Perindopril-Teva - instructions for use, dose, side effects, contraindications

1 tablet contains: active substance perindopril tosylate 2.50 mg / 5.00 mg / 10.00 mg; Excipients: lactose monohydrate 35.981 mg / 71.962 mg / 143.924 mg; corn starch 1.35 mg / 2.70 mg / 5.40 mg; sodium bicarbonate 0.793 mg / 1.586 mg / 3.172 mg; starch corn pregelatinized 3.60 mg / 7.20 mg / 14.40 mg; povidone-KZO 0.90 mg / 1.80 mg / 3.60 mg; magnesium stearate 0.45 mg / 0.90 mg / 1.80 mg;

sheath for tablets 2.5 mg: Opadry II white 85F18422 (polyvinyl alcohol partially hydrolyzed 0.9000 mg, titanium dioxide (13171) 0.5625 mg, macrogol-3350 0.4545 mg, talc 0.3330 mg);

sheath for tablets 5 mg: Opadry II green 85F210014 (polyvinyl alcohol partially hydrolyzed 1.8000 mg, titanium dioxide (E171) 1.0935 mg macrogol-3350 0.9090 mg, talc 0.6660 mg, indigocarmip (K 132) 0.0144 mg: dye, brilliant blue (E133) 0.0081 mg, dye iron oxide yellow (13172) 0.0045 mg, dye quinoline yellow (E104) 0.0045 mg);

sheath for tablets 10 mg: Opadry II green 85F2J0013 (polyvinyl alcohol partially hydrolyzed 3.6000 mg, titanium dioxide (E171) 2.1330 mg, macrogol-3350 1.8180 mg: talc 1.3320 mg, indigocarmip (E132) 0.0495 mg, color blue diamond (E13.3) 0.0315 mg, color iron oxide yellow (E172) 0.0180 mg, dye quinoline yellow (EL 04) 0.0180 mg).

Description:

Tablets 2.5 mg. Round biconvex tablets, covered with a film coating of white color. On one side - engraving "T". On the cross-section - the core is white or almost white.

Tablets 5 mg. Oval biconvex tablets covered with a film shell of light green color, with decorative risk on the edge of the tablet on both sides. On one side is the engraving "T". On the cross-section - the core is white or almost white.

Tablets 10 mg. Round biconvex tablets, covered with a film membrane of green color. On one side - engraving "10", on the other - "T". On the cross-section - the core is white or almost white.

Pharmacotherapeutic group:inhibitor of angiotensin-converting enzyme (ACE).

ATX: & nbsp

C.09.A.A.04 Perindopril

Pharmacodynamics:

Perindopril is an inhibitor of the angiotensin-converting enzyme (ACE). ACE, or kininase, is an exopeptidase that converts angiotensin 1 into an angiotensin II vasoconstrictor, as well as the destruction of bradykinin, which has a vasodilating action, to an inactive heptapeptide.

The suppression of ACE activity leads to a decrease in angiotensin II concentration in blood plasma,as a result, the activity of renin in the blood plasma increases (due to the inhibition of negative feedback, which inhibits the release of renin) and decreases the secretion of aldosterone. Since ACE inactivates bradykinin, suppression of ACE is accompanied by an increase in the activity of both the circulating, hack and tissue kallikrein-kinin system, and the system of prostaglandins is activated. It is possible that this effect is part of the mechanism of antihypertensive action of ACE inhibitors. and also the mechanism of development of some undesirable reactions of preparations of this group (for example, cough).

Perindopril has a therapeutic effect due to the active metabolite, perindoprilat. Other metabolites of the drug nc have an inhibitory effect on ACE in vitro.

