Prestarium A 5mg tablets 30
Women's clothing size
With your arms relaxed at your sides, measure around the fullest part of your chest.
Measure around the narrowest part of your natural waist, generally around the belly button. To ensure a comfortable fit, keep one finger between the measuring tape and your body.
Lactose monohydrate, magnesium stearate, maltodextrin, silicon dioxide colloidal hydrophobic, carboxymethyl starch sodium, glycerol, hypromellose, macrogol 6000, titanium dioxide.
The composition of tablets of 5 mg and 10 mg includes copper dye chlorophyllin (E141ii).
Suppression of ACE leads to a decrease in the content of angiotensin II in the blood plasma, as a result of which the activity of plasma renin increases (due to the inhibition of negative feedback, which prevents the release of renin) and the secretion of aldosterone decreases. Since ACE inactivates bradykinin, the suppression of ACE is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin system, while the prostaglandin system is activated. Perindopril reduces OPSS, which leads to a decrease in blood pressure. In this case, peripheral blood flow is accelerated, but the heart rate does not increase.
Perindopril has a therapeutic effect due to the active metabolite, perindoprilate. Other metabolites of the drug do not have an inhibitory effect on ACE in vitro.
Arterial hypertensionWith arterial hypertension against the background of its use of the drug, there is a decrease in both systolic and diastolic blood pressure in the supine position and standing. A decrease in blood pressure is achieved quickly enough. In patients with a positive response to treatment, normalization of blood pressure occurs within a month. In this case, the effect of addiction is not observed.
Discontinuation of treatment is not accompanied by the development of withdrawal syndrome. Perindopril has a vasodilating effect, helps to restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces hypertrophy of the left ventricle. The concomitant appointment of thiazide diuretics enhances the hypotensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also leads to a decrease in the risk of hypokalemia while taking diuretics.
Heart failurePerindopril normalizes the work of the heart, reducing preload and afterload. In patients with chronic heart failure receiving perindopril, a decrease in filling pressure in the left and right ventricles of the heart was detected; reduction of OPSS; increased cardiac output and an increase in the cardiac index. A study of the drug compared with placebo showed that changes in blood pressure after the first intake of Prestarium A at a dose of 2.5 mg in patients with mild and moderate heart failure were not statistically significantly different from the changes in blood pressure observed after taking placebo.
Cerebrovascular diseasesThe International Multicenter Study (PROGRESS) evaluated the effect of active perindopril therapy (monotherapy or in combination with indapamide) for 4 years on the risk of recurrent stroke in patients with a history of cerebrovascular disease. After the introductory period of use of perindopril trentbutylamine 2 mg (equivalent to perindopril arginine 2.5 mg) 1 time / day for 2 weeks and then 4 mg (equivalent to perindopril arginine 5 mg) 1 time / day for the next two weeks, 6105 patients were randomized into two groups: placebo (n = 3054) and perindopril tretbutylamine 4 mg (corresponding to 5 mg of perindopril arginine) (monotherapy) or in combination with indapamide (n = 3051). Indapamide was additionally prescribed to patients who did not have direct indications or contraindications for the use of diuretics. This therapy was prescribed in addition to the standard therapy for stroke and / or arterial hypertension or other pathological conditions. All randomized patients had a history of cerebrovascular disease (stroke or transient ischemic attack) within the last 5 years. The value of blood pressure was not a criterion for inclusion: 2916 patients had arterial hypertension and 3189 had normal blood pressure. After 3.9 years of therapy, the value of blood pressure (systolic / diastolic) decreased by an average of 9/4 mm Hg. A significant reduction in the risk of recurrence of stroke (both ischemic and hemorrhagic nature) was also shown by about 28% (95% CI (17; 38), p< 0.0001) compared to placebo (10.1% vs13.8%). Additionally, a significant reduction in the risk of fatal or disabling strokes has been shown; major cardiovascular complications, including myocardial infarction, including fatal outcome; stroke-related dementia; serious deterioration of cognitive functions.
