Perindopril-Teva, 30 pcs., 10 mg, film-coated tablets

Compound

Directions for use and doses

Inside.

It is recommended to take 1 time per day, preferably in the morning, before meals.

The dose of the drug is selected individually for each patient, depending on the severity of the disease and individual response to treatment.

Arterial hypertension

The drug Perindopril-Teva can be used in monotherapy and in combination with other antihypertensive drugs.

The recommended starting dose is 5 mg/day, in the morning.

In patients with severe activation of the RAAS (for example, with renovascular hypertension, hypovolemia and/or hyponatremia, decompensated CHF or severe arterial hypertension), a pronounced decrease in blood pressure may develop after taking the first dose of the drug. At the beginning of therapy, such patients should be under close medical supervision. The recommended starting dose is 2.5 mg/day in one dose. If necessary, within a month the dose can be increased to 10 mg/day in one dose and if the previous dose is well tolerated.

The maximum daily dose is 10 mg.

The addition of ACE inhibitors to patients taking diuretics may cause them to develop arterial hypotension. In this regard, it is recommended to carry out therapy with caution, stop taking diuretics 2-3 days before starting treatment with Perindopril-Teva, or start treatment with Perindopril-Teva with an initial dose of 2.5 mg/day in one dose. Monitoring of blood pressure, renal function and serum potassium levels is necessary. In the future, the dose of the drug can be increased depending on the dynamics of blood pressure. If necessary, diuretic therapy can be resumed.

In elderly patients, the recommended initial daily dose is 2.5 mg. In the future, the dose can be gradually increased to 5 mg/day and, if necessary, to a maximum of 10 mg/day in one dose, taking into account the state of renal function.

CHF

The recommended starting dose is 2.5 mg/day in one dose, in the morning, under medical supervision. After 2 weeks, the dose can be increased to 5 mg/day in one dose, under blood pressure monitoring. Treatment of symptomatic CHF is usually combined with potassium-sparing diuretics, beta-blockers and/or digoxin.

In patients with CHF, renal failure and a tendency to water and electrolyte disturbances (hyponatremia), as well as in patients taking diuretics and/or vasodilators at the same time, treatment with Perindopril-Teva begins under strict medical supervision.

In patients at high risk of developing clinically significant arterial hypotension (for example, when taking high doses of diuretics), if possible, hypovolemia and fluid and electrolyte disturbances should be eliminated before starting Perindopril-Teva. It is recommended to carefully monitor blood pressure, renal function and serum potassium levels before and during therapy.

Prevention of recurrent stroke (combination therapy with indapamide)

In patients with a history of cerebrovascular disease, therapy with Perindopril-Teva should be started with a dose of 2.5 mg for the first 2 weeks, then increased to 5 mg over the next 2 weeks before using indapamide. Therapy should be started at any time (from 2 weeks to several years) after a stroke.

Stable ischemic heart disease

In patients with stable coronary artery disease, the recommended initial dose of Perindopril-Teva is 5 mg/day in one dose. After 2 weeks, the dose is increased to 10 mg/day in one dose, provided that the dose of 5 mg/day is well tolerated and renal function is monitored.

Special patient groups

Elderly age.

Treatment of elderly patients should begin with a dose of 2.5 mg/day in one dose, which after a week can be increased to 5 mg/day in one dose. If necessary, after another week you can increase the dose to 10 mg/day in one dose with mandatory preliminary monitoring of renal function. In elderly patients, the dose of the drug can be increased only if the previous, lower dose is well tolerated.

Kidney failure.

In patients with renal failure, the dose of the drug should be adjusted taking into account creatinine Cl.

Recommended doses:

*Dialysis clearance of perindoprilate is 70 ml/min.

The drug Perindopril-Teva must be taken after a dialysis session.

Liver diseases.

No dose adjustment is required.

If one or more doses are missed at the next dose, Perindopril-Teva should be taken at the usual dose; You cannot take a higher dose.

Perindopril-Teva

Stable ischemic heart disease

If an episode of unstable angina (significant or not) develops during the first month of therapy with Perindopril-Teva, it is necessary to assess the benefit/risk ratio of therapy with this drug.

Arterial hypotension

ACE inhibitors can cause a sharp decrease in blood pressure. In patients with uncomplicated hypertension, symptomatic hypotension rarely occurs after the first dose. The risk of excessive reduction in blood pressure is increased in patients with reduced blood volume during diuretic therapy, while following a strict salt-free diet, hemodialysis, as well as with diarrhea or vomiting, or with severe renin-dependent arterial hypertension. Severe arterial hypotension was observed in patients with severe CHF, both in the presence of concomitant renal failure and in its absence. The most common arterial hypotension can develop in patients with more severe CHF, taking loop diuretics in high doses, as well as against the background of hyponatremia or renal failure. Close medical monitoring is recommended for these patients during initiation of therapy and during dosage titration. The same applies to patients with coronary artery disease or cerebrovascular diseases, in whom an excessive decrease in blood pressure can lead to myocardial infarction or cerebrovascular complications.

If arterial hypotension develops, it is necessary to place the patient in a horizontal position with raised legs and, if necessary, administer a 0.9% sodium chloride solution intravenously to increase blood volume. Transient arterial hypotension is not a contraindication for further therapy. After restoration of blood volume and blood pressure, treatment can be continued subject to careful selection of the dose of the drug.

In some patients with CHF and normal or low blood pressure, an additional decrease in blood pressure may occur during therapy with Perindopril-Teva. This effect is expected and is usually not a reason to discontinue the drug. If arterial hypotension is accompanied by clinical manifestations, it may be necessary to reduce the dose or discontinue Perindopril-Teva.

Renal dysfunction

In patients with renal failure (creatinine clearance less than 60 ml/min), the initial dose of Perindopril-Teva should be adjusted in accordance with the clinical clearance (see section "Method of administration and dosage") and then depending on the therapeutic response. For such patients, regular monitoring of potassium levels and serum creatinine concentrations is necessary.

In patients with symptomatic heart failure, arterial hypotension that develops during the initial period of therapy with ACE inhibitors can lead to deterioration of renal function. Cases of acute renal failure, usually reversible, have sometimes been reported in such patients.

In some patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney (especially in the presence of renal failure), an increase in serum concentrations of urea and creatinine was observed during therapy with ACE inhibitors, which was reversible after discontinuation of therapy.

In patients with renovascular hypertension during therapy with ACE inhibitors, there is an increased risk of developing severe arterial hypotension and renal failure. Treatment of such patients should begin under close medical supervision, with small doses of the drug and with further adequate dose selection. During the first weeks of therapy with Perindopril-Teva, it is necessary to discontinue diuretics and regularly monitor renal function.

In some patients with arterial hypertension in the presence of previously undetected renal failure, especially with concomitant diuretic therapy, there was a slight and temporary increase in serum urea and creatinine concentrations. In this case, it is recommended to reduce the dose of Perindopril-Teva and/or discontinue the diuretic.

Hemodialysis patients

Several cases of persistent, life-threatening anaphylactic reactions have been reported in patients undergoing dialysis using high-flux membranes and concomitantly taking ACE inhibitors. If hemodialysis is necessary, a different type of membrane must be used.

Kidney transplant

There is no experience with the use of Perindopril-Teva in patients who have recently undergone kidney transplantation.

Hypersensitivity, angioedema

Rarely in patients taking ACE inhibitors, incl. perindopril, angioedema of the face, extremities, lips, tongue, vocal folds and/or larynx developed. In patients taking mTOR inhibitors concomitantly, the risk of angioedema may be increased. This condition can develop at any time during treatment. If angioedema develops, treatment should be stopped immediately, and the patient should be under medical supervision until symptoms disappear completely.

Angioedema of the lips and face usually does not require treatment; Antihistamines can be used to reduce the severity of symptoms. Angioedema of the tongue, vocal folds, or larynx can be fatal. If angioedema develops, it is necessary to immediately administer epinephrine (adrenaline) subcutaneously and ensure airway patency.

Patients with a history of angioedema not associated with the use of ACE inhibitors may be at high risk of developing angioedema while taking an ACE inhibitor.

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. Diagnosis was made using abdominal computed tomography, ultrasound, or surgery. Symptoms disappeared after stopping 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”).

In black patients taking ACE inhibitors, angioedema was observed more often than in representatives of other races.

Concomitant use of perindopril with the combination of valsartan + sacubitril is contraindicated, as this increases the risk of developing angioedema. The use of the combination of valsartan + sacubitril is possible no earlier than 36 hours after taking perindopril. The use of perindopril is possible no earlier than 36 hours after taking the combination of valsartan + sacubitril.

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

An increased risk of angioedema has been observed in patients concomitantly taking ACE inhibitors and drugs such as mTOR inhibitors (temsirolimus, sirolimus, everolimus), dipeptidyl peptidase type IV inhibitors (sitagliptin, saxagliptin, vildagliptin, linagliptin), estramustine and tissue plasminogen activators.

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. The use of 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.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are usually not susceptible to antihypertensive drugs that act by inhibiting the RAAS. Therefore, the use of this drug in such patients is not recommended.

Anaphylactoid reactions during low-density lipoprotein apheresis (LDL apheresis)

In patients prescribed ACE inhibitors during the procedure of LDL apheresis using dextran sulfate, in rare cases, an anaphylactic reaction may develop. It is recommended to temporarily discontinue the ACE inhibitor before each apheresis procedure.

Anaphylactic reactions during desensitization

In patients receiving ACE inhibitors during a course of desensitization (for example, hymenoptera venom), in very rare cases, life-threatening anaphylactic reactions may develop. It is recommended to temporarily discontinue the ACE inhibitor before each desensitization procedure.

Liver failure

During therapy with ACE inhibitors, it is sometimes possible to develop a syndrome that begins with cholestatic jaundice and then progresses to fulminant liver necrosis, sometimes with death. The mechanism of development of this syndrome is unclear. If jaundice occurs or an increase in liver enzyme activity occurs while taking an ACE inhibitor, the ACE inhibitor should be discontinued immediately and the patient should be closely monitored. It is also necessary to conduct an appropriate examination.

Neutropenia, agranulocytosis, thrombocytopenia, anemia

Cases of neutropenia, agranulocytosis, thrombocytopenia and anemia have been reported in patients treated with ACE inhibitors. With normal renal function in the absence of other complications, neutropenia rarely develops.

Perindopril-Teva should be used with great caution in patients with systemic connective tissue diseases (for example, SLE, scleroderma), simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as when combining all of these factors, especially with existing renal impairment. Such patients may develop severe infections that do not respond to intensive antibiotic therapy. When carrying out therapy with Perindopril-Teva in patients with the above factors, it is recommended to periodically monitor the number of leukocytes in the blood and warn the patient about the need to inform the doctor about the appearance of any symptoms of infection.

In patients with congenital deficiency of glucose-6-phosphate dehydrogenase, isolated cases of hemolytic anemia have been reported.

Negroid race

Like other ACE inhibitors, perindopril is less effective in lowering blood pressure in black patients, possibly due to the higher prevalence of low-renin conditions in this population of patients with arterial hypertension.

Cough

During therapy with ACE inhibitors, a persistent, non-productive cough may develop, which stops after discontinuation of the drug. This should be taken into account in the differential diagnosis of cough.

Surgery and general anesthesia

In patients whose condition requires major surgery or general anesthesia with drugs that cause hypotension, ACE inhibitors, including perindopril, may block the formation of angiotensin II with compensatory renin release. One day before surgery, therapy with ACE inhibitors must be discontinued. If the ACE inhibitor cannot be canceled, then arterial hypotension developing according to the described mechanism can be corrected by increasing the volume of blood volume.

Hyperkalemia

During therapy with ACE inhibitors, including perindopril, potassium levels in the blood may increase in some patients. The risk of hyperkalemia is increased in patients with renal and/or heart failure, advanced age (>70 years), decompensated diabetes mellitus, hypoaldosteronism, metabolic acidosis, dehydration, and in patients using potassium-sparing diuretics, potassium supplements, or other drugs that cause hyperkalemia (eg, heparin, co-trimoxazole (trimethoprim + sulfamethoxazole).If it is necessary to prescribe these drugs simultaneously, it is recommended to regularly monitor the potassium level in the blood serum, since hyperkalemia can lead to arrhythmia, sometimes fatal.

Diabetes

In patients with diabetes mellitus taking oral hypoglycemic agents or insulin, blood glucose concentrations should be carefully monitored during the first few months of ACE inhibitor therapy.

Lactose

Perindopril-Teva tablets contain lactose. Therefore, patients with hereditary lactose intolerance, lactase deficiency or malabsorption syndrome should not take this drug.

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, double blockade of the RAAS by combining an ACE inhibitor with an ARA II or aliskiren is not recommended. The simultaneous use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients.

Mitral stenosis/aortic stenosis/hypertrophic obstructive cardiomyopathy

Perindopril, 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.

Concomitant use of ACE inhibitors with ARB II is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.