Arterial hypertension

With arterial hypertension, the background of the use of perindonaryl shows a decrease in both systolic and diastolic arterial pressure (BP) in the "lying" and "standing" positions. Perindopril reduces overall peripheral vascular resistance (OPSS), which leads to a decrease in blood pressure.The peripheral blood flow is accelerated, but the heart rate (heart rate) does not increase. Renal blood flow, as a rule, increases, while the rate of glomerular filtration does not change. The maximum antihypertensive effect is achieved 4-6 hours after a single ingestion perindonril; the antihypertensive effect persists for 24 hours, and after 24 hours the drug still provides 87% to 100% maximum effect. Decrease in blood pressure is achieved quickly enough. Stabilization of anti-hypertensive action is observed after 1 month of therapy and persists for a long time. Termination of therapy is not accompanied by the syndrome of "withdrawal".

Perindopril has vasodilating effect, contributes to the restoration of elasticity and large arteries of the vascular wall structure of small arteries and reduces left ventricular hypertrophy. Simultaneous reception of thiazide diuretics enhances the antihypertensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of developing hypocalysis with diuretics.

Chronic heart failure (XCN)

Perindopril normalizes the heart, reducing preload and postnagruzku. In patients with CHF who received perindopril, a decrease in filling pressure in the left and right ventricles of the heart, a decrease in OPSS, an increase in cardiac output and an increase in the cardiac index were revealed.

Cerebrovascular diseases

When using perindopril tretbutylamine 2-4 mg / day (equivalent to 2.5-5 mg perindopril arginine or perindopril tosylate) in both monotherapy and in combination with indapamide, simultaneously with standard therapy of stroke and / or arterial hypertension or other pathological conditions, u patients with a history of cerebrovascular disease (stroke or transient ischemic attack) during the last 5 years, the risk of recurrent stroke (both ischemic and hemorrhagic nature) is significantly reduced. Additionally, the risk of developing lethal or disabling strokes is reduced; major cardiovascular complications, including myocardial infarction, incl. with lethal outcome; dementia associated with stroke; serious deterioration of cognitive functions.

These therapeutic advantages are observed both in patients with arterial hypertension and at normal BP. regardless of age, sex, the presence or absence of diabetes mellitus and the type of stroke.

Stable ischemic heart disease (CHD)

Therapy with perindopril tert-butylamine of 8 mg (equivalent to K) mg perindopril arginine or perindopril tosylate) in patients with stable coronary artery disease with no signs of heart failure, with a history of myocardial infarction and coronary revascularization, with simultaneous use with antiplatelet agents, lipid-lowering agents and beta-blockers leads to a significant reduction in the absolute risk of the primary endpoint (cardiovascular death, myocardial infarction without a fatal outcome and / or cardiac arrest followed by a successful resuscitation).

Pharmacokinetics:

After oral administration perindopril quickly absorbed in the gastrointestinal tract and reaches the maximum concentration in the blood plasma (C_max) for 1 hour. Bioavailability is 65-70%.

In the process of metabolism, 20% is transformed into an active metabolite - perindoprilat.The half-life (T1/2) from the blood plasma of neeridopril is 1 hour. FROM_max Perindonol is achieved in 3-4 hours.

Taking the drug during meals is accompanied by a decrease in the conversion of perindopril to perindoprilat, and the bioavailability of the drug decreases accordingly. The volume of distribution of free perindonolilate is 0.2 l / kg. The connection with blood plasma proteins is insignificant, the connection of perindoprilata with ACE is less than 30%. but depends on its concentration.

Perindoprilat is excreted by the kidneys. The T1 / 2 free fraction is about 3-5 hours. The dissociation of perinoplatinum perimals associated with ACE is slow. As a consequence, the "effective" T1/2 is 25 hours.

Do not cumulate. T1/2 Perindonrilate with repeated admission corresponds to the period of its activity. In elderly patients, in patients with renal and chronic heart failure, excretion of the doprilat perinel is slowed.

Perindoprilat is removed during hemodialysis (rate 70 ml / min, 1.17 ml / sec) and peritoneal dialysis.

In patients with cirrhosis of the liver, the "hepatic" clearance of perindopril is changed, while the total amount of perindonrilate formed does not change and correction of the dosing regimen is required.

