Preductal OD extended release capsules 80mg №10×3

Name Preductal OD caps. with extended release 80mg in bl. in pack. No. 10×3 The main active ingredient Trimetazidine Release form Capsules Dosage 80 mg Special instructions Preductal OD should not be used to stop angina attacks. The drug is not intended for the initial course of therapy for unstable angina and the treatment of myocardial infarction at the stage before hospitalization or during the first days of hospitalization. With the development of an angina attack, the therapy (treatment or revascularization procedure) should be reviewed and adapted. Due to the possible appearance or worsening of parkinsonism symptoms, regular appropriate monitoring of patients should be carried out, especially in the elderly. In cases of suspicion, a neurological examination is required. The occurrence of movement disorders during therapy (tremor, increased tone, akinesia, restless legs syndrome, unsteady gait) is the basis for canceling Preductal OD. Symptoms of parkinsonism are usually transient and usually resolve within four months after discontinuation of therapy. If they persist longer, it is recommended to consult a neurologist. It should be borne in mind that with instability in the Romberg position, a shaky gait, or a pronounced decrease in blood pressure, there may be cases of falling, especially against the background of simultaneous use of antihypertensive drugs. Pharmacological propertiesPharmacodynamics Preductal OD is an antianginal drug that ensures normal functioning of membrane ion channels, transmembrane transfer of sodium and potassium ions, and maintenance of cellular homeostasis. The mechanism of action of the drug is due to the ability of trimetazidine to maintain the energy metabolism of cells in a state of hypoxia and, thus, to prevent a decrease in the intracellular concentration of adenosine triphosphate (ATP). The pharmacological properties of Preductal OD are based on switching energy metabolism from fatty acid oxidation to glucose oxidation. Selective inhibition of the mitochondrial long chain fatty acid isoform 3-ketoacyl-CoA thiolase (3-CAT) by trimetazidine causes inhibition of fatty acid oxidation. This enhances glucose oxidation and accelerates glycolysis with glucose oxidation, which determines the protection of the myocardium from ischemia. Trimetazidine has the following pharmacodynamic properties: maintaining the energy metabolism of the heart and neurosensory tissues during ischemia; a decrease in the severity of intracellular acidosis and a change in the transmembrane ion flux characteristic of ischemia; decrease in the level of migration and infiltration of polynuclear neutrophils in reperfused and ischemic heart tissues; reduction in the size of myocardial damage; no direct impact on hemodynamic parameters. In patients suffering from angina pectoris, after 15 days of trimetazidine therapy, coronary reserve increases, which leads to a slower onset of exercise-induced ischemia. Without significant changes in heart rate (heart rate), the drug limits the fluctuations in blood pressure (BP) caused by exercise. There is a significant reduction in the incidence of angina attacks and the need for short-acting nitroglycerin. The contractile function of the left ventricle improves in patients with ischemic dysfunction. When conducting clinical studies, it was found that in the absence of a sufficient effect of other antianginal drugs in the treatment of stable angina pectoris, the use of trimetazidine for monotherapy or as part of combination therapy was effective and safe. When combined with metoprolol, there was a statistically significant improvement in the results of stress tests and clinical symptoms. The use of atenolol increases the time until the development of ischemic depression of the ST segment by 1 mm. Pharmacokinetics After taking the capsules orally, trimetazidine has a linear pharmacokinetic profile, reaching a maximum plasma concentration (Cmax) in approximately 14 hours. Simultaneous food intake does not affect the bioavailability of trimetazidine at a dose of 80 mg. The equilibrium state is reached after 3 days of therapy. Trimetazidine is well distributed in tissues, its Vd (volume of distribution) is 4.8 l / kg. Plasma protein binding is quite low, approximately 16% of the dose taken. T1 / 2 (half-life) in young patients is about 7 hours, over the age of 65 years – about 12 hours. The drug is excreted mainly through the kidneys, mostly unchanged. Renal clearance of trimetazidine is related to creatinine clearance (CC) and decreases with age of the patient. With a moderate degree of renal failure (CC 30-60 ml / min), the exposure of trimetazidine increases by 2.4 times, with severe (CC less than 30 ml / min) – an average of 4 times. Due to the age-related decrease in kidney function in elderly patients (after 75 years), an increase in the exposure of trimetazidine is possible. In a special study conducted in patients of this age group, when taking tablets at a dose of 35 mg 2 times a day, it was found that in severe renal failure (CC less than 30 ml / min), the exposure of the active substance in blood plasma is on average 2 times higher than in patients with CC more than 60 ml / min. Information about other features of the use of Preductal OD in the elderly is not available. The safety and efficacy of trimetazidine in patients under 18 years of age have not been established. Indications for use The use of Preductal OD is indicated for long-term therapy of coronary heart disease (CHD) in order to prevent attacks of stable angina pectoris (as monotherapy or as part of a combination treatment). Dosage and administration Preductal OD capsules are taken orally, swallowed and washed down with water in the morning during breakfast. Recommended dosage: 1 pc. 1 per day. The doctor determines the duration of the course of treatment individually. Evaluation of the effectiveness of therapy can be carried out only after 90 days of regular use of the drug. In the absence of the expected therapeutic result, Preductal OD should be discontinued. With a moderate degree of renal failure (CC 30-60 ml / min) and in patients over the age of 75 years, the daily dose of trimetazidine should not exceed 35 mg. Application during pregnancy and lactation It is not recommended to prescribe trimetazidine during gestation and breastfeeding. If it is necessary to use Preductal OD during lactation, breastfeeding should be discontinued. Interaction with other drugs When prescribing Preductal OD, the doctor must take into account all the drugs taken by the patient. Contraindications symptoms of parkinsonism, including tremor, restless leg syndrome and other movement disorders; Parkinson’s disease; severe degree of renal failure with CC less than 30 ml / min; intolerance to fructose and / or sucrose, glucose-galactose malabsorption syndrome, deficiency of sucrase and isomaltase; age up to 18 years; hypersensitivity to the components of the drug. Caution should be exercised when prescribing Preductal OD to patients with severe hepatic insufficiency (10-15 points on the Child-Pugh scale), moderate renal insufficiency (CC 30-60 ml / min), over the age of 75 years. Since there are no data on the safety of the use of Preductal OD during pregnancy and breastfeeding, the administration of the drug during these periods of a woman’s life is not recommended. Composition 1 capsule contains: active ingredient: trimetazidine dihydrochloride – 80 mg (in the form of film-coated granules); auxiliary components: sugar spheres 710-850 microns in size (sucrose, corn starch, starch hydrolysis products, dyes), hypromellose; the composition of the film shell of the granules: ethylcellulose, tributylacetylcitrate, talc; composition for dusting granules: talc, magnesium stearate; composition of the capsule body: titanium dioxide (E171), gelatin; capsule cap composition: gelatin, titanium dioxide (E171), iron oxide red (E172); ink composition: shellac, simethicone, propylene glycol, titanium dioxide, ammonium hydroxide. Overdose Symptoms of overdose have not been established. When ingesting an increased dose of Preductal OD, you should immediately consult a doctor to prescribe symptomatic therapy. Side effects on the part of the cardiovascular system: rarely – a pronounced decrease in blood pressure, palpitations, tachycardia, extrasystole, orthostatic hypotension (including accompanied by general weakness, loss of balance or dizziness, more often with the simultaneous use of antihypertensive drugs), flushing of blood to the skin of the face; from the side of the central nervous system: often – headache, dizziness; frequency not established – insomnia, drowsiness, symptoms of parkinsonism (including tremor, akinesia, increased tone), reversible movement disorders (including gait unsteadiness, restless legs syndrome); from the lymphatic system and the hematopoietic system: the frequency has not been established – agranulocytosis, thrombocytopenic purpura, thrombocytopenia; from the digestive system: often – dyspepsia, abdominal pain, nausea, vomiting, diarrhea; frequency not established – constipation, hepatitis; dermatological reactions: often – pruritus, rash, urticaria; frequency not established – Quincke’s edema, acute generalized exanthematous pustulosis; general disorders: often – asthenia. Storage conditionsKeep away from children. Store at temperatures up to 25 °C. Buy Preductal OD extended release capsules 80mg #10×3