The action of Perinev tablets. At what pressure should Perinev tablets be taken according to the instructions for use? Chronic heart failure

13.03.2020

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Owner/Registrar

KRKA-RUS, OOO

International Classification of Diseases (ICD-10)

G45 Transient transient cerebral ischemic attacks [attacks] and related syndromes I10 Essential [primary] hypertension I20 Angina pectoris [angina pectoris] I50.0 Congestive heart failure I63 Cerebral infarction I69 Consequences of cerebrovascular diseases

Pharmacological group

ACE inhibitor

Arterial hypertension;

Chronic heart failure;

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

Stable coronary artery disease: reduced risk of cardiovascular complications in patients with previous myocardial infarction and / or coronary revascularization.

Angioedema in history (hereditary, idiopathic or angioedema due to the use of ACE inhibitors);

Age up to 18 years (efficacy and safety not established);

Hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption syndrome;

Hypersensitivity to perindopril or other components of the drug;

Hypersensitivity to other ACE inhibitors.

FROM caution should be used for renovascular hypertension, in patients with bilateral renal artery stenosis, stenosis of the artery of a single kidney - the risk of developing severe arterial hypotension and kidney failure; with chronic heart failure in the stage of decompensation, arterial hypotension, with chronic renal failure (CC less than 60 ml / min), with significant hypovolemia and hyponatremia (salt-free diet and / or previous diuretic therapy, dialysis, vomiting, diarrhea), cerebrovascular diseases (in including cerebrovascular insufficiency, ischemic heart disease, coronary insufficiency) - the risk of developing an excessive decrease in blood pressure; with aortic stenosis or mitral valve, hypertrophic obstructive cardiomyopathy, hemodialysis using high-flow polyacrylonitrile membranes - the risk of developing anaphylactoid reactions; in patients after kidney transplantation - no experience clinical application; before the LDL apheresis procedure, simultaneously with desensitizing therapy with allergens (for example, hymenoptera venom) - the risk of developing anaphylactoid reactions; in diseases connective tissue(including SLE, scleroderma), inhibition of bone marrow hematopoiesis while taking immunosuppressants, allopurinol or procainamide - the risk of developing agranulocytosis and neutropenia; with congenital deficiency of glucose-6-phosphate dehydrogenase - isolated cases of development hemolytic anemia; in representatives of the Negroid race - the risk of developing anaphylactoid reactions; at surgical intervention(the need for general anesthesia) - the risk of developing an excessive decrease in blood pressure; at diabetes(necessary to control the concentration of glucose in the blood); with hyperkalemia; in elderly patients.

Frequency detection adverse reactions: very often (>1/10), often (>1/100,<1/10), иногда (>1/1000, <1/100), редко (>1/10 000, <1/1000), очень редко (<1/10 000, включая отдельные сообщения).

From the side of the central nervous system and peripheral nervous system: often - headache, dizziness, paresthesia; sometimes - sleep or mood disorders; very rarely - confusion.

From the sense organs: often - visual impairment, tinnitus.

From the side of the cardiovascular system: often - a pronounced decrease in blood pressure; very rarely - arrhythmias, angina pectoris, myocardial infarction or stroke, possibly secondary, due to severe arterial hypotension in high-risk patients; vasculitis (frequency unknown).

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

From the digestive system: often - nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhea, constipation; sometimes - dryness of the oral mucosa; rarely - pancreatitis; very rarely - cytolytic or cholestatic hepatitis.

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

From the hematopoietic and lymphatic systems: very rarely - with prolonged use in high doses, a decrease in the concentration of hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, agranulocytosis, pancytopenia; very rarely - hemolytic anemia (in patients with congenital deficiency of glucose-6-phosphate dehydrogenase).

Laboratory indicators: increased serum urea and plasma creatinine, hyperkalemia, reversible after discontinuation of the drug (especially in patients with renal insufficiency, severe chronic heart failure and renovascular hypertension); rarely - increased activity of liver enzymes and bilirubin in the blood serum; hypoglycemia.

From the side of the skin: often - skin rash, itching; sometimes - increased sweating, angioedema of the face, limbs, urticaria; very rarely - erythema multiforme.

Others: often - asthenia, muscle cramps.

The drug is administered orally 1 time / day, before meals, preferably in the morning. The dose is selected individually for each patient, depending on the severity of the disease and the individual response to treatment.

Arterial hypertension

Perineva ® can be used as monotherapy or in combination with other antihypertensive agents.

For patients with severe activation of the RAAS (for example, with renovascular hypertension, hypovolemia and / or hyponatremia, chronic heart failure in the stage of decompensation or severe arterial hypertension), the recommended initial dose is 2 mg / day in one dose. If therapy is ineffective within a month, the dose can be increased to 8 mg 1 time / day with good tolerability of the previous dose.

The addition of ACE inhibitors to patients taking diuretics may cause hypotension. In this regard, it is recommended to carry out therapy with caution, stop taking diuretics 2-3 days before the start of treatment with Perineva ® or start treatment with Perineva ® with an initial dose of 2 mg / day in one dose. It is necessary to control blood pressure, kidney function and the concentration of potassium ions in the blood serum. In the future, the dose of the drug may be increased depending on the dynamics of the level of blood pressure. If necessary, diuretic therapy can be resumed.

At elderly patients The recommended starting dose is 2 mg/day in one dose. In the future, the dose can be gradually increased to 4 mg and, if necessary, up to a maximum of 8 mg / day, provided that the lower dose is well tolerated.

Chronic heart failure

The recommended starting dose is 2 mg/day in the morning, under medical supervision. After 2 weeks, the dose can be increased to 4 mg / day in 1 dose, under the control of blood pressure. Treatment of symptomatic chronic heart failure is usually combined with non-potassium-sparing diuretics, beta-blockers, and/or digoxin.

In patients with chronic heart failure, with renal insufficiency and with a tendency to electrolyte disturbances (hyponatremia), as well as in patients taking diuretics and / or vasodilators at the same time, treatment with the drug is started under strict medical supervision.

In patients with a high risk of developing clinically pronounced arterial hypotension (for example, when taking high doses of diuretics), if possible, hypovolemia and electrolyte disturbances should be eliminated before starting the drug Perinev ®. It is recommended before and during therapy to carefully monitor the level of blood pressure, the state of kidney function and the concentration of potassium ions in the blood serum.

Prevention of recurrent stroke in patients with a history of cerebrovascular disease

Therapy with Perineva® should begin with 2 mg during the first 2 weeks before taking indapamide. Treatment should begin at any time (from 2 weeks to several years) after a stroke.

Stable coronary artery disease

Treatment elderly patients should start with a dose of 2 mg, which after a week can be increased to 4 mg / day. In the future, if necessary, after another week, the dose can be increased to 8 mg / day with mandatory preliminary monitoring of kidney function. In elderly patients, the dose of the drug can be increased only if the previous, lower dose is well tolerated.

At patients with kidney disease the dose of the drug Perineva ® is set depending on the degree of impaired renal function. During treatment, the content of potassium ions and creatinine in the blood serum should be regularly monitored. Recommended doses are presented in the table.

*- Dialysis clearance of perindoprilat is 70 ml/min. Perineva ® must be taken after a dialysis session.

Patients with liver disease dose adjustment is not required.

Arterial hypertension is a serious illness that can cause the development of life-threatening complications.

It is possible to normalize high blood pressure with the help of antihypertensive drugs, in particular, ACE inhibitors.

One of these drugs is Perineva, created on the basis of perindopril.

You can buy pills in pharmacies only by prescription, so you won’t be able to do without visiting a therapist.

Remember: hypertension is a complex and dangerous disease, which must be treated under medical supervision.

pharmachologic effect

Perinev tablets are prescribed to patients to reduce diastolic and systolic pressure. Taking the drug leads to a decrease in peripheral vascular resistance and vasodilation, which together ensures the onset of a hypotensive effect.

Regular use of tablets by patients with CHF provides an increase in endurance during physical exertion, normalization of cardiac activity in a state of activity and rest.

After oral administration of the drug, the therapeutic effect is recorded after 60 minutes. This effect becomes maximum after 4 hours, and persists for a day.

Indications for use on Perinev

Taking pills is possible for:

treatment of hypertension;
preventing the development of cardiovascular complications in people suffering from stable coronary artery disease;
prevention of recurrent stroke in people who have had a stroke or a transient cerebrovascular accident of an ischemic type (used in combination therapy with indapamide);
treatment of CHF.

Mode of application

Perineva is usually prescribed 1 tablet per day daily. In this case, the person himself chooses when to take the drug - in the evening or in the morning.

The optimal dosage for starting treatment is a dose of 4 mg (if the patient is a pensioner, treatment begins with 2 mg, gradually increasing the dose to 4 mg).

From taking diuretics should be abandoned at least two to three days before the start of taking Perineva. If it is impossible to stop treatment with diuretics, Perinev is prescribed in the smallest dosage - 2 mg, gradually increasing the dose to 4 mg. Similarly, a treatment regimen is selected for people with chronic heart failure.

The doctor's task is to evaluate the effectiveness of the prescribed treatment 30 days after the start of therapy. In the presence of unsatisfactory dynamics, the drug is prescribed at a dose of 8 mg.

Release form, composition

Perineva is a tablet for oral administration. Like many other drugs, Perineva is sold in cardboard packs, inside of which there are blisters with tablets. Each package is accompanied by instructions for the use of the medicine.

The active ingredient is perindopril ebumin in an amount of 4 or 8 mg.

Additional ingredients are: crospovidone, lactose monohydrate, calcium chloride hexahydrate, magnesium stearate, MCC, colloidal silicon dioxide.

Interaction with other drugs

It is not necessary to prescribe the drug Perinev in parallel with antihypertensive drugs. This combination can cause a sharp decrease in blood pressure, as well as the development of vascular collapse.

Taking the drug simultaneously with non-steroidal anti-inflammatory drugs and acetylsalicylic acid leads to a weakening of the antihypertensive effect. When prescribing such therapy, it is necessary to correctly calculate the dose of the drug.

With caution, tablets are prescribed to people who take potassium-sparing diuretics. With such drug interactions, it is necessary to monitor blood pressure indicators to avoid the development of electrolyte imbalance and hypovolemia. If necessary, the dose of the antihypertensive drug is adjusted.

Under the influence of Perinev tablets, the therapeutic effect of insulin and hypoglycemic agents is enhanced, which is fraught with the development of hypoglycemia and even coma. People with diabetes are advised to take the medicine under the supervision of a therapist and monitor their blood glucose levels. If necessary, adjust the dose of insulin.

Side effects

Peripheral nervous system, CNS	dizziness, headache, paresthesia; sometimes - mood or sleep disturbances; extremely rarely - confusion.
hearing organ	often - the appearance of tinnitus.
Respiratory system	often - shortness of breath, coughing fits; sometimes - bronchospasm; extremely rarely - eosinophilic pneumonia, rhinitis.
Organ of vision	often - visual disturbances.
Vessels, heart	often - a noticeable decrease in pressure; extremely rarely - angina pectoris, arrhythmias, stroke or myocardial infarction, possibly secondary, due to severe hypertension in high-risk people; unknown frequency - vasculitis.
Skin	often - rashes on the skin, itching; sometimes - angioedema of the extremities and / or face, urticaria; extremely rare - erythema multiforme.
digestive tract	often - dysgeusia, abdominal pain, constipation, nausea, diarrhea, vomiting, dyspepsia; sometimes - a feeling of dryness in the mouth; rarely - pancreatitis; extremely rarely - cholestatic or cytolytic hepatitis.
General violations	often - asthenia; sometimes - increased sweating.
Musculoskeletal system	often - muscle cramps.
Lymphatic system and hematopoietic organs	extremely rarely - with prolonged use in high doses, thrombocytopenia, agranulocytosis, leukopenia / neutropenia, pancytopenia, a decrease in the concentration of hematocrit and hemoglobin can be observed; extremely rarely - hemolytic anemia (with congenital deficiency of glucose-6-phosphate dehydrogenase).
genitourinary system	sometimes - impotence, renal failure; extremely rare - acute renal failure.
Laboratory indicators	elevated serum urea, increased plasma creatinine, hyperkalemia, reversible after discontinuation of therapy (especially in people with renovascular hypertension, severe CHF and renal failure); rarely - hypoglycemia, increased activity of liver enzymes and bilirubin in the blood serum.

Overdose

If the patient takes the medicine uncontrollably and does not comply with the dosage, he experiences a sharp decrease in pressure. In this case, shock conditions, coughing, kidney failure, anxiety, hypoventilation (insufficient breathing), a sharp slowdown or increase in heart rate may develop.

If symptoms of an overdose of the drug appear, the person should be laid on his back, raising his legs above body level. Then it is necessary to introduce special solutions to replenish the volume of blood circulation. A hormone such as angiotensin II is also administered intravenously (for lack of such, catecholamines can be used).

Contraindications

Perinev is not used in case of:

With caution, Perinev is used for:

renovascular hypertension;
cerebrovascular pathologies (including ischemic heart disease, cerebrovascular insufficiency, coronary insufficiency) - the risk of excessive pressure reduction;
bilateral stenosis of the arteries of the kidneys and stenosis of the artery of the only working kidney - the likelihood of developing renal failure, severe arterial hypotension;
significant hyponatremia and hypovolemia (due to salt-free diet, diarrhea, dialysis, previous diuretic treatment, vomiting);
arterial hypotension, CHF in the stage of decompensation; connective tissue pathologies, oppression of bone marrow hematopoiesis while taking immunosuppressants, procainamide or allopurinol - the risk of developing neutropenia and agranulocytosis;
chronic renal failure;
treatment of the elderly;
hypertrophic obstructive cardiomyopathy, mitral / aortic valve stenosis, hemodialysis using polyacrylonitrile high-flow membranes - the likelihood of developing anaphylactoid reactions; surgical interventions with general anesthesia - the risk of excessive pressure reduction;
hyperkalemia;
condition after kidney transplantation - no clinical experience; diabetes mellitus (blood glucose control);
parallel desensitizing treatment with allergens (for example, hymenoptera venom), preparation for the LDL apheresis procedure - the risk of anaphylactoid reactions;
treatment of persons of the Negroid race - the possibility of developing anaphylactoid reactions;
congenital deficiency of glucose-6-phosphate dehydrogenase - there were isolated cases of hemolytic anemia.

During pregnancy

If the patient suspects pregnancy, is carrying a child or is breastfeeding, Perinev's tablets are not prescribed. The active ingredient is able to provoke pathological changes in the renal apparatus associated with its functioning. In some cases, oligohydramnios develops. Early ossification of the bone cranial tissue of the child can also be observed.

If women took Perineva late in pregnancy, their children showed signs of excess potassium content, kidney failure developed, and a sharp decrease in pressure occurred.

If it was not possible to avoid taking Perineva during pregnancy, it is necessary to conduct an ultrasound examination to check the condition of the bones of the skull and kidneys of the fetus.

Terms and conditions of storage

Tablets, regardless of their dosage, should be stored at temperatures up to +30 degrees in dark and dry places. It is strictly forbidden to store Pereneva in conditions of high humidity and bright sunlight.

It is important to ensure that the place where the pills are stored is inaccessible to pets, children and people with mental illness.

You can store and take the tablets for two years.

Price

Packing Perineva in Russia costs 260-1500 rubles. The price depends on the city, dosage, number of tablets in a pack.

Approximate price of Perineva 4 mg in Ukraine- 300 hryvnia, and 8 mg - 600 hryvnia.

Analogues

The following drugs have an effect similar to the action of Perinev's tablets:

Prenessa;

Composition

Description of the dosage form

Tablets 4 mg: oval, slightly biconvex, white or almost white, scored on one side and chamfered.

