Prestarium A tab disperg 5mg N30 (Servier)

pharmachologic effect

Manufacturer: Les Laboratoires Servier (France)
Release form: tablets

Active ingredient: perindopril

Analogues: Perindopril, Prestance, Losartan

Prestarium, acting on one of the main enzymes of the blood pressure regulation system (ACE), helps to reduce it. Under the influence of the drug, partially impaired function of the cardiovascular system is restored. The number of heart contractions decreases, the elasticity of the vascular wall increases, and left ventricular hypertrophy decreases.

Indications for use of Prestarium

The medication is prescribed as a therapeutic and prophylactic agent for the following diseases:

• hypertonic disease;
• chronic cardiovascular failure;
• coronary heart disease in the form of a stable course;
• prevention after a stroke or transient vascular pathology.

The drug can be used for hypertension of any severity. While taking the medicine, a drop in blood pressure occurs in any body position (standing or lying down).

Contraindications

Prestarium is prohibited for use in the following pathologies:

• angioedema;
• intolerance to ACE inhibitors;
• galactosemia.

Breastfeeding and pregnancy at all stages are also reasons to exclude the drug from the treatment regimen. The drug should be used with caution in cases of electrolyte imbalance, after internal organ transplantation, aortic valve stenosis, and systemic connective tissue pathologies. Patients on hemodialysis or taking antidepressants should carefully select the dosage and monitor their well-being. Conditions accompanied by excessive vomiting, diarrhea, dehydration, and renal failure also require special attention.

Analogues of Prestarium

The medical industry supplies the pharmaceutical market with a sufficient number of analogues and substitutes for the drug Prestarium. These medications provide an equivalent therapeutic effect in the treatment of vascular pathology and are sold in pharmacies in the form of:

• synonyms;
• generics;
• combination drugs.

If prescribed by a doctor, you can purchase analogues of Prestarium from Russian and foreign pharmaceutical companies.

Table of Prestarium analogues with price and country of origin.

The different prices for Prestarium analogues depend on the manufacturer and the amount of ingredients included in the medicine. The budget cost of Russian-made Prestarium analogues does not affect the properties of the drugs and does not reduce their effectiveness.

What else can replace Prestarium 5 mg, what drugs? You can supplement the list of analogues of Prestarium with the following medications:

• Ramipril;
• Edarby;
• Lerkamen 20;
• Enap;
• Cardosal;
• Dalneva;
• Bisoprolol;
• Egilok;
• Moxonidine;
• Renitek;
• Parnavel.

Only the doctor will decide which substitute for Prestarium in tablets is suitable for the patient.

Prestarium or Perindopril - which is better, what is the difference

Manufacturer: Minskintercaps (Belarus)
Release form: tablets

Active ingredient: perindopril erbumine

Both medications have the same active substances and an equivalent mechanism of action. Despite the similarity of the drugs, there are a number of differences between them. Prestarium will be a better remedy compared to Perindopril, since:

• the amount of active substance in tablets is higher;
• wider range of indications;
• the presence of a dispersible, that is, easily soluble in the oral cavity, form of the drug.

The presence of such advantages makes Prestarium a more effective remedy. According to doctors, the drug is well tolerated by patients and, with long-term use, stably maintains normal blood pressure, preventing its rise.

Prestarium or Prestance – which is better?

Manufacturer: Servier (France)
Release form: tablets

Active ingredient: perindopril, amlodipine

Prestarium and its analog have the equivalent active ingredient perindopril. But Prestance also contains amlodipine, which enhances the effect of the medication. It will be best for patients suffering from arterial hypertension complicated by coronary heart disease with stable angina.

According to reviews from patients taking Prestance, the medicine effectively lowers blood pressure, prevents angina attacks and significantly reduces the clinical manifestations of the disease.

Prestarium or Noliprel – which is better?

Manufacturer: Servier (France)
Release form: tablets

Active ingredient: indapamide, perindopril

Both medications have equivalent indications and the same active substances. But Noliprel contains one more component - indapamide, which has a diuretic effect. The combination of 2 active substances in Noliprel forte tablets enhances the hypotensive effect.

The drug will be best for patients suffering from hypertension and a tendency to edema, as well as shortness of breath during physical exertion.

Prestarium or Perineva – which is better?

Manufacturer: KRKA-RUS (Russia)
Release form: tablets

Active ingredient: perindopril

Perineva and Prestarium have the same active substance and mechanism of action. The difference between medications lies in the dosage of the drugs and the additional ingredients included in their composition.

According to patient reviews, Perineva is in high demand, since the medication is well tolerated, convenient to take, and you can also buy this Prestarium substitute cheaper.

Prestarium or Losartan – which is better?

Manufacturer: OZONE (Russia)
Release form: tablets

Active ingredient: losartan

Losartan and Prestarium have the same treatment effect, but different active substances and mechanism of action.

Prestarium will be the best for the treatment of hypertension and chronic heart failure. It has wider indications, fewer contraindications and side effects. Patients report good results from its use.

The Russian analogue of Prestarium Losartan is more often prescribed as part of complex therapy and has the advantage of low cost.

How to use Prestarium: instructions

The doctor prescribes the exact treatment regimen depending on the type of disease and the age of the patient. General recommendations:

• The tablets must be taken on an empty stomach, in the morning, with plenty of water; there is no need to chew the drug;
• the prescribed dose is taken once: it can range from 2 to 8 mg per day;
• in acute conditions, the drug is taken no earlier than complete normalization and remission.

For elderly people and other risk groups, the dosage is adjusted downwards. It is prohibited to change the number of tablets on your own. The course of treatment is continued until the physical condition is stabilized and the existing pathologies are normalized. If necessary, Prestarium is taken for several months in a row or continuously. It is allowed to combine it with diuretic medications.

The drug is incompatible with narcotic analgesics, corticosteroid hormones, immunosuppressants, cytostatics, diabetes treatments, antipsychotics, since when taken simultaneously, the risk of side effects mutually increases.

Prestarium or Lisinopril - which is better?

Manufacturer: VERTEX (Russia)
Release form: tablets

Active ingredient: lisinopril

Prestarium and its Russian analogue Lisinopril have the same indications and are used to treat hypertension.

In the presence of diabetes mellitus and diabetic nephropathy in patients with hypertension, Lisinopril will be the best. It protects the kidneys from further development of pathology.

Side effects

Prestarium can cause the following undesirable reactions from the body:

• nausea, dry mouth, loss of appetite;
• dry cough;
• increased uric acid levels;
• dizziness, headaches;
• physical weakness, apathy, increased drowsiness;
• depression;
• swelling of the ankles;
• thrombocytopenia, decreased hemoglobin, red blood cells and other blood count disorders.

Allergic reactions may cause skin itching, rashes, swelling of the mucous membranes and skin, and respiratory problems. Men may experience decreased libido. In case of overdose, vascular collapse, bradycardia, and impaired coordination of movements are likely.

Prestarium or Lorista – which is better?

Manufacturer: KRKA (Slovenia)
Release form: tablets

Active ingredient: losartan

Lorista and Prestarium are prescribed for the treatment of arterial hypertension and chronic heart failure, but have different mechanisms of action due to different active substances.

For patients suffering from diabetes mellitus with the presence of protein in the urine, Lorista will be the best. This analogue, in addition to lowering blood pressure, slows down the progression of chronic renal failure.

Instructions for use PRESTARIUM®

Stable ischemic heart disease

If episodes of unstable angina (severe or not) occur during the first month of taking perindopril, it is recommended that a careful assessment of the risk/benefit ratio be carried out before continuing treatment.

Arterial hypotension

ACE inhibitors may cause a decrease in blood pressure. Arterial hypotension with clinical manifestations rarely develops in patients with arterial hypertension without concomitant diseases, more often it occurs in patients with reduced blood volume (taking diuretics, on a diet with limited salt intake, patients on dialysis, patients with diarrhea or vomiting) or in patients with severe renin-dependent hypertension. Symptomatic hypotension has been reported in patients with symptomatic severe heart failure with or without concomitant renal failure. Arterial hypotension may more often develop in patients with more severe heart failure, as a result of taking high-dose loop diuretics, hyponatremia, or functional renal failure. Patients at increased risk of developing symptomatic hypotension should be closely monitored during initiation of therapy and during dose adjustments. A similar approach should also be followed when treating patients with ischemia and/or cerebrovascular disease, in whom severe hypotension can lead to myocardial infarction or stroke.

If arterial hypotension develops, it is necessary to place the patient on his back and, if necessary, replenish the blood volume by intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not a contraindication for further use of the drug, which can be continued after blood pressure has increased again after an increase in blood volume.

In some patients with congestive heart failure with normal or low blood pressure, taking Prestarium® may lead to an additional decrease in systemic blood pressure (usually does not require discontinuation of the drug). If clinical manifestations of arterial hypotension develop, it may be necessary to reduce the dose or discontinue taking Prestarium®.

Aortic stenosis, mitral stenosis, hypertrophic cardiomyopathy

Like other ACE inhibitors, Prestarium should be administered with extreme caution to patients with mitral valve stenosis and left ventricular outflow obstruction, for example, aortic stenosis or hypertrophic cardiomyopathy.

Renal dysfunction

In case of impaired renal function (creatinine clearance < 60 ml/min), the initial dose should be adjusted according to the patient's creatinine clearance and then depending on the patient's response to treatment. Potassium and creatinine levels need to be monitored.

If arterial hypotension develops at the beginning of therapy with ACE inhibitors in patients with heart failure with clinical manifestations, further deterioration of renal function is possible. There are reports of the development of acute renal failure, which is usually reversible.

In some patients with bilateral renal artery stenosis or solitary renal artery stenosis taking ACE inhibitors, there have been cases of increases in blood urea and serum creatinine, reversible after discontinuation of therapy (more common in patients with renal failure). With renovascular hypertension there is also an increased risk of severe hypotension and renal failure. Treatment of such patients should be initiated under close medical supervision, with low doses and careful dose titration. Since diuretics may be a factor contributing to the development of the conditions described above, in the first weeks of treatment with Prestarium®, diuretics should be discontinued and renal function should be constantly monitored.

In some patients with arterial hypertension without visible renal vascular impairment, an increase in blood urea and serum creatinine concentrations was observed, usually slight and transient, especially in the case of concomitant use of Prestarium® and diuretics. These changes are most likely in patients with existing renal impairment. In this case, it may be necessary to reduce the dose and/or stop taking the diuretic and/or Prestarium.

Patients on hemodialysis

In some patients undergoing hemodialysis using high-flux membranes and simultaneously receiving ACE inhibitors, cases of anaphylactoid reactions have been reported. For such patients, the use of a different type of membrane or a different class of antihypertensive drug should be considered.

Kidney transplant

There is no experience with the use of Prestarium® in patients with recent kidney transplantation.

Hypersensitivity/angioedema

Rarely, angioedema of the face, extremities, lips, mucous membranes, tongue, vocal cords and/or larynx has been reported. These reactions may occur at any time during therapy. In such cases, Prestarium should be stopped immediately and appropriate monitoring should be carried out until symptoms disappear completely. Typically, when swelling affected only the face and lips, it resolved without any treatment, although antihistamines helped relieve symptoms.

Angioedema that extends to the larynx can be fatal. If there is swelling of the tongue, vocal cords or larynx, which may lead to airway obstruction, appropriate measures should be taken immediately. Emergency care may include giving epinephrine (adrenaline) and/or maintaining an airway. The patient should be under medical supervision until symptoms disappear completely and permanently.

An increased risk of developing angioedema while taking ACE inhibitors exists for patients who have had angioedema not associated with taking ACE inhibitors.

In rare cases, angioedema of the intestine has been reported in patients treated with ACE inhibitors. These patients experienced abdominal pain (with or without nausea and vomiting); in several cases there was no previous facial edema and C-1 esterase levels were normal. Angioedema was diagnosed by abdominal CT, ultrasound, or surgery; symptoms resolved after discontinuation of ACE inhibitors. The development of angioedema of the intestine should be taken into account in the differential diagnosis of patients with abdominal pain during treatment with ACE inhibitors.

Anaphylactoid reactions during hemodialysis or LDL apheresis procedures

Rare cases of life-threatening anaphylactoid reactions have been reported in some patients undergoing hemodialysis using high-flux membranes or receiving LDL apheresis using dextran sulfate absorption when prescribed ACE inhibitors. These reactions can be avoided by temporarily discontinuing the ACE inhibitor each time before apheresis.

Anaphylactoid reactions during desensitization

Anaphylactoid reactions have occurred in some patients receiving ACE inhibitors during desensitization therapy (eg, hymenopteric venom). In some patients, these reactions were avoided by temporarily discontinuing the ACE inhibitor, but they occurred again if the drug was taken carelessly.

Liver dysfunction

In rare cases, ACE inhibitors have been associated with a syndrome that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not yet clear. In patients receiving ACE inhibitors, if jaundice or a marked increase in liver enzyme activity develops, the ACE inhibitor should be discontinued and a thorough medical examination should be performed.

Neutropenia, agranulocytosis, thrombocytopenia, anemia

Neutropenia/agranulocytosis, thrombocytopenia and anemia were observed while taking ACE inhibitors. In patients with normal liver function and in the absence of other complicating factors, neutropenia rarely develops. Perindopril should be used with extreme caution in patients with diffuse connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, especially in patients with pre-existing liver dysfunction. Some of these patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should report any signs of infectious diseases (eg, sore throat, fever) to their doctor.

Cough

Taking an ACE inhibitor may cause a dry cough. The cough is non-productive and persists while taking the drug, but disappears when it is discontinued. This symptom may have an iatrogenic etiology. Cough caused by taking an ACE inhibitor should be considered in the differential diagnosis of cough.

Surgery, anesthesia

During surgery or during anesthesia with drugs that cause arterial hypotension, Prestarium® can block the formation of angiotensin II, as a result of compensatory release of renin. It is recommended to stop treatment the day before surgery. When arterial hypotension occurs, which is presumably associated with this mechanism of action, the blood volume should be increased.

Hyperkalemia

In some patients treated with ACE inhibitors, incl. perindopril, cases of elevated serum potassium levels have been reported. Risk factors for the development of hyperkalemia include renal failure, deterioration of renal function, age (>70 years), diabetes mellitus, intercurrent events such as dehydration, acute heart failure, metabolic acidosis, concomitant use of potassium-sparing diuretics (eg, spironolactone, eplerenone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, or taking other drugs that cause increases in serum potassium (eg, heparin). Taking potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes, especially in patients with impaired renal function, may result in significant increases in serum potassium levels. Hyperkalemia can cause serious arrhythmias, sometimes fatal. If concomitant administration of perindopril or the above drugs is considered necessary, they should be taken with caution and with regular monitoring of serum potassium levels.

Diabetes

In diabetic patients already taking oral hypoglycemic agents or insulin, glycemic levels should be carefully monitored, especially during the first month of taking an ACE inhibitor.

Lithium preparations

The combined use of perindopril and lithium is usually not recommended.

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

The combination of perindopril with potassium-sparing diuretics, potassium supplements, and potassium-containing salt substitutes is generally not recommended.

Double blockade of the RAAS

Cases of hypotension, syncope, stroke, hyperkalemia, and impaired renal function (including acute renal failure) have been reported in susceptible patients, particularly when receiving combined medications that affect this system. In this regard, double blockade of the RAAS by combined administration of an ACE inhibitor and an angiotensin II receptor antagonist or aliskiren is not recommended.

Combined use with aliskiren in patients with diabetes mellitus or renal failure (GFR < 60 ml/min/1.73 m2) is contraindicated.

Race

When treated with ACE inhibitors, angioedema develops more often in patients of the Black race than in patients of other races.

Like other ACE inhibitors, the effectiveness of perindopril in lowering blood pressure may be lower in patients of the black race than in patients of other races, perhaps the reason for this is that hypertension in black patients very often resolves against the background of low renin levels.

Excipients

Prestarium® tablets contain lactose, so the drug should not be prescribed to patients with rare problems of hereditary lactose intolerance, glucose-galactose malabsorption or lapp lactase deficiency.

Use in pediatrics

Safety and effectiveness of Prestarium in children and adolescents under 18 years of age

have not been established, so prescribing the drug to this category of patients is not recommended.

Impact on the ability to drive vehicles and operate machinery

Prestarium® does not affect the ability to concentrate and the speed of psychomotor reactions. However, in some patients, especially at the beginning of treatment or when combined with other antihypertensive drugs, individual reactions may develop with a decrease in blood pressure. This leads to a deterioration in the ability to drive vehicles and operate machinery.

Preclinical safety data

Reversible renal impairment was observed in oral chronic toxicity studies in rats and monkeys. No mutagenicity was observed in in vivo or in vitro studies. No carcinogenicity was observed in rats or mice with long-term administration.

Reproductive toxicity studies (in rats, mice, rabbits and monkeys) showed no evidence of embryotoxicity or teratogenicity. However, ACE inhibitors as a class have been shown to have adverse effects on late fetal development, resulting in fetal death and congenital disorders in rodents and rabbits; kidney damage and an increase in perinatal and postnatal mortality were observed. No effects on fertility were observed in male or female rats.

Enalapril

Manufacturer: OZON LLC (Russia)
Release form: tablets

Active ingredient: enalapril

Enalapril therapy for a long time has a beneficial effect on patients with chronic heart failure, reducing its severity.

This analogue of Prestarium 5 mg increases cardiac output and resistance to physical stress, slows the progression of a serious complication - dilation (expansion) of the left ventricle.

Prestarium® A

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® A, the benefits and risks should be assessed before continuing therapy.

Arterial hypotension

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic hypotension rarely develops in patients with uncomplicated arterial hypertension. The risk of an excessive decrease in blood pressure is increased in patients with reduced blood volume, which can be observed during diuretic therapy, while following a strict salt-free diet, hemodialysis, diarrhea and vomiting, as well as in patients with severe arterial hypertension with high renin activity (see sections “Interaction” with other drugs" and "Side effects").

Symptomatic hypotension may occur 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 high-dose loop diuretics, hyponatremia, or functional renal failure.

In patients at increased risk of developing symptomatic arterial hypotension, blood pressure, renal function and serum potassium levels should be carefully monitored during therapy with Prestarium® A.

A similar approach is used in patients with coronary artery disease and cerebrovascular diseases, in whom severe arterial hypotension can lead to myocardial infarction or cerebrovascular accident.

If arterial hypotension develops, the patient should be transferred to the supine position with legs elevated. If necessary, the volume of circulating blood should be replenished with intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle to further taking the drug. After restoration of blood volume and blood pressure, treatment can be continued.

In some patients with chronic heart failure (CHF) and normal or low blood pressure, Prestarium® A 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® A, like other ACE inhibitors, should be administered with caution to patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as to patients with mitral stenosis.

Renal dysfunction

For patients with renal failure (creatinine clearance less than 60 ml/min), the initial dose of Prestarium® A 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 serum creatinine and potassium concentrations is necessary (see section “Side Effects”).

Hypotension, which sometimes develops when starting ACE inhibitors in patients with symptomatic CHF, 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 serum, 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 in such patients.

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 plasma potassium and creatinine levels should be regularly monitored during the first few weeks of therapy.

In some patients with arterial hypertension without indication of pre-existing renal vascular disease, serum urea and creatinine concentrations may increase, especially with simultaneous use of diuretics. These changes are usually mild and reversible. The likelihood of developing these disorders is higher in patients with a history of renal failure. In such cases, it may be necessary to discontinue or reduce the dose of Prestarium® A and/or the diuretic.

Hemodialysis

In patients undergoing hemodialysis using high-flow membranes, cases of anaphylactic reactions have been reported during therapy with ACE inhibitors. Prescription of ACE inhibitors should be avoided when using this type of membrane. In such situations, consideration should be given to prescribing a different class of antihypertensive drug or using a different type of dialysis membrane.

Kidney transplant

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

Hypersensitivity/angioedema

When taking ACE inhibitors, including perindopril, in rare cases and during any period of therapy, the development of angioedema of the face, upper and lower extremities, lips, mucous membranes, tongue, vocal folds and/or larynx may be observed (see section “Side effects”). action"). If symptoms appear, the drug should be stopped immediately and the patient should be observed until signs of edema completely disappear.

If the swelling affects only the face and lips, it usually resolves on its own, although antihistamines may be used to treat 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 treatment is required, including subcutaneous administration of epinephrine (adrenaline) and/or ensuring airway patency. The patient should be under medical supervision until symptoms disappear completely and permanently.

Patients with a history of angioedema not associated with taking ALP 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 has developed during therapy with ALP inhibitors. In this case, patients experienced 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 levels of C1-esterase. Diagnosis was made using abdominal computed tomography, ultrasound, or surgery.

Symptoms disappeared after stopping the ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, when carrying out differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine (see section “Side effects”).

Anaphylactoid reactions during low-density lipoprotein (LDL) apheresis

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

Anaphylactoid reactions during desensitization

There are isolated reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitization therapy, such as hymenoptera venom. In these patients, such reactions were prevented by temporary discontinuation of ACE inhibitors, but with accidental or careless resumption of treatment, the reactions could develop again.

Liver dysfunction

In rare cases, while taking ACE inhibitors, a syndrome of development of cholestatic jaundice with transition to fulminant liver necrosis, sometimes with death, was observed. The mechanism of development of this syndrome is unclear. If jaundice appears or a significant increase in the activity of liver enzymes while taking ACE inhibitors, you should stop taking the drug (see section “Side Effects”), the patient should be under appropriate medical supervision.

Neutropenia/ agranulocytosis/ thrombocytopenia/ anemia

While taking ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia rarely develops.

Prestarium® A should be used with extreme caution in patients with systemic connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, or a combination of these risk factors, especially in the presence of underlying renal impairment.

Some patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing Prestarium® A to such patients, it is recommended to periodically monitor the level of leukocytes in the blood.

Patients should report any signs of infectious diseases (eg, sore throat, fever) to their doctor.

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® A 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 persistent dry cough may occur, which stops after discontinuation of the drug. This should be taken into account when carrying out the differential diagnosis of cough.

Surgery/general anesthesia

In patients who are planning to undergo major surgery or use anesthetic agents that cause arterial hypotension, the use of perindopril may block the formation of angiotensin II against the background of compensatory release of renin. Treatment should be stopped one day before surgery. If arterial hypotension develops according to this mechanism, blood pressure should be maintained by replenishing blood volume.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, including perindopril. Risk factors for hyperkalemia are renal failure, decreased renal function, age over 70 years, diabetes mellitus, some concomitant conditions (dehydration, acute heart failure, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride) , potassium supplements/preparations or potassium-containing table salt substitutes, as well as the use of other drugs that increase potassium levels in the blood (for example, heparin).

The use of potassium supplements/preparations, potassium-sparing diuretics, and potassium-containing table salt substitutes can lead to a significant increase in potassium levels in the blood, especially in patients with reduced renal function. Hyperkalemia can cause serious, sometimes fatal, abnormal heart rhythms.

If simultaneous use of Prestarium® A and the above drugs is necessary, treatment should be carried out with caution against the background of regular monitoring of potassium levels in the blood serum (see section “Interaction with other drugs”).

Patients with diabetes mellitus

When prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral administration or insulin, during the first month of therapy it is necessary to regularly monitor the concentration of glucose in the blood (see section “Interaction with other drugs”).

Lithium preparations

The simultaneous use of Prestarium® A 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

The simultaneous administration of Prestarium® A and potassium-sparing diuretics, as well as potassium preparations, potassium-containing table salt substitutes and food additives is not recommended (see section “Interaction with other drugs”).

Double blockade of the RAAS

There is evidence that concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren increases the risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure). Thus, double blockade of the RAAS by combined use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is not recommended (see sections “Interaction with other drugs” and “Pharmacodynamics”).

If dual block therapy is considered absolutely necessary, it should only be carried out under strict medical supervision and with regular monitoring of renal function, blood electrolytes and blood pressure.

ACE inhibitors should not be used in combination with angiotensin II receptor antagonists in patients with diabetic nephropathy.

Lozap

Manufacturer: ZENTIVA (Slovakia)
Release form: tablets

Active ingredient: losartan

Lozap is used to treat hypertension. Under the influence of this analogue of Prestarium, a decrease in pressure in the pulmonary circulation occurs with the subsequent development of a diuretic effect. The medication reduces afterload and prevents myocardial hypertrophy.

The therapeutic effect of systematic use of the drug occurs after 3–6 weeks.

Concor

Manufacturer: Merck (Germany)
Release form: tablets

Active ingredient: bisoprolol

Concor is a selective beta-blocker with hypotensive and antiarrhythmic effects. A special feature of the drug is its ability to quickly eliminate arrhythmia, which is stopped within 30–40 minutes from the moment of taking the Prestarium substitute.

Amlodipine

Manufacturer: OZON LLC (Russia)
Release form: tablets

Active ingredient: amlodipine

Amlodipine belongs to the group of calcium channel blockers. The Prestarium analogue has the ability to lower blood pressure by relaxing the smooth muscles of the vascular wall.

Therapy with the drug leads to expansion of the capillary network of the myocardium during ischemia, increases the supply of oxygen to the heart muscle and prevents the development of coronary vascular spasm.

Dosage form and composition

Prestarium is produced in the form of tablets for oral use. The active ingredient of the product is perindopril salt. The substance blocks the activity of the enzyme hormone angiotensin, which provokes an increase in blood pressure. The drug has several varieties, differing in dosage and content of auxiliary compounds:

• Prestarium tablets: containing 2, 4 and 8 mg. perindopril;
• Prestarium A: with an increased dosage: 2.5, as well as 5 and 10 mg;
• Bi-Prestarium: tablets in double dosage containing amlodipine, a calcium channel blocker.

All types of Prestarium have a similar effect, but they are prescribed for varying severity of hypertension.

Indapamide

Manufacturer: Teva (Israel)
Release form: tablets

Active ingredient: indapamide

Indapamide is an antihypertensive drug similar to thiazide diuretics. This analogue of Prestarium has a moderate diuretic effect and lowers blood pressure by reducing the tone of vascular smooth muscles.

The drug reduces left ventricular hypertrophy and is effective in the treatment of edema syndrome in chronic heart failure.

Prestarium A tab disperg 5mg N30 (Servier)

Stable ischemic heart disease

If any episode of unstable angina develops during the first month of perindopril therapy, the benefits and risks should be assessed before continuing therapy.

Arterial hypotension

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic hypotension rarely develops in patients with uncomplicated arterial hypertension. The risk of excessive reduction in blood pressure is increased in patients with reduced blood volume, which can be observed during diuretic therapy, while following a strict salt-free diet, dialysis, diarrhea and vomiting, as well as in patients with severe renin-dependent hypertension.

Symptomatic hypotension may occur in patients with clinical manifestations of heart failure, regardless of the presence of renal failure. This is more likely in patients with severe heart failure, as a reaction to high-dose loop diuretics, hyponatremia, or functional renal failure.

In patients at increased risk of developing symptomatic arterial hypotension, blood pressure, renal function and serum potassium levels should be carefully monitored when initiating therapy with Prestarium® A and during dose adjustment.

A similar approach is used in patients with coronary artery disease and cerebrovascular diseases, in whom severe arterial hypotension can lead to myocardial infarction or cerebrovascular accident.

If arterial hypotension develops, the patient should be transferred to the supine position with legs elevated. If necessary, the volume of circulating blood should be replenished with intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle to further taking the drug. After restoration of blood volume and blood pressure, treatment can be continued.

In some patients with chronic heart failure (CHF) and normal or low blood pressure, the drug Prestarium® A 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 valve stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy

The drug Prestarium® A, like other ACE inhibitors, should be prescribed with caution to patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as to patients with mitral valve stenosis.

Renal dysfunction

For patients with renal failure (creatinine clearance less than 60 ml/min), the initial dose of perindopril is selected depending on the clearance value and then depending on the therapeutic effect. For such patients, regular monitoring of serum creatinine and potassium concentrations is necessary.

Hypotension, which sometimes develops when starting ACE inhibitors in patients with symptomatic CHF, 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 serum, which usually resolves when therapy is discontinued. The additional presence of renovascular hypertension causes an increased risk of severe hypotension and renal failure in such patients.

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 plasma potassium and creatinine levels should be regularly monitored during the first few weeks of therapy.

In some patients with arterial hypertension without indication of pre-existing renal vascular disease, serum urea and creatinine concentrations may increase, especially with simultaneous use of diuretics. These changes are usually mild and reversible. The likelihood of developing these disorders is higher in patients with a history of renal failure. In such cases, it may be necessary to discontinue or reduce the dose of Prestarium® A and/or the diuretic.

Hemodialysis

In patients undergoing hemodialysis using high-flow membranes, cases of anaphylactic reactions have been reported during therapy with ACE inhibitors. In such situations, consideration should be given to prescribing a different class of antihypertensive drug or using a different type of dialysis membrane.

Kidney transplant

There are no data on the use of the drug Prestarium® A in patients after kidney transplantation.

Renovascular hypertension

In patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney, the risk of developing arterial hypotension and renal failure increases during therapy with ACE inhibitors. Taking diuretics may be an additional risk factor. Deterioration of renal function can be observed with even a slight change in serum creatinine concentration, even in patients with unilateral renal artery stenosis.

Hypersensitivity/angioedema

When taking ACE inhibitors, including perindopril, in rare cases and during any period of therapy, the development of angioedema of the face, upper and lower extremities, lips, mucous membranes, tongue, vocal folds and/or larynx may be observed (see section “Side effects”). action"). If symptoms appear, the drug should be stopped immediately and the patient should be observed until signs of edema completely disappear. If the swelling affects only the face and lips, it usually resolves on its own, although antihistamines may be used to treat 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 treatment is required, including subcutaneous administration of epinephrine (adrenaline) and/or ensuring airway patency. The patient should be under close medical supervision until symptoms disappear completely and permanently.

In patients with a history of angioedema not associated with taking ACE inhibitors, the risk of its development may be increased 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 levels of C1-esterase. The diagnosis was made using abdominal computed tomography, ultrasound, or surgery. Symptoms disappeared after stopping the ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, when carrying out differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.

Combined use with combination drugs containing valsartan + sacubitril

The combined use of perindopril with combination drugs containing valsartan + sacubitril is contraindicated, as the risk of developing angioedema is increased (see section "Contraindications").

The use of a combination drug containing valsartan + sacubitril is possible no earlier than 36 hours after the last dose of perindopril. The use of perindopril is possible no earlier than 36 hours after stopping the combination drug containing valsartan + sacubitril.

When taking ACE inhibitors concomitantly with other neprilysin inhibitors (for example, racecadotril), the risk of developing angioedema may be increased (see section "Interaction with other drugs"). In patients receiving perindopril, a careful risk/benefit assessment should be performed before initiating treatment with enkephalinase inhibitors (eg, racecadotril).

Concomitant use with mTOR inhibitors (for example, sirolimus, everolimus, temsirolimus)

When used together with mTOR inhibitors (for example, sirolimus, everolimus, temsirolimus), the risk of developing angioedema (for example, swelling of the airways or tongue, with or without impaired respiratory function) increases.

Anaphylactoid reactions during low-density lipoprotein (LDL) apheresis

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

Anaphylactoid reactions during desensitization

There are isolated reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, for example, with hymenoptera venom. In these patients, such reactions were prevented by temporary discontinuation of ACE inhibitors, but with accidental or careless resumption of treatment, the reactions could develop again.

