Perindopril 8mg pills 8

Indications and usage

- arterial hypertension (as monotherapy and as part of combination therapy);

- chronic heart failure;

- ischemic heart disease: reducing the risk of cardiovascular complications in patients who have previously had a myocardial infarction and / or coronary revascularization;

- prevention of recurrent stroke (in combination with indapamide) in patients who have had a stroke or transient cerebral circulation in the ischemic type.

The drug is taken orally, before meals, 1 time per day, preferably in the morning.

When choosing a dose, it is necessary to take into account the peculiarities of the clinical situation and the degree of reduction in blood pressure during the treatment.

Arterial hypertension

Perindopril-SZ can be used both as monotherapy and as part of combination therapy. The recommended initial dose is 4 mg 1 time / day.

In patients with pronounced activation of the RAAS (especially in case of renovascular hypertension, hypovolemia and / or reduction of plasma electrolytes, decompensation of heart failure or severe arterial hypertension), after taking the first dose of the drug, an excessive decrease in blood pressure may be observed. At the beginning of therapy, such patients should be under close medical supervision. The recommended initial dose for these patients is 2 mg 1 time / day.

If necessary, one month after the start of therapy, you can increase the dose of the drug to 8 mg 1 time / day.

At the beginning of therapy with Perindopril-SZ, symptomatic arterial hypotension may occur. In patients receiving diuretics at the same time, the risk of arterial hypotension is higher due to possible hypovolemia and a decrease in the electrolyte content of blood plasma. Caution should be exercised when using the drug Perindopril-SZ in these patients.

It is recommended, if possible, to stop taking diuretics 2-3 days before the intended start of therapy with Perindopril-SZ. In the absence of the possibility of diuretic cancellation, the initial dose of Perindopril-SZ should be 2 mg. It is necessary to monitor the kidney function and the content of potassium in the serum.Subsequently, if necessary, the dose of the drug may be increased. If necessary, diuretic administration can be resumed.

Have elderly patients treatment should begin with a dose of 2 mg / day, and later, if necessary, 1 month after starting therapy, the dose can be increased to 4 mg / day, and then to a maximum dose of 8 mg / day, taking into account the state of kidney function (see Table 1).

Chronic heart failure

The recommended initial dose of Perindopril-SZ is 2 mg 1 time / day. Patients should be under close medical supervision. As a rule, the drug is used in combination with potassium-sparing diuretics and / or Digoxin and / or beta-blockers. Subsequently, depending on the tolerance and therapeutic response, 2 weeks after the start of therapy, the dose of Perindopril-SZ can be increased to 4 mg 1 time / day.

Particular caution at the beginning of therapy should be observed in patients with severe chronic heart failure of the IV functional class according to the NYHA classification, as well as in other patients from the high-risk group (impaired renal function and the possibility of developing disorders of the water electrolyte balance of the blood, concomitant diuretic therapy and / or vasodilators).

If possible, before initiating the use of the drug Perindopril-SZ in patients at high risk of developing arterial hypotension, the BCC should be adjusted. Indicators such as blood pressure, kidney function and potassium in the blood plasma should be monitored both before and during the treatment with Perindopril-SZ.

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

In patients with a stable course of IHD, treatment with Perindopril-SZ should be started with a dose of 4 mg 1 time / day for 2 weeks. Then the daily dose may be increased to 8 mg 1 time / day.

Elderly patients therapy should be started with a dose of 2 mg 1 time / day for one week, then 4 mg 1 time / day for the next week. Then, taking into account the state of renal function, the dose should be increased to 8 mg 1 time / day (see table. 1). It is possible to increase the dose of the drug only if it is well tolerated at the previously recommended dose.

Prevention of recurrent stroke (in combination with indapamide) in patients who have had a stroke or transient cerebral circulation by ischemic type

In patients with a history of cerebrovascular diseases, treatment with Perindopril-SZ should be started with a dose of 2 mg 1 time / day for the first 2 weeks before taking Indapamide.

Therapy should be initiated at any time (from 2 weeks to several years) after a stroke or cerebral circulation.

Have patients with renal failure The dose of the drug should be selected taking into account QC.

Table. Dose of Perindopril-SZ in renal failure

* dialysis clearance of perindoprilat - 70 ml / min. The drug should be taken after a dialysis session.