Tablets 8 mg: round, slightly biconvex, white or almost white with a risk on one side and a chamfer.

pharmachologic effect

pharmachologic effect— vasodilating, cardioprotective, hypotensive.

Pharmacodynamics

Perindopril - an ACE inhibitor, or kininase II - refers to oxopeptidases. It converts angiotensin I into the vasoconstrictor angiotensin II and destroys the vasodilator bradykinin to an inactive hexapeptide. Suppression of ACE activity leads to a decrease in the level of angiotensin II, an increase in plasma renin activity (suppressing the negative feedback of renin release), and a decrease in aldosterone secretion. Since ACE also destroys bradykinin, ACE suppression also leads to an increase in the activity of the circulating and tissue kallikrein-kinin system, while the PG system is activated.

Perindopril has a therapeutic effect due to the active metabolite - perindoprilat.

Perindopril reduces both systolic and diastolic blood pressure in the supine and standing positions. Perindopril reduces OPSS, which leads to a decrease in blood pressure. At the same time, peripheral blood flow is accelerated. However, the heart rate does not increase. Renal blood flow usually increases while glomerular filtration rate does not change. The maximum antihypertensive effect is achieved 4-6 hours after a single oral administration of perindopril; the hypotensive effect persists for 24 hours, and after 24 hours the drug still provides from 87 to 100% of the maximum effect. The decrease in blood pressure develops rapidly. Stabilization of the antihypertensive effect is observed after 1 month of therapy and persists for a long time. Termination of therapy is not accompanied by a "withdrawal" syndrome. Perindopril reduces left ventricular myocardial hypertrophy. With long-term administration, it reduces the severity of interstitial fibrosis, normalizes the isoenzyme profile of myosin. Increases the concentration of HDL, in patients with hyperuricemia reduces the concentration of uric acid.

Perindopril improves the elasticity of large arteries, eliminates structural changes in small arteries.

Perindopril normalizes the work of the heart, reducing pre- and afterload.

In patients with CHF during perindopril therapy, the following was noted:

Decrease in filling pressure in the left and right ventricles;

Reducing OPSS;

Increased cardiac output and cardiac index.

Taking the initial dose of perindopril (2 mg) in patients with CHF I-II functional class according to the NYHA classification was not accompanied by a statistically significant decrease in blood pressure compared with placebo.

Pharmacokinetics

After oral administration, perindopril is rapidly absorbed from the gastrointestinal tract and reaches maximum plasma concentrations within 1 hour. Bioavailability is 65-70%, 20% of the total amount of absorbed perindopril is converted to perindoprilat (active metabolite). T1 / 2 from the blood plasma of perindopril is 1 hour. Cmax of perindoprilat in plasma is reached after 3-4 hours.

Taking the drug during a meal is accompanied by a decrease in the conversion of perindopril to perindoprilat, respectively, the bioavailability of the drug decreases. The volume of distribution of unbound perindoprilat is 0.2 l/kg. Plasma protein binding is negligible, the binding of perindoprilat to ACE is less than 30% and depends on its concentration.

Perindoprilat is excreted by the kidneys. T 1/2 of the unbound fraction is about 3-5 hours. Does not accumulate. In elderly patients, in patients with renal and chronic heart failure (CHF), the excretion of perindoprilat is slowed down. Perindoprilat is removed during hemodialysis (speed - 70 ml / min, 1.17 ml / s) and peritoneal dialysis.

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

Indications for Perineva ®

arterial hypertension;

chronic heart failure;

prevention of recurrent stroke (combination therapy with indapamide) in patients who have had a stroke or transient ischemic cerebrovascular accident;

stable CAD: reduced risk of cardiovascular complications in patients with stable CAD.

Contraindications

hypersensitivity to the active substance, other ACE inhibitors and excipients that make up the drug;

hereditary/idiopathic angioedema;

angioedema (Quincke's edema) in history associated with taking an ACE inhibitor;

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

hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

Carefully: renovascular hypertension, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney - the risk of developing severe arterial hypotension and renal failure; CHF in the stage of decompensation, arterial hypotension; chronic renal failure (Cl creatinine -<60 мл/мин); значительная гиповолемия и гипонатриемия (вследствие бессолевой диеты и/или предшествующей терапии диуретиками, диализа, рвоты, диареи), цереброваскулярные заболевания (в т.ч. недостаточность мозгового кровообращения, ИБС , коронарная недостаточность) — риск развития чрезмерного снижения АД; стеноз аортального или митрального клапана, гипертрофическая обструктивная кардиомиопатия, гемодиализ с использованием высокопроточных полиакрилнитриловых мембран — риск развития анафилактоидных реакций; состояние после трансплантации почки — отсутствует опыт клинического применения; перед процедурой афереза ЛПНП , одновременное проведение десенсибилизирующей терапии аллергенами (например ядом перепончатокрылых) — риск развития анафилактоидных реакций; заболевания соединительной ткани (в т.ч. системная красная волчанка (СКВ ) , склеродермия), угнетение костномозгового кроветворения на фоне приема иммунодепрессантов, аллопуринола или прокаинамида — риск развития агранулоцитоза и нейтропении; врожденный дефицит глюкозо-6-фосфатдегидрогеназы — единичные случаи развития гемолитической анемии; у представителей негроидной расы — риск развития анафилактоидных реакций; хирургическое вмешательство (общая анестезия) — риск развития чрезмерного снижения АД; сахарный диабет (контроль концентрации глюкозы в крови); гиперкалиемия; пожилой возраст.

Use during pregnancy and lactation

During pregnancy, the use of the drug is contraindicated. It should not be used in the first trimester of pregnancy, therefore, when pregnancy is confirmed, Perineva ® should be discontinued as soon as possible. It is known that the effect of ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to a violation of its development (decrease in kidney function, oligohydramnios, slowing of the ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia). If, nevertheless, the drug was used in the II-III trimesters of pregnancy, then it is necessary to conduct an ultrasound scan of the kidneys and bones of the fetal skull.

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

Side effects

Classification of the incidence of side effects (WHO): very often -> 1/10; often - from > 1/100 to<1/10; иногда — от >1/1000 to<1/100; редко — от >1/10000 to<1/1000; очень редко — от <1/10000, включая отдельные сообщения.

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

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

From the organ of hearing: often - tinnitus.

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

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

From the side of the skin: often - skin rash, itching; sometimes - angioedema of the face, limbs, urticaria; very rarely - erythema multiforme.

From the musculoskeletal system: often - muscle cramps.

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

General violations: often - asthenia; sometimes - increased sweating.

From the side of the hematopoietic organs and the lymphatic system: very rarely - with prolonged use in high doses, a decrease in the concentration of hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, agranulocytosis, pancytopenia; very rarely - hemolytic anemia (in patients with congenital deficiency of glucose-6-phosphate dehydrogenase).

Laboratory indicators: increased serum urea and plasma creatinine and hyperkalemia, reversible after discontinuation of the drug (especially in patients with renal insufficiency, severe CHF and renovascular hypertension); rarely - increased activity of liver enzymes and bilirubin in the blood serum; hypoglycemia.

Interaction

Diuretics. Patients receiving diuretics, especially those that remove fluid and / or salts, at the beginning of therapy with perindopril, there may be a pronounced decrease in blood pressure, the risk of which can be reduced by discontinuing the diuretic, replenishing the loss of fluid or salts before starting therapy with perindopril, as well as prescribing perindopril in low dose with further gradual increase.

Potassium-sparing diuretics (such as triamterene, amyloride, spironolactone and its derivative eplerenone), potassium salts. Hyperkalemia (with a possible fatal outcome), especially with impaired renal function (additional effects associated with hyperkalemia). The simultaneous use of perindopril with the above-mentioned drugs is not recommended.

These combinations should be prescribed only in case of hypokalemia, taking precautions and regularly monitoring the concentration of potassium ions in the blood serum.

Lithium. With the simultaneous use of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and lithium toxicity may develop. The simultaneous use of ACE inhibitors with thiazide diuretics can further increase the concentration of lithium in the blood serum and increase the risk of developing its toxic effects. The simultaneous use of perindopril and lithium is not recommended.

If necessary, such a combination therapy is carried out under regular monitoring of the concentration of lithium in the blood serum.

NSAIDs, incl. acetylsalicylic acid in doses of 3 g / day and above. NSAID therapy may weaken the antihypertensive effect of ACE inhibitors. In addition, NSAIDs and ACE inhibitors have an additive effect on increasing the concentration of potassium ions in the blood serum, which can provoke a deterioration in kidney function. This effect is usually reversible. In rare cases, acute renal failure may develop, especially in patients with pre-existing renal impairment, such as elderly patients or against the background of dehydration.

Other antihypertensive agents and vasodilators. The simultaneous use of perindopril with other antihypertensive agents may enhance the antihypertensive effect of perindopril. The simultaneous use of nitroglycerin, other nitrates or vasodilators may lead to an additional hypotensive effect.

Hypoglycemic agents. The simultaneous use of ACE inhibitors and hypoglycemic agents (insulin or oral hypoglycemic agents) can enhance the hypoglycemic effect, up to the development of hypoglycemia. As a rule, this phenomenon occurs in the first weeks of combination therapy in patients with renal insufficiency.

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

Tricyclic antidepressants, antipsychotics (neuroleptics), general anesthetics (general anesthetics). Combined use with ACE inhibitors may lead to an increase in the hypotensive effect.

Sympathomimetics. May weaken the antihypertensive effect of ACE inhibitors. When prescribing such a combination, the effectiveness of ACE inhibitors should be regularly evaluated.

Dosage and administration

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

Arterial hypertension. Perineva® can be used as monotherapy and in combination with other antihypertensive agents.

The recommended starting dose is 4 mg once a day, in the morning. For patients with severe activation of the renin-angiotensin-aldosterone system (for example, with renovascular hypertension, hypovolemia and / or hyponatremia, chronic heart failure in the stage of decompensation or severe arterial hypertension), the recommended initial dose is 2 mg / day in one dose. If therapy is ineffective within a month, the dose can be increased to 8 mg 1 time per day and if the previous dose is well tolerated.

The addition of ACE inhibitors to patients taking diuretics may cause hypotension. In this regard, it is recommended to carry out therapy with caution, stop taking diuretics 2-3 days before the start of treatment with Perinev ® or start treatment with Perinev ® a with an initial dose of 2 mg / day, in one dose. It is necessary to control blood pressure, kidney function and the concentration of potassium ions in the blood serum. In the future, the dose of the drug may be increased, depending on the dynamics of the level of blood pressure. If necessary, diuretic therapy can be resumed.

In elderly patients the recommended initial daily dose is 2 mg at a time. In the future, the dose can be gradually increased to 4 mg and, if necessary, up to a maximum of 8 mg 1 time per day, provided that the lower dose is well tolerated.

CHF. Treatment of patients with CHF with Perineva® in combination with potassium-sparing diuretics and / or digoxin and / or beta-blockers is recommended to begin under close medical supervision, prescribing Perineva® at an initial dose of 2 mg 1 time per day, in the morning. After 2 weeks of treatment, the dose of the drug can be increased to 4 mg 1 time per day, provided that the dose of 2 mg is well tolerated and the response to therapy is satisfactory.

In patients at high risk of developing clinically significant arterial hypotension(for example, when taking high doses of diuretics), if possible, hypovolemia and electrolyte disturbances should be eliminated before starting the drug Perinev ®. It is recommended before and during therapy to carefully monitor the level of blood pressure, the state of kidney function and the concentration of potassium ions in the blood serum.

Prevention of recurrent stroke in patients with a history of cerebrovascular disease. Therapy with Perineva® should begin with 2 mg during the first 2 weeks before taking indapamide. Treatment should begin at any time (from 2 weeks to several years) after a stroke.

stable ischemic heart disease. In patients with stable CAD, the recommended initial dose of Perinev is 4 mg/day. After 2 weeks, the dose is increased to 8 mg / day, provided that the dose of 4 mg / day is well tolerated and renal function is monitored. Treatment of elderly patients should begin with a dose of 2 mg, which after a week can be increased to 4 mg / day. In the future, if necessary, after another week, you can increase the dose to 8 mg / day with mandatory preliminary monitoring 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 kidney disease, the dose of Perinev ® is set depending on the degree of impaired renal function. Monitoring the patient's condition usually includes regular determination of the concentration of potassium ions and creatinine in the blood serum.

* Dialysis clearance of perindoprilat is 70 ml/min. Perineva ® must be taken after a dialysis session.

For liver diseases: dose adjustment is not required.

Overdose

Symptoms: pronounced decrease in blood pressure, shock, water and electrolyte imbalance (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 take measures to replenish the BCC, if possible - in / in the introduction of angiotensin II and / or / in a solution of catecholamines. With the development of severe bradycardia, not amenable to drug therapy (including atropine), the installation of an artificial pacemaker (pacemaker) is indicated. It is necessary to monitor vital functions and the concentration of creatinine and electrolytes in the blood serum. Perindopril can be removed from the systemic circulation by hemodialysis. The use of high flow polyacrylonitrile membranes should be avoided.

special instructions

stable ischemic heart disease. With the development of an episode of unstable angina (significant or minor) during the first month of therapy with Perineva ®, it is necessary to evaluate the benefit / risk ratio of therapy with this drug.

Arterial hypotension. ACE inhibitors can cause a sharp drop in blood pressure. In patients with uncomplicated hypertension, symptomatic hypotension rarely occurs after the first dose. The risk of an excessive decrease in blood pressure is increased in patients with reduced BCC during diuretic therapy, with a strict salt-free diet, hemodialysis, as well as with diarrhea or vomiting, or in those suffering from severe renin-dependent hypertension. Severe arterial hypotension was observed in patients with severe CHF, both in the presence of concomitant renal insufficiency, and in its absence. Most often, severe arterial hypotension can develop in patients with more severe CHF, taking high doses of loop diuretics, as well as against the background of hyponatremia or renal 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 coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or cerebrovascular complications.

In the event of arterial hypotension, it is necessary to give the patient a horizontal position with raised legs and, if necessary, inject intravenous sodium chloride solution to increase BCC. Transient arterial hypotension is not a contraindication for further therapy. After the restoration of BCC 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 during therapy with Perineva ®, an additional decrease in blood pressure may occur. This effect is expected and is usually not a reason to stop the drug. If arterial hypotension is accompanied by clinical manifestations, it may be necessary to reduce the dose or discontinue the drug Perinev ®.

Aortic or mitral valve stenosis/hypertrophic cardiomyopathy. ACE inhibitors, incl. and perindopril should be used with caution in patients with mitral valve stenosis and left ventricular outflow tract obstruction (aortic valve stenosis and hypertrophic cardiomyopathy).

Impaired kidney function. In patients with renal insufficiency (Cl creatinine<60 мл/мин) начальная доза препарата Перинева ® должна быть подобрана в соответствии с Cl креатинина (см. раздел «Способ применения и дозы») и затем — в зависимости от терапевтического ответа. Для таких пациентов необходим регулярный контроль концентрации ионов калия и креатинина в сыворотке крови.

In patients with symptomatic heart failure, arterial hypotension that develops during the initial period of therapy with ACE inhibitors can lead to a deterioration in renal function. These patients have occasionally experienced acute renal failure, which is usually reversible.

In some patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney (especially in the presence of renal failure), during therapy with ACE inhibitors, an increase in serum urea and creatinine concentrations was noted, which is 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 Perinev ®, it is necessary to cancel diuretics and regularly monitor kidney function. In some patients with arterial hypertension, in the presence of previously undiagnosed renal 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, it is recommended to reduce the dose of Perinev ® and / or cancel the diuretic.

Patients on hemodialysis. Several cases of persistent, life-threatening anaphylactic reactions have been noted in patients on dialysis using high-flow membranes and taking concomitant ACE inhibitors. If hemodialysis is required, a different type of membrane must be used.

Kidney transplant. There is no experience with the use of perindopril in patients with recent kidney transplantation.

Hypersensitivity/angioedema. Rarely in patients taking ACE inhibitors, incl. perindopril, angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx developed. This condition can develop at any time during treatment. With the development of angioedema, treatment should be stopped immediately, the patient should be under medical supervision until the symptoms disappear completely. Angioedema of the lips and face usually does not require treatment; Antihistamines may be used to reduce symptoms. Angioedema of the tongue, glottis, or larynx can be fatal. With the development of angioedema, it is necessary to immediately inject epinephrine (adrenaline) s / c and ensure airway patency. ACE inhibitors are more likely to cause angioedema in black patients.

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.

Anaphylactoid reactions during LDL apheresis (LDL apheresis). In rare cases, patients receiving ACE inhibitors while undergoing LDL apheresis using dextran sulfate absorption may develop an anaphylactic reaction. Temporary withdrawal of the ACE inhibitor before each apheresis procedure is recommended.

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. Temporary withdrawal of the ACE inhibitor is recommended prior to 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 hepatic necrosis, sometimes with a fatal outcome. The mechanism by which this syndrome develops is unclear. If jaundice occurs or an increase in liver enzymes 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. In patients treated with ACE inhibitors, there have been cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. With normal renal function in the absence of other complications, neutropenia rarely develops. The drug Perineva ® must be used with great caution in patients with systemic connective tissue diseases (eg SLE, scleroderma) who are simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as when all of these factors are combined, especially with existing impaired renal function. These patients may develop severe infections that are not amenable to intensive antibiotic therapy. During therapy with Perineva ® 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 glucose-6-phosphate dehydrogenase deficiency isolated cases of hemolytic anemia have been noted.

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

Cough. Against the background of therapy with ACE inhibitors, a persistent, unproductive cough may develop, which stops after discontinuation of the drug. This should be considered in the differential diagnosis of cough.

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

Hyperkalemia. During therapy with ACE inhibitors, including perindopril, the concentration of potassium ions in the blood may increase in some patients. The risk of hyperkalemia is increased in patients with renal and / or heart failure, decompensated diabetes mellitus and patients using potassium-sparing diuretics, potassium supplements or other drugs that cause hyperkalemia (eg heparin). If necessary, the simultaneous appointment of these drugs, it is recommended to regularly monitor the content of potassium in the blood serum.

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

In this article, you can read the instructions for using the drug Perineva. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Perineva in their practice are presented. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Perineva in the presence of existing structural analogues. Use for the treatment of arterial hypertension and pressure reduction in adults, children, as well as during pregnancy and lactation. The composition of the antihypertensive drug.

Perineva And Ko-Perineva- ACE inhibitor. It is a prodrug from which the active metabolite perindoprilat is formed in the body. It is believed that the mechanism of antihypertensive action is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin 1 to angiotensin 2, which is a powerful vasoconstrictor. As a result of a decrease in the concentration of angiotensin 2, a secondary increase in plasma renin activity occurs due to the elimination of negative feedback on renin release and a direct decrease in aldosterone secretion. Due to the vasodilating effect, it reduces OPSS (afterload), wedge pressure in the pulmonary capillaries (preload) and resistance in the pulmonary vessels; increases cardiac output and exercise tolerance.

The hypotensive effect develops within the first hour after taking Perinev, reaches a maximum after 4-8 hours and lasts for 24 hours.

In clinical studies, the use of perindopril (monotherapy or in combination with a diuretic) has shown a significant reduction in the risk of recurrent stroke (both ischemic and hemorrhagic), as well as the risk of fatal or disabling strokes; major cardiovascular complications, including myocardial infarction, incl. fatal; stroke-related dementia; severe cognitive impairment. These therapeutic benefits have been noted in both hypertensive and normal BP patients, regardless of age, gender, presence or absence of diabetes mellitus, and type of stroke.

It has been shown that against the background of the use of perindopril tertbutylamine at a dose of 8 mg per day (equivalent to 10 mg of perindopril arginine) in patients with stable coronary artery disease, there is a significant reduction in the absolute risk of complications provided by the main criterion of effectiveness (mortality from cardiovascular diseases, the incidence of non-fatal myocardial infarction and/or cardiac arrest followed by successful resuscitation) by 1.9%. In patients with a previous myocardial infarction or a coronary revascularization procedure, the absolute risk reduction was 2.2% compared with the placebo group.

Perindopril is used both in the form of monotherapy and in the form of fixed combinations with indapamide, with amlodipine.

Indapamide is a sulfonamide derivative and is a diuretic. Inhibits sodium reabsorption in the cortical segment of the renal tubules, increasing the excretion of sodium and chlorine by the kidneys, thus leading to increased diuresis. To a lesser extent, increases the excretion of potassium and magnesium. Possessing the ability to selectively block slow calcium channels, indapamide increases the elasticity of arterial walls and reduces peripheral vascular resistance. It has a hypotensive effect in doses that do not have a pronounced diuretic effect. Increasing the dose of indapamide does not increase the antihypertensive effect, but increases the risk of adverse events.

Indapamide in patients with arterial hypertension has no effect on lipid metabolism - TG, LDL and HDL; on carbohydrate metabolism, even in patients with diabetes and hypertension.

Composition

Perindopril erbumine + excipients (Perineva).

Perindopril erbumine + Indapamide + excipients (Co-Perineva).

Pharmacokinetics

Perindopril

After oral administration, Perinev is rapidly absorbed from the gastrointestinal tract. Bioavailability is 65-70%. In the process of metabolism, perindopril is biotransformed with the formation of an active metabolite - perindoprilat (about 20%) and 5 inactive compounds. The binding of perindoprilat to plasma proteins is insignificant (less than 30%) and depends on the concentration of the active substance. Does not accumulate. Repeated reception does not lead to cumulation. When taken with food, the metabolism of perindopril slows down. Perindoprilat is excreted from the body by the kidneys. In elderly patients, as well as in renal and heart failure, the excretion of perindoprilat slows down.

Indapamide

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. Eating somewhat slows down absorption, but does not significantly affect the amount of absorbed indapamide. Plasma protein binding is 79%. Does not accumulate. Metabolized in the liver. It is excreted by the kidneys (70%) mainly in the form of metabolites (the fraction of unchanged drug is about 5%) and by the intestine with bile in the form of inactive metabolites (22%). In patients with renal insufficiency, the pharmacokinetic parameters of indapamide do not change significantly.

Indications

arterial hypertension;
chronic heart failure;
prevention of recurrent stroke (combination therapy with indapamide) in patients who have had a stroke or transient ischemic cerebrovascular accident;
stable CAD: reduced risk of cardiovascular complications in patients with stable CAD.

Release forms

Tablets 2 mg, 4 mg and 8 mg (Perineva).

Tablets 2 mg + 625 mcg, 4 mg + 1.25 mg, 8 mg + 2.5 mg (Co-Perineva).

Orally dispersible tablets 4 mg and 8 mg (Perineva Ku-Tab).

Instructions for use and dosage

Perineva

The initial dose is 1-2 mg per day in 1 dose. Maintenance doses - 2-4 mg per day for congestive heart failure, 4 mg (less often - 8 mg) - for arterial hypertension in 1 dose.

In case of impaired renal function, a correction of the dosing regimen is required, depending on the CC values.

Ko-Perineva

The drug is taken orally 1 time per day, preferably in the morning before breakfast, with a sufficient amount of liquid.

If possible, the use of the drug should begin with the selection of doses of perindopril and indapamide separately. In case of clinical necessity, it is possible to prescribe a combination therapy with Ko-Perinev immediately after monotherapy.

Doses are given for the perindopril/indapamide ratio.

The initial dose of Co-Perinev is 2 mg / 0.625 mg (1 tablet) 1 time per day. If after 1 month of using the drug it is not possible to achieve adequate control of blood pressure, then the dose of the drug should be increased to 4 mg / 1.25 mg (1 tablet) 1 time per day.

If necessary, to achieve a more pronounced hypotensive effect, it is possible to increase the maximum daily dose of Ko-Perinev - 1 tablet (8 mg / 2.5 mg) 1 time per day.

For elderly patients, the initial dose of Ko-Perinev is 2 mg / 0.625 mg (1 tablet) 1 time per day. Treatment with the drug should be prescribed after monitoring renal function and blood pressure.

The drug Ko-Perinev is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min). Patients with moderately severe renal insufficiency (CC 30-60 ml / min) are recommended to start therapy with the required doses of drugs (in monotherapy) that are part of the drug Ko-Perinev; the maximum daily dose of the drug Ko-Perinev 4 mg / 1.25 mg. Patients with CC more than 60 ml / min dose adjustment is not required. During therapy, it is necessary to regularly monitor the concentration of creatinine and the content of potassium in the blood serum.

The drug is contraindicated in patients with severe hepatic impairment. With moderately severe liver failure, dose adjustment is not required.

Side effect

eosinophilia, decreased hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, agranulocytosis, pancytopenia, hemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase;
hypoglycemia, hyperkalemia, reversible after discontinuation of the drug;
paresthesia;
headache;
dizziness;
sleep disorders;
mood lability;
drowsiness;
fainting;
confusion;
visual impairment;
noise in ears;
excessive decrease in blood pressure and related symptoms;
vasculitis;
tachycardia;
feeling of heartbeat;
heart rhythm disturbances;
angina;
myocardial infarction and stroke, possibly due to an excessive decrease in blood pressure in patients at high risk;
cough;
dyspnea;
bronchospasm;
eosinophilic pneumonia;
rhinitis;
constipation, diarrhea;
nausea, vomiting;
abdominal pain;
taste disorder;
dyspepsia;
dryness of the oral mucosa;
pancreatitis;
hepatitis (cholestatic or cytolytic);
skin itching;
rash;
photosensitivity;
increased sweating;
angioedema;
hives;
erythema multiforme;
muscle spasms;
arthralgia;
myalgia;
acute renal failure;
erectile dysfunction;
asthenia;
chest pain;
peripheral edema;
weakness;
fever.

Contraindications

angioedema in history (hereditary / idiopathic or angioedema while taking other ACE inhibitors in history);
hypokalemia;
severe renal failure (CC less than 30 ml / min);
bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney;
refractory hyperkalemia;
severe liver failure (including with encephalopathy);
lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
simultaneous use of drugs that lengthen the QT interval on the ECG;
simultaneous use with antiarrhythmic drugs that can cause ventricular tachycardia of the "pirouette" type;
pregnancy;
breastfeeding period;
age up to 18 years (efficacy and safety have not been established);
hypersensitivity to active substances, any ACE inhibitor, sulfonamide derivatives or any auxiliary components of the drug.

Use during pregnancy and lactation

The drug Perineva is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children and adolescents under 18 years of age (efficacy and safety not established).

special instructions

With caution, Perinev should be used with bilateral stenosis of the renal arteries or stenosis of the renal artery of a single kidney; renal failure; systemic connective tissue diseases; therapy with immunosuppressants, allopurinol, procainamide (risk of developing neutropenia, agranulocytosis); reduced BCC (diuretics, salt-restricted diet, vomiting, diarrhea); angina; cerebrovascular diseases; renovascular hypertension; diabetes mellitus; chronic heart failure 4 functional class according to the NYHA classification; simultaneously with potassium-sparing diuretics, potassium preparations, potassium-containing table salt substitutes, with lithium preparations; with hyperkalemia; surgery/general anesthesia; hemodialysis using high-flow membranes; desensitizing therapy; LDL apheresis; condition after kidney transplantation; aortic stenosis/mitral stenosis/hypertrophic obstructive cardiomyopathy; in black patients.

Cases of arterial hypotension, syncope, stroke, hyperkalemia and impaired renal function (including acute renal failure) have been reported in predisposed patients, especially when used simultaneously with drugs that affect the RAAS. Therefore, dual blockade of the RAAS by combining an ACE inhibitor with an angiotensin II receptor antagonist or aliskiren is not recommended.

Before starting treatment with perindopril, all patients are recommended to study kidney function.

During treatment with perindopril, kidney function, liver enzyme activity in the blood, and peripheral blood tests should be regularly monitored (especially in patients with diffuse connective tissue diseases, in patients who receive immunosuppressive drugs, allopurinol). Patients with sodium and fluid deficiency should be corrected for fluid and electrolyte disturbances before starting treatment.

drug interaction

The risk of developing hyperkalemia increases with the simultaneous use of Perinev with other drugs that can cause hyperkalemia: aliskiren and aliskiren-containing drugs, potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin 2 receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs), heparin, immunosuppressants such as cyclosporine or tacrolimus, trimethoprim.

With simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (GFR less than 60 ml / min), the risk of hyperkalemia, deterioration of kidney function and an increase in the incidence of cardiovascular morbidity and mortality increases (in patients of these groups, this combination is contraindicated).

Simultaneous use with aliskiren is not recommended in patients who do not have diabetes mellitus or impaired renal function, because. possible increased risk of hyperkalemia, deterioration of renal function and increased incidence of cardiovascular morbidity and mortality.

It has been reported in the literature that in patients with established atherosclerotic disease, heart failure, or diabetes mellitus with end organ damage, concomitant therapy with an ACE inhibitor and an angiotensin 2 receptor antagonist is associated with a higher incidence of hypotension, syncope, 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 an ACE inhibitor is combined with an angiotensin II receptor antagonist) should be limited to individual cases with careful monitoring of renal function, potassium and blood pressure.

Simultaneous use with estramustine may lead to an increased risk of side effects such as angioedema.

With the simultaneous use of lithium preparations and perindopril, a reversible increase in the concentration of lithium in the blood serum and associated toxic effects are possible (this combination is not recommended).

Simultaneous use with hypoglycemic drugs (insulin, oral hypoglycemic agents) requires special care, because. ACE inhibitors, incl. perindopril, may enhance the hypoglycemic effect of these drugs up to the development of hypoglycemia. As a rule, this is observed in the first weeks of simultaneous therapy and in patients with impaired renal function.

Baclofen enhances the antihypertensive effect of Perinev, while the use may require dose adjustment of the latter.

In patients receiving diuretics, especially those that remove fluid and / or salts, at the beginning of perindopril therapy, an excessive decrease in blood pressure may be observed, the risk of which can be reduced by discontinuing the diuretic, replenishing the loss of fluid or salts before starting perindopril therapy, and using perindopril in low initial dose followed by a gradual increase.

In chronic heart failure in the case of the use of diuretics, perindopril should be used at a low dose, possibly after reducing the dose of the simultaneously used potassium-sparing diuretic. In all cases, renal function (creatinine concentration) should be monitored during the first weeks of ACE inhibitor use.

The use of eplerenone or spironolactone in doses from 12.5 mg to 50 mg per day and ACE inhibitors (including perindopril) in low doses: in the treatment of heart failure 2-4 functional class according to the NYHA classification with a left ventricular ejection fraction of less than 40% and previously used ACE inhibitors and "loop" diuretics, there is a risk of developing hyperkalemia (with a possible fatal outcome), especially if the recommendations regarding this combination are not followed. Before using this combination, you need to make sure that there is no hyperkalemia and impaired renal function. It is recommended to regularly monitor the concentration of creatinine and potassium in the blood - weekly in the first month of treatment and monthly thereafter.

The simultaneous use of perindopril with NSAIDs (acetylsalicylic acid at a dose that has an anti-inflammatory effect, COX-2 inhibitors and non-selective NSAIDs) can lead to a decrease in the antihypertensive effect of ACE inhibitors. The simultaneous use of ACE inhibitors and NSAIDs can lead to deterioration of renal function, including the development of acute renal failure, and an increase in serum potassium, especially in patients with reduced renal function. Use this combination with caution in elderly patients. Patients should receive adequate fluids; it is recommended to carefully monitor renal function, both at the beginning and during treatment.

