Accupro, 10 mg, film-coated tablets, 30 pcs.

Pharmacological properties of the drug Accupro

Quinapril hydrochloride (INN - Quinaprilum) is an ethyl ester of the ACE inhibitor quinaprilate, which does not contain a sulfide group. When the drug is taken orally, quinapril rapidly deesterifies to quinapril (a diacid of quinapril, the main metabolite), which is an effective ACE inhibitor. The mechanism of action of quinapril is to inhibit circulating blood and tissue ACE, which reduces vasopressor activity and aldosterone secretion. A decrease in the level of angiotensin II through a feedback mechanism leads to an increase in the secretion of renin and its activity in the blood plasma. Although the main mechanism of the antihypertensive effect is believed to be through the renin-angiotensin-aldosterone system, quinapril exhibits antihypertensive effects even in patients with low-renin hypertension (arterial hypertension). Prescribing quinapril to patients with moderate to severe hypertension (arterial hypertension) at a dose of 10–40 mg leads to a decrease in blood pressure in both sitting and standing positions, with minimal effect on heart rate. The antihypertensive effect develops within 1 hour, the maximum effect occurs 2-4 hours after taking the drug. In some patients, a stable hypotensive effect is observed after 2 weeks of treatment. When used in recommended doses, the antihypertensive effect of the drug is maintained in most patients for 24 hours and persists with prolonged use of the drug. The decrease in blood pressure caused by quinapril is accompanied by a decrease in peripheral vascular resistance and renal vascular resistance with little or no change in heart rate, cardiac index, renal blood flow, glomerular filtration rate and filtration fraction. After oral administration, the maximum concentration of quinapril in the blood plasma is achieved within 1 hour. Approximately 60% of the drug is absorbed, systemic bioavailability in the form of quinapril is 38%. The maximum plasma concentration of quinapril is achieved approximately 2 hours after oral administration of quinapril. The half-life of plasma elimination is about 1 hour. Quinaprilat is eliminated mainly by renal excretion and has a half-life of effective cumulation (approximately 3 hours). Approximately 97% of quinapril or quinaprilat circulating in blood plasma is protein bound. In patients with renal impairment, the half-life of quinaprilat increases with a decrease in creatinine clearance. Pharmacokinetic studies conducted in patients with severe renal impairment undergoing chronic hemodialysis or continuous ambulatory peritoneal dialysis indicate that dialysis does not have a significant effect on the clearance of quinapril and quinalaprilat. There is a linear correlation between plasma clearance of quinalaprilat and creatinine clearance. Elimination of quinalaprilat is also reduced in elderly patients (over 65 years of age). Concentrations of quinalaprilat are reduced in patients with alcoholic cirrhosis due to impaired deesterification of quinapril. Quinapril and its metabolites do not penetrate the BBB.

Use of the drug Accupro

Arterial hypertension (AH) Monotherapy: the recommended initial dose of Accupro for patients who do not take diuretics is 10–20 mg once a day. Depending on the clinical effect, the dose may be increased to 20–40 mg/day in 1–2 doses. If necessary, dose adjustments can be made at intervals of 2–4 weeks. Effective blood pressure control in most patients is achieved by taking the drug once a day. The maximum dose of quinapril is 80 mg/day.

Co-administration of diuretics: in patients who must continue treatment with diuretics, the initial recommended dose of Accupro is 5 mg; later it can be gradually increased until the optimal effect is achieved.

Congestive heart failure The recommended starting dose is 5 mg in 1–2 divided doses. If the initial dose of quinapril is well tolerated, it can be gradually increased to an effective dose, usually 10–40 mg/day in 2 equal doses. Elimination of quinapril depends on the functional state of the kidneys. The recommended starting dose of Accupro in patients with creatinine clearance above 30 ml/min is 5 mg, and in patients with creatinine clearance less than 30 ml/min - 2.5 mg. If the initial dose is well tolerated, the drug can be taken 2 times a day from the next day. In the absence of excessive hypotension or significant deterioration in renal function, the dose may be increased at 1-week intervals based on clinical and hemodynamic effect.