When using the drug Perindopril-SZ in patients with impaired liver function dose adjustment is not required.

Perindopril-SZ should not be used in children and adolescents under the age of 18 due to the lack of data on the effectiveness and safety of patients in this age group.

The frequency of adverse reactions that may occur during perindopril therapy is given in the form of the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1000); very rarely (<1/10 000), including individual reports (World Health Organization classification).

Nervous system: often - paresthesias, headache, dizziness, vertigo; infrequently - sleep disturbances, mood lability, drowsiness, fainting; very rarely - confusion.

Special senses: often - visual impairment.

From the organ of hearing: often - tinnitus.

Hemic and lymphatic: infrequently - hypoglycemia, hyperkalemia, reversible after drug withdrawal, hyponatremia, eosinophilia; very rarely, hemoglobin and hematocrit decrease, thrombocytopenia, leukopenia / neutropenia, pancytopenia, agranulocytosis.

In patients with congenital deficiency of glucose-6-phosphate dehydrogenase in very rare cases, hemolytic anemia occurs.

Cardiovascular: often - excessive decrease in blood pressure, incl.orthostatic hypotension; infrequently - vasculitis, tachycardia, palpitations; very rarely, cardiac arrhythmias, angina pectoris, myocardial infarction, and stroke, possibly due to an excessive decrease in blood pressure in high-risk patients.

Respiratory: often - cough, shortness of breath; infrequently - bronchospasm, chest pain; very rarely - eosinophilic pneumonia, rhinitis.

Gastrointestinal: often - nausea, vomiting, abdominal pain, taste disturbance, dyspepsia, diarrhea, constipation; infrequently - dryness of the oral mucosa; very rarely - pancreatitis, hepatitis (cholestatic or cytolytic), angioedema, intestinal edema.

From the skin and subcutaneous fat: often - skin rash, itching; infrequently - angioedema of the face, lips, upper and lower extremities, mucous membranes, tongue, vocal cords and / or larynx, photosensitization, pemphigus, urticaria; very rarely - erythema multiforme.

From the musculoskeletal system: often - muscle spasms; infrequently - arthralgia, myalgia.

From the urinary system: infrequently - renal dysfunction; very rarely, acute renal failure.

From the reproductive system: infrequently - erectile dysfunction.

Common disorders and symptoms: often - asthenia; infrequently - increased sweating, peripheral edema, weakness, fever, falls.

Laboratory values: infrequently - an increase in the concentration of urea and creatinine in the blood plasma, reversible after discontinuation of the drug, more often in patients with renal insufficiency, severe chronic heart failure and renovascular hypertension; rarely - increased activity of hepatic transaminases and serum bilirubin.

- angioedema (angioedema) in history, associated with taking ACE inhibitors;

- hereditary / idiopathic angioedema;

- simultaneous use with aliskiren and aliskiren-containing drugs in patients with diabetes mellitus or impaired renal function (glomerular filtration rate (GFR) <60 ml / min / 1.73m²);

- pregnancy;

- breastfeeding period;

- age up to 18 years (efficacy and safety have not been established);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

- hypersensitivity to perindopril or excipients that are part of the drug, as well as to other ACE inhibitors.

Carefully the drug should be prescribed for bilateral renal artery stenosis, arterial stenosis of the only functioning kidney; chronic renal failure; systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.); simultaneous administration of immunosuppressants, Allopurinol, procainamide (risk of developing neutropenia, agranulocytosis); reduced blood volume (BCC) (diuretic intake, salt-free diet, vomiting, diarrhea); angina pectoris; atherosclerosis; cerebrovascular diseases; renovascular hypertension; diabetes; severe chronic heart failure, functional class IV, NYHA; aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy; taking potassium-saving diuretics, potassium preparations, potassium-containing substitutes for edible salt and lithium; hyperkalemia; surgical intervention / general anesthesia; when performing hemodialysis using high-flow membranes (for example, AN69^®); desensitizing therapy, apheresis of low density lipoprotein (LDL); condition after kidney transplantation (due to the lack of clinical data); Negroid patients in old age.

The drug Perindopril-SZ is contraindicated in pregnancy.

