Comparing Perindopril and Prestarium | Determining the best

Updated: 04/23/2021 15:13:41

Expert: Abramova Tsilya

With age, the risk of diseases of the cardiovascular system increases significantly; prerequisites for hypertension (high blood pressure) appear even in young people. To prevent this and maintain the condition within normal limits, antihypertensive drugs are used. Our team has analyzed two popular drugs in this group and is ready to conclude which drug is better - Perindopril or Prestarium.

Prestarium - features

The drug Prestarium is an antihypertensive drug. The main active ingredient is perindopril. This substance has a vasodilating effect, acting as a catalyst for a number of chemical processes in the body.

The product is available in tablet form. You can get it with a doctor's prescription. It has strict indications and contraindications, which excludes self-medication. Before prescribing the medicine, the doctor prescribes a series of diagnostic procedures that allow you to determine the most optimal treatment tactics.

Reference!

There is also a drug Bi-Prestarium, which already contains 2 components - perindopril and amlodipine.

Pharmacological properties of the drug Bi-prestarium

Perindopril is an ACE inhibitor that converts angiotensin I into the vasoconstrictor angiotensin II, and also causes the breakdown of the vasodilator bradykinin. ACE inhibition leads to a decrease in the concentration of angiotensin II in the blood plasma, an increase in the activity of renin in the blood plasma and a decrease in the secretion of aldosterone. Also, ACE inhibition leads to an increase in bradykinin levels, the activity of the circulating and local kalikreinin system, as well as activation of the prostaglandin system. This mechanism of action determines a decrease in blood pressure. The action of perindopril is due to its active metabolite - perindoprilat. Other metabolites are inactive. Hypertension (arterial hypertension) Perindopril effectively reduces systolic and diastolic blood pressure in hypertension (arterial hypertension) of any severity: mild, moderate and severe. Perindopril reduces peripheral vascular resistance, which leads to a decrease in blood pressure. As a result, peripheral blood flow increases, but heart rate does not change. Renal blood flow increases, but the glomerular filtration rate does not change. The maximum antihypertensive effect develops 4–6 hours after taking a single dose and persists for at least 24 hours: the T/R ratio (the ratio of the residual effect to the maximum) of perindopril is 87–100%. Blood pressure decreases quickly. In patients who responded to treatment, blood pressure normalizes within a month and persists for a long time without the occurrence of tachyphylaxis. When you stop taking perindopril, there is no withdrawal effect. Perindopril reduces left ventricular hypertrophy. Perindopril has vasodilatory properties, improves the elasticity of large arteries and reduces the wall thickness to lumen ratio of small vessels. Prevention of cardiovascular complications in patients with documented stable coronary artery disease. The 4-year EUROPA study (European Trial on the Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease) with the participation of more than 12 thousand patients with coronary artery disease proved that treatment with perindopril significantly reduces probability:

• development of fatal and non-fatal myocardial infarction by 24%;
• development of heart failure, which requires hospitalization, by 39%.

Amlodipine Amlodipine is a calcium ion antagonist (slow calcium channel blocker), which blocks the transmembrane flow of calcium ions to myocardial and vascular smooth muscle cells. The mechanism of the antihypertensive effect of amlodipine is due to a direct relaxing effect on vascular smooth muscle. The antianginal effect of amlodipine is achieved by two mechanisms:

• expansion of peripheral arterioles, and, as a result, a decrease in total peripheral resistance (afterload). Since heart rate does not change, reducing the load on the heart reduces myocardial energy consumption and its oxygen demand;
• expansion of the main coronary arteries and arterioles in both unchanged and ischemic areas of the myocardium. This dilation increases the supply of oxygen to the myocardium in patients with vasospastic angina (Prinzmetal's angina or variant angina).

In patients with hypertension (arterial hypertension), taking amlodipine once a day provides a clinically significant decrease in blood pressure over 24 hours. Due to the slow onset of action of amlodipine, a sharp decrease in blood pressure was not observed. In patients with angina pectoris, amlodipine prolongs the total time of physical activity, the time before the onset of an angina attack and increases the time before the onset of depression of the S-T by 1 mm during exercise, and also reduces the frequency of angina attacks and reduces the need for nitroglycerin. Amlodipine does not cause undesirable metabolic effects or changes in plasma lipid levels, so it can be used in patients with asthma, diabetes mellitus and gout. Properties common to perindopril and amlodipine The ASCOT-BLPA study (Anglo-Scandinavian Cardiac outcomes Trial - Blood Pressure Lowering Arm) involving 19,257 patients with hypertension (arterial hypertension) and cardiovascular risk factors proved the advantages of long-term therapy with amlodipine and perindopril compared with therapy with atenolol and a diuretic to reduce the incidence of cardiovascular complications. According to the results of the study, patients in the group that received amlodipine + perindopril had a significantly reduced risk of cardiovascular complications, namely, a reduced risk of:

• coronary complications and interventions - by 16%;
• overall mortality - by 11%;
• cardiovascular mortality - by 24%;
• fatal and non-fatal stroke - by 23%;
• non-fatal myocardial infarction (except silent) and fatal complications of coronary artery disease - by 13%.

The rate and degree of absorption of perindopril and amlodipine, both as single drugs and as part of the drug Bi-Prestarium, do not differ significantly. Perindopril After oral administration, perindopril is rapidly absorbed, the maximum concentration in the blood plasma is reached within 1 hour. The half-life of perindopril in the blood plasma is 1 hour. Perindopril is a prodrug. 27% of the total amount of perindopril taken is determined in the blood in the form of an active metabolite - perindoprilate. In addition to the active metabolite - perindoprilate, the drug forms 5 inactive metabolites. The maximum concentration of perindoprilate in the blood plasma is achieved 3–4 hours after administration. There is a linear relationship between the dose of perindopril and its concentration in the blood plasma. Eating food slightly slows down the conversion of perindopril to perindoprilat, so perindopril should be taken before meals. The volume of distribution of unbound perindoprilate is 0.2 l/kg. The binding of perindoprilate to plasma proteins is 20%, mainly with ACE, this indicator is dose-dependent. Perindoprilat is excreted in the urine. The stage of equilibrium concentration in blood plasma occurs 4 days after the start of treatment. The kinetics of perindopril changes in patients with liver cirrhosis. The hepatic clearance of perindopril is reduced by half. However, the amount of perindoprilate formed does not decrease. Therefore, such patients do not need to adjust the dose. Dialysis clearance of perindoprilate is 70 ml/min. Amlodipine After oral administration in therapeutic doses, amlodipine is well absorbed and reaches maximum concentration in the blood 6-12 hours after administration. Absolute bioavailability is 64–80%. Volume of distribution - 21 l/kg. Food intake does not affect the bioavailability of amlodipine. in vitro study showed that 97.5% of circulating amlodipine is bound to plasma proteins. The half-life from blood plasma is 35–50 hours, which allows the drug to be administered once a day. Amlodipine is metabolized in the liver to form inactive metabolites, 10% of the drug is excreted in the urine unchanged and 60% in the form of metabolites.

Perindopril - features

Perindopril tablets contain the substance of the same name. Auxiliary components are magnesium stearate, cellulose, lactose, primellose. The medicine belongs to ACE inhibitors.

In addition to the main effect, lowering blood pressure, the drug has a positive effect on the condition of arterial vessels. When used systematically, it normalizes the functioning of the heart as a whole.

Perindopril can be prescribed for chronic heart failure to reduce the severity of the disease. According to the bicycle ergometer test, the product increases endurance, that is, tolerance to physical activity.

Overdose of the drug Bi-prestarium

No cases have been reported. Overdose of amlodipine can lead to excessive peripheral vasodilation and, as a result, significant and possibly prolonged systemic hypotension. Amlodipine is not excreted during hemodialysis. Information on perindopril is limited. An overdose of ACE inhibitors may cause arterial hypotension, circulatory shock, electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough, etc. Perindopril can be removed from the systemic circulation using hemodialysis.

Indications for use

The main indication for the use of antihypertensive drugs Perindopril and Prestarium is high blood pressure. Moreover, each drug has several positive effects, which contribute to their use in a number of diseases of the cardiovascular system.

For what diseases and conditions is Prestarium prescribed:

1. arterial hypertension;
2. prevention of complications in coronary heart disease;
3. prevention of repeated ischemia in cerebrovascular disorders;
4. stroke prevention;
5. heart failure.

Regular use of the drug helps delay the progression of the disease in heart failure. Treatment improves survival and reduces hospitalizations.

Perindopril has the following indications:

1. arterial hypertension;
2. chronic heart failure;
3. prevention of stroke recurrence and micro-stroke;
4. reducing the risk of complications in persistent ischemic disease.

