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 ® A, 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 with uncomplicated course of arterial hypertension. The risk of excessive reduction in blood pressure is increased in patients with reduced BCC, which can be observed against diuretic therapy, with strict salt-free diet, hemodialysis, diarrhea and vomiting, as well as in patients with severe hypertension with high renin activity (see "Interactions with other medicinal products "and" Side effect "). Patients with an increased risk of developing symptomatic arterial hypotension should carefully monitor blood pressure, kidney function and potassium content in the blood serum during therapy with Prestarium ® A.
A similar approach is also used in patients with ischemic heart disease and cerebrovascular diseases in which severe arterial hypotension can lead to myocardial infarction or impaired cerebral circulation.
In the case of development of arterial hypotension the patient should be transferred to the "lying" position on the back with raised legs. If necessary, replenish the volume of circulating blood by intravenous administration of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle for further administration of the drug. After restoration BCC and AD treatment can be continued.
In some patients with chronic heart failure (CHF) and normal or reduced BP Prestarium ® A can 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 ® A, like other ACE inhibitors, should be administered with caution to patients with obstruction of the left ventricular outflow tract (aortic stenosis,hypertrophic obstructive cardiomyopathy), as well as patients with mitral stenosis.
Impaired renal function
For patients with renal insufficiency (KC less than 60 ml / min), the initial dose of Prestarium ® A is selected depending on the value of the CC (see the "Method of administration and dose" section) and then depending on the therapeutic effect. For such patients, regular monitoring is necessary concentrations of creatinine and potassium at serum blood (see section "Side effect").
Arterial hypotension, which sometimes develops early in the administration of ACE inhibitors in patients with symptomatic CHF, 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 arteries 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 serum, usually taking place with the withdrawal of therapy, is possible. The additional presence of reninvascular hypertension causes an increased risk of severe arterial hypotension and kidney failure in these patients.
Treatment of such patients begins under careful medical supervision with the use of low doses of the drug and further adequate selection of doses. Diuretic treatment should be temporarily discontinued and regular monitoring of potassium and creatinine in the blood plasma during the first few weeks of therapy.
In some patients with hypertension Without indicating the presence of a previous disease of the kidneys can increase the concentration urea and creatinine in the blood serum, especially with the simultaneous use of diuretics. These changes are usually not very pronounced and are reversible. The probability of these disorders is higher in patients with a history of renal insufficiency. In such cases, it may be necessary to cancel or reduce the dose of Prestarium ® A and / or diuretic.
Hemodialysis
In patients on hemodialysis using high-permeability membranes (for example, AN69®), cases of development of anaphylactic reactions on the background of therapy with ACE inhibitors. The use of ACE inhibitors should be avoided when using this type of membrane.
Kidney Transplantation
Data on the use of Prestarium ® A in patients after kidney transplantation are not available.
Hypersensitivity / angioedema
When taking ACE inhibitors, including perindopril, in rare cases and in any period of therapy may develop angioedema, edema of the face, upper and lower limbs, lips, mucous membranes, tongue, vocal cords and / or larynx (see section "Side effect"). When symptoms appear, taking the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely. If the swelling affects only the face and lips, then its manifestations usually pass on their own, although antihistamines can be used to treat the symptoms.
Angioedema, accompanied by swelling of the larynx, can lead to death. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction. When such symptoms appear emergency treatment is required, including subcutaneous administration epinephrine (adrenaline) and / or providing airway patency.The patient should be under medical supervision until the symptoms disappear completely and persistently.
Patients with a history of Quinck's edema who are not associated with taking ACE inhibitors may be at increased risk of developing this drug when taking this drug (see "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 levels of C1-esterase. The diagnosis was established using computed tomography of the abdominal region, ultrasound examination or surgical intervention. Symptoms disappeared after discontinuation of ACE inhibitors. Therefore, patients with abdominal pain receiving ACE inhibitors should take into account the possibility of angioedema edema development during differential diagnosis (see section "Side effect").
Anaphylactoid reactions during apheresis of low density lipoproteins (LDL)
In rare cases in patients receiving ACE inhibitors, during the procedure of apheresis of LDL with the use of dextran sulfate may develop life threatening anaphylactoid reactions. To prevent anaphylactoid reaction, therapy with an ACE inhibitor should be temporarily discontinued before each apheresis procedure.
Anaphylactoid reactions during desensitization
There are some reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, for example, by the venom of Hymenoptera. ACE inhibitors should be used with caution in patients prone to allergic reactions undergoing desensitization procedures. The use of ACE inhibitors should be avoided for patients receiving immunotherapy with bee venom. However, this reaction can be avoided by the temporary withdrawal of the ACE inhibitor before the desensitization procedure begins.
Impaired liver function
In rare cases, when taking ACE inhibitors there was a syndrome of development cholestatic jaundice with the transition to fulminant liver necrosis, sometimes fatal.The mechanism of development of this syndrome is unclear. When there is jaundice or a significant increase in the activity of "hepatic" Enzymes on the background of taking ACE inhibitors should stop taking the drug (see the section "Side effect"), the patient should be under appropriate medical supervision.
Neutropenia / agranulocytosis / thrombocytopenia / anemia
Against the background of taking ACE inhibitors, neutropenia / agranulocytosis, thrombocytopenia and anemia can occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia develops rarely. With extreme caution follow the apply Prestarium® A in patients with systemic connective tissue diseases, with immunosuppressant, allopurinol or procainamide, especially in patients with impaired renal function.
Some patients had severe infections, in some cases, resistant to intensive antibiotic therapy. When appointing Prestarium® A such patients are advised to periodically monitor content leukocytes in the blood. Patients should inform the doctor of any signs of infectious diseases (eg, sore throat, fever).
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, Prestarium ® A 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
On the background of therapy with an inhibitor ACE may arise persistent dry cough, which stops after the drug is discontinued. This should be taken into account in the differential diagnosis of cough.
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 when using drugs for general anesthesia that have an antihypertensive effect. Prestarium ® A 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 alert the surgeon / anesthesiologist that the patient is taking ACE inhibitors.
Hyperkalemia
Hyperkalemia can develop during treatment with ACE inhibitors, including, and perindopril. Risk factors for hyperkalemia are renal failure, decreased kidney function, age over 70 years, diabetes mellitus, some concomitant conditions (dehydration, acute heart failure, metabolic acidosis), simultaneous reception of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride), food additives / potassium preparations or potassium-containing substitutes for edible salt, as well as the use of other drugs that increase the potassium content in the blood (for example, heparin). Application food additives / potassium preparations, potassium-sparing diuretics, potassium-containing substitutes for edible salt can lead to a significant increase in potassium levels in the blood, especially in patients with reduced renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If simultaneous reception is required Prestarium® A and the above drugs, treatment should be carried out with caution in the background of regular monitoring of potassium content in serumblood (see the section "Interaction with other medicinal products").
Patients with diabetes mellitus
When prescribing a drug for patients with diabetes mellitus receiving hypoglycemic agents for ingestion or insulin, during the first month of therapy it is necessary to regularly monitor concentration glucose in the blood (see section "Interaction with other medicinal products"). Lithium preparations
The simultaneous use of Prestarium ® A and lithium preparations is not recommended (see the section "Interaction with Other Drugs"),
Potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for edible salt and food additives
It is not recommended the simultaneous administration of Prestarium A and potassium-sparing diuretics, as well as preparations of potassium, potassium-containing substitutes for edible salt and food additives (see the section "Interaction with other medicinal products").
Double blockade of RAAS
Arterial hypotension, fainting, stroke, hyperkalemia and renal dysfunction (including acute renal failure) have been reported in susceptible patients, especially when used with medications that affect this system.Therefore, the double blockade of RAAS due to a combination of an ACE inhibitor with ARAP or aliskiren is not recommended.
The combination with aliskiren is contraindicated in patients with diabetes mellitus or renal dysfunction (GFR <60 mL / min / 1.73 m2) (see the sections "Contraindications" and "Interaction with other medicinal products").