Perindopril-SZ should not be used in the first trimester of pregnancy. When planning pregnancy or when it is diagnosed while using Perindopril-SZ, it is necessary to stop taking the drug as soon as possible and carry out another anti-hypertensive therapy with a proven safety profile during pregnancy. Appropriate controlled studies of the use of ACE inhibitors in pregnant women have not been conducted. The limited data available on the effects of the drug in the first trimester of pregnancy indicate that the use of ACE inhibitors does not lead to fetal developmental defects associated with fetotoxicity.

It is known that prolonged exposure of the ACE inhibitors to the fetus in the second and third trimesters of pregnancy can lead to impaired development (reduced kidney function, oligohydramnion, slowed down ossification of the skull bones) and the development of complications in the newborn (such as renal failure, arterial hypotension, hyperkalemia). If the patient received Perindopril-SZ in the II or III trimester of pregnancy, an ultrasound scan is recommended to assess the state of the bones of the skull and the kidney function of the fetus.

The use of the drug Perindopril-SZ during breastfeeding is not recommended due to the lack of data on the possibility of its penetration into breast milk. If the use of the drug is necessary during lactation, breastfeeding should be stopped.

When using the drug Perindopril-SZ in patients with impaired liver function dose adjustment is not required.

Carefully the drug should be prescribed for bilateral renal artery stenosis, arterial stenosis of the only functioning kidney; chronic renal failure, condition after kidney transplantation (due to the lack of clinical data).

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

Precautions should be prescribed medication to elderly patients.

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

With the development of unstable angina during the first month of therapy with Perindopril-SZ, the benefits and risks should be assessed before continuing therapy.

Hypotension

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients with uncomplicated arterial hypertension. The risk of an excessive decrease in blood pressure is increased in patients with reduced BCC, which can be observed during diuretic therapy, with a strict salt-free diet, hemodialysis, vomiting and diarrhea, as well as in patients with severe arterial hypertension with high plasma renin activity.In most cases, episodes of marked reduction 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 impaired renal function. At the beginning of therapy and with an increase in the dose of Perindopril-SZ, patients should be under close medical supervision. Such an approach should be used in patients with angina and cerebrovascular diseases in whom severe hypotension can lead to the development of myocardial infarction or cerebrovascular complications.

With a significant decrease in blood pressure, the patient should be placed in a supine position with the headboard lowered and the BCC should be replenished immediately (for example, IV infusion of 0.9% sodium chloride solution). A pronounced decrease in blood pressure at the first dose of the drug is not an obstacle for the further use of the drug. After the restoration of BCC and blood pressure, treatment can be continued with careful selection of doses of the drug Perindopril-SZ.

In some patients with chronic heart failure and normal or decreased blood pressure, Perindopril-SZ may cause an additional decrease in blood pressure. This effect is predictable and usually does not require cessation of therapy. If symptoms appear, a pronounced decrease in blood pressure should reduce the dose of the drug or stop taking it.

Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy

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

Renal dysfunction

For patients with renal insufficiency (CC less than 60 ml / min.), The initial dose of the drug Perindopril-SZ is selected depending on the value of CC and then depending on the therapeutic effect. For these patients, regular monitoring of creatinine concentrations and potassium levels in plasma is necessary.

Hypotension, which sometimes develops at the beginning of the use of ACE inhibitors in patients with symptomatic chronic heart failure, can lead to a deterioration in renal function. Perhaps the development of acute renal failure, as a rule, reversible.In patients with bilateral renal artery stenosis or arterial stenosis of a single kidney (especially in the presence of renal failure) during therapy with ACE inhibitors, it is possible to increase the concentration of urea and creatinine in the blood plasma, usually taking place when therapy is canceled. The additional presence of renovascular hypertension causes an increased risk of developing severe arterial hypotension and renal failure. The treatment of these patients begins under close medical supervision with the use of low doses of the drug and further adequate selection of doses. Treatment with diuretics should be temporarily discontinued and regular monitoring of serum potassium and creatinine should be conducted during the first few weeks of therapy.

In some patients with arterial hypertension in the presence of previously undetected renal failure, especially with the simultaneous use of diuretics, the concentration of urea and creatinine in the blood serum may increase. These changes are usually expressed slightly and are reversible. In such cases, you may need to cancel or reduce the dose of Perindopril-SZ and / or diuretic.

