at levels greater than or equal to 75% of maximum.
The equilibrium state concentration of drug in the blood is reached after 60 hours.
Food intake does not affect the pharmacokinetic properties of trimetazidine. The volume of distribution of 4.8 l / kg. Communication with plasma proteins and low in vitro is 16%.
Trimetazidine displayed in the kidney primarily in the unchanged form.
When administered in a dose of 35 mg half-life in young healthy volunteers, an average of 7 hours in patients older than 65 years – 12 hours.
Overall renal clearance trimetazidine directly correlated 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 approximately 2.4-fold in patients with impaired renal function moderate severity (CC 30-60 ml / min), and approximately 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 in pregnant women are not available. Animal studies have not revealed the presence of a teratogenic effect. The potential risk of use in pregnant women is unknown. The drug trimetazidine MB-Teva is contraindicated during pregnancy.
It is not known whether the trimetazidine is released from breast milk, so if necessary, the drug-CF Trimetazidine Teva lactation discontinue breastfeeding.
In reproductive toxicity studies in animals have not determined the influence of trimetazidine fertility.
Conditions of supply of pharmacies
Prescription.
side effects
To assess the frequency of adverse effects, the following criteria:
very often (> 1/10); common (> 1/100,
special instructions
When skipping one or more methods of preparation Trimetazidine CF-Teva should not take the higher dose the next reception.
Preparation Trimetazidine CF-Teva is not designed for the relief of anginal attacks, it is also not shown, as a means for the initial treatment of unstable angina or myocardial infarction. It should not be taken before admission and during the first days of hospitalization.
When an attack of angina pectoris of coronary vascular pathology to be re-evaluated and corrected applied treatment (medical treatment and possibly revascularization).
Preparation Trimetazidine CF-Teva can cause parkinsonism symptoms (tremor, akinesia, increased muscle tone) or degrade over. the condition of patients, especially in the elderly should be regularly monitored. In cases of doubt, the patient must be referred to a neurologist for appropriate examination.
The development of movement disorders such as parkinsonism symptoms, a syndrome of “restless legs”, tremor, unsteadiness when walking, may result in cancellation of trimetazidine.
The frequency of motor disorders of development is low, they are reversible and disappear after discontinuation of the drug. If parkinsonian symptoms persist for more than 4 months after discontinuation of the drug, should consult a neurologist.
When unstable walking or low muscle tone, particularly in the application of antihypertensive therapy, the patient may drop (cm. See “Side effect”).
It should be used with caution in trimetazidine patients who may increase its exposure:
– at moderate impaired renal function (see “Dosing and dose.”);
– in elderly 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 ° C.
Keep out of the reach of children!
Dosing and Administration
Inside, during a meal time.
1 tablet (35 mg), 2 times a day (morning and evening). Tablets should be taken whole, without chewing, washing down with water.
The duration of treatment is determined by the attending physician. The result of treatment was assessed after three months. In the absence of the drug treatment efficacy Trimetazidine CF-Teva should be discontinued.
Patients with impaired renal function
Patients with impaired moderate renal function (creatinine clearance of 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning during breakfast.
Elderly patients over 75 years old
Older patients may have an increased exposure of trimetazidine for age-related decrease in renal function. Patients with impaired moderate renal function (creatinine clearance of 30-60 ml / min), the recommended dose is 35 mg (1 tablet) in the morning during breakfast.
Caution should be exercised in the selection of doses in elderly patients.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist