Prestarium A tab. dispers. 5mg No. 30 (bottles) Servier RUS/Russia

Prestarium A

Use during pregnancy and breastfeeding

Prestarium® A is contraindicated for use during pregnancy.
Prestarium® A should not be used in the first trimester of pregnancy. If you are planning pregnancy or if it occurs while using the drug Prestarium® A, you should immediately stop taking the drug and, if necessary, prescribe alternative antihypertensive therapy with a proven safety profile for use during pregnancy.

It is known that the effect of ACE inhibitors on the fetus in the second and third trimesters of pregnancy can lead to disruption of its development (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia).

If the patient received ACE inhibitors in the second or third trimester of pregnancy, it is recommended to conduct an ultrasound examination of the newborn to assess the condition of the skull bones and kidney function.

It is not known whether perindopril is excreted in breast milk, therefore the use of Prestarium® A during lactation (breastfeeding) is not recommended. If the use of the drug is necessary during lactation, then breastfeeding should be discontinued.

Fertility

Preclinical studies have shown no effect of perindopril on reproductive function in rats of both sexes.

Use for liver dysfunction

In patients with liver cirrhosis, the hepatic clearance of perindopril is reduced by 2 times. However, the amount of perindoprilate formed does not decrease and no changes in the dose of the drug are required.

When prescribing the drug to patients with impaired liver function, no dose changes are required.

Use for renal impairment

The drug should be used with caution in cases of bilateral renal artery stenosis or the presence of only one functioning kidney; renal failure.

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

If renal function is impaired, the dose of Prestarium® A should be selected taking into account the degree of renal failure and under regular monitoring of potassium and QC levels.

* dialysis clearance of perindoprilate: 70 ml/min. The drug should be taken after the dialysis procedure.

Use in children

The use of the drug is contraindicated in patients under the age of 18 years (the effectiveness and safety of use have not been established).

Use in elderly patients

For arterial hypertension in elderly patients, treatment should begin with a dose of 2.5 mg/day. If necessary, a month after the start of therapy, the dose can be increased to 5 mg/day, and then to a maximum dose of 10 mg/day, taking into account the state of renal function.

For coronary artery disease, to reduce the risk of cardiovascular complications in patients who have previously suffered a myocardial infarction and/or coronary revascularization, elderly patients should begin therapy with a dose of 2.5 mg 1 time / day for 1 week, then 5 mg 1 time / day in over the next week. Then, taking into account the state of renal function, the dose can be increased to 10 mg 1 time / day (see table). The dose of the drug can be increased only if it is well tolerated at the previously recommended dose.

special instructions

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

In patients with coronary artery disease, if an episode of unstable angina occurs during the first month of therapy with Prestarium® A, the benefits and risks should be assessed before continuing treatment.

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 therapy with diuretics, while following a strict salt-free diet, hemodialysis, vomiting and diarrhea, as well as in patients with severe arterial hypertension with high renin activity. In patients at increased risk of developing symptomatic hypotension, blood pressure, renal function, and serum potassium levels should be carefully monitored during therapy with Prestarium® A. A similar approach is also used in patients with coronary artery disease or cerebrovascular disease, in whom severe hypotension may lead to to the development of myocardial infarction or cerebrovascular complications.

If arterial hypotension develops, the patient should be placed in a horizontal position with a low headboard. If necessary, the blood volume should be replenished using intravenous administration of saline. Transient arterial hypotension is not an obstacle to further use of the drug. After restoration of blood volume and blood pressure, treatment can be continued.

In some patients with chronic heart failure 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 prescribed 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

In patients with renal failure (creatinine clearance <60 ml/min), the initial dose of Prestarium® A should be adjusted 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 initiating 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 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-flux membranes (eg, AN69®), several cases of persistent, life-threatening anaphylactic reactions have been reported during therapy with ACE inhibitors. Prescription of ACE inhibitors should be avoided when using this type of membrane.

Kidney transplant

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

Hypersensitivity/angioedema

When using ACE inhibitors, incl. 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. If symptoms appear, use of 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, incl. 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 ACE inhibitors may have an increased risk of developing it when taking drugs of this group.

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.

Anaphylactoid reactions during 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. ACE inhibitors should be used with caution in patients susceptible 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

In rare cases, during the use of 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 or a significant increase in the activity of liver enzymes occurs during the use of ACE inhibitors, the drug should be stopped and the patient should be under appropriate medical supervision.

Neutropenia/agranulocytosis/thrombocytopenia/anemia

Neutropenia/agranulocytosis, thrombocytopenia and anemia may occur during the use of ACE inhibitors. 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, especially in patients with impaired renal function.

Some patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing Prestarium® A in 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, perindopril is less effective as an antihypertensive agent 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

The use of ACE inhibitors in patients whose condition requires surgery and/or general anesthesia may lead to an excessive decrease in blood pressure, especially when using drugs for general anesthesia that have an antihypertensive effect. Taking Prestarium® A 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 surgeon/anesthesiologist that the patient is taking ACE inhibitors.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, incl. 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.

Patients with diabetes mellitus

When 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.

Lithium preparations

The simultaneous use of Prestarium® A and lithium preparations is not recommended.

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.

Double blockade of the RAAS

Cases of hypotension, syncope, stroke, hyperkalemia and renal dysfunction (including acute renal failure) have been reported in susceptible patients, especially when used concomitantly with drugs that affect this system. Therefore, dual blockade of the RAAS by combining an ACE inhibitor with an angiotensin II receptor antagonist or aliskiren is not recommended.

Combination with aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR <60 ml/min/1.73 m2).

Impact on the ability to drive vehicles and operate machinery

Prestarium® A should be prescribed with caution to patients driving vehicles and engaging in activities that require increased concentration and speed of psychomotor reactions, due to the risk of developing arterial hypotension and dizziness.

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”).