Side effects of the drug Accupro

Usually mild and short-lived. The most common side effects observed in controlled trials were headache (7.2%), dizziness (5.5%), cough (3.9%), fatigue (3.5%), rhinitis (3.2%). ), nausea and/or vomiting (2.8%), myalgia (2.2%). It should be noted that the cough is usually non-productive and persistent and disappears after cessation of therapy. Clinically, adverse reactions are probably, possibly or definitely associated or uncertainly associated with quinapril therapy (with or without concomitant diuretic therapy) in controlled and uncontrolled studies and less frequently reported in clinical studies or after registration surveillance * include.

Disorders of the hematopoietic and lymphatic system : hemolytic anemia*, thrombocytopenia*. From the immune system: anaphylactoid reactions*. From the side of the central nervous system: vertigo, nervousness, depression, drowsiness. From the organ of vision: amblyopia. From the cardiovascular system: angina pectoris, palpitations, tachycardia, postural hypotension*, syncope*, vasodilation. From the digestive system: dry mouth or throat, flatulence, pancreatitis*. For the skin: alopecia*, exfoliative dermatitis*, itching, increased sweating, pemphigus*, photosensitivity reactions*, skin rash. From the musculoskeletal system: arthralgia From the genitourinary system: urinary tract infections, impotence. General disorders and reactions at the injection site: edema (peripheral and generalized), Isolated side effects: angioedema* was observed in 0.1% of patients using quinapril. Sometimes, as with the use of other ACE inhibitors, eosinophilic pneumonitis* and hepatitis were observed with the use of quinapril. Results of clinical laboratory tests: rarely - agranulocytosis and neutropenia (their cause-and-effect relationship with the use of quinapril is unreliable), hyperkalemia. Creatinine and blood urea nitrogen. Increases (more than 1.25 times the upper limit of normal) in serum creatinine and urea nitrogen levels were observed in 2 and 2% of cases, respectively, during quinapril therapy. An increase is more likely in patients receiving the drug in combination with diuretics than in patients receiving quinapril monotherapy. Angioedema. Angioedema has been reported in patients receiving ACE inhibitors (including 0.1% of patients receiving quinapril). If the patient develops angioedema of the larynx, face, tongue, use of quinapril should be stopped immediately; the patient should be given adequate therapy and observed until the swelling completely disappears. If swelling appears only on the face and lips, specific treatment is not required in most cases; To eliminate symptoms, it is advisable to use antihistamines. Angioedema of the tongue, larynx and glottis can be life-threatening. If it develops, appropriate emergency therapy should be immediately prescribed, necessarily including the subcutaneous administration of 0.3–0.5 ml of adrenaline (epinephrine) solution (1:1000). Patients with a history of angioedema not related to ACE inhibitor therapy are also at increased risk of angioedema during treatment with an ACE inhibitor. In patients of the Negroid race who were treated with ACE inhibitors, cases of angioedema were more common than in patients of other races. In patients of the Negroid race, a slightly smaller effect of ACE inhibitors on blood pressure was also noted compared to other races. Intestinal angioedema. In patients using ACE inhibitors, manifestations of intestinal angioedema were observed. Such patients complained of abdominal pain (with/without nausea or vomiting); in some cases, there was no indication in the anamnesis of the development of angioedema of the face and a normal level of C-1 esterase was determined. The diagnosis of angioedema was made using abdominal computed tomography or ultrasound or during surgery. These manifestations disappeared after stopping the drug. Intestinal angioedema should be included in the differential diagnosis in patients with abdominal pain who are receiving ACE inhibitor therapy. Patients with a history of angioedema not related to ACE inhibitor therapy may have an increased risk of angioedema during treatment with an ACE inhibitor. Anaphylactoid reactions. Desensitization . Life-threatening anaphylactoid reactions have been observed in patients receiving ACE inhibitors during desensitization therapy to Hymenoptera venom. In some patients, these reactions did not occur during a temporary break in taking ACE inhibitors, but occurred again with an accidental re-provocation. Low-density lipoprotein apheresis. In patients who underwent LDL apheresis with dextran sulfate absorption, anaphylactoid reactions were observed with concomitant therapy with an ACE inhibitor. Hemodialysis Clinical data have shown that patients undergoing hemodialysis using certain types of high-flux membranes (polyacrylonitrile membranes) may develop anaphylactoid reactions while receiving an ACE inhibitor. This combination should be avoided by using alternative antihypertensive drugs or alternative hemodialysis membranes. Arterial hypotension. In patients with uncomplicated hypertension (arterial hypertension) receiving Accupro, hypotension rarely developed, but it was a likely consequence of therapy with ACE inhibitors in patients with impaired water and electrolyte balance due to taking diuretics, following a low-salt diet, or dialysis. In patients with congestive heart failure, in whom the risk of developing severe hypotension is particularly high, treatment with quinapril should be initiated at the recommended dose under medical supervision; These patients should be monitored during the first 2 weeks of treatment and whenever the dose of quinapril is increased. If symptomatic hypotension develops, the patient should be placed on his back and, if necessary, given an intravenous infusion of isotonic sodium chloride solution. A short-term hypotensive reaction is not a contraindication for further use of the drug; however, if such a reaction develops, the use of lower doses of the drug or discontinuation of diuretics should be considered. Patients who received diuretic therapy at the beginning of treatment with quinapril may develop symptomatic hypotension. It is advisable to discontinue the diuretic 2–3 days before starting treatment with quinapril. If blood pressure is not controlled with quinapril monotherapy, diuretics should be resumed. If the use of diuretics cannot be avoided, the use of Accupro should be started with a low initial dose. Neutropenia and agranulocytosis . Taking ACE inhibitors can sometimes be accompanied by agranulocytosis and bone marrow depression in patients with uncomplicated hypertension (arterial hypertension), but more often occurs, as a rule, in patients with renal failure, as well as collagen diseases. When using ACE inhibitors in patients with collagen diseases and/or renal failure, regular monitoring of the leukocyte count is necessary. Cough. Cough has sometimes occurred in patients using ACE inhibitors, including quinapril. Usually the cough was non-productive, persistent and disappeared after cessation of therapy. Cough induced by the use of ACE inhibitors should be considered in the differential diagnosis of cough.