The likelihood of developing these disorders is higher in patients with impaired renal function in history.

Hemodialysis

In patients on hemodialysis using high-flow membranes (for example, AN69^®), there have been several cases of persistent, life-threatening Anaphylactic reactions. The use of ACE inhibitors when using this type of membrane should be avoided.

Kidney transplantation

Data on the use of the drug Perindopril-SZ after kidney transplantation are not available.

Hypersensitivity / Angioedema

Patients taking ACE inhibitors in rare cases, especially during the first few weeks of therapy, may develop angioedema of the face, extremities, lips, tongue, voice folds and / or larynx. In rare cases, severe angioedema can occur during prolonged use of an ACE inhibitor. With the appearance of these symptoms, the use of the drug Perindopril-SZ should be immediately discontinued; preparations of another pharmacotherapeutic group should be used as a replacement.

Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, vocal cords or larynx can lead to airway obstruction. During its development, emergency therapy includes, in addition to other prescriptions, immediate s / c administration of a solution of epinephrine (adrenaline) 1: 1000 (1 mg / ml) 0.3-0.5 ml or slow i / v its introduction (in accordance with the instructions for preparing an infusion solution ) under the control of ECG and blood pressure. The patient should be hospitalized for treatment and observation for at least 12-24 hours and until complete regression of the symptoms.

In patients with a history of angioedema, not associated with taking ACE inhibitors, the risk of its development when taking drugs in this group may be increased.

In rare cases, against the background of therapy with ACE inhibitors, angioedema of the intestines develops. At the same time, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without prior angioedema of the face and during normal activity of the enzyme C-1 esterase. The diagnosis is established using CT scan of the abdominal area, ultrasound or at the time of surgery. Symptoms disappear after discontinuation of ACE inhibitors. In patients with abdominal pain, receiving ACE inhibitors, when conducting a differential diagnosis, it is necessary to take into account the possibility of developing angioedema.

Anaphylactic reactions in the apheresis of LDL

In rare cases, patients receiving ACE inhibitors may experience life-threatening anaphylactic reactions during an apheresis LDL procedure using dextran sulfate. To prevent an anaphylactic reaction, it is necessary to temporarily discontinue therapy with an ACE inhibitor before performing 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 desensitization 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 temporarily canceling the ACE inhibitor before the desensitization procedure begins.

Liver dysfunction

Acceptance of ACE inhibitors is sometimes associated with the syndrome, starting with the development of cholestatic jaundice, progressing to fulminant necrosis of the liver, and (sometimes) fatal. The mechanism of development of this syndrome is unclear. If jaundice symptoms appear or liver enzymes become more active in patients taking ACE inhibitors, the therapy should be discontinued and the examination should be carried out.

Neutropenia / agranulocytosis / thrombocytopenia / anemia

During therapy with ACE inhibitors, neutropenia / agranulocytosis, thrombocytopenia, and anemia can develop. With normal kidney function and the absence of other complications, neutropenia rarely occurs. ACE inhibitors are used only in emergency cases with systemic vasculitis, immunosuppressive therapy, taking allopurinol or procainamide, as well as combining all these factors, especially against the background of previous renal failure. There is a risk of developing severe infectious diseases resistant to intensive antibiotic therapy. During therapy with Perindopril-SZ in patients with the above factors, it is necessary to regularly monitor the content of leukocytes.

Ethnic differences

It should be borne in mind that patients of the Negroid race are more likely to develop angioedema. Like other ACE inhibitors, Perindopril-SZ is less effective in reducing blood pressure in Negroid patients. This effect is probably associated with a pronounced predominance of low-rootine status in patients of the Negroid race with arterial hypertension.

Cough

During therapy with an ACE inhibitor, a dry non-productive cough may occur, which stops after discontinuation of the drug, this should be considered when conducting a differential diagnosis of cough.

Surgical intervention / general anesthesia

The use of ACE inhibitors in patients who are to undergo surgery with general anesthesia can lead to a pronounced decrease in blood pressure, especially when using agents for general anesthesia that have antihypertensive effects. Reception of the drug Perindopril-SZ should be stopped one day before surgery.With the development of arterial hypotension should maintain blood pressure by replenishing the BCC.