Indications:

- Arterial hypertension;

- chronic heart failure;

- prevention of recurrent stroke (as part of complex therapy with indapamide) in patients with a history of cerebrovascular disease (stroke or transient cerebral ischemic attack);

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

Contraindications:

Hypersensitivity to perindoyril or other components of the drug, as well as to other ACE inhibitors; pregnancy; the period of breastfeeding; angioedema in the anamnesis (hereditary, idiopathic or angioedema due to the administration of ACE inhibitors); hereditary lactose intolerance, lactase deficiency or malabsorption syndrome: age under 18 years (efficacy and safety not established), concomitant use with aliskiren and aliskiren-containing drugs in patients with diabetes mellitus or renal dysfunction (GFR) <60 ml / min / 1.73m²).

Carefully:Renovascular hypertension, bilateral stenosis of the renal arteries,stenosis of the artery of a single kidney - the risk of severe arterial hypotension and renal failure; CHF in the stage of decompensation, arterial hypotension; chronic renal failure (creatinine clearance (CK) less than 60 ml / min); hypovolaemia and hyponatremia (due to a salt-free diet and / or previous diuretic therapy, dialysis, vomiting, diarrhea), cerebrovascular diseases (including cerebral circulatory insufficiency, coronary insufficiency) - the risk of excessive blood pressure lowering; stenosis of the aortic or mitral valve, hypertrophic obstructive cardiomyopathy (GOKMG1). hemodialysis using high-flow polyacrylonitrile membranes - the risk of developing anaphylactoid reactions; condition after kidney transplantation - there is no clinical experience; before the procedure of apheresis of low density lipoproteins (LINI), simultaneous conduct of desensitizing therapy with allergens (for example, Hymenoptera venom) - the risk of developing anaphylactoid reactions; connective tissue diseases (including systemic lupus erythematosus (SLE), scleroderma),oppression of bone marrow hematopoiesis with the use of immunosuppressants, allopuripol or procainamide - the risk of agranulocytosis and neutropenia; congenital deficiency of glucose-6-phosphate dehydrogenase - single cases of hemolytic anemia; use in representatives of the Negroid race; surgical intervention (general anesthesia) - the risk of developing excessive blood pressure lowering; diabetes mellitus (monitoring the concentration of glucose in the blood); hyperkalemia: the elderly.

Pregnancy and lactation:

In pregnancy, the use of Perindopril-Teva is contraindicated. Do not use the drug in the first trimester of pregnancy, so when planning pregnancy or when diagnosing it, the Perindopril-Teva drug should be discontinued as early as possible and another antihypertensive therapy should be performed. Appropriate controlled trials of the use of ACE inhibitors in pregnant women have not been conducted. The limited information available on the effect of the drug in the first trimester of pregnancy suggests that the use of ACE inhibitors does not lead to fetal malformations associated with fetotoxicity. The drug Perindopril-Teva is contraindicated in II-III trimesters of pregnancy, because it can cause fetotoxic effects in the fetus (decreased kidney function, low blood pressure, slowing ossification of the fetal bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkaliemia). If nevertheless used the drug in II-II1 trimesters of pregnancy, it is necessary to conduct ultrasound examination of the kidneys and bones of the fetal skull.

The use of the drug Perindopril-Teva during breast-feeding is not recommended, due to the lack of data on the possibility of its isolation in breast milk. If it is necessary to use the drug during this period, it is necessary to stop breastfeeding.

Dosing and Administration:

Inside. It is recommended to take once a day, before meals, preferably at a throm, not chewing.

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 initial dose is 5 mg once a day, in the morning.

For patients with pronounced activation of the renn-angiotensin-achosterosterone system (eg, with renovascular hypertension, hypovolemia and / or hyponatremia, CHF in decompensation or severe hypertension), the recommended initial dose is 2.5 mg / day in a single dose. If the therapy is ineffective for a month, the dose may be increased to 10 mg / day in one dose and with good tolerability of the previous dose.