Accupro®

Angioedema of the tissues of the head and neck

During treatment with ACE inhibitors, cases of angioedema in the head and neck area have been described, including in 0.1% of patients receiving Accupro®. If a guttural whistle or angioedema of the face, tongue or vocal folds occurs, Accupro® should be discontinued immediately. The patient must be given adequate treatment and observed until symptoms of edema resolve. Antihistamines may be used to reduce symptoms. Angioedema involving the larynx can be fatal. If swelling of the tongue, vocal folds or larynx threatens the development of airway obstruction, adequate emergency therapy is necessary, including subcutaneous administration of a solution of epinephrine (adrenaline) 1:1000 (0.3-0.5 ml).

Patients receiving concomitant therapy with mTOR enzyme inhibitors (eg, temsirolimus) or DPP-4 inhibitors (gliptins) or neutral endopeptidase inhibitors (NEP) or estramustine may be at greater risk of developing angioedema. Caution should be exercised when using these drugs simultaneously with Accupro®.

Angioedema of the intestinal walls

Cases of intestinal angioedema have also been described during treatment with ACE inhibitors. Patients reported abdominal pain (with/without nausea or vomiting); in some cases without previous angioedema of the face and normal C1-esterase activity. Diagnosis was made using abdominal computed tomography, ultrasound, or at the time of surgery. Symptoms disappeared after stopping the ACE inhibitors. Therefore, in patients with abdominal pain taking ACE inhibitors, when establishing a differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.

Patients with a history of angioedema not associated with an ACE inhibitor may be at increased risk of developing it when treated with drugs of this group.

Anaphylactoid reactions

Patients receiving ACE inhibitors during desensitization therapy with hymenoptera venom may develop life-threatening anaphylactoid reactions. By temporarily stopping the use of ACE inhibitors, these reactions were avoided, but they occurred again with accidental use of these drugs.

Anaphylactoid reactions may also occur with the use of ACE inhibitors in patients undergoing low-density lipoprotein absorption apheresis with dextran sulfate or in patients undergoing hemodialysis using high-flux membranes such as polyacrylonitrile. Therefore, such combinations should be avoided by using either other antihypertensive drugs or alternative hemodialysis membranes.

Arterial hypotension

Symptomatic arterial hypotension rarely occurs during treatment with Accupro in patients with uncomplicated arterial hypertension, but it can develop as a result of therapy with ACE inhibitors in patients with reduced blood volume, for example, when following a diet with limited salt intake, hemodialysis. If symptomatic arterial hypotension occurs, it is necessary to carry out symptomatic therapy (the patient should be laid down, legs elevated and, if necessary, given an intravenous infusion using 0.9% sodium chloride solution). Transient arterial hypotension is not a contraindication to further use of the drug, however, in such cases, its dose should be reduced or the advisability of simultaneous therapy with diuretics should be assessed.