These therapeutic advantages are observed both in patients with arterial hypertension and with normal blood pressure, regardless of age, sex, the presence or absence of diabetes mellitus and the type of stroke.
Stable CHDIn an international multicenter randomized, double-blind, placebo-controlled EUROPA study lasting 4 years, the efficacy of perindopril in patients with stable chD was studied. The clinical trial involved 12218 patients older than 18 years: 6110 patients took perindopril tretbutylamine 8 mg (equivalent to 10 mg of perindopril arginine) and 6108 patients - placebo.
The main evaluation criteria were cardiovascular mortality, nonfatal myocardial infarction and/ or cardiac arrest followed by successful resuscitation. To participate in the study, patients with coronary artery disease with established myocardial infarction at least 3 months before screening, who underwent coronary revascularization at least 6 months before screening, angiographically detected stenosis (at least 70% narrowing of one or more major coronary arteries) or a positive stress test in the presence of a history of chest pain were selected. The drug was prescribed in addition to the standard therapy used for hyperlipidemia, arterial hypertension and diabetes mellitus.
Most patients took antiplatelet agents, lipid-lowering agents, and beta-blockers. By the end of the study, the ratio of the number of patients taking these groups of drugs was 91%, 69% and 63%, respectively. After 4.2 years as a result of perindopril therapy with tretbutylamine at a dose of 8 mg 1 time / day there was a significant reduction in the relative risk by 20% (95% CI) of the development of predetermined complications: in 488 (8%) patients from the group taking perindopril tretbutylamine, and in 603 (9.9%) patients from the placebo group (p = 0.0003).
The result did not depend on gender, age, blood pressure and the presence of myocardial infarction in the anamnesis.
Indications for use
- arterial hypertension;
- chronic heart failure;
- prevention of repeated stroke (combination therapy with indapamide) in patients who have had a stroke or transient cerebral circulation disorder of the ischemic type;
- stable CHD: to reduce the risk of cardiovascular complications.
- hypersensitivity to the active substance, other ACE inhibitors and excipients that make up the drug;
- angioedema (angioedema) in the anamnesis associated with taking an ACE inhibitor;
- hereditary / idiopathic angioedema;
- simultaneous use with aliskiren-containing drugs in patients with diabetes mellitus or impaired renal function (GFR <60 ml / min / 1.73 m 2 surface area of the body);
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
- the period of breastfeeding;
– age up to 18 years (efficacy and safety have not been established).
With caution, the drug should be used for bilateral stenosis of the renal arteries or the presence of only one functioning kidney, renal failure; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma); Therapy immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis); reduced BCC (taking diuretics, salt-free diet, vomiting, diarrhea); angina pectoris; cerebrovascular diseases; renovascular hypertension; diabetes mellitus; chronic heart failure IV FC according to the NYHA classification; simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt, lithium preparations; hyperkalemia; surgery/general anesthesia; hemodialysis using high-flow membranes; desensitizing therapy; LDL apheresis; condition after kidney transplantation; aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy; in patients of the Negroid race.
Use in pregnancy and lactationPrestarium ® And contraindicated for use during pregnancy.
At the moment, there are no irrefutable epidemiological data on teratogenic risk when taking ACE inhibitors in the first trimester of pregnancy. However, a slight increase in the risk of fetal development disorders cannot be ruled out. When planning pregnancy or its occurrence during the use of the drug Prestarium ® And you should immediately stop taking the drug and, if necessary, prescribe another antihypertensive therapy with a proven safety profile of use during pregnancy.
It is known that the effect of ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to a violation of its development (decreased renal function, oligohydramnion, slowing down the ossification of the bones of the skull) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia).
If the patient received ACE inhibitors in the II and III trimesters of pregnancy, it is recommended to conduct an ultrasound to assess the condition of the bones of the skull and kidney function.
Newborns, mothers who received ACE inhibitors during pregnancy should be monitored because of the risk of developing arterial hypotension.
Breastfeeding periodAt the moment, it has not been established whether perindopril is excreted in breast milk. Due to the lack of information regarding the use of perindopril during breastfeeding, its use is not recommended. It is preferable to use other drugs with a more studied safety profile during breastfeeding, especially when feeding newborns or premature infants.
FertilityIn preclinical studies, the absence of effects of perindopril on reproductive function in rats of both sexes was shown.
Use in case of impaired liver functionWhen prescribing the drug to patients with impaired liver function, dose changes are not required.
Use in renal dysfunctionWith caution, the drug should be used when bilateral stenosis of the renal arteries or the presence of only one functioning kidney; renal failure, a condition after kidney transplantation.
Use in childrenContraindicated use of the drug in patients under the age of 18 years (efficacy and safety of use have not been established).
Use in elderly patientsIn elderly patients, treatment should begin with a dose of 2.5 mg / day.
Special instructionsCHD: reduced risk of cardiovascular complications in patients who have previously had myocardial infarction and / or coronary revascularization
With the development of unstable angina pectoris during the first month of therapy with Prestarium ® And, the benefits and risks should be evaluated before continuing therapy.
Arterial hypotensionACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients with an uncomplicated course Hypertension. The risk of excessive decrease in blood pressure is increased in patients with reduced BCC, which can be noted against the background of diuretic therapy, subject to a strict salt-free diet, hemodialysis, vomiting and diarrhea, as well as in patients with severe arterial hypertension with high renin activity. Symptomatic arterial hypotension can be observed in patients with clinical manifestations of heart failure, both with and without renal failure. This risk is more likely in patients with severe heart failure, as a reaction to taking "loop" diuretics in high doses, hyponatremia or functional renal failure. In patients with an increased risk of developing symptomatic arterial hypotension, blood pressure, kidney function and serum potassium content should be carefully monitored during therapy with Prestarium ® And.
A similar approach is used in patients with coronary artery disease and cerebrovascular diseases, in which severe arterial hypotension can lead to myocardial infarction or impaired cerebral circulation.
In the case of arterial hypotension, the patient should be transferred to a supine position with elevated legs. If necessary, the BCC should be replenished by intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle to the further use of the drug. After the restoration of BCC and blood pressure, treatment can be continued.
In some patients with chronic heart failure and normal or reduced blood pressure Prestarium ® And it can cause an additional decrease in blood pressure. This effect is predictable and usually does not require discontinuation of therapy. When symptoms of a pronounced decrease in blood pressure appear, the dose of the drug should be reduced or stop taking it.
Mitral stenosis/aortic stenosis/hypertrophic obstructive cardiomyopathyPrestarium ® And, like other ACE inhibitors, caution should be administered to patients with obstruction of the exit tract of the left ventricle (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as patients with mitral stenosis.
Impaired renal functionPatients with renal insufficiency (CC <60 ml / min) initial dose of Prestarium ® And it should be selected depending on the value of QC and then - depending on the therapeutic effect. For such patients, regular monitoring of the concentration of creatinine and potassium in the blood serum is necessary.
Arterial hypotension, which sometimes develops at the beginning of taking ACE inhibitors in patients with symptomatic chronic heart failure, can lead to a deterioration in kidney function. It is possible to develop acute renal failure, usually reversible.
In patients with bilateral renal stenosis arteries or stenosis of the artery of a single kidney (especially in the presence of renal failure) against the background of therapy with ACE inhibitors, an increase in the concentration of urea and creatinine in the blood serum is possible, usually passing with the abolition of therapy. The additional presence of renovascular hypertension causes an increased risk of developing severe arterial hypotension and renal failure in such patients. Treatment of such patients begins under close medical supervision with the use of low doses of the drug and further adequate selection of doses. Treatment with diuretics should be temporarily discontinued and regular monitoring of potassium and creatinine in the blood plasma during the first few weeks of therapy should be carried out.
In some patients with arterial hypertension, without indicating the presence of previous vascular disease of the kidneys, the concentration of urea and creatinine in the blood serum may increase, especially with the simultaneous use of diuretic agents. Data the changes are usually mild and reversible. The likelihood of developing these disorders is higher in patients with a history of renal insufficiency. In such cases, it may be necessary to cancel or reduce the dose of the drug Prestarium ® And/or diuretics.
HemodialysisIn patients on hemodialysis using high-flow membranes, cases of the development of anaphylactic reactions against the background of therapy with ACE inhibitors were noted. The appointment of ACE inhibitors should be avoided when using this type of membrane. In such situations, consideration should be given to prescribing a hypotensive drug of another class or using a dialysis membrane of another type.
Kidney transplantationData on the use of the drug Prestarium ® And in patients after transplantation, kidneys are absent.
Hypersensitivity/ angioedemaWhen taking inhibitors ACE, incl. perindopril, in rare cases and in any period of therapy, the development of angioedema of the face, upper and lower extremities, lips, mucous membranes, tongue, vocal folds and / or larynx can be observed. When symptoms appear, the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely. If the swelling affects only the face and lips, then its manifestations usually go away on their own, although antihistamines can be used to treat the symptoms.
Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, vocal folds, or larynx can lead to airway obstruction. When such symptoms appear, emergency therapy is required, incl. p/c administration of epinephrine (adrenaline) and / or ensuring airway patency. The patient should be under medical supervision until the symptoms completely and persistently disappear.
In patients with angioedema in the anamnesis, not associated with taking ACE inhibitors, the risk of its development may be increased when taking drugs in this group.
In rare cases, against the background of therapy with ACE inhibitors, angioedema of the intestine develops. At the same time, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without previous angioedema of the face and with a normal level of C1-esterase. The diagnosis was established using computed tomography of the abdominal cavity, ultrasound examination or surgical intervention. Symptoms disappeared after discontinuation of ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during LDL apheresisIn rare cases, in patients, receiving ACE inhibitors, during the LDL apheresis procedure using dextran sulfate, life-threatening anaphylactoid reactions may develop. To prevent an anaphylactoid reaction, therapy with an ACE inhibitor should be temporarily discontinued before each apheresis procedure.
Anaphylactoid reactions during desensitizationThere are isolated reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, for example, hymenopteran insect venom. In these patients, such reactions were prevented by temporarily canceling ACE inhibitors, but with accidental or careless resumption of treatment, reactions could develop again.
HyperkalemiaHyperkalemia can develop during treatment with ACE inhibitors, incl. perindopril. Risk factors for hyperkalemia are renal failure, decreased renal function, age over 70 years of age, diabetes mellitus, some concomitant conditions (dehydration, acute heart failure, metabolic acidosis), simultaneous administration of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride), food additives / potassium preparations or potassium-containing substitutes for edible salt, as well as the use of other drugs that contribute to Increase the content of potassium in the blood (for example, heparin). The use of food additives / potassium preparations, potassium-sparing diuretics, potassium-containing substitutes for edible salt can lead to a significant increase in the potassium content in the blood, especially in patients with reduced renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If it is necessary to simultaneously use the drug Prestarium ® And the above drugs, treatment should be carried out with caution against the background of regular monitoring of the potassium content in the blood serum.
Patients with diabetes mellitusWhen prescribing the drug to patients with diabetes mellitus receiving hypoglycemic drugs for oral administration or insulin, during the first month of therapy, it is necessary to regularly monitor the concentration of glucose in the blood.
Influence on the ability to drive vehicles and control mechanismsPrestarium ® And it should be used with caution in patients driving vehicles and engaged in activities that require increased concentration of attention and speed of reaction, due to the risk of developing arterial hypotension and dizziness.
Dosage and Administration
The most frequent adverse events reported in clinical studies and observed with the use of perindopril are: dizziness, headache, paresthesia, vertigo, visual impairment, tinnitus, excessive decrease in blood pres
- Dosage form
- 10 mg
- Number of tablets
- INN Russian
- Russian title