Addition of LIF inhibitors patients taking diuretics, can cause the development of arterial hypotension. In this regard, it is recommended to take care with caution, to cancel diuretics 2-3 days before starting treatment with Perindopril-Teva or to start treatment with Perindopril-Teva from the initial dose of 2.5 mg / day in one session. It is necessary to control blood pressure, kidney function and potassium 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 2.5 mg / day. In the future, the dose can be gradually increased to 5 mg / day and, if necessary, up to a maximum of 10 mg / day in one dose, provided a good tolerability of a smaller dose.

Chronic heart failure

The recommended initial dose is 2.5 mg / day in one session in the morning, under medical supervision. After 2 weeks, the dose can be increased to 5 mg / day in one session, under the control of blood pressure. Treatment of CHF with clinical manifestations is usually combined with potassium-sparing diuretics, beta-blockers and / or di toxin.

Have patients with CHF. with renal insufficiency and with a tendency to water-electrolyte disorders (hyponatremia), and so in patients taking both diuretics and / or vasodilators, The treatment with Perindopril-Teva is started under strict medical supervision.

Have patients with a high risk of developing clinically significant arterial hypotension (eg, taking high doses of diuretics) As far as possible before the start of taking Perindopril-Teva, hypovolume and water 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-Teva should be started with 2.5 mg / day in one dose during the first 2 weeks before using indapamide. Treatment should be started at any time (from 2 weeks to several years) after a stroke.

Stable ischemic heart disease

In patients with stable IU, the recommended initial dose of Perindopril-

Teva is 5 mg / day in one session. After 2 weeks, the dose is increased to 10 mg / day in one dose, provided that the dose is well tolerated at 5 mg / day and the kidney function is monitored.

Treatment elderly patients should start with a dose of 2.5 mg / day in a single dose, which in a week can be increased to 5 mg / day in one session. If necessary, after a week, you can increase the dose to 10 mg / day in one session with mandatory pre-control of kidney function. In elderly patients, the dose of the drug can be increased only if the previous, lower dose is well tolerated.

With renal failure: In patients with renal insufficiency, the dose of the drug should be selected taking into account the clearance of creatinine (CC).

Recommended doses:

CK (ml / min.)	Recommended dose
greater than or equal to 60	5 mg / day daily
more than 30 and less than 60	2.5 mg / day daily
more than 15 and less than 30	2.5 mg / day every other day
Patients on hemodialysis * 15	2.5 mg / day in day of dialysis

* - Dialyz clearance of perindoprilata is 70 ml / min.

The drug Psrindopril-Teva should be taken after a dialysis session. With liver diseases correction of the dose is not required.

If you miss one or more doses in the next dose, Perindopril-Teva should be taken in the usual dose; you can not take a higher dose.

Side effects:

The incidence of adverse reactions described below was determined in accordance with the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%. but less than 10%; infrequently - not less than 0,1%. but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual reports; frequency is unknown (can not be calculated from available data).

From the central and peripheral nervous system: often - headache, dizziness, paresthesia, vertigo; infrequently - disturbances of sleep or mood,drowsiness, fainting; very rarely confusion.

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

From the organ of hearing: often - noise in the ears.

From the cardiovascular system: often marked decrease in blood pressure; infrequently - tachycardia, palpitation; very rarely - arrhythmias, angina, myocardial infarction or stroke, possibly secondary, due to severe arterial hypotension in patients at high risk; vasculitis (frequency unknown).

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

From the digestive tract: often - nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea, constipation; infrequent - dryness of the oral mucosa; rarely - pancreatitis; very rarely - cytolytic or cholestatic hepatitis (see section "Special instructions"), angioedema of the intestine.

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

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

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

Common violations: often - asthenia; infrequently - increased sweating.