Patients who have suffered a stroke can use this antihypertensive medication in the comprehensive prevention of complications. In this case, it is combined with indapamide.

Interactions of the drug Bi-prestarium

All warnings associated with each of the components of the drug apply to the drug Bi-Prestarium. For perindopril, simultaneous use with:

• potassium-sparing diuretics, potassium supplements, or potassium salt substitutes, as these may significantly increase serum potassium levels. Their simultaneous use with Bi-Prestarium is not recommended. If concomitant use is indicated due to the presence of documented hypokalemia, they should be used with caution. It is necessary to monitor blood plasma potassium levels;
• lithium Concomitant use of lithium and ACE inhibitors is not recommended due to the possible occurrence of a reverse increase in the concentration of lithium in the blood serum and, accordingly, an increase in its toxicity (severe neurotoxicity). However, if this is truly necessary, serum lithium concentrations should be carefully monitored;
• estramustine - increased risk of angioedema.

Drugs that require monitoring when co-administered: NSAIDs, including acetylsalicylic acid at a dose of ≥3 g/day, may increase the risk of renal impairment, including acute renal failure, and increased serum potassium levels, especially in patients with existing impairment kidney function. Prescribe with caution, especially for elderly patients. Periodic monitoring of renal function is necessary. Antidiabetic agents (insulin, hypoglycemic sulfonamides): when used simultaneously with ACE inhibitors, the hypoglycemic effect may be enhanced (possibly due to increased glucose tolerance). Diuretics: to reduce the risk of arterial hypotension, it is recommended to stop taking diuretics and restore water and electrolyte balance before starting treatment with ACE inhibitors. Sympathomimetics may reduce the antihypertensive effects of ACE inhibitors. Gold : with the simultaneous use of ACE inhibitors, including perindopril, and injectable gold preparations (sodium aurothiomalate), reactions similar to those with the use of nitrates (facial redness, hot flushes, nausea, vomiting and hypotension) may rarely occur. For amlodipine, simultaneous administration of: Dantrolene (infusion): simultaneous administration of dantrolene and calcium antagonists is not recommended due to the risk of ventricular fibrillation. Drugs for which simultaneous use requires caution Inducers of CYP 3A4 (rifampicin, hypericum perforatum, anticonvulsants such as carbamazepine, phenobarbital, fosphenytoin, phenytoin, primidone): simultaneous use may lead to a decrease in the concentration of amlodipine in the blood plasma. Amlodipine should be prescribed in combination with CYP3A4 inducers with caution; if necessary, the dose of amlodipine can be adjusted. CYP3A4 inhibitors (itraconazole, ketoconazole): simultaneous use may increase the plasma concentration of amlodipine and the incidence of its side effects. Amlodipine should be prescribed in combination with these drugs with caution; if necessary, the dosage of amlodipine can be changed. β-receptor blockers used for heart failure (bisoprolol, carvedilol, metoprolol): risk of arterial hypotension, cardiac weakness in patients with heart failure (both latent and uncontrolled). Co-administration of amlodipine is safe with thiazide diuretics, ACE inhibitors, β-receptor blockers, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, drugs to reduce gastric acidity (aluminum hydroxide gel, magnesium hydroxide, simethicone), cimetidine, NSAIDs , antibiotics and oral hypoglycemic drugs. Consuming grapefruit juice does not significantly affect the pharmacokinetics of amlodipine. General properties of perindopril and amlodipine Drugs whose simultaneous administration requires monitoring: baclofen - may enhance the antihypertensive effect; antihypertensive drugs (such as beta-receptor blockers) and vasodilators : the simultaneous use of these drugs may enhance the hypotensive effect of perindopril and amlodipine; α-receptor blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin): enhance the antihypertensive effect and increase the risk of orthostatic hypotension; GCS, tetracosactide : weakening of the antihypertensive effect (through the retention of water and salts of GCS); amifostine : may enhance the hypotensive effect; tricyclic antidepressants/antipsychotics/anesthetics : increased antihypertensive effect and increased risk of orthostatic hypotension.

Contraindications and adverse reactions

A common contraindication for the two drugs is intolerance to perindopril and allergy to auxiliary components. Otherwise, the drugs have a number of contraindications, which must be taken into account when choosing the best drug for treatment.