Other causes of decreased blood volume, such as vomiting or diarrhea, can also lead to a pronounced decrease in blood pressure. In such cases, patients should consult a doctor. In patients receiving diuretics, the use of Accupro® may also lead to the development of symptomatic arterial hypotension. It is advisable for such patients to temporarily stop taking the diuretic 2-3 days before starting treatment with Accupro®, except for patients with malignant or difficult-to-treat hypertension. If monotherapy with Accupro® does not provide the required therapeutic effect, then treatment with diuretics should be resumed. If it is impossible to cancel the diuretic, then Accupro® is used in a low initial dose.

In patients with chronic heart failure who are at increased risk of severe hypotension, treatment with Accupro® should be started at the recommended dose under close medical supervision; Patients should be observed during the first two weeks of treatment, as well as in all cases when the dose of Accupro® is increased.

Agranulocytosis

When treated with ACE inhibitors in patients with uncomplicated arterial hypertension, in rare cases, agranulocytosis developed, which was more common in patients with impaired renal function and connective tissue diseases. Agranulocytosis rarely developed during treatment with Accupro®. When using this drug (as well as other AI1P inhibitors) in patients with connective tissue diseases and/or kidney disease, the number of leukocytes in the blood should be monitored.

Renal dysfunction

In susceptible patients, suppression of RAAS activity may lead to renal dysfunction. In patients with severe chronic heart failure, in whom renal function may be dependent on the activity of the RAAS, treatment with ACE inhibitors, including quinapril, may be accompanied by oliguria and/or progressive azotemia, and in rare cases, acute renal failure and/or death.

The use of ARA II, ACE inhibitors or aliskiren can lead to a “double” blockade of RAAS activity. This effect may be manifested by a decrease in blood pressure, hyperkalemia and changes in renal function (including acute renal failure) compared with monotherapy. Blood pressure, renal function and plasma electrolyte levels should be carefully monitored in patients taking Accupro® and other drugs that affect the RAAS. The simultaneous use of RAAS-active agents and quinapril should be avoided. If it is necessary to use this combination, the ratio of the expected benefit to the possible risk of using the combination should be assessed in each individual case and renal function and potassium levels should be regularly monitored.

In patients with chronic heart failure or arterial hypertension with unilateral or bilateral renal artery stenosis, an increase in blood urea nitrogen and serum creatinine was observed in some cases during treatment with ACE inhibitors. These changes were almost always reversible and disappeared after discontinuation of the ACE inhibitor and/or diuretic. In such cases, renal function should be monitored during the first few weeks of treatment.

The half-life of quinaprilat increases with a decrease in CC. In patients with CC less than 60 ml/min, Accupro® should be used at a lower initial dose. In such patients, the dose of the drug should be increased taking into account the therapeutic effect, with regular monitoring of renal function, although in clinical studies no further deterioration of renal function was observed during treatment with the drug.

Liver dysfunction

Accupro® in combination with diuretics should be used with caution in patients with impaired function or progressive liver disease, since small changes in water and electrolyte balance can cause the development of hepatic coma. Hyperkalemia

ACE inhibitors, including quinapril, may increase serum potassium levels.

The use of Accupro® in combination therapy with potassium-sparing diuretics has not been studied. Given the risk of a further increase in serum potassium, combination therapy with potassium-sparing diuretics or other drugs that increase serum potassium should be carried out with caution, under monitoring of serum potassium levels. Accupro® may reduce the hypokalemia caused by thiazide diuretics when used concomitantly.

Hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIAD)

Syndrome of inappropriate antidiuretic hormone secretion (SIADH) and subsequent hyponatremia have been observed in some patients treated with other ACE inhibitors. It is recommended to regularly monitor serum sodium concentrations in elderly patients, as well as in patients of all age groups, for the risk of hyponatremia.

Hypoglycemia and diabetes mellitus

Patients with diabetes mellitus may require closer monitoring and dosage adjustments of oral hypoglycemic agents and insulin, especially during the first month of ACE inhibitor therapy, including quinapril.