From the organs of hematopoiesis and lymphatic system: very rarely - with prolonged use in high doses, it is possible to reduce hemoglobin and hematocrit, thrombocytopenia, leukopoeia / neutropenia, agranulocytosis, pancytopenia; very rarely - hemolytic anemia (in patients with congenital deficiency of glucose-6-phosphate dehydrogenase).

Laboratory indicators: increased urea concentration in blood serum and plasma creatinine, and hyperkalemia reversible after drug withdrawal (especially in patients with renal insufficiency, severe XCN and renousvascular hypertension); rarely - increased activity of "hepatic" enzymes and bilirubin in the blood serum, hypoglycemia.

Overdose:

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

Treatment: emergency measures are reduced to removing the drug from the body: washing the stomach and / or taking activated charcoal, followed by the restoration of the water-electrolyte balance.

In the case of a marked decrease in blood pressure, give the patient a horizontal position with raised legs and take measures to replenish the volume of circulating blood (BCC). With the development of severe bradycardia, which is not amenable to drug therapy (including atropine), an artificial pacemaker is shown. It is necessary to monitor the vital functions and concentrations of creatinine and electrolytes in the blood serum. Periodoprilat, an active metabolite of perindopril, can be removed from the systemic blood flow by hemodialysis. It is necessary to avoid the use of high-flow polyacrylonitrile membranes.

Interaction:

Medicines, causing hyperkalemia

Some drugs or preparations of other pharmacological classes may increase the risk of hyperkalemia: aliskiren and aliskiren containing preparations, potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin receptor antagonists II (APA II), Non-steroidal anti-inflammatory drugs (NSAIDs), heparin, immunosuppressants, such as ciclosporin or tacrolimus, trimethoprim. The combination of these drugs increases the risk of hyperkalemia. Simultaneous use is contraindicated

Aliskiren

In patients with diabetes mellitus or renal dysfunction (GFR less than 60 mL / min), the risk of hyperkalemia, impaired renal function, and increased incidence of cardiovascular morbidity and mortality increases. Simultaneous use is not recommended

Aliskiren

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

Double blockade of RAAS

In the literature it was reported that in patients with established atherosclerotic disease, heart failure or diabetes mellitus with target organ damage, concurrent therapy with an ACE inhibitor and an ARA II is associated with a higher incidence of hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) compared with the use of only one drug that affects RAAS.Double blockade (eg, with the combination of an ACE inhibitor with an APA II) should be limited to individual cases with careful monitoring of kidney function, potassium content in blood plasma and LD. Diuretics

In patients taking diuretics, especially with excessive excretion of fluid and / shga electrolytes, at the beginning of therapy with ACE inhibitors, excessive arterial hypotension may develop. The risk of excessive reduction in blood pressure can be reduced by eliminating the diuretic, intravenously administering a 0.9% solution of sodium chloride, and by prescribing an ACE inhibitor at lower doses. Further increase in the dose of Perindopril-Teva should be carried out with caution.

With arterial hypertension In patients receiving diuretics, especially when excess fluid and / or electrolytes are removed, diuretics should be either discontinued before the use of an ACE inhibitor (with a potassium-sparing diuretic may be re-assigned later), or an ACE inhibitor should be prescribed at a low dose with further its gradual increase.

Potassium-sparing diuretics, potassium preparations, potassium-containing foods and nutritional supplements

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 diuretics (eg, spironolactone and its derivative eplerenone, triamterene or amiloride), potassium or potassium-containing products and nutritional supplements may cause hyperkalemia. Therefore, it is not recommended to combine Perindonyl-Teva with these preparations. Assign these combinations should only in the case of hypokalemia, observing the precautionary measures and regularly monitoring the potassium content in the blood serum.

