Trimetazidine Valium n / a film about modif.vysv. 35mg 60 pcs Izvarino Pharma

Description

Composition
Active substance:
1 tablet contains: trimetazidine dihydrochloride – 35.0 mg ,.
Excipients:
Calcium hydrogen phosphate anhydrous – 157.0 mg; Hypromellose – 50.0 mg; Colloidal silicon dioxide – 2.0 mg; crospovidone – 2.5 mg; Talc – 2.0 mg; Magnesium stearate – 1.5 mg.
shell composition Tablets: Opadry II pink (85F34610) – 8,0 mg (polyvinyl alcohol – 40.00% titanium dioxide – 24.24% Macrogol 3350 – 20.20% talc – 14.80% colorant ferric oxide yellow – 0.37% colorant red iron oxide – 0.36%, iron oxide black dye – 0.03%).
Description:
The tablets of round, lenticular shapes, film-coated from pink to brownish-pink color, with the mark on one side. On cross-section – the core of the white or nearly white to white with a yellowish tint.
Product form:
The modified-release tablet, film-coated, 35 mg.
10 tablets in blisters made of PVC film and aluminum foil printed patent.
At 1, 3, 6, 12 or 18 contour cell packages together with instructions for medical application is placed in a cardboard pack.
Contraindications
Hypersensitivity to any component of the drug.
Parkinson’s disease, parkinsonism, tremor, a syndrome of “restless legs”.
Severe renal impairment (creatinine clearance less than 30 mL / min).
Due to the lack of sufficient clinical data in patients under 18 years of use of the drug is not recommended.
Precautions: Patients with moderate renal impairment (creatinine clearance of 30-60 ml / min); Patients older than 75 years.
Dosage
35 mg
Indications
Long-term therapy of coronary heart disease: prevention of attacks of stable angina in the composition of mono- or combination therapy.
Interaction with other drugs
It was not observed.
Overdose
There is only limited information on overdosage with trimetazidine. In the case of an overdose should be symptomatic therapy.
pharmachologic effect
Pharmacological group:
Antihypoxanth means.
Pharmacodynamics:
It provides anti-hypoxic action.
Directly affecting the cardiomyocytes and neurons in the brain, it improves their metabolism and function. Cytoprotective effect is due to an increase in potential energy, the activation of the oxidative decarboxylation and the rationalization of oxygen consumption (increasing aerobic glycolysis and fatty acid oxidation by inhibition of blockade long-chain 3-ketoacyl-CoA thiolase).
Experimentally confirmed that trimetazidine has the following properties: supports myocardial contractility, prevents intracellular depletion of adenosine triphosphate and creatine; in acidosis conditions normalize the functioning of ionic channels membranes, prevents the accumulation of sodium and calcium ions in cardiomyocytes normalizes the intracellular concentration of potassium ions; reduces intracellular acidosis and increased phosphate content, due to myocardial ischemia and reperfusion; prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electric potential decreases creatine output from cells and the severity of ischemic myocardial injury; It has no direct effect on hemodynamic parameters.
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; improves contractile function of the left coronary dysfunction.
Pharmacokinetics:
Suction:
After oral administration of trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract. Bioavailability – 90%. The time to reach maximum plasma concentration -. About 5 hours Over 24 hours trimetazidine concentration in plasma is maintained at a level greater than and equal to 75% of the maximum concentration determined for 11h. The equilibrium concentration when taken regularly achieved after 60 hours. Simultaneous food intake has no effect on the bioavailability of trimetazidine.
Distribution:
The volume of distribution of 4.8 l / kg. The degree of binding to plasma proteins is quite low – about 16% in vitro.
excretion:
Trimetazidine is excreted mainly by the kidneys (approximately 60% – unchanged). The half-life in young healthy volunteers, approximately 7 hours, in patients older than 65 years – about 12 hours.
Clearance characterized trimetazidine more renal clearance, which directly correlates with creatinine clearance (CC), and to a lesser degree – with hepatic clearance which decreases with the age of the patient.
