IHD: a reduction in the risk of cardiovascular complications in patients who have had previous myocardial infarction and / or coronary revascularization
With the development of unstable angina 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 excessive reduction in blood pressure is elevated in patients with a reduced BCC, which can be observed against a background of diuretic therapy, while observing strict salt-free diet, hemodialysis, vomiting and diarrhea, as well as in patients with severe hypertension with high renin activity of blood plasma (see the sections "Interaction with other medicinal products" and "Special instructions"). In most cases, episodes of marked 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. Most often, this side effect is observed in patients receiving "loop" diuretics in high doses, as well as in patients with hyponatremia or with renal dysfunction. At the beginning of therapy and with an increase in the dose of Prestarium ®, patients should be under careful medical supervision (see the sections "Dosing and Administration" and "Side-effects"). This approach should be used in patients with angina and cerebrovascular diseases,in whom severe arterial hypotension can lead to the development of myocardial infarction or cerebrovascular complications.
With a significant decrease in blood pressure, the patient should be transferred to the "lying" position on the back with raised legs and immediate replacement of the bcc (for example, intravenous infusion of 0.9% sodium chloride solution). Intravenous administration of angiotensin II and / or catecholamines is also possible. The pronounced decrease in blood pressure at the first intake of the drug is not an obstacle for the further use of the drug. After the recovery of bcc and blood pressure, treatment can be continued with a careful selection of doses of Prestarium®.
In some patients with chronic heart failure and normal or low blood pressure, Prestarium ® may cause an additional reduction in blood pressure. This effect is predictable and usually does not require discontinuation of therapy. If symptoms of a marked decrease in blood pressure appear, reduce the dose or stop taking it.
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.
Impaired renal function
For patients with renal insufficiency (CC less than 60 ml / min.), The initial dose of Prestarium ® is chosen depending on the value of the CC (see the section "Method of administration and dose") and then depending on the therapeutic effect. For such patients, regular monitoring of QC and potassium levels in blood plasma (see section "Side effect") is necessary.
Arterial hypotension, which sometimes develops early in the administration of ACE inhibitors in patients with symptomatic chronic heart failure, can lead to impaired renal function. It is possible to develop acute renal failure, as a rule, reversible.
In patients with bilateral stenosis of the renal artery or stenosis of the artery of a single kidney (especially in the presence of kidney failure) against the background of therapy with ACE inhibitors, an increase in the concentration of urea and creatinine in the blood plasma, usually taking place when the therapy is withdrawn.The additional presence of reninvascular hypertension causes an increased risk of severe arterial hypotension and kidney failure. Treatment of such patients begins under careful medical supervision with the use of low doses of the drug and further adequate selection of doses. Diuretics should be discontinued and regular monitoring of serum potassium and creatinine levels during the first few weeks of therapy.
In some patients with arterial hypertension, in the presence of previously unrecognized renal failure, especially with the simultaneous use of diuretics, the concentration of urea and creatinine in serum can increase. These changes are usually not very pronounced and are reversible. In such cases, it may be necessary to cancel or reduce the dose of Prestarium ® and / or diuretic.
Hemodialysis
In patients on hemodialysis using high-flow membranes (for example, AN69®), Several cases of development of persistent, life-threatening anaphylactic reactions were noted.The use of ACE inhibitors should be avoided when using this type of membrane.
Kidney transplantation
Data on the use of Prestarium ® after kidney transplantation are not available.
Hypersensitivity / angioedema. In patients taking ACE inhibitors, in rare cases, especially during the first few weeks of therapy, angioedema may develop swelling of the face, extremities, lips, tongue, glottis and / or larynx. In rare cases, severe angioedema may occur with prolonged use of an ACE inhibitor. If these symptoms appear, Prestarium® should be discontinued immediately, and preparations of another pharmacotherapeutic group should be used as a substitute. Angioedema, accompanied by swelling of the larynx, can lead to death. Swelling of the tongue, glottis or larynx can lead to airway obstruction. In its development, emergency therapy includes, in addition to other prescriptions, immediate subcutaneous injection of an epinephrine (adrenaline) 1: 1000 (1 mg / ml) solution of 0.3-0.5 ml or slow intravenous administration (according to the instructions for preparation infusion solution) under the control of ECG and blood pressure.The patient should be hospitalized for treatment and supervision for at least 12-24 hours and until the symptoms regress completely.