The hypotensive effect of perindopril may be enhanced when used simultaneously with other antihypertensive drugs, vasodilators, including short-acting and long-acting nitrates.

Simultaneous use of gliptins (linagliptin, saxagliptin, sitagliptin, vitagliptin) with ACE inhibitors (including perindopril) may increase the risk of developing angioedema due to suppression of dipeptidyl peptidase 4 activity by gliptin.

Simultaneous use of perindopril with tricyclic antidepressants, antipsychotics and general anesthesia agents may lead to an increase in the antihypertensive effect.

Sympathomimetics can weaken the antihypertensive effect of perindopril.

When using ACE inhibitors, incl. perindopril, in patients receiving an intravenous preparation of gold (sodium aurothiomalate), a symptom complex was described, in which facial skin hyperemia, nausea, vomiting, arterial hypotension were observed.

Analogues of the drug Perinev and Ko-Perinev

Structural analogues for the active substance:

Arentopres;
Hypernicus;
Coverex;
Co-preness;
Noliprel;
Noliprel A;
Noliprel A Bi-forte;
Noliprel forte;
Parnavel;
Perindide;
Perindopril;
perindopril arginine;
perindopril erbumine;
Perindopril + Indapamide Sandoz;
Perindopril plus Indapamide;
Perindopril-Indapamide Richter;
Perineva Ku-Tab;
Perinpress;
Piristar;
Prestarium;
Prestarium A;
Stoppress.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

Active substance

Perindopril

Dosage form

tablets

Manufacturer

Krka, Slovenia

Composition

Active ingredients: perindopril erbumine 8 mg;

Excipients: calcium chloride hexahydrate; lactose monohydrate; crospovidone; MCC; silicon dioxide colloidal; magnesium stearate

pharmachologic effect

Perineva - cardioprotective, vasodilating, hypotensive.

Pharmacodynamics

Perindopril has a therapeutic effect due to the active metabolite - perindoprilat.

Perindopril improves the elasticity of large arteries, eliminates structural changes in small arteries.

Perindopril normalizes the work of the heart, reducing pre- and afterload.

In patients with CHF during perindopril therapy, the following was noted:

Decrease in filling pressure in the left and right ventricles;

Reducing OPSS;

Increased cardiac output and cardiac index.

Reception of the initial dose of perindopril (2 mg) in patients with CHF I-II functional class according to the NYHA classification was not accompanied by a statistically significant decrease in blood pressure compared with placebo.

Pharmacokinetics

Taking the drug during a meal is accompanied by a decrease in the conversion of perindopril to perindoprilat, respectively, the bioavailability of the drug decreases. The volume of distribution of unbound perindoprilat is 0.2 l/kg. The binding to plasma proteins is negligible, the binding of perindoprilat to ACE is less than 30% and depends on its concentration.

Perindoprilat is excreted by the kidneys. T1 / 2 of the unbound fraction is about 3-5 hours. It does not accumulate. In elderly patients, in patients with renal and chronic heart failure (CHF), the excretion of perindoprilat is slowed down. Perindoprilat is removed during hemodialysis (speed - 70 ml / min, 1.17 ml / s) and peritoneal dialysis.

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 coronary artery disease: reduced risk of cardiovascular complications in patients with previous myocardial infarction and / or coronary revascularization.

Use during pregnancy and lactation

During pregnancy, the use of the drug is contraindicated. It should not be used in the first trimester of pregnancy, therefore, when pregnancy is confirmed, Perinev should be discontinued as soon as possible. The drug is contraindicated in the II-III trimesters of pregnancy, since the use during this period of pregnancy can cause fetotoxic effects (decreased kidney function, oligohydramnios, slowing down the ossification of the fetal skull bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia). If, nevertheless, the drug was used in the II-III trimesters of pregnancy, then it is necessary to conduct an ultrasound scan of the kidneys and bones of the fetal skull.

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

Contraindications

hypersensitivity to perindopril or other components of the drug, as well as to other ACE inhibitors;
angioedema in history (hereditary, idiopathic or angioedema due to the use of ACE inhibitors);
age up to 18 years (efficacy and safety not established);
hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome.

With caution: renovascular hypertension, bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney - the risk of developing severe arterial hypotension and renal failure; CHF in the stage of decompensation, arterial hypotension; chronic renal failure (Cl creatinine -

Side effects

From the side of the central and peripheral nervous system: often - headache, dizziness, paresthesia; sometimes - sleep or mood disorders; very rarely - confusion.

On the part of the organ of vision: often - visual impairment.

On the part of the organ of hearing: often - tinnitus.

From the side of the cardiovascular system: often - a pronounced decrease in blood pressure; very rarely - arrhythmias, angina pectoris, myocardial infarction or stroke, possibly secondary, due to severe arterial hypotension in high-risk patients; vasculitis (frequency unknown).

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

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

From the side of the skin: often - skin rash, itching; sometimes - angioedema of the face, limbs, urticaria; very rarely - erythema multiforme.

From the musculoskeletal system: often - muscle cramps.

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

General disorders: often - asthenia; sometimes - increased sweating.

On the part of the hematopoietic organs and the lymphatic system: very rarely - with prolonged use in high doses, a decrease in the concentration of hemoglobin and hematocrit, thrombocytopenia, leukopenia / neutropenia, agranulocytosis, pancytopenia; very rarely - hemolytic anemia (in patients with congenital deficiency of glucose-6-phosphate dehydrogenase).

Laboratory indicators: an increase in the concentration of urea in the blood serum and plasma creatinine and hyperkalemia, reversible after discontinuation of the drug (especially in patients with renal insufficiency, severe CHF and renovascular hypertension); rarely - increased activity of liver enzymes and bilirubin in the blood serum; hypoglycemia.

Interaction

Diuretics. In patients taking diuretics, especially with excessive fluid and / or sodium excretion, excessive arterial hypotension may develop at the beginning of therapy with ACE inhibitors. The risk of developing excessive arterial hypotension can be reduced by discontinuing the diuretic, in / in the introduction of 0.9% sodium chloride solution, and also by prescribing an ACE inhibitor at lower doses. Further increase in the dose of perindopril should be carried out with caution.

Potassium-sparing diuretics, potassium preparations, potassium-containing foods and nutritional supplements. Usually, during therapy with ACE inhibitors, the concentration of potassium in the blood serum remains within normal values, but hyperkalemia may develop in some patients. The combined use of ACE inhibitors and potassium-sparing diuretics (eg spironolactone, triamterene or amiloride), potassium preparations or potassium-containing foods and dietary supplements may cause hyperkalemia.

Therefore, it is not recommended to combine perindopril with these drugs. These combinations should be prescribed only in case of hypokalemia, taking precautions and regularly monitoring the concentration of potassium ions in the blood serum.

Lithium. With the simultaneous use of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and lithium toxicity may develop. The simultaneous use of ACE inhibitors with thiazide diuretics can further increase the concentration of lithium in the blood serum and increase the risk of developing its toxic effects. The simultaneous use of perindopril and lithium is not recommended.

If necessary, such a combination therapy is carried out under regular monitoring of the concentration of lithium in the blood serum.

NSAIDs, incl. acetylsalicylic acid in doses of 3 g / day and above. Therapy with NSAIDs may weaken the antihypertensive effect of ACE inhibitors. In addition, NSAIDs and ACE inhibitors have an additive effect on increasing the concentration of potassium ions in the blood serum, which can provoke a deterioration in kidney function. This effect is usually reversible. In rare cases, acute renal failure may develop, especially in patients with pre-existing renal impairment, such as elderly patients or against the background of dehydration.

Other antihypertensive agents and vasodilators. The simultaneous use of perindopril with other antihypertensive agents may enhance the antihypertensive effect of perindopril. The simultaneous use of nitroglycerin, other nitrates or vasodilators may lead to an additional hypotensive effect.