When using diuretics in the case of chronic heart failure an ACE inhibitor should be given at a low dose, possibly after a reduction in the dose of the simultaneously used potassium-sparing diuretic. In all cases, renal function (creatinine concentration) should be monitored in the first weeks of the use of ACE inhibitors. Potassium-sparing diuretics (eplerenone, spironolactone)

The use of eplerenone or spironolactone in doses from 12.5 mg to 50 mg per day and low doses of ACE inhibitors:

When treating heart failure II-IV functional class by classification NYMA with a left ventricular ejection fraction <40% and previous ACE inhibitors and loop diuretics, there is a risk of hyperkalemia (possibly fatal), especially in the case of non-compliance with recommendations for this combination of drugs.

Before using this combination of drugs, you need to make sure there is no hypercalism and renal dysfunction. It is recommended to regularly monitor the concentration of creatinine and potassium in the blood: weekly in the first month of treatment and every month thereafter. NSAIDs. including high doses of acetylsalicylic acid (more than 3 g / day).

Lithium

With simultaneous use of lithium drugs and AG1F inhibitors, it is possible to develop a reversible increase in serum lithium and lithium toxicity. The simultaneous use of ACE inhibitors with thiazide diuretics can further increase the serum lithium content and increase the risk of its toxic effects. Simultaneous use of the drug Psrindopril-Tswa and lithium preparations is not recommended.If necessary, this combination therapy is carried out under regular control of the lithium content in the blood serum. Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid in doses from 3 g / day and above

Therapy of HPVG1 can weaken the anti-hypertensive effect of ACE inhibitors. In addition, PPAI and ACE inhibitors have an additive effect on the increase in serum potassium, 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 already existing disturbance of the function of the nights, for example, in elderly patients or with dehydration of the body.

Other antihypertensives and vasodilators

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

Hypoglycemic agents

Simultaneous application of inhibitors AI1F and hypoglycemic agents (insulin or hypoglycemic agents for oral administration) may 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.

Acetylsalicylic acid, thrombolytic agents, beta-addressinhibitors and nitrates

The drug Perindopril-Teva can be combined with acetylsalicylic acid (as an antiplatelet agent), thrombolytic agents and run-adrenoblockers and / or nitrates.

Tricyclic antidepressants / antipsychotic means (antipsychotics) / agents for general anesthesia (general anesthetics)

Simultaneous use with inhibitors APF can lead to an increase in antihypertensive effect.

Sympathomimetics

Sympathomimetics can weaken the antiginergic effect of ACE inhibitors. When using this combination, the efficacy of ACE inhibitors should be evaluated regularly.

When used simultaneously with myelotoxic agents, the myelotoxic effect may be enhanced.

Special instructions:

Special instructions Stable ischemic heart disease

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

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 with severe renin-dependent hypertension. The expressed arterial hypotension was observed in patients with severe CHF, as in the presence of concomitant renal insufficiency, as well as in the 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 case of development of arterial hypotension, it is necessary to give the patient a horizontal position with raised legs, and if necessary, administer intravenously 0.9% solution of sodium chloride to increase the BCC. Transient arterial hypotension ns is a contraindication for further therapy. After the recovery of bcc and LD, treatment can be continued provided that the dose of the drug is carefully selected.

In some patients with CHF and normal or low LD during therapy with the drug Perindopril-Teva, there may be an additional reduction in blood pressure. 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 drug cancellation may be required Perindopril -Teva Impaired renal function

In patients with renal insufficiency (CC less than 60 ml / min), the initial dose of Perindopril-Teva should be matched in accordance with QC (see Fig.section "Method of administration and dose") and then - depending on the therapeutic response. For such patients, regular monitoring of the potassium content and serum creatinine concentration 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.

In patients with renovaecular hypertension in patients with ACE inhibitors, there is an increased risk of severe arterial 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 therapy with the drug Perindopril-Teva, it is necessary to cancel diuretics and regularly monitor the kidney function.

In some patients with arterial hypertension, in the presence of previously unrecognized renal failure, especially with concomitant diuretic therapy, there was a slight and temporary increase in the concentration of urea and creatinine in the blood supply. In this case, a reduction in the dose of Perindopril-Teva and / or removal of the diuretic is recommended.