What are the contraindications for the drug Prestarium:

1. angioedema of hereditary type, including idiopathic;
2. aortic stenosis;
3. severe autoimmune collagenosis, scleroderma;
4. intolerance to drugs of the ACE inhibitor group;
5. coronary and cerebral insufficiency bleeding;
6. diabetes;
7. elderly age;
8. chronic renal failure, which is accompanied by hypercalcemia.

Medicines are not prescribed to women during pregnancy, during pregnancy planning and during breastfeeding. The drugs have a systemic effect, the components are able to penetrate the placenta and into breast milk.

The drug Perindopril has the following contraindications:

1. previous angioedema while taking ACE inhibitors;
2. idiopathic and hereditary angioedema;
3. severe autoimmune connective tissue diseases;
4. kidney transplantation;
5. chronic renal failure;
6. impaired blood circulation in the bone marrow while taking immunosuppressants;
7. dehydration of the body;
8. condition after general anesthesia;
9. a diet with reduced sodium intake;
10. childhood, pregnancy and lactation.

There are conditions in which an antihypertensive drug may be prescribed with caution. In particular, these are diseases associated with circulatory disorders.

The prescription of medication for coronary insufficiency, acute ischemic disease, when there is a risk of a strong decrease in blood pressure, is considered individually. The medicine is used with caution in cases of cerebrovascular accident.

Contraindications to the use of the drug Bi-prestarium

Hypersensitivity to perindopril (or any other ACE inhibitors), amlodipine (or other dihydropyridines) or to any excipient; history of angioedema associated with previous treatment with ACE inhibitors; congenital or idiopathic angioedema; During pregnancy and breastfeeding; severe arterial hypotension; shock, including cardiogenic; obstruction of the exit from the left ventricle (for example, clinically significant aortic stenosis); unstable angina (with the exception of Prinzmetal angina); heart failure after acute myocardial infarction (during the first 28 days).

Comparison of side effects by frequency

The risk of side effects from Prestarium and Perindopril increases if the instructions for use are not followed. Important

strictly follow the course of treatment and dosage prescribed by your doctor.

Price and analogues

You can buy the drug Prestarium at a price of 370 rubles, Perindopril - from 90 rubles, the average cost from different manufacturers is about 250 rubles.

When choosing analogues, a doctor may consider the following options:

1. Prilamide;
2. Bi-Prestarium;
3. Prestarium-Combi;
4. Promepril;
5. Triplix;
6. Triveram.

The drugs Prestarium and Perindopril are analogues. The choice of medication depends on the underlying disease and associated disorders.

Dosage and method of administration

Prestarium 2.5 and 10 mg cannot be divided and are taken in one dose. 5 mg tablets can be divided into two doses. It is recommended to take 1 time per day at the same time. The dosage is selected by the doctor individually, taking into account the underlying disease and associated disorders. Prestarium can be used both independently and in complex therapy.

Perindopril should be taken in the morning on an empty stomach. The initial standard dosage is 4 mg/day. Gradually the dose can be increased to 8 mg/day. In elderly patients, the initial dose may be 2 mg/day with further increases. For kidney disease, the dosage may be reduced depending on blood and urine test results.

Which medicine is better - the opinion of doctors and patients

Perindopril and Prestarium contain a similar main component in the composition. Tablets have different dosages and excipients. Each antihypertensive drug is prescribed according to strict indications specified in the instructions.

When choosing a treatment, it is impossible to say which medicine is better, because each has advantages and disadvantages. Prestarium is more expensive and has been showing its effectiveness for more than 20 years. Perindopril is a similar drug, but with other auxiliary components.

Medicines have the same indications and contraindications. This takes into account the effect of additional components on the body, which can be decisive when choosing a drug.

Risks and Precautions

It's important to remember the risk

development of severe arterial hypotension, especially when the water-salt balance in the body is disturbed. During the treatment period, you need to undergo regular tests in order to notice and prevent sodium loss in time.

You cannot combine Prestarium and Perindopril with a diuretic

. For the period of treatment, the latter are canceled at least 3 days before the start of the course of treatment. Patients at risk with severe systemic diseases undergo therapy under the supervision of medical personnel.

Due to the risk of dizziness and hypotension, driving and engaging in activities requiring increased attention are limited for the entire treatment period. The drugs may affect concentration and motor activity.

Both drugs cope with their task and are widely used to treat arterial hypertension. If one medicine is poorly tolerated by the patient, the doctor may prescribe another. The means have more in common than differences. If you follow your doctor's instructions, each medication is well tolerated with minimal chance of adverse reactions. Be aware of the risks of self-medication and always tell your doctor about unusual symptoms that occur during treatment.