It is necessary to warn the anesthesiologist 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 and latent diabetes mellitus. Usually it is not recommended to use potassium preparations, potassium-sparing diuretics, and other drugs associated with the risk of increasing the potassium content (for example, heparin), because of the possibility of severe hyperkalemia. If a joint intake of these drugs is necessary, then therapy should be accompanied by regular monitoring of the content of potassium in the blood serum.

Diabetes

In patients taking hypoglycemic agents for oral administration or insulin, during the first month of treatment with ACE inhibitors should regularly monitor the concentration of glucose in the blood plasma.

Lithium preparations

The combined use of the drug Perindopril-SZ and lithium preparations is not recommended.

Potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes and food additives

Not recommended for combined use with ACE inhibitors.

Double blockade of RAAS

Cases of arterial hypotension, fainting, stroke, hyperkalemia and impaired renal function (including acute renal failure) have been reported in susceptible patients, especially when used concurrently with medications that affect this system. Therefore, a double blockade of RAAS as a result of a combination of an ACE inhibitor with ARA II or aliskiren is not recommended.

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

Influence on ability to drive motor transport and control mechanisms

Perindopril-SZ should be used with caution to patients driving vehicles and engaging in activities that require increased concentration and quick response, due to the danger of arterial hypotension and dizziness.

Symptoms: excessive decrease in blood pressure, shock, water-electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.

Treatment: emergency measures are reduced to the removal of the drug from the body - washing the stomach and / or taking Activated carbon with the subsequent restoration of water and electrolyte balance. With a significant decrease in blood pressure, the patient should be placed in a supine position with the head lowered and the BCC should be replenished immediately; a 0.9% solution of sodium chloride should be introduced in / in. Perindoprilat, the active metabolite of perindopril, can be removed from the body through dialysis. With the development of treatment-resistant bradycardia, an artificial pacemaker may be required. The main vital functions of the body, the content of serum electrolytes and QC should be under constant monitoring.

Hyperkalemia Drugs

Some drugs or medications other pharmacological classes can increase the risk of hyperkalemia: aliskiren and aliskirensoderzhaschie drugs, salts of potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists (ARA II), non-steroidal anti-inflammatory drugs (NSAIDS), Heparin, immunosuppressants, such as cyclosporine or tacrolimus, trimethoprim. The combination of these drugs increases the risk of hyperkalemia.

Simultaneous use is contraindicated

Aliskiren. In patients with diabetes mellitus or impaired renal function (GFR less than 60 ml / min), the risk of hyperkalemia, deterioration of renal function and an increase in the incidence of cardiovascular morbidity and mortality increases.

Simultaneous use is not recommended.

Aliskiren. In patients without diabetes mellitus or impaired renal function, there may be an increased risk of hyperkalemia, deterioration of renal function and an increase in the incidence of cardiovascular morbidity and mortality.

Double blockade of RAAS

In patients with established atherosclerotic disease, heart failure, or diabetes mellitus with target organ damage, simultaneous therapy with an ACE inhibitor and ARA II is associated with a higher incidence of arterial hypotension, fainting, hyperkalemia, and deterioration of renal function (including acute renal failure) compared with the use of only one drug that affects the RAAS.Double blockade (for example, when combining an ACE inhibitor with ARA II) should be limited to individual cases with careful monitoring of kidney function, potassium and blood pressure.

Estramustin

Simultaneous use may increase the risk of side effects such as angioedema.

Diuretics

In patients receiving diuretics, especially with excessive removal of fluid and / or electrolytes, at the beginning of perindopril therapy, an excessive decrease in blood pressure can be observed, the risk of developing which can be reduced by canceling the diuretic, replenishing fluid loss (w / w infusion of 0.9% sodium chloride solution), and also applying perindopril in lower doses.

Potassium-sparing diuretics, potassium and potassium-containing products and food supplements

With perindopril therapy, serum potassium usually remains within the normal range, but hyperkalemia may develop in some patients. The combined use of ACE inhibitors and potassium-sparing diuretics (for example, spironolactone, triamterene, amiloride, eplerenone (a spironolactone derivative)), potassium and potassium-containing products, and food additives can lead to a significant increase in serum potassium. Therefore, the combined use of perindopril and the above drugs is not recommended. These combinations should be used only in the case of hypokalemia, observing