Patients on hemodialysis

In patients on dialysis using high-flux membranes and concurrently taking ACE inhibitors, several cases of persistent, life-threatening anaphylactic reactions were noted. If you need hemodialysis, you need to use a different type of membrane.

Kidney Transplantation

The experience of using the drug Perindopril-Teva in patients after the recent transplantation of the night is absent.

Hypersensitivity, angioedema

Rarely, in patients taking ACE inhibitors, incl. perindopril, developed angioedema, edema of the face, limbs, lips. tongue, vocal folds and / or larynx. 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 a legal outcome. With the development of angioedema, immediately subcutaneously epinephrine (epinephrine) and ensure airway patency. Patients with an angioneurotic edema in the history, ns associated with the use of ACE inhibitors, may be at high risk of developing angioedema while taking an ACE inhibitor.

Anaphylactoid reactions during the procedure of apheresis of low-density lipoproteins (LDL-apheresis)

In patients with the appointment of ACE inhibitors against the background of the procedure of LDL-apheresis with the help of dextran sulfate, in rare cases, the development of an anaphylactic reaction is possible. A temporary withdrawal of an ACE inhibitor is recommended before each apheresis procedure.

Anaphylactic reactions during desensitization

In patients receiving ACE inhibitors during the course of desensitization (for example, the venom of Hymenoptera), in very rare cases development of life threatening anaphylactic reactions is possible. A temporary withdrawal of the ACE inhibitor is recommended before each desensitization procedure begins.

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 the DFT inhibitor or the activity of "liver" enzymes is increased, the ACE inhibitor should be immediately discontinued and the patient should be carefully monitored. It is also necessary to conduct an appropriate examination.

Neutropenia, agranulocytosis, thrombocytopenia, anemia

In patients on the background of therapy with AIF 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. The drug Perindopril-Teva should be used with great care in patients with systemic connective tissue diseases (eg, systemic lupus erythematosus, scleroderma), simultaneously receiving 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 are possible development of severe infections, not amenable intensive antibiotic therapy. When performing therapy with Perindopril-Teva in patients with the above factors recommended 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 development of hemolytic anemia were noted.

Negroid race

Like other ACE inhibitors. perindopril is less effective in reducing blood pressure in patients of the Negroid race, possibly because of the greater prevalence of low-grade conditions in the population of this group of patients with hypertension.

Cough

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

Surgery and 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. One day before surgery, therapy with AIF inhibitors should be canceled. If the ACE inhibitor can not be canceled, then the arterial hypotension, which develops but the mechanism described, can be corrected by an increase in BCC.

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, decomposed diabetes mellitus, and in patients using potassium-sparing diuretics, potassium preparations or other drugs that cause hyperkalismia (eg, heparin). If it is necessary to simultaneously prescribe these drugs, it is recommended to regularly monitor the potassium content in the blood serum.

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.

Lactose

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

Double blockade of RA AS

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 impaired function of the night (GFR <60 mL / min / 1.73 m2).

Effect on the ability to drive transp. cf. and fur:It is necessary to take into account the possibility of developing arterial hypotension or dizziness, which can affect the ability to drive vehicles and work with technical means that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 2.5 mg. 5 mg and 10 mg.

For 30 tablets in a white polypropylene container with a polyethylene lid with a drying insert, equipped with a polyethylene limiter with the control of the first opening.

1 The container together with instructions for use in a cardboard bundle.

Packaging:(30) - polypropylene containers (1) - cardboard packs

Storage conditions:

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:

2 of the year. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002979

Date of registration:28.04.2015

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

TEVA Pharmaceutical Works Private, Ltd. Co. Hungary

Representation: & nbspTeva Teva Israel

Information update date: & nbsp28.08.2015

Illustrated instructions

Instructions

Perindopril-Teva (Perindopril-Teva)