Active substancePerindoprilPerindopril
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    1 tablet, film-coated 2 mg contains:

    Tablet core composition:

    Active substance: perindopril erbumine 2.0 mg.

    Excipients: corn starch pregelatinized starch -

    15,0 mg; cellulose microcrystalline - 71.0 mg; crospovidone - 10.0 mg; silicon dioxide colloidal - 1.0 mg; magnesium stearate 1.0 mg.

    Composition of the tablet shell: fall off II white (85F18422) 3.0 mg (polyvinyl alcohol 40,000%, titanium dioxide 25,000%, macrogol 3350-20,200%, talcum 14,800%).

    1 tablet, film-coated 4 mg contains:

    Tablet core composition:

    Active substance: Perindopril erbumine 4.0 mg.

    Excipients: corn starch pregelatinized starch -

    15.0 mg; cellulose microcrystalline - 69.0 mg; crospovidone - 10.0 mg; silicon dioxide colloid -1,0 mg; magnesium stearate 1.0 mg.

    The composition of the tablet shell: opadrai II green (85F21738) 3.0 mg (polyvinyl alcohol 40,000%, titanium dioxide 24.345%, macrogol 3350-20.200%, talc 14.800%, indigocarmine 0.540%, aluminum aluminum varnish-0.115%).

    1 tablet, film-coated 8 mg contains:

    Tablet core composition:

    Active substance: Perindopril erbumine - 8.0 mg.

    Excipients: corn starch pregelatinized starch -

    15.0 mg; cellulose microcrystalline - 65.0 mg; crospovidone - 10.0 mg; silicon dioxide colloid -1,0 mg; magnesium stearate -1.0 mg.

    Composition of the tablet shell: opadrai II green (85F21867) 3.0 mg (polyvinyl alcohol 40,000%, titanium dioxide 21,000%, macrogol 3350-20,200%, talc 14,800%, indigocarmine 2,500%, iron oxide yellow oxide 1,500%.

    Description:

    Tablets 2 mg

    The tablets are round, biconvex, covered with a film coat of white or almost white color. On the cross section - the core is white or almost white.

    Tablets 4 mg

    Tablets are round, biconvex, covered with a film membrane from light green to green. On the cross section - the core is white or almost white.

    Tablets 8 mg

    Tablets are round, biconvex, covered with a film membrane from gray-green to green with a grayish hue. On the cross section - the core is white or almost white.

    Pharmacotherapeutic group:Angiotensin-converting enzyme (ACE) inhibitor.
    ATX: & nbsp

    C.09.A.A.04   Perindopril

    Pharmacodynamics:

    Perindopril is an ACE inhibitor. ACE is an exopeptidase, which carries out both the conversion of angiotensin I into a vasoconstrictor substance, angiotensin II, and the destruction of bradykinin, which has a vasodilating action,to the inactive heptapeptide. Suppression of ACE leads to a decrease in angiotensin II in the blood plasma, resulting in increased plasma renin activity (due to the inhibition of negative feedback, which prevents the release of renin) and decreases the secretion of aldosterone. Since ACE inactivates bradykinin, ACE inhibition is accompanied by an increase in the activity of both the circulating and tissue kallikrein kinin system, while the system of prostaglandins is activated. Perindopril It has a therapeutic effect due to an active metabolite, perindoprilat. Other metabolites of the drug have no inhibitory effect on ACE in vitro.

    Perindopril reduces both systolic and diastolic blood pressure (BP). Perindopril reduces overall peripheral resistance of blood vessels, which leads to a decrease in blood pressure (BP), while peripheral circulation improves without changing the heart rate (heart rate).

    The maximum hypotensive effect is achieved 4-6 hours after taking the drug and lasts 24 hours.In patients with a positive response to therapy, BP normalization occurs within a month of constant intake of the drug, while the effect of "addiction" is not observed. It was established that the abrupt withdrawal of the drug is not accompanied by the syndrome of "withdrawal".

    Perindopril has a vasodilating effect, helps restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces hypertrophy of the left ventricular myocardium.

    The concomitant use of thiazide diuretics increases the severity of hypotensive action. Combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of developing hypokalemia with diuretics.

    The use of perindopril in patients with chronic heart failure reduces prednagruzku and afterload on the heart. Perindopril reduces the filling pressure of the left and right ventricles, reduces the overall peripheral resistance of the vessels, increases cardiac output with an improvement in the cardiac index, and increases the regional muscle blood flow.

    When perindopril was used, there was a decrease in the risk of cardiovascular complications (mortality fromcardiovascular diseases, the incidence of non-fatal myocardial infarction, etc.).

    Pharmacokinetics:

    After oral administration perindopril quickly absorbed from the gastrointestinal tract. Time to reach the maximum concentration (TCmax) perindopril in blood plasma for 1 hour, perindoprilat - 3 - 4 hours.

    Approximately 27% of the total amount of absorbed perindopril is converted to perindoprilat, the active metabolite. Besides Perindoprilata in the process of metabolism is formed 5 more metabolites - all they are inactive substances. Half-life (T1/2) perindopril from the blood plasma is 1 h. T1 / 2 perindoprilata - 3-4 hours.

    The intake of the drug during meals is accompanied by a decrease in the conversion of perindopril to perindoprilat, thus decreasing the bioavailability of the drug.

    Distribution

    The binding of perindoprilat to plasma proteins is 20%, mainly with ACE, and is dose-dependent. The volume of distribution of free perindoprilata is approximately 0.2 l / kg.

    Excretion

    Perindoprilat is excreted by the kidneys and the general period T1 / 2 unbound fraction is 17 hours, which provides an equilibrium concentration for 4 days.

    Pharmacokinetics in elderly patients and people with concomitant diseases

    The excretion of perindoprilat is delayed in old age, as well as in patients with cardiac and renal insufficiency. In case of renal insufficiency, correction of the dose of the drug should be carried out taking into account the degree of renal dysfunction.

    The dialytic clearance of perindoprilat is 70 ml / min.

    In patients with cirrhosis, the liver clearance of perindopril is reduced by half. Nevertheless, the amount of perindoprilat formed does not decrease and no change in the dose of the drug is required.

    Indications:

    - arterial hypertension;

    - chronic heart failure;

    - prevention of recurrent stroke (as part of complex therapy with indapamide) in patients who underwent a stroke or transient cerebral circulation disorder by ischemic type;

    - stable coronary heart disease (CHD): a reduced risk of developing cardiovascular complications in patients who had had previous myocardial infarction and / or coronary revascularization.

    Contraindications:

    Hypersensitivity to perindopril or any of the excipients of the drug, or to other ACE inhibitors;

    - An angioneurotic edema in the history as a result of previous therapy with ACE inhibitors, hereditary and / or idiopathic angioedema;

    - Pregnancy, lactation;

    - Age under 18 years (efficiency and safety not established);

    Carefully:Reduction in the volume of circulating blood (diuretics, the use of potassium-containing drugs and dietary supplements, salt-free diet, vomiting, diarrhea, hemodialysis), hyponatremia, cerebrovascular disease, ischemic heart disease - the risk of a sharp decline in blood pressure; chronic heart failure in the stage of decompensation, arterial hypotension, renovascular hypertension, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney - the risk of severe arterial hypotension and renal failure; chronic renal failure; systemic connective tissue diseases (systemic lupus erythematosus, scleraRhoderma) and immunosuppressive therapysites (including after transplantation of the kidney) - the risk of developing agranulocytosis and neutropenia; giperkalemia; stenosis of the aortic or mitral valve, hypertrophicobstructive cardiomyopathy;

    procedure of hemodialysis usinghigh-strength polyacryliclnitrile membranes; before the processfool apheresis lipoproteins low density (LDL); simultaneous desensitizing therapy with allergens; use of patients after transplantation kidneys (there is no clinical experienceapplication); surgical intervention (general anesthesia);

    patients with diabetes mellitus,radiating hypoglycemic mediafor oral administration or insulin, it is recommended to monitor thethe concentration of glucose in the blood; crochetdeficiency of glucose-6-phosphate dehydrogenases - single cases of development of hemolytic anemia; reception of potassium-sparing diuretics, potassium preparations, kafood-containing substitutessalt and lithium; application toblack-backed race; elderly age.

    Pregnancy and lactation:

    In pregnancy, perindopril is contraindicated. Do not use perindopril in the first trimester of pregnancy, therefore, when confirming pregnancy, perindopril intake should be canceled as soon as possible.

    Perindopril is contraindicated in the second and third trimesters of pregnancy, as it can cause fetotoxic effects of the fetus (decreased kidney function, low blood pressure, slowing ossification of the fetal bones) and neonatal toxic effects (renal failure, hypertension, hyperkalemia). If nevertheless applied perindopril in the second and third trimesters of pregnancy, it is necessary to perform an ultrasound examination of the function of the kidneys and bones of the fetal skull.

    ACE inhibitors can be excreted into breast milk, so if perindopril is needed during lactation, breastfeeding should be stopped.

    If it is necessary to use ACE inhibitors, women of reproductive age should use reliable methods of contraception.

    Dosing and Administration:

    Inside, it is recommended to take once a day, before meals, preferably in the morning.

    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 can be used in monotherapy and in combination with other antihypertensive drugs.

    The recommended initial dose is 4 mg once a day, in the morning.

    For patients with marked activation of the renin-angiotensin-aldosterone system (RAAS) (for example, with renal vascular hypertension, hypovolemia and / or hyponatremia, CHF in decompensation or severe hypertension), the recommended initial dose is 2 mg per day in a single dose. If the therapy is ineffective for a month, the dose can be increased to 8 mg once a day and with good tolerability of the previous dose.

    Addition of ACE inhibitors patients taking diuretics, can cause the development of arterial hypotension. In this regard, it is recommended to take care with caution, to stop taking diuretics 2 to 3 days before the start of treatment with perindopril or to start treatment with perindopril from the initial dose of 2 mg per day, in a single dose. Control is required: blood pressure, kidney function and potassium content in the blood serum. In the future, the dose of the drug may be increased, depending on the dynamics of blood pressure. If necessary, diuretic therapy can be resumed.

    Have elderly patients the recommended initial daily dose is 2 mg, in a single dose. In the future, the dose can be gradually increased to 4 mg and, if necessary, to a maximum of 8 mg once a day, provided that the dose is well tolerated.

    Chronic heart failure

    The recommended initial dose is 2 mg in the morning, under medical supervision. After 2 weeks, the dose can be increased to 4 mg per day in one session, under the control of blood pressure. Treatment of CHF with clinical manifestations is usually combined with potassium-sparing diuretics, beta-adrenoblockers and / or digoxin.

    Have patients with CHF, with renal failure and with a tendency to electrolyte disorders (hyponatremia), as well as in patients taking both diuretics and / or vasodilators, The treatment with perindopril is started under strict medical supervision.

    Have patients with a high risk of developing clinically significant arterial hypotension (eg, taking high doses of diuretics), if possible, before the initiation of perindopril, hypovolemia and electrolyte disturbances must be eliminated. It is recommended to carefully monitor blood pressure, the state of kidney function and the content of potassium in the blood serum before and during therapy.

    Prevention of recurrent stroke in patients with cerebrovascular disease in history

    Therapy with perindopril should be started with a dose of 2 mg 1 day during the first 2 weeks before taking indapamide, after possibly increasing the dose to 4 mg once a day.Treatment should be started at any time (from 2 weeks to several years) after a stroke.

    Stable ischemic heart disease (CHD)

    In patients with stable ischemic heart disease, the recommended initial dose of perindopril is 4 mg once daily. After 2 weeks, the dose is increased to 8 mg per day, provided that the dose is well tolerated at 4 mg per day and that the kidney function is monitored.

    Treatment elderly patients should start with a dose of 2 mg, which in a week can be increased to 4 mg once a day. In the future, if necessary, after a week, you can increase the dose to 8 mg per day with mandatory pre-control of kidney function. In elderly patients, the dose of perindopril can be increased only if the previous, lower dose is well tolerated.

    With renal failure: in patients with kidney diseases, the dose of perindopril is determined depending on the degree of renal function impairment. Patient monitoring usually involves regular determination of serum potassium and serum creatinine. Recommended doses:

    CK (ml / min)

    Recommended dose

    from 60 ml / min and above

    4 mg per day

    from 30 to 60 ml / min

    2 mg per day

    from 15 to 30 ml / min

    2 mg every other day

    Patients on hemodialysis * (SC less than 15 mL / min)

    2 mg per day of dialysis

    * - Dialyz clearance of perindoprilata is 70 ml / min. Perindopril must be taken after a dialysis session.

    With liver diseases: correction of doses is not required.

    Side effects:

    To determine the frequencyadverse effects of the drug

    apply the following classificationtion:

    Very often (> 1/10)

    Often (> 1/100 and <1/10)

    Infrequently (> 1/1000 and <1/100)

    Rarely (> 1/10 000 and <1/1000)

    Very rarely (> 1/10 000)

    Frequency is unknown (frequency not moto be calculated by available data)

    From the side of cardiovascular system: often: less pronouncedvery rarely: arrhythmias, stenocardia, myocardial infarction or insult, possibly secondary, afterseverity of arterial hypertensionpotency in patients of the group is highwho is at risk; frequency is unknown: youkulit, tachycardia, palpitation.

    From the genitourinary system: infrequently: renal failure, impotence, very rarely: acute renal failure.

    From the respiratory system: often: cough, shortness of breath; infrequently: bronchospasm, very rarely: eosinophilic pneumonia, rhinitis.

    From the digestive system: often: nausea, vomiting, abdominal pain, dysgeusia, indigestion, diarrhea, constipation; infrequently: dry mouth; very rarely: cytolytic or cholestatic hepatitis (see section "Special instructions"), pancreatitis, angioedema, intestinal edema. From the skin and subcutaneous fat: often: skin rash, itching; infrequently: angioedema, swelling of the face, limbs, urticaria; very rarely: erythema multiforme; frequency unknown: photosensitivity, eczema.

    From the central nervous system: often: headache, godizziness, paresthesia; infrequently: sleep or mood disturbances; very rarely: confusion.

    Common violations: often: asthenia; infrequently: increased sweatingtion; frequency unknown: drowsiness, fainting.

    From the side of the organ of vision: often: visual impairment.

    From the organs of hearing: often: noise in ears.

    From the side of the musculoskeletal systemstems: often: muscle cramps; frequency unknown: arthralgia, mialgia.

    Laboratory indicators: rarely: increased content of potassium in blood serum; very rarely: decrease in content hemoglobin and hematocrit, lowernumber of platelets and leukocytestov; in some cases, possible agranulocytosis or pancytopenia, in In rare cases,the activity of "hepatic" transaminase, bilirubin concentrationbina serum; hypoglycaMiya. With congenital deficiency glucose-6-phosphate dehydrogenase fromisolated cases of hemolyticanemic anemia; frequency unknown: eosinophilia, increase in urea concentration and plasma creatinine; theseafter the cancellation of the preparat and are more common in the presence of renal failure, severe chronic heart failure or renovascular hypertension.

    With glomerular nephropathy, the use of ACE inhibitors can cause proteinuria. In special cases (after kidney transplantation or hemodialysis), the use of ACE inhibitors leads to anemia (see section "Special instructions").

    Overdose:

    Symptoms: marked decrease in blood pressure, shock, disturbance of water electrolyte balance (hyperkalemia, hyponatremia), renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough.

    Treatment: with a pronounced decrease in blood pressure - give the patient a horizontal position with raised legs and carry out measures for replenishing the volume of circulating blood (BCC), if possible - intravenous administration of a solution of catecholamines. With the development of severe bradycardia, not amenable to drug therapy (including atropine), the installation of an artificial pacemaker is shown. It is necessary to monitor the vital functions and concentrations of creatinine and electrolytes in the blood serum. Perindopril can be removed from the systemic blood flow by hemodialysis. It is necessary to avoid the use of high permeability polyacrylonitrile membranes.

    Interaction:

    Not recommended combinations

    Potassium-sparing diuretics, prePotassium paraffin, potassium-containing foods and food additives Usually, with the ACE inhibitor therapy, the serum potassium content remains within normal limits, but some patients may develop hyperkalemia. Combined use of ACE inhibitors and potassium-sparing agents diuretics (eg, spironolactone, triamterene or amiloride),potassium or potassium-containing products and food additives can cause hyperkalemia. Therefore, it is not recommended to combine perindopril with these drugs. Assign these combinations should only in the case of hypokalemia, observing the precautionary measures and regularly monitoring the potassium content in the blood serum.