Cough

When treated with ACE inhibitors, including quinapril, the development of cough was noted. Typically, it is nonproductive, persistent, and resolves upon cessation of therapy. In the differential diagnosis of cough, its possible connection with ACE inhibitors should be taken into account.

Patients undergoing surgery and/or anesthesia

Before surgery (including dentistry), the surgeon/anesthesiologist must be warned about the use of ACE inhibitors.

Neutropenia

If any symptoms of infection (eg, acute tonsillitis, fever) appear, the patient should consult a doctor immediately, as they may be a manifestation of neutropenia.

Conditions that impede the outflow of blood from the left ventricle

The use of Accupro® is contraindicated in patients with a condition that impedes the outflow of blood from the left ventricle (aortic or mitral stenosis; hypertrophic obstructive cardiomyopathy).

Kidney transplant

The use of Accupro® is contraindicated in patients after kidney transplantation

Ethnic differences

ACE inhibitors are more likely to cause angioedema in black patients than in Caucasian patients. As with other ACE inhibitors, quinapril may be less effective in lowering blood pressure in black patients.

Elderly patients

Especially at the beginning of treatment, Accupro® should always be used in combination with careful monitoring of blood pressure and/or representative laboratory parameters.

Special instructions for the use of Accupro

Decreased renal function: The half-life of quinaprilat increases as creatinine clearance decreases. Recommended starting doses for patients with impaired renal function are:

*There is no experience to date to date specific dosing recommendations for these patients.

In persons with hypersensitivity due to inhibition of the activity of the renin-angiotensin-aldosterone system, renal function may be impaired. In patients with severe heart failure in whom renal function is dependent on the activity of the renin-angiotensin-aldosterone system, therapy with ACE inhibitors, including quinapril, can lead to the development of oliguria and/or progressive azotemia and, rarely, acute renal failure, including death. The elimination period of quinaprilat is increased due to a decrease in creatinine clearance. In patients with creatinine clearance ≤60 ml/min, quinapril should be prescribed at a lower dose (see APPLICATION). In such patients, the dose of the drug should be titrated from low to higher, taking into account the therapeutic effect, and renal function should be regularly monitored (although initial studies did not reveal further deterioration of renal function with quinapril). In some patients with hypertension (arterial hypertension) or heart failure without obvious signs of renal vascular damage, an increase in serum urea nitrogen and creatinine levels was observed when treated with quinapril, especially in combination with a diuretic. This increase is usually minor and reversible when the ACE inhibitor and/or diuretic is discontinued. The risk of such changes is higher in patients with impaired renal function. In such cases, it may be necessary to reduce the dose and discontinue the diuretic and/or quinapril. In clinical studies of patients with hypertension (arterial hypertension) and unilateral or bilateral renal artery stenosis, an increase in blood urea nitrogen and serum creatinine was observed after therapy with an ACE inhibitor. This increase was almost always reversible when ACE inhibitor and/or diuretic therapy was discontinued. In such cases, it is necessary to monitor the patient's renal function during the first few weeks of therapy. Liver dysfunction. Quinapril in combination with a diuretic should be used with caution in patients with impaired function or progressive liver disease, since small changes in water and electrolyte balance may cause the development of hepatic coma. The metabolism of quinapril to quinaprilat normally occurs under the action of hepatic esterase. Quinaprilat concentrations are reduced in patients with alcoholic cirrhosis due to impaired deesterification of quinapril. Hyperkalemia and potassium-sparing diuretics. Both with the use of other ACE inhibitors and with the use of quinapril, the level of potassium ions in the serum may increase. When used concomitantly, quinapril may reduce hypokalemia caused by thiazide diuretics. Studies of the combined use of quinapril and potassium-sparing diuretics have not been conducted. Because there is a risk of increased serum potassium concentrations, it is important that combination therapy in patients receiving potassium-sparing diuretic therapy is initiated cautiously with careful monitoring of serum potassium levels. Hypoglycemia and diabetes. The use of ACE inhibitors may be accompanied by hypoglycemia in diabetic patients who take insulin or oral hypoglycemic agents. Therefore, it is necessary to carefully monitor the condition of such patients. Surgery/anesthesiology. If surgical intervention is necessary, the anesthesiologist should be informed that the patient is taking quinapril, since severe arterial hypotension/collapse may develop. Use in elderly people. Age does not have a significant effect on the effectiveness and safety profile of the drug, therefore the recommended initial dose of Accupro in elderly patients is 10 mg 1 time per day; if necessary, it can be adjusted taking into account the level of blood pressure. Use during pregnancy and lactation When used during pregnancy, ACE inhibitors may cause fetal and neonatal morbidity and mortality. Before using quinapril during pregnancy, its possible adverse effects on the fetus should be considered. If pregnancy occurs while taking quinapril, the drug must be discontinued. Hypotension, renal failure, cranial hypoplasia and/or neonatal death have been reported when taking ACE inhibitors during the second and third trimesters of pregnancy. Oligohydroamnion has also been reported, likely due to decreased fetal renal function; in connection with this, contractures of the limbs, craniofacial deformities, pulmonary hypoplasia and intrauterine growth retardation were noted. If during the first trimester the embryo or fetus was influenced by the drug, the mother should be informed as early as possible about the degree of risk, even if the occurrence of side effects was not diagnosed. Women who used ACE inhibitors during the second and third trimesters of pregnancy should be informed of the potential risk to the fetus; To diagnose oligohydroamnion, frequent ultrasound examinations are necessary. In the case of diagnosis of oligohydroamnion, the use of quinapril must be discontinued; use can only be extended only if it is vital for the mother. Other potential risks to the fetus and newborn when using ACE inhibitors are intrauterine growth retardation, prematurity, and non-closure of the ductus arteriosus; Fetal death may also occur. However, it remains unknown what causes the development of such side effects - the use of the drug or concomitant diseases of the mother. It is also unknown what unfavorable factor acting in the first trimester of pregnancy can cause damage to the fetus. Infants whose mothers received an ACE inhibitor during pregnancy, and therefore the children were exposed to the intrauterine influence of ACE inhibitors, require observation to monitor hypotension, oliguria and hyperkalemia. If oliguria occurs, attention must be paid to maintaining blood pressure and renal perfusion. ACE inhibitors, including quinapril, are excreted in breast milk in limited quantities. Therefore, during treatment with Accupro, it is recommended to stop breastfeeding. Children. The safety and effectiveness of Accupro in pediatric patients have not been studied. The ability to influence the speed of reaction when driving vehicles and working with potentially dangerous mechanisms: The speed of reactions when driving vehicles or working with other mechanisms may be impaired at the beginning of treatment with Accupro.