Patients with a history of Quincke edema who are not associated with the administration of ACE inhibitors may be at increased risk of developing it with the use of this group of drugs (see section "Contraindications").
In rare cases, against the background of therapy with ACE inhibitors, angioedema develops in the intestine. Thus, patients have a pain in the abdomen as an isolated symptom or in combination with nausea and vomiting in some cases without prior angioneurotic edema of the face and at normal enzyme activity C-1 esterase. The diagnosis is established using computed tomography of the abdominal region, ultrasound or at the time of surgery. Symptoms disappear after stopping the intake of ACE inhibitors. In patients with abdominal pain receiving ACE inhibitors, the differential diagnosis should take into account the possibility of developing angioedema edema of the intestine.
Anaphylactic reactions in the apheresis of low-density lipoproteins (LDL)
In rare cases in patients receiving ACE inhibitors, during the procedure of apheresis of low density lipoproteins with the help of dextran sulfate may develop life-threatening anaphylactic reactions. To prevent an anaphylactic reaction, therapy with an ACE inhibitor should be temporarily discontinued before each procedure for LDL apheresis using dextran sulfate.
Anaphylactic reactions during desensitization '
There are separate reports on 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 in patients receiving immunotherapy with bee venom should be avoided. However, this reaction can be avoided by the temporary withdrawal of the ACE inhibitor before the desensitization procedure begins.
Impaired liver function
The administration of ACE inhibitors is sometimes associated with a syndrome that begins with the development of cholestatic jaundice,progressing to fulminant liver necrosis, and (sometimes) fatal. The mechanism of development of this syndrome is unclear. If symptoms of jaundice appear or the activity of liver enzymes increases in patients taking ACE inhibitors, drug therapy should be discontinued and an appropriate examination performed (see "Side effect" section).
Neutropenia / agranulocytosis / thrombocytopenia / anemia
Against the background of therapy with ACE inhibitors, neutropenia / agranulocytosis, thrombocytopenia and anemia can develop. With normal kidney function and no other complications, neutropenia occurs rarely. ACE inhibitors are used only in emergency cases in the presence of systemic vasculitis, immunosuppressive therapy, reception of 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 resistant to intensive antibiotic therapy. When Prestarium ® is administered to patients with the above factors, it is necessary to regularly monitor the white blood cell count.
Ethnic differences
It should be borne in mind that in patients of the Negroid race the risk of angioedema development is higher. Like other ACE inhibitors, Preterium ® is less effective in reducing blood pressure in patients of the Negroid race.
This effect is probably associated with a marked predominance of low-grade status in patients of the Negroid race with arterial hypertension.
Cough
Against the background of therapy with an ACE inhibitor, a dry, unproductive cough may occur, which stops after the drug is discontinued.
Surgery / general anesthesia
The use of ACE inhibitors in patients who undergo surgery with general anesthesia can lead to a marked decrease in blood pressure, especially with the use of general anesthetics, which have an antihypertensive effect. Prestarium® should be discontinued one day before surgery. With the development of arterial hypotension, blood pressure should be maintained by replenishing the BCC.
It is necessary to warn the anesthesia doctor that the patient is taking ACE inhibitors.
Hyperkalemia
Hyperkalemia can develop during treatment with ACE inhibitors,especially if the patient has renal and / or heart failure, latent diabetes mellitus. It is usually not recommended to use potassium preparations, potassium-sparing diuretics and other drugs associated with the risk of increasing the potassium content (eg, heparin), because of the possibility of pronounced hyperkalemia. If joint intake of these drugs is necessary, then therapy should be accompanied by regular monitoring of potassium in the blood serum.
Diabetes
In patients taking hypoglycemic drugs for ingestion or insulin, during the first month of therapy with ACE inhibitors should regularly monitor the concentration of glucose in the blood plasma (see section "Interaction with other drugs").
Lithium preparations
Joint use of Prestarium ® and lithium preparations is not recommended (see the section "Interaction with other medicinal products").
Potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and food additives
It is not recommended joint use with ACE inhibitors (see section "Interaction with other drugs").