    Double blockade of the renin-angiotensin-aldosterone system (RAAS) with angiotensin II receptor antagonists, ACE inhibitors or aliskiren is associated with increased anti-

    risk of hypotension, hypercoliemia, and renal dysfunction (including acute renal failure) compared with monotherapy of these drugs. It is necessary to carefully monitor blood pressure, kidney function and electrolyte balance in patients receiving medicines that affect RAAS (incl. aliskiren).

    It is not recommended joint use of ACE inhibitors and aliskiren in patients with diabetes mellitus and renal insufficiency (CC less than 60 ml / min).

    Preparations of gold With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate for intravenous use) describes the symptom-complex, which includes face flushing, nausea, vomiting and lowering of blood pressure.

    Combinations with medicines for which caution is necessary

    Diuretics

    In patients taking diuretics, especially when you are overweightfluid and / or sodium, in the beginning of therapy with ACE inhibitors may develop excessive arterieshypotension. Risk of development excessive hypotensioncan be reduced by canceling diuretic, intravenous 0.9% solution of sodium chloride, and also prescribing an ACE inhibitor in lower doses. Further ondose doses perindoprila shouldbut be carried out carefullytion.

    Lithium

    With simultaneous application lithium preparations and inhibitors ACE may develop reversiblyth increase in the content of lithium in serum and lithium toxicitytion. Simultaneous application ACE inhibitors with thiazide diurethics can additionally increase lithium contentand increase the risk ofits toxic effects. Simultaneous use of perindopril and lithium is not recommended. If necessary, this combination therapy is carried out under regular control of the lithium content in the blood serum. Hypoglycemic agents Simultaneous use of ACE inhibitors and hypoglycemic agents (insulin or hypoglycemic agents for oral administration) can increase the hypoglycemic effect, up to the development of hypoglycemia. As a rule, this phenomenon occurs in the first weeks of combined therapy in patients with renal insufficiency.

    Tricyclic antidepressants / antipsychotic facilities

    (antipsychotics) / general anesthetic agents (general anesthetics) Co-administration with ACE inhibitors can lead to an increased hypotensive effect. Other antihypertensives and vasodilators

    The simultaneous use of perindopril with other antihypertensive drugs can enhance the hypotensive effect of perindopril. Simultaneous use of nitroglycerin, other nitrates or vasodilators can lead to an additional hypotensive effect.

    Allopurinol, cytostatic agents and immunosuppressants, sStem Glucocorticosteroids, procainamide.

    Taking these drugs simultaneously with ACE inhibitors may increase the risk of leukopenia.

    Non-steroidal anti-inflammatory(NSAIDs), including number of acetylsalicylic acid at doses from 3 g / day and above

    Therapy of NSAIDs may reduce the hypotensive effect of ACE inhibitors. In addition, NSAIDs and ACE inhibitors have an additive effect on the increase in potassium in the serum of the bloodvie, which can lead to impaired renal function. This effect is usually reversible. In rare cases, acute renal failure may develop, especially in patients with an existing renal dysfunction, for example, in elderly patients or with dehydration. Sympathy Sympathomimetics can weaken the hypotensive effect of ACE inhibitors. When this combination is prescribed, the effectiveness of ACE inhibitors should be evaluated regularly.

    Ethanol (alcohol) strengthens the hypotensive effect of the drug.

    Acetylsalicylic acid, thrombolytic agents, beta-blockers and nitrates Perindopril can be prescribed with acetylsalicylic acid (as an antiplatelet agent), thrombolytic agents and beta-blockers and / or nitrateratami.

    Special instructions:

    Stable ischemic heart disease (CHD)

    When the episode of unstable angina develops (significant or not) duringThe first month of therapy with perindopril should be evaluated for the benefit / risk ratio of further use of the drug Perindopril.

    Arterial hypotension ACE inhibitors can cause a sharp decrease in blood pressure. In patients with uncomplicated arterial hypertension, symptomatic arterial hypotension rarely occurs after taking the first dose. The risk of excessive reduction in blood pressure is increased in patients with a reduced bcc against diuretic therapy, with strict salt-free diet, hemodialysis, as well as with diarrhea or vomiting, or in patients with severe renin-dependent hypertension. The expressed arterial hypotension was observed in patients with chisevere 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 hyponatremia or kidney failure. These patients are recommended careful medical supervision at the beginning of therapy and when titrating doses of the drug. The same applies to patients with IHD or cerebrovascular disease, in whom excessive reduction of blood pressure can lead to myocardial infarction or cerebrovascular complications.In the case of development of arterial hypotension, it is necessary to give the patient a horizontal position with raised legs, and if necessary, administer a solution of sodium chloride intravenously to increase the BCC. Transient arterial hypotension is not a contraindication for further therapy. After the recovery of bcc and blood pressure, treatment can be continued provided that the dose of the drug is carefully selected.