Accupro tablets 10 mg No. 30

Compound

Active ingredient: 10 mg quinapril hydrochloride,
Excipients: magnesium carbonate, magnesium stearate, lactose, gelatin, crospovidone, hydroxypropyl methylcellulose, hydroxypropylcellulose, titanium dioxide, macrogol 400, candelyl wax, Opadry White OY-S-7331.

Pharmacokinetics

Accupro is an antihypertensive drug, an ACE inhibitor.

Indications for use

Arterial hypertension, chronic heart failure.

Contraindications

• history of angioedema associated with treatment with ACE inhibitors, hereditary and/or idiopathic angioedema,
• children and adolescents up to 18 years of age,
• pregnancy,
• lactation period (breastfeeding),
• lactase deficiency, lactose intolerance and glucose-galactose malabsorption syndrome,
• simultaneous use with aliskiren and aliskiren-containing drugs, with angiotensin II receptor antagonists or with other drugs that inhibit the RAAS (dual blockade of the RAAS), in patients with diabetes mellitus or in patients with diabetes mellitus with target organ damage (diabetic nephropathy), with impaired function kidneys (GFR less than 60 ml/min/1.73 m2), with hyperkalemia (more than 5 mmol/l), with chronic heart failure and arterial hypertension,
• hypersensitivity to any component of the drug.

The drug should be prescribed with caution to patients with symptomatic arterial hypotension, who have previously taken diuretics and are on a diet with limited salt intake, with severe heart failure in patients with a high risk of severe arterial hypotension, with a decrease in the volume of the bcc (including vomiting or diarrhea) , with hyperkalemia, suppression of bone marrow hematopoiesis, with aortic stenosis, hypertrophic obstructive cardiomyopathy, mitral stenosis, with cerebral circulatory failure, coronary artery disease, coronary insufficiency (a sharp decrease in blood pressure during therapy with ACE inhibitors can worsen the course of these diseases), condition after kidney transplantation, with bilateral renal artery stenosis or stenosis of the artery of a single kidney, with impaired renal function, in patients on hemodialysis