Liver dysfunction

In rare cases, while taking ACE inhibitors, a syndrome of development of cholestatic jaundice with transition to fulminant liver necrosis, sometimes with death, was observed. The mechanism of development of this syndrome is unclear. If jaundice appears or a significant increase in the activity of liver enzymes while taking ACE inhibitors, the drug should be stopped and the patient should be under appropriate medical supervision.

Neutropenia / agranulocytosis / thrombocytopenia / anemia

While taking ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia rarely develops. Perindopril should be used with extreme caution in patients with systemic connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, or a combination of these risk factors, especially in the presence of underlying renal impairment.

Some patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the content of leukocytes in the blood. Patients should report any signs of infectious diseases (eg, sore throat, fever) to their healthcare provider.

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, the drug Prestarium® A 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 persistent dry cough may occur, which stops after discontinuation of the drug. This should be taken into account when carrying out the differential diagnosis of cough.

Surgery/general anesthesia

In patients who are planning to undergo major surgery or use anesthetic agents that cause arterial hypotension, the use of perindopril may block the formation of angiotensin II against the background of compensatory release of renin. Treatment should be stopped one day before surgery. If arterial hypotension develops according to this mechanism, blood pressure should be maintained by replenishing blood volume.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, including perindopril. Risk factors for hyperkalemia include renal failure, decreased renal function, age over 70 years, diabetes mellitus, certain concomitant conditions, in particular dehydration, acute heart failure, metabolic acidosis, and concomitant use of potassium-sparing diuretics (such as spironolactone and its derivatives eplerenone, triamterene, amiloride), food supplements/potassium preparations or potassium-containing table salt substitutes, as well as the use of other drugs that increase potassium levels in the blood (for example, heparin, co-trimoxazole (a fixed combination of sulfamethoxazole and trimethoprim).

The use of potassium supplements/preparations, potassium-sparing diuretics, and potassium-containing table salt substitutes can lead to a significant increase in potassium levels in the blood, especially in patients with reduced renal function.

Hyperkalemia can cause serious, sometimes fatal, abnormal heart rhythms. If simultaneous use of the drug Prestarium® A and the above drugs is necessary, treatment should be carried out with caution against the background of regular monitoring of potassium levels in the blood serum.

Patients with diabetes mellitus

When prescribing the drug to patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose concentrations should be regularly monitored during the first month of therapy with an ACE inhibitor.

Lithium preparations

Concomitant use of perindopril and lithium preparations is not recommended

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

The combined use of perindopril and potassium-sparing diuretics, as well as potassium preparations, potassium-containing table salt substitutes and food additives is not recommended.

Double blockade of the RAAS

There is evidence that concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren increases the risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure). Thus, dual blockade of the RAAS by concomitant use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is not recommended. If dual block therapy is considered absolutely necessary, it should only be carried out under strict medical supervision and with regular monitoring of renal function, blood electrolytes and blood pressure.

The use of ACE inhibitors in combination with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are usually not susceptible to antihypertensive drugs that act by inhibiting the RAAS. Therefore, taking the drug is not recommended.

Valsacor

Manufacturer: KRKA (Slovenia)
Release form: tablets

Active ingredient: valsartan

This analogue of Prestarium tablets is used in therapeutic practice as a means of lowering blood pressure. Valsacor reduces peripheral vascular resistance, improves cardiac blood output, but does not affect heart rate. Drug therapy reduces shortness of breath and swelling in patients with chronic heart failure.

Taking Prestarium substitutes, recommended by a doctor, will improve heart function, lower blood pressure and avoid serious vascular complications.

How does Prestarium work?

The drug reduces the production of the hormone aldosterone, the breakdown of bradykinin and renin activity. The decrease in blood pressure as a result of taking it is not accompanied by a disturbance in heart rate. The use of Prestarium has a beneficial effect on renal blood flow. In this case, the main functions of the organs are not affected. During treatment, the size of the enlarged left ventricle is normalized, and the elasticity of the coronary and other large vessels improves. Prestarium containing amlodipine has a complex effect:

• dilates blood vessels;
• normalizes blood flow in the heart vessels and capillaries;
• reduces the load on the myocardium, improves its blood supply.

The medicine does not affect cholesterol metabolism and does not lead to metabolic disorders. The therapeutic effect develops within 1 hour after taking the tablets. It has a cumulative mechanism of action, the maximum is observed on days 4–5 from the start of the course and persists throughout its entire duration. Metabolites of the drug are excreted in the urine. Its remains do not accumulate inside the body. After withdrawal, patients do not exhibit addiction syndrome.