    In some patients with CHF and normal or low blood pressure during therapy with perindopril, an additional decrease in blood pressure may occur. This effect is expected and usually is not a basis for drug discontinuation. If arterial hypotension is accompanied by clinical manifestations, a dose reduction or perindopril cancellation may be required.

    Impaired renal function and renovascular hypertension

    In patients with renal insufficiency (CC less than 60 ml / min), the initial dose of perindopril should be selected according to the QC (see the section "Dosing and Administration") and then, depending on the therapeutic response to the therapy. For such patients, regular monitoring of potassium and creatinine in the blood plasma is necessary.

    In patients with symptomatic heart failure, arterial hypotension, which develops during the initial period of therapy with ACE inhibitors, can lead to impaired renal function. In these patients, sometimes there were cases of acute renal failure, usually reversible.

    In some patients with bilateral renal artery stenosis or stenosis of the renal artery to a solitary kidney (especially in the presence of renal failure) during therapy with ACE inhibitors was an increase in serum concentrations of urea and creatinine, reversible after discontinuation of therapy. Patients with renovascular hypertension during therapy with ACE inhibitors are at increased risk of severe hypotension and renal insufficiency. Treatment of such patients should start under close medical supervision with low doses and with further adequate dose selection. During the first weeks of perindopril therapy, diuretine remedies should be abolished and the kidney function monitored regularly.

    Some patients with hypertension, the presence of previously undetected kidney failure,especially with concomitant diuretic therapy, there was a slight and temporary increase in the concentration of urea and creatinine in the blood serum. In this case, a reduction in the dose of perindopril and / or removal of the diuretic is recommended.

    Anaphylactoid reactions in time of procedure atelow-density lipoprotein cut(LDL-apheresis)

    In patients with the appointment of ACE inhibitors against the background of the procedure for the apheresis of low density lipoprotein (LDL) with dextran sulfate, in rare cases, the development of an anaphylactic reaction. It is recommended that the ACE inhibitor be temporarily withdrawn (at least 24 hours before) each apheresis procedure. Anaphylactic reactions during desensitization There are isolated reports of prolonged life-threatening anaphylactoid reactions in patients taking ACE inhibitors during desensitizing therapy with poisons of Hymenoptera (bees, wasps). ACE inhibitors should be given with caution to patients with allergies and receiving desensitizing therapy. However, these reactions can be prevented by the temporary withdrawal of the ACE inhibitor at least 24 hours before each desensitization procedure.

    Increased sensitivity / angioedema Rarely, in patients taking ACE inhibitors, incl. perindopril, angioneurotic edema of the face, limbs, lips, mucous membranes, tongue, vocal cords and / or larynx developed. This condition can develop at any time of treatment. With the development of angioedema, treatment should immediately be discontinued, the patient should be under medical supervision until the symptoms disappear completely. Angioedema of the lips and face usually does not require treatment; To reduce the severity of symptoms, you can use antihistamines.

    Angioedema, swelling of the tongue, vocal cords or larynx can lead to death. With the development of angioedema, immediately subcutaneously epinephrine (adrenaline) and ensure the patency of the respiratory tract.

    ACE inhibitors often cause angioedema in patients of the Negroid race. Patients with a history of anginaevrotic edema not associated with the use of ACE inhibitors may be at high risk of developing angioedema when taking an ACE inhibitor.

    In rare cases, against the background of therapy with ACE inhibitors, angioedema develops in the intestine.

    In this case, patients have abdominal pain, possibly in combination with nausea and vomiting; in some cases without a previous angioedema and a normal level of C1-esterase.

    Diagnosed with computer tomography or ultrasound examination of the abdominal organs, or during a surgical procedure. Symptoms disappear after discontinuing therapy with an ACE inhibitor. Patients receiving ACE inhibitors should consider the possibility of angioedema edema of the intestine and differential diagnosis of abdominal pain.