Hypoglycemic agents. The simultaneous use of ACE inhibitors and hypoglycemic agents (insulin or oral hypoglycemic agents) can enhance the hypoglycemic effect, up to the development of hypoglycemia. As a rule, this phenomenon occurs in the first weeks of combination therapy in patients with renal insufficiency.

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

Tricyclic antidepressants, antipsychotics (neuroleptics), general anesthetics (general anesthetics). Combined use with ACE inhibitors may lead to an increase in the hypotensive effect.

Sympathomimetics. May weaken the antihypertensive effect of ACE inhibitors. When prescribing such a combination, the effectiveness of ACE inhibitors should be regularly evaluated.

How to take, course of administration and dosage

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

Arterial hypertension. Perinev can be used as monotherapy and in combination with other antihypertensive agents.

The addition of ACE inhibitors to patients taking diuretics may cause hypotension. In this regard, it is recommended to carry out therapy with caution, stop taking diuretics 2-3 days before the start of treatment with Perinev, or start treatment with Perinev with an initial dose of 2 mg / day, in one dose. It is necessary to control blood pressure, kidney function and the concentration of potassium ions in the blood serum. In the future, the dose of the drug may be increased, depending on the dynamics of the level of blood pressure. If necessary, diuretic therapy can be resumed.

In elderly patients, the recommended initial daily dose is 2 mg at a time. In the future, the dose can be gradually increased to 4 mg and, if necessary, up to a maximum of 8 mg 1 time per day, provided that the lower dose is well tolerated.

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

In patients with CHF, with renal insufficiency and with a tendency to electrolyte disturbances (hyponatremia), as well as in patients taking diuretics and / or vasodilators at the same time, treatment with the drug is started under strict medical supervision.

In patients with a high risk of developing clinically pronounced arterial hypotension (for example, when taking high doses of diuretics), if possible, hypovolemia and electrolyte disturbances should be eliminated before starting the drug Perinev. It is recommended before and during therapy to carefully monitor the level of blood pressure, the state of kidney function and the concentration of potassium ions in the blood serum.

Prevention of recurrent stroke in patients with a history of cerebrovascular disease. Therapy with Perinev should be started at 2 mg for the first 2 weeks before taking indapamide. Treatment should begin at any time (from 2 weeks to several years) after a stroke.

stable ischemic heart disease. In patients with stable CAD, the recommended starting dose of Perinev is 4 mg/day. After 2 weeks, the dose is increased to 8 mg / day, provided that the dose of 4 mg / day is well tolerated and renal function is monitored. Treatment of elderly patients should begin with a dose of 2 mg, which after a week can be increased to 4 mg / day. In the future, if necessary, after another week, you can increase the dose to 8 mg / day with mandatory preliminary monitoring of kidney function. In elderly patients, the dose of the drug can be increased only if the previous, lower dose is well tolerated.

Overdose

Symptoms: pronounced decrease in blood pressure, shock, water and electrolyte imbalance (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 take measures to replenish the BCC, if possible - in / in the introduction of angiotensin II and / or in / in the solution of catecholamines. With the development of severe bradycardia, not amenable to drug therapy (including atropine), the installation of an artificial pacemaker (pacemaker) is indicated. It is necessary to monitor vital functions and the concentration of creatinine and electrolytes in the blood serum. Perindopril can be removed from the systemic circulation by hemodialysis. The use of high flow polyacrylonitrile membranes should be avoided.

Special Instructions

stable ischemic heart disease. With the development of an episode of unstable angina (significant or minor) during the first month of therapy with Perinev, it is necessary to evaluate 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 an excessive decrease in blood pressure is increased in patients with reduced BCC during diuretic therapy, with a strict salt-free diet, hemodialysis, as well as with diarrhea or vomiting, or in those suffering from severe renin-dependent hypertension. Severe arterial hypotension was observed in patients with severe CHF, both in the presence of concomitant renal insufficiency and in its absence. Most often, severe arterial hypotension can develop in patients with more severe CHF, taking high doses of loop diuretics, as well as against the background of hyponatremia or renal 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 coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or cerebrovascular complications.

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

Aortic or mitral valve stenosis/hypertrophic cardiomyopathy. ACE inhibitors, incl. and perindopril should be used with caution in patients with mitral valve stenosis and left ventricular outflow tract obstruction (aortic valve stenosis and hypertrophic cardiomyopathy).

Impaired kidney function. In patients with renal insufficiency (Cl creatinine

In some patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney (especially in the presence of renal failure), during therapy with ACE inhibitors, an increase in serum urea and creatinine concentrations was noted, which is 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 Perinev, it is necessary to cancel diuretics and regularly monitor kidney function. In some patients with arterial hypertension, in the presence of previously undiagnosed renal 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, it is recommended to reduce the dose of Perinev and / or cancel the diuretic.

Patients on hemodialysis. In patients on dialysis using high-flow membranes and taking concomitant ACE inhibitors, there have been several cases of persistent, life-threatening anaphylactic reactions. If hemodialysis is required, a different type of membrane must be used.

Kidney transplant. There is no experience with the use of perindopril in patients with recent kidney transplantation.

Hypersensitivity/angioedema. Rarely in patients taking ACE inhibitors, incl. perindopril, angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx developed. This condition can develop at any time during treatment. With the development of angioedema, treatment should be stopped immediately, the patient should be under medical supervision until the symptoms disappear completely. Angioedema of the lips and face usually does not require treatment; Antihistamines may be used to reduce symptoms. Angioedema of the tongue, glottis, or larynx can be fatal. With the development of angioedema, it is necessary to immediately inject epinephrine (adrenaline) s / c and ensure airway patency. ACE inhibitors are more likely to cause angioedema in black patients.

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.

Anaphylactoid reactions during LDL apheresis (LDL apheresis). In rare cases, patients receiving ACE inhibitors while undergoing LDL apheresis using dextran sulfate absorption may develop an anaphylactic reaction. Temporary withdrawal of the ACE inhibitor before each apheresis procedure is recommended.

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. Temporary withdrawal of the ACE inhibitor is recommended prior to 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 hepatic necrosis, sometimes with a fatal outcome. The mechanism by which this syndrome develops is unclear. If jaundice occurs or an increase in liver enzymes 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. In patients treated with ACE inhibitors, there have been cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. With normal renal function in the absence of other complications, neutropenia rarely develops. Perinev should be used with great caution in patients with systemic connective tissue diseases (e.g. SLE, scleroderma) who are simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as when all of these factors are combined, especially with existing impaired renal function. These patients may develop severe infections that are not amenable to intensive antibiotic therapy. When conducting therapy with Perineva 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 noted.

Negroid race. The risk of developing angioedema in patients of the Negroid race is higher. Like other ACE inhibitors, perindopril is less effective in lowering blood pressure in black patients, possibly due to the greater prevalence of low-renin states in the population of this group of patients with arterial hypertension.

Cough. Against the background of therapy with ACE inhibitors, a persistent, unproductive cough may develop, which stops after discontinuation of the drug. This should be considered in the differential diagnosis of cough.

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

Hyperkalemia. During therapy with ACE inhibitors, including perindopril, the concentration of potassium ions in the blood may increase in some patients. The risk of hyperkalemia is increased in patients with renal and / or heart failure, decompensated diabetes mellitus and patients using potassium-sparing diuretics, potassium supplements or other drugs that cause hyperkalemia (eg heparin). If necessary, the simultaneous appointment of these drugs, it is recommended to regularly monitor the content of potassium in the blood serum.

Diabetes. In patients with diabetes mellitus taking oral hypoglycemic agents or insulin, blood glucose concentrations must be carefully monitored in the first few months of therapy with ACE inhibitors.

Potassium-sparing diuretics, potassium-containing drugs, potassium-containing foods, and nutritional supplements. Co-administration with ACE inhibitors is not recommended.

Lactose. Perinev's tablets contain lactose. Therefore, patients with hereditary galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this drug.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. It is necessary to take into account the possibility of developing arterial hypotension or dizziness, which can affect driving and working with technical equipment.

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