Prestarium®

IHD: reducing the risk of cardiovascular complications in patients who have previously had myocardial infarction and/or coronary revascularization

If unstable angina develops during the first month of therapy with Prestarium®, the benefits and risks should be assessed before continuing therapy.

Arterial hypotension

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients without concomitant diseases. The risk of an excessive decrease in blood pressure is increased in patients with reduced blood volume, which can be observed during diuretic therapy, following a strict salt-free diet, hemodialysis, vomiting and diarrhea, as well as in patients with severe arterial hypertension with high plasma renin activity (see sections “Interaction with other drugs” and “Special instructions”).

In most cases, episodes of pronounced decrease in blood pressure are observed in patients with severe chronic heart failure, both in the presence of concomitant renal failure and in its absence. This side effect is most often observed in patients receiving loop diuretics in high doses, as well as in patients with hyponatremia or impaired renal function.

At the beginning of therapy and when increasing the dose of Prestarium®, patients should be under close medical supervision (see sections “Dosage and Administration” and “Side Effects”). A similar approach should be used in patients with angina pectoris and cerebrovascular diseases, in whom severe arterial hypotension can lead to the development of myocardial infarction or cerebrovascular complications.

If there is a significant decrease in blood pressure, the patient should be transferred to the “lying” position on his back with his legs elevated and immediately replenish the blood volume (for example, intravenous infusion of 0.9% sodium chloride solution). Intravenous administration of angiotensin II and/or catecholamines is also possible. A pronounced decrease in blood pressure when taking the drug for the first time is not an obstacle to further use of the drug. After restoration of blood volume and blood pressure, treatment can be continued with careful selection of doses of the drug Prestarium®.

In some patients with chronic heart failure and normal or low blood pressure, Prestarium® may cause an additional decrease in blood pressure. This effect is predictable and does not usually require discontinuation of therapy. If symptoms of a pronounced decrease in blood pressure appear, the dose of the drug should be reduced or discontinued.

Mitral stenosis/aortic stenosis/hypertrophic obstructive cardiomyopathy

Prestarium®, like other ACE inhibitors, should be used with caution in patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as in patients with mitral stenosis.

Renal dysfunction

For patients with renal failure (creatinine clearance less than 60 ml/min.), the initial dose of Prestarium® is selected depending on the clearance value (see section “Method of administration and dosage”) and then depending on the therapeutic effect. For such patients, regular monitoring of QC and potassium levels in the blood plasma is necessary (see section “Side Effects”).

Hypotension, which sometimes develops when starting ACE inhibitors in patients with symptomatic chronic heart failure, can lead to deterioration of renal function. Acute renal failure may develop, usually reversible.

In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney (especially in the presence of renal failure), during therapy with ACE inhibitors, there may be an increase in the concentration of urea and creatinine in the blood plasma, which usually resolves when therapy is discontinued.

The additional presence of renovascular hypertension causes an increased risk of developing severe arterial hypotension and renal failure. Treatment of such patients begins under close medical supervision using low doses of the drug and further adequate selection of doses. Treatment with diuretics should be temporarily discontinued and serum potassium and creatinine levels monitored regularly during the first few weeks of therapy.

In some patients with arterial hypertension, in the presence of previously undetected renal failure, especially with simultaneous use of diuretics, the concentration of urea and creatinine in the blood serum may increase. These changes are usually mild and reversible. In such cases, it may be necessary to discontinue or reduce the dose of Prestarium® and/or diuretic.

Hemodialysis

Several cases of persistent, life-threatening anaphylactic reactions have been reported in patients undergoing hemodialysis using high-flux membranes (eg, AN69®). Prescription of ACE inhibitors should be avoided when using this type of membrane.

Kidney transplantation

There are no data on the use of Prestarium® after kidney transplantation.

Hypersensitivity/angioedema

In patients taking ACE inhibitors, in rare cases, especially during the first few weeks of therapy, angioedema of the face, extremities, lips, tongue, glottis and/or larynx may develop. In rare cases, severe angioedema may occur during prolonged use of an ACE inhibitor. If these symptoms appear, the use of the drug Prestarium® should be stopped immediately, and drugs of another pharmacotherapeutic group should be used as a replacement.

Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, glottis, or larynx can lead to airway obstruction. When it develops, emergency therapy includes, among other prescriptions, immediate subcutaneous administration of a solution of epinephrine (adrenaline) 1:1000 (1 mg/ml) 0.3-0.5 ml or slow intravenous administration (in accordance with the preparation instructions infusion solution) under ECG and blood pressure control. The patient should be hospitalized for treatment and observation for at least 12-24 hours until complete regression of symptoms.

Patients with a history of angioedema not associated with taking ACE inhibitors may have an increased risk of developing it when taking drugs of this group (see section “Contraindications”).

In rare cases, angioedema of the intestine develops during therapy with ACE inhibitors. In this case, patients experience abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without previous angioedema of the face and with normal activity of the C-1 esterase enzyme. The diagnosis is made using computed tomography of the abdominal region, ultrasound, or at the time of surgery. Symptoms disappear after stopping ACE inhibitors. In patients with abdominal pain receiving ACE inhibitors, the possibility of developing angioedema of the intestine must be taken into account when making a differential diagnosis.

Anaphylactic reactions during low-density lipoprotein (LDL) apheresis

In rare cases, life-threatening anaphylactic reactions may occur in patients receiving ACE inhibitors during low-density lipoprotein apheresis with dextran sulfate. To prevent an anaphylactic reaction, ACE inhibitor therapy should be temporarily discontinued before each LDL apheresis procedure using dextran sulfate.

Anaphylactic reactions during desensitization

There are isolated reports of the development of life-threatening anaphylactic reactions in patients receiving ACE inhibitors during desensitizing therapy with bee venom (bees, wasps). ACE inhibitors should be used with caution in patients with a predisposition to allergic reactions undergoing desensitization procedures. The use of ACE inhibitors should be avoided in patients receiving bee venom immunotherapy. However, this reaction can be avoided by temporarily discontinuing the ACE inhibitor before starting the desensitization procedure.

Liver dysfunction

Taking ACE inhibitors is sometimes associated with a syndrome starting with the development of cholestatic jaundice, progressing to fulminant hepatic necrosis, and (sometimes) death. The mechanism of development of this syndrome is unclear. If symptoms of jaundice or increased activity of liver enzymes appear in patients taking ACE inhibitors, drug therapy should be discontinued and appropriate examination should be carried out (see section “Side Effects”).

Neutropenia/agranulocytosis/thrombocytopenia/anemia

During therapy with ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may develop. With normal renal function and the absence of other complications, neutropenia rarely occurs. ACE inhibitors are used only in emergency cases in the presence of systemic vasculitis, immunosuppressive therapy, taking allopurinol or procainamide, as well as when combining all of these factors, especially against the background of previous renal failure. There is a risk of developing severe infectious diseases that are resistant to intensive antibiotic therapy. When carrying out therapy with Prestarium® in patients with the above factors, it is necessary to regularly monitor the leukocyte count.

Ethnic differences

It should be taken into account that patients of the Negroid race have a higher risk of developing angioedema. Like other ACE inhibitors, Prestarium® is less effective in lowering blood pressure in black patients.

This effect may be associated with a pronounced predominance of low-renin status in black patients with arterial hypertension.

Cough

During therapy with an ACE inhibitor, a dry, non-productive cough may occur, which stops after discontinuation of the drug.

Surgery/general anesthesia

The use of ACE inhibitors in patients undergoing surgery under general anesthesia can lead to a significant decrease in blood pressure, especially when using general anesthetic agents that have an antihypertensive effect. Taking Prestarium® should be stopped one day before surgery. If arterial hypotension develops, blood pressure should be maintained by replenishing blood volume.

It is necessary to warn the anesthesiologist that the patient is taking ACE inhibitors.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, especially if the patient has renal and/or heart failure or latent diabetes mellitus. The use of potassium supplements, potassium-sparing diuretics, and other drugs associated with a risk of potassium elevation (eg, heparin) is generally not recommended due to the potential for severe hyperkalemia. If the combined use of these drugs is necessary, then therapy should be accompanied by regular monitoring of potassium levels in the blood serum.

Diabetes

In patients taking oral hypoglycemic agents or insulin, plasma glucose concentrations should be regularly monitored during the first month of therapy with ACE inhibitors (see section “Interaction with other drugs”).

Lithium preparations

The combined use of Prestarium® and lithium preparations is not recommended (see section “Interaction with other drugs”).

Potassium-sparing diuretics, potassium supplements, potassium-containing table salt substitutes and food supplements

Concomitant use with ACE inhibitors is not recommended (see section “Interaction with other drugs”).