Description
Release form
modified release tablets.
Packing
60 pcs.
Pharmacological action
Pharmacological properties. Pharmacodynamics
Has an antihypoxic effect. Normalizes the energy metabolism of cells undergoing hypoxia or ischemia. Directly affecting cardiomyocytes and brain neurons, it optimizes their metabolism and function. The cytoprotective effect is due to increased energy potential, the activation of oxidative decarboxylation and the rationalization of oxygen consumption (increased aerobic glycolysis and slowed down the oxidation of fatty acids due to selective inhibition of long chain 3-ketoacyl-CoA thiolase).
Trimetazidine supports myocardial contractility, prevents a decrease in the intracellular content of adenosine triphosphoric acid (ATP) and creatine phosphate.
Under conditions of acidosis, it normalizes the functioning of the ion channels of membranes, prevents the accumulation of calcium and sodium ions in cardiomyocytes, and normalizes the intracellular concentration of potassium ions.
Reduces intracellular acidosis and increased phosphate levels due to myocardial ischemia and reperfusion. It prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, increases the duration of the electric potential, reduces the yield of creatine phosphokinase from the cells and the severity of ischemic damage to the myocardium.
With angina pectoris it reduces the frequency of seizures, reduces the need for nitrates, after 2 weeks of treatment increases exercise tolerance, and sharp fluctuations in blood pressure are reduced. Reduces dizziness and tinnitus of ischemic etiology. With vascular pathology, the eye restores the functional activity of the retina.
Pharmacokinetics
After oral administration, trimetazidine is rapidly and almost completely absorbed in the gastrointestinal tract. Eating does not affect the pharmacokinetic properties of the drug. Bioavailability is 90%. The time to reach the maximum concentration in blood plasma is 3-5 hours. During the day, the concentration in the blood plasma remains at a level exceeding 75% of the concentration, determined 11 hours after taking one tablet of the drug. Equilibrium plasma concentration is reached after about 60 hours from the start of treatment. The distribution volume is 4.8 l / kg, the connection with blood plasma proteins is 16%. It easily penetrates the histohematological barriers. It is displayed unchanged, mainly by the kidneys (about 60%). The elimination half-life is about 7 hours, in patients older than 65 years – about 12 hours. Renal clearance of trimetazidine directly correlates with creatinine clearance (CC), and hepatic clearance decreases with age.
Indications
Cardiology: coronary heart disease – prevention of attacks of stable angina (as part of combination therapy).
Otorhinolaryngology: treatment of cochleo-vestibular disorders of ischemic nature (such as dizziness, tinnitus, hearing impairment).
Ophthalmology: chorioretinal vascular disorders with an ischemic component.
Contraindications
Hypersensitivity to the components of the drug, severe renal failure (creatinine clearance less than 15 ml / min), severe hepatic impairment, pregnancy, lactation, age under 18 (efficacy and safety have not been established).
Special instructions
Rimekor MV is not intended for the relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction, as well as in preparation for hospitalization or in its early days !!!
In the event of an attack of angina pectoris, treatment should be reviewed and adapted.
Due to the lack of relevant clinical data, the use of the drug Rimecor MB is not recommended for patients with renal failure with creatinine clearance less than 15 ml / min, as well as for patients with severe hepatic impairment.
Influence on the ability to drive vehicles and operate machinery
Caution is advised when driving vehicles and engaging in other potentially hazardous activities, requiring increased concentration of attention and speed of psychomotor reactions.
Composition
1 sustained-release film-coated tablet contains:
active substance: trimetazidine dihydrochloride (in terms of 100% substance) – 35.0 mg
excipients: mannitol – 13.5 mg, microcrystalline cellulose – 21.0 mg, mountain glycolic wax (montan wax) – 39.0 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [1: 2: 0.1] (Eudragit RS PO) – 40.0 mg, magnesium stearate – 1.5 mg
coating – 8.0 mg: FD&C aluminum blue varnish No. 2 – 0.07%, FD&C yellow aluminum varnish No. 6 – 0.77%, macrogol (polyethylene glycol) – 20.20%, polyvinyl alcohol – 40.00%, aluminum Ponso 4R varnish – 0.24%, talc – 14.80%, titanium dio ksid – 23.92%.
Dosage and Administration
Inside, with meals.
Rimekor MV is used 1 tablet 2 times a day (morning and evening).
If you skip one dose, the second dose should not be doubled.
The course of treatment – on the recommendation of a doctor.
Side effects
Frequency of side effects: very often (more than 1/10) often (more than 1/100 and less than 1/10) infrequently (more than 1/1000 and less than 1/100) rarely (more than 1/10000 and less than 1 / 1000) is very rare (more than 1/10000), including individual messages.
From the digestive system
Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
On the part of the cardiovascular system
Rarely: orthostatic hypotension, “flushing” of blood to the skin of the face.
From the central nervous system
Often: dizziness, headache, asthenia.
Very rare: extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.
From the skin
Often: skin rash, itching, urticaria.
Drug Interactions
No information.
Overdose
Data on overdose cases are limited. In case of an overdose, symptomatic therapy should be carried out.
Storage Conditions
At 15 ° C to 25 ° C.
Keep out of the reach and sight of children.
Expiration
2 years.
conditions granted through pharmacies
In retseptu
Dosage form
tablet prolong.
Indications
angina, coronary heart disease
Possible product names
RIMEKOR MV 0.035 N60 TABLE PROLONG s / o
Rimekor MV tab s / n prolonged valid 35mg N60
Rimekor MV tab prol / s 35lkp 60 s. PROLONG. DI P / O CAPTURE. 35MG No. 60
RIMEKOR MV TAB.PROLONG.P.P.O. 35MG No. 60
Nizhpharm, Russia