Special groups.
Patients older than 75 years.
Patients increasing the concentration of trimetazidine in the blood plasma can be observed over 75 years due to age-related decrease in renal function. Special study was conducted in a population of patients older than 75 years when receiving trimetazidine tablets of 35 mg 2 times a day. An analysis conducted by the kinetic method populational showed an average two-fold increase in plasma concentration in patients with severe renal failure patients (creatinine clearance less than 30 mL / min) compared to patients with CC more than 60 ml / min.
Nothing special about the safety in patients older than 75 years compared with the general population was found.
Patients with renal insufficiency.
plasma trimetazidine concentration was increased by an average 2.4-fold in patients with moderate renal impairment (creatinine clearance of 30-60 ml / min) and an average of 4-fold – in renal failure patients with severe (CC less than 30 ml / min) compared with healthy volunteers with normal renal function.
Nothing special about safety in this population of patients compared with the general population was found.
Use in children and adolescents.
Trimetazidine Pharmacokinetics in children and adolescents under the age of 18 years have not been studied.
Pregnancy and breast-feeding
Animal studies have not revealed the presence of the direct or indirect reproduction toxicity. Reproductive toxicity studies showed no effect of trimetazidine on reproductive function in rats of both sexes. As a precaution, do not use the drug trimetazidine MB during pregnancy.
Data on the allocation of trimetazidine or its metabolites in breast milk are not available. Risk can not be ruled out for the newborn baby. You should not use the drug trimetazidine MB during breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
Adverse reactions that are defined as unwanted phenomena at least having a potential relevance to the treatment of trimetazidine are shown in the following gradation: very often (> 1/10); common (> 1/100,
special instructions
Trimetazidine MB is not intended for the relief of angina attacks and is not indicated for the initial course of therapy of unstable angina or myocardial infarction in the prehospital or in the first days of hospitalization. In the case of angina attack should review and adapt the treatment (drug therapy or revascularization procedures).
Trimetazidine MB may cause or worsen the symptoms of parkinsonism (tremor, akinesia, body toning), therefore it is necessary to carry out regular monitoring of patients, particularly the elderly. In doubtful cases, patients should be referred to a neurologist for appropriate examination.
When the movement disorders such as parkinsonism symptoms, a syndrome of “restless legs”, tremor, unsteadiness in Romberg and “precariousness” gait, trimetazidine MB to be completely abolished.
Such cases are rare, and symptoms usually resolve after discontinuation of therapy: the majority of patients – within 4 months after discontinuation of the drug. If parkinsonian symptoms persist for more than 4 months after discontinuation of the drug should consult a neurologist.
Cases may occur drop associated with instability in Romberg and “unsteadiness” gait or a marked reduction in blood pressure, particularly in patients taking antihypertensive drugs (see. the section “Side effect”).
It should be used with caution drug Trimetazidine CF patients who may increase trimetazidine concentration in blood plasma, with moderate renal failure (see sections “Pharmacological properties” and “Dosage and Administration”.); in elderly patients older than 75 years (see. section “Dosage and administration”).
Storage conditions
Store in a dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Tablets should be taken whole, without chewing, washing down with water.
Inside, 1 tablet 2 times a day, morning and evening, during meal time. Duration of treatment is determined by the doctor.
The maximum daily dose is 70 mg.
Special groups.
Patients with renal insufficiency.
In patients with moderate renal impairment (creatinine clearance of 30-60 ml / min), the daily dose is 35 mg (1 tablet), morning during breakfast.
Patients older than 75 years.
In patients older than 75 years may experience increased concentration of trimetazidine plasma due to age-related decrease in renal function (see. Section “Pharmacokinetics”). In patients with moderate renal impairment (creatinine clearance of 30-60 ml / min), the recommended daily dosage is 35 mg (1 tablet), morning during breakfast. Dose adjustments in patients older than 75 years should take place with care (see. “Special Instructions” section).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist