Preductal OD capsules with prolonged release. 80 mg 30 pcs. (Trimetazidine)
Special Price
$40.59
Regular Price
$41.00
In stock
SKU
florida606100
Latin name
PREDUCTAL OD Buy Preductal OD capsules with prolonged release. 80 mg 30 pcs. (Trimetazidine) in florida free shipping. Fast international shipping USA, AU, EU, UK and others.
PREDUCTAL OD Buy Preductal OD capsules with prolonged release. 80 mg 30 pcs. (Trimetazidine) in florida free shipping. Fast international shipping USA, AU, EU, UK and others.
Latin name
PREDUCTAL OD
Release form
Sustained-release capsules hard gelatin, No. 2, with a white case and an orange-red lid on the lid, the company logo and the inscription 80 are printed in white * the contents of the capsule are spherical granules of white or almost white color.
Pharmacological action of
Trimetazidine prevents a decrease in the intracellular concentration of adenosine triphosphate (ATP) by maintaining the energy metabolism of cells in a state of hypoxia. Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions and preservation of cellular homeostasis.
Trimetazidine inhibits fatty acid oxidation by selectively inhibiting the 3-ketoacyl-CoA-thiolase (3-CAT) enzyme of the mitochondrial long chain fatty acid isoform, which leads to increased glucose oxidation and accelerated glycolysis with glucose oxidation, which causes myocardium protection from ischemia. Switching energy metabolism from fatty acid oxidation to glucose oxidation underlies the pharmacological properties of trimetazidine.
Pharmacodynamic properties
- supports energy metabolism of the heart and sensorineural tissues during
ischemia - reduces the severity of intracellular acidosis and changes in the transmembrane ion flux resulting from
ischemia - lowers the level of migration and infiltration of polynuclear neutrophils in ischemic heart disease - myocardium
- does not directly affect hemodynamic parameters.
In patients with angina pectoris, trimetazidine increases the coronary reserve, thereby slowing the onset of ischemia caused by physical activity, starting from the 15th day of therapy it limits the fluctuations in blood pressure, caused by physical activity, without significant changes in heart rate significantly reduces the frequency of angina attacks and the need for short-acting nitroglycerin improves left ventricular contractility in patients with ischemic dysfunction.
The results of clinical studies have confirmed the efficacy and safety of trimetazidine in patients with stable angina pectoris, both in monotherapy and in combination therapy with insufficient effect of other antianginal drugs.
In a study of 426 patients with stable angina, the addition of trimetazidine (60 mg / day) to 100 mg / day metoprolol therapy (50 mg 2 times / day) for 12 weeks, statistically significantly improved exercise test results and clinical symptoms compared with a placebo: the total duration of the stress tests was +20.1 s, p = 0.023, the total execution time of the load was +0.54 METs, p = 0.001, the time before the development of ST segment depression was 1 mm +33.4 s, p = 0.003, the time before the development of an angina attack was +33.9 s , p
In a study of 223 patients with stable angina, the addition of trimetazidine at a dose of 35 mg (2 times / day) to atenolol at a dose of 50 mg (1 time / day) for 8 weeks led to an increase in the time until the development of ischemic depression ST segment per 1 mm (+34.4 s, p = 0.03) during stress tests in a subgroup of patients (n = 173), In comparison with placebo, 12 hours after ingestion. This difference was also shown for the time of development of angina attacks (p = 0.049). There were no significant differences between the groups for other secondary endpoints (total duration of exercise tests, total exercise time, and clinical endpoints).
In a study of 1962 patients with stable angina, trimetazidine in two dosages (70 mg / day and 140 mg / day) compared with placebo was added to atenolol therapy 50 mg / day. In the general population, including patients, both without symptoms and with symptoms of angina pectoris, trimetazidine did not show ergometric advantages (total duration of stress tests, time to 1 mm of ischemic ST segment depression, and time to development of an angina pectoris attack) and clinical endpoints . However, in a retrospective analysis in a subgroup of patients with symptoms of angina pectoris (n = 1574), trimetazidine (140 mg) significantly improved the total time of the stress test (+23.8 s compared to +13.1 s for placebo p = 0.001) and the time before the development of an angina attack (+46.3 s compared to +32.5 for placebo p = 0.005).
Indications
Long-term therapy for coronary artery disease: prevention of attacks of stable angina as part of mono- or combination therapy.
Contraindications
- severe renal failure (CC less than 30 ml / min)
- Parkinson's disease, symptoms of parkinsonism, tremor, restless legs syndrome and other related motor disorders
- fructose / sucrose intolerance, glucose-galactose malabsorption syndrome, sucrose / isomaltase deficiency and other enzymes associated with sucrose intolerance, which is part of the
preparation - age under 18 years (due to lack of sufficient clinical data)
- hypersensitivity to any of the components of the drug.
With caution, the drug should be prescribed to patients with severe hepatic insufficiency (from 10 to 15 points on the Child-Pugh scale), moderate renal insufficiency (CC 30-60 ml / min), patients older than 75 years (see sections Dosage regimen and Special instructions ).
Use during pregnancy and lactation
There are no data on the use of the drug Preductal® OD in pregnant women. Animal studies have not revealed the presence of direct or indirect reproductive toxicity. Reproductive toxicity studies have not shown the effect of trimetazidine on reproductive function in rats of either sex. As a precaution, It is not recommended to use the drug Preductal® OD during pregnancy.
There are no data on the release of trimetazidine or its metabolites in breast milk. The risk to the newborn / child cannot be excluded. If it is necessary to use the drug Preductal® OD during lactation, breastfeeding should be stopped.
Special instructions
PreductalВ® OD 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 at the prehospital stage or in the early days of hospitalization.
In the event of an attack of angina pectoris, treatment (drug therapy or a revascularization procedure) should be reviewed and adapted. PreductalВ® OD can cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), therefore, regular monitoring of patients, especially the elderly, should be carried out. In doubtful cases, the patient should be referred to a neurologist for an appropriate examination.
In the event of motor impairment, such as symptoms of parkinsonism, restless legs syndrome, tremors, unsteady gait, PreductalВ® OD should be permanently withdrawn. Such cases are rare and symptoms usually disappear after discontinuation of therapy: in most patients, within 4 months after discontinuation of the drug. If symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, consult a neurologist.
There may be cases of a fall associated with instability in the Romberg position and unsteady gait or a marked decrease in blood pressure, especially in patients taking antihypertensive drugs (see section Adverse effects).
Caution is advised to administer PreductalВ® OD to patients in whom exposure may be increased:
for moderate renal failure (see sections Pharmacological action and Dosage regimen)
- in elderly patients older than 75 years (see section Dosage regimen).
The preparation contains sucrose, therefore the drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome and sucrose-isomaltase deficiency.
Influence on the ability to drive vehicles and control mechanisms
During clinical trials, the effect of trimetazidine on hemodynamic parameters was not detected, however, during post-registration use, there were cases of dizziness and drowsiness (see section Adverse effects). These symptoms may affect the ability to drive vehicles and perform work that requires an increased rate of physical and mental reactions.
Composition
1 caps. - trimetazidine dihydrochloride (in granules) 80 mg
1 sustained-release hard capsule contains: granules with a layer of trimetazidine dihydrochloride film-coated: 144.85 mg.
Excipients: sugar spheres (710-850 microns) - 36.68 mg, hypromellose - 6.4 mg.
The composition of the film coat of granules: ethyl cellulose - 8 mg, tributylacetyl citrate - 1.2 mg, talc - 12 mg.
The composition of the mixture for dusting granules: talc - 0.43 mg, magnesium stearate - 0.14 mg.
Dosage and administration
The drug is taken orally, 1 capsule 1 time / day, in the morning during breakfast. Capsules should be taken whole without chewing, washed down with water.
Evaluation of the benefits of treatment can be carried out after 3 months of use of the drug. If there is no improvement during this time, the use of the drug Preductal® OD should be discontinued.
Duration of treatment is determined by the physician.
In patients with moderate renal failure (CC 30-60 ml / min) (see sections Pharmacokinetics and Special instructions) a dose reduction is recommended, i.e. 1 tablet containing 35 mg of trimetazidine per day.
Caution should be exercised in the treatment of patients with severe hepatic insufficiency (see the Special Instructions section), since the available data are limited and cannot completely exclude the absence of the effect of liver dysfunction on the metabolism of trimetazidine.
Patients older than 75 years may experience increased exposure to trimetazidine due to an age-related decrease in renal function (see Pharmacokinetics section). In patients with moderate renal insufficiency (CC 30-60 ml / min), a dose reduction is recommended, i.e. 1 tablet containing 35 mg of trimetazidine per day. Dose selection in patients older than 75 years should be done with caution (see section Special instructions).
Safety and efficacy of trimetazidine in patients under the age of 18 have not been established. No data available.
Side effects
Adverse reactions, defined as undesirable phenomena, at least related to trimetazidine treatment, are given in the following gradation: very often (? 1/10) often (? 1/100,
From the central nervous system: often - dizziness, headache of unspecified frequency - symptoms of parkinsonism (tremor, akinesia, increased tone), gait shakiness, restless legs syndrome, other associated motor disorders, usually reversible after stopping therapy Sleep disturbances (insomnia, drowsiness)
From the cardiovascular system: rarely - sensed palpitations, extrasystole, tachycardia, marked decrease in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially with the simultaneous use of antihypertensive drugs, flushing of the face.
From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting of unspecified frequency - constipation.
From the liver and biliary tract: unspecified frequency - hepatitis.
From the hemopoietic system: unspecified frequency - agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
From the skin and subcutaneous fat: often - a skin rash, itching, urticaria of unspecified frequency - Quincke's edema, acute generalized exanthematous pustulosis.
General disorders: often - asthenia.
Drug Interactions
Not observed. The patient must inform the doctor about all medications taken.
Overdose
There is only very limited information on trimethazidine overdose.
Treatment: symptomatic therapy should be performed in case of overdose.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 25 ° C.
shelf life
2 years
Deystvuyushtee substance
trimetazidine
Terms and conditions
prescription
dosage form
prolonged-action capsules
Indications Indications
Angina Coronary
Pharmstandard-Leksredstva, Russia
Preductal OD capsules with prolonged release. 80 mg 30 pcs. (Trimetazidine) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Preductal OD capsules with prolonged release. 80 mg 30 pcs. - Sale. PayPal accept. Free shipping florida. Fast international shipping.
PREDUCTAL OD
Release form
Sustained-release capsules hard gelatin, No. 2, with a white case and an orange-red lid on the lid, the company logo and the inscription 80 are printed in white * the contents of the capsule are spherical granules of white or almost white color.
Pharmacological action of
Trimetazidine prevents a decrease in the intracellular concentration of adenosine triphosphate (ATP) by maintaining the energy metabolism of cells in a state of hypoxia. Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions and preservation of cellular homeostasis.
Trimetazidine inhibits fatty acid oxidation by selectively inhibiting the 3-ketoacyl-CoA-thiolase (3-CAT) enzyme of the mitochondrial long chain fatty acid isoform, which leads to increased glucose oxidation and accelerated glycolysis with glucose oxidation, which causes myocardium protection from ischemia. Switching energy metabolism from fatty acid oxidation to glucose oxidation underlies the pharmacological properties of trimetazidine.
Pharmacodynamic properties
- supports energy metabolism of the heart and sensorineural tissues during
ischemia - reduces the severity of intracellular acidosis and changes in the transmembrane ion flux resulting from
ischemia - lowers the level of migration and infiltration of polynuclear neutrophils in ischemic heart disease - myocardium
- does not directly affect hemodynamic parameters.
In patients with angina pectoris, trimetazidine increases the coronary reserve, thereby slowing the onset of ischemia caused by physical activity, starting from the 15th day of therapy it limits the fluctuations in blood pressure, caused by physical activity, without significant changes in heart rate significantly reduces the frequency of angina attacks and the need for short-acting nitroglycerin improves left ventricular contractility in patients with ischemic dysfunction.
The results of clinical studies have confirmed the efficacy and safety of trimetazidine in patients with stable angina pectoris, both in monotherapy and in combination therapy with insufficient effect of other antianginal drugs.
In a study of 426 patients with stable angina, the addition of trimetazidine (60 mg / day) to 100 mg / day metoprolol therapy (50 mg 2 times / day) for 12 weeks, statistically significantly improved exercise test results and clinical symptoms compared with a placebo: the total duration of the stress tests was +20.1 s, p = 0.023, the total execution time of the load was +0.54 METs, p = 0.001, the time before the development of ST segment depression was 1 mm +33.4 s, p = 0.003, the time before the development of an angina attack was +33.9 s , p
In a study of 223 patients with stable angina, the addition of trimetazidine at a dose of 35 mg (2 times / day) to atenolol at a dose of 50 mg (1 time / day) for 8 weeks led to an increase in the time until the development of ischemic depression ST segment per 1 mm (+34.4 s, p = 0.03) during stress tests in a subgroup of patients (n = 173), In comparison with placebo, 12 hours after ingestion. This difference was also shown for the time of development of angina attacks (p = 0.049). There were no significant differences between the groups for other secondary endpoints (total duration of exercise tests, total exercise time, and clinical endpoints).
In a study of 1962 patients with stable angina, trimetazidine in two dosages (70 mg / day and 140 mg / day) compared with placebo was added to atenolol therapy 50 mg / day. In the general population, including patients, both without symptoms and with symptoms of angina pectoris, trimetazidine did not show ergometric advantages (total duration of stress tests, time to 1 mm of ischemic ST segment depression, and time to development of an angina pectoris attack) and clinical endpoints . However, in a retrospective analysis in a subgroup of patients with symptoms of angina pectoris (n = 1574), trimetazidine (140 mg) significantly improved the total time of the stress test (+23.8 s compared to +13.1 s for placebo p = 0.001) and the time before the development of an angina attack (+46.3 s compared to +32.5 for placebo p = 0.005).
Indications
Long-term therapy for coronary artery disease: prevention of attacks of stable angina as part of mono- or combination therapy.
Contraindications
- severe renal failure (CC less than 30 ml / min)
- Parkinson's disease, symptoms of parkinsonism, tremor, restless legs syndrome and other related motor disorders
- fructose / sucrose intolerance, glucose-galactose malabsorption syndrome, sucrose / isomaltase deficiency and other enzymes associated with sucrose intolerance, which is part of the
preparation - age under 18 years (due to lack of sufficient clinical data)
- hypersensitivity to any of the components of the drug.
With caution, the drug should be prescribed to patients with severe hepatic insufficiency (from 10 to 15 points on the Child-Pugh scale), moderate renal insufficiency (CC 30-60 ml / min), patients older than 75 years (see sections Dosage regimen and Special instructions ).
Use during pregnancy and lactation
There are no data on the use of the drug Preductal® OD in pregnant women. Animal studies have not revealed the presence of direct or indirect reproductive toxicity. Reproductive toxicity studies have not shown the effect of trimetazidine on reproductive function in rats of either sex. As a precaution, It is not recommended to use the drug Preductal® OD during pregnancy.
There are no data on the release of trimetazidine or its metabolites in breast milk. The risk to the newborn / child cannot be excluded. If it is necessary to use the drug Preductal® OD during lactation, breastfeeding should be stopped.
Special instructions
PreductalВ® OD 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 at the prehospital stage or in the early days of hospitalization.
In the event of an attack of angina pectoris, treatment (drug therapy or a revascularization procedure) should be reviewed and adapted. PreductalВ® OD can cause or worsen symptoms of parkinsonism (tremor, akinesia, increased tone), therefore, regular monitoring of patients, especially the elderly, should be carried out. In doubtful cases, the patient should be referred to a neurologist for an appropriate examination.
In the event of motor impairment, such as symptoms of parkinsonism, restless legs syndrome, tremors, unsteady gait, PreductalВ® OD should be permanently withdrawn. Such cases are rare and symptoms usually disappear after discontinuation of therapy: in most patients, within 4 months after discontinuation of the drug. If symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, consult a neurologist.
There may be cases of a fall associated with instability in the Romberg position and unsteady gait or a marked decrease in blood pressure, especially in patients taking antihypertensive drugs (see section Adverse effects).
Caution is advised to administer PreductalВ® OD to patients in whom exposure may be increased:
for moderate renal failure (see sections Pharmacological action and Dosage regimen)
- in elderly patients older than 75 years (see section Dosage regimen).
The preparation contains sucrose, therefore the drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome and sucrose-isomaltase deficiency.
Influence on the ability to drive vehicles and control mechanisms
During clinical trials, the effect of trimetazidine on hemodynamic parameters was not detected, however, during post-registration use, there were cases of dizziness and drowsiness (see section Adverse effects). These symptoms may affect the ability to drive vehicles and perform work that requires an increased rate of physical and mental reactions.
Composition
1 caps. - trimetazidine dihydrochloride (in granules) 80 mg
1 sustained-release hard capsule contains: granules with a layer of trimetazidine dihydrochloride film-coated: 144.85 mg.
Excipients: sugar spheres (710-850 microns) - 36.68 mg, hypromellose - 6.4 mg.
The composition of the film coat of granules: ethyl cellulose - 8 mg, tributylacetyl citrate - 1.2 mg, talc - 12 mg.
The composition of the mixture for dusting granules: talc - 0.43 mg, magnesium stearate - 0.14 mg.
Dosage and administration
The drug is taken orally, 1 capsule 1 time / day, in the morning during breakfast. Capsules should be taken whole without chewing, washed down with water.
Evaluation of the benefits of treatment can be carried out after 3 months of use of the drug. If there is no improvement during this time, the use of the drug Preductal® OD should be discontinued.
Duration of treatment is determined by the physician.
In patients with moderate renal failure (CC 30-60 ml / min) (see sections Pharmacokinetics and Special instructions) a dose reduction is recommended, i.e. 1 tablet containing 35 mg of trimetazidine per day.
Caution should be exercised in the treatment of patients with severe hepatic insufficiency (see the Special Instructions section), since the available data are limited and cannot completely exclude the absence of the effect of liver dysfunction on the metabolism of trimetazidine.
Patients older than 75 years may experience increased exposure to trimetazidine due to an age-related decrease in renal function (see Pharmacokinetics section). In patients with moderate renal insufficiency (CC 30-60 ml / min), a dose reduction is recommended, i.e. 1 tablet containing 35 mg of trimetazidine per day. Dose selection in patients older than 75 years should be done with caution (see section Special instructions).
Safety and efficacy of trimetazidine in patients under the age of 18 have not been established. No data available.
Side effects
Adverse reactions, defined as undesirable phenomena, at least related to trimetazidine treatment, are given in the following gradation: very often (? 1/10) often (? 1/100,
From the central nervous system: often - dizziness, headache of unspecified frequency - symptoms of parkinsonism (tremor, akinesia, increased tone), gait shakiness, restless legs syndrome, other associated motor disorders, usually reversible after stopping therapy Sleep disturbances (insomnia, drowsiness)
From the cardiovascular system: rarely - sensed palpitations, extrasystole, tachycardia, marked decrease in blood pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially with the simultaneous use of antihypertensive drugs, flushing of the face.
From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting of unspecified frequency - constipation.
From the liver and biliary tract: unspecified frequency - hepatitis.
From the hemopoietic system: unspecified frequency - agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
From the skin and subcutaneous fat: often - a skin rash, itching, urticaria of unspecified frequency - Quincke's edema, acute generalized exanthematous pustulosis.
General disorders: often - asthenia.
Drug Interactions
Not observed. The patient must inform the doctor about all medications taken.
Overdose
There is only very limited information on trimethazidine overdose.
Treatment: symptomatic therapy should be performed in case of overdose.
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 25 ° C.
shelf life
2 years
Deystvuyushtee substance
trimetazidine
Terms and conditions
prescription
dosage form
prolonged-action capsules
Indications Indications
Angina Coronary
Pharmstandard-Leksredstva, Russia
Preductal OD capsules with prolonged release. 80 mg 30 pcs. (Trimetazidine) florida in pharmacy online. Cheap price, instruction, side effects, dosage. Preductal OD capsules with prolonged release. 80 mg 30 pcs. - Sale. PayPal accept. Free shipping florida. Fast international shipping.
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