    Cough

    Against the background of therapy with ACE inhibitors, a persistent, unproductive dry cough may develop, which stops after the drug is discontinued. This should be taken into account in the differential diagnosis of cough.

    Elderly patients

    In elderly patients, the hypotensive effect of ACE inhibitors may be more pronounced than in young patients.

    It is recommended to start treatment with low doses and assess kidney function at the beginning of the drug.

    Hyperkalemia

    Against the background of therapy with ACE inhibitors, including perindopril, in some patients the potassium content in the blood can increase. The risk of hyperkalemia is elevated in patients with renal and / or heart failure, decompensated diabetes mellitus, and in patients using potassium-sparing diuretics, potassium preparations or other drugs that cause hyperkalemia (eg, heparin).

    If it is necessary to simultaneously prescribe these drugs, it is recommended to regularly monitor the potassium content in the blood serum.

    Surgical interventionstoi / general anesthesia

    In patients whose condition requires extensive surgical intervention or general anesthesia with drugs that cause arterial hypotension, ACE inhibitors, including perindopril, can block the formation of angiotensin II with compensatory release of renin. The day before the surgery, therapy with ACE inhibitors should be canceled. If the ACE inhibitor can not be canceled, then the arterial hypotension, which develops according to the mechanism described, can be corrected by an increase in BCC.

    Stenosis of the aortic or mitral valve / hypertrophic obstructive cardiomyopathy

    ACE inhibitors, incl. and perindopril, should be administered with caution to patients with mitral valve stenosis and left ventricular outflow tract obstruction (aortic valve stenosis and hypertrophic obstructive cardiomyopathy).

    Neutropenia / Agranulocytosis / Anemia

    In patients on the background of therapy with ACE inhibitors, cases of development of neutropenia / agranulocytosis, thrombocytopenia and anemia were noted. With normal kidney function, in the absence of other complications, neutropenia develops rarely. Perindopril it is necessary to use with very great care in patients with systemic connective tissue diseases (for example, systemic lupus erythematosus, scleroderma) who simultaneously received immunosuppressive therapy, allopurinol or procainamide, as well as when combining all of these factors, especially if there is an existing impairment of kidney function. Such patients may develop severe infections that do not respond to intensive antibiotic therapy.When carrying out perindopril therapy in patients with the above factors, it is recommended to periodically monitor the number of white blood cells 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 development of hemolytic anemia were noted.

    Diabetes

    In patients with diabetes who take hypoglycemic agents for ingestion or insulin, in the first few months of therapy with ACE inhibitors, the concentration of glucose in the blood should be carefully monitored.

    Proteinuria

    Proteinuria can develop in patients already having impaired renal function, as well as during the administration of high doses of ACE inhibitors.

    Liver failure

    During therapy with ACE inhibitors, it is sometimes possible to develop a syndrome that starts with cholestatic jaundice and then progresses to fulminant liver necrosis, sometimes with a fatal outcome. The mechanism of development of this syndrome is unclear. If jaundice appears during the administration of an ACE inhibitor or an increase in the activity of "hepatic" transaminases occurs, the ACE inhibitor should be immediately discontinued,and the patient should be under close medical supervision.

    Negroid race

    The risk of angioedema development in patients of the Negroid race.

    Effect on the ability to drive transp. cf. and fur:

    Given the possibility of developing arterial hypotension or dizziness, which can affect the management of vehicles and work with mechanisms, care should be taken when driving vehicles or working with mechanisms.

    Form release / dosage:

    Tablets, film-coated 2 mg, 4 mg, 8 mg. 10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

    For 1, 2, 3, 5, 6 or 9 contour cell packs, together with instructions for medical use, put in a pack of cardboard box.

    Packaging:(10) - packings, cellular, outline (1) - packs, cardboard
    (10) - packings, cellular, outline (2) - packs, cardboard
    (10) - packings, cellular, outline (3) - packs, cardboard
    (10) - packings, cellular planimetric (5) - packs cardboard
    (10) - packings, cell planimetric (6) - packs cardboard
    (10) - packings, cellular planimetric (9) - packs cardboard
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.


    Shelf life:

    2 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002192
    Date of registration:22.08.2013
    The owner of the registration certificate:IZVARINO PHARMA, LLC IZVARINO PHARMA, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.08.2015
    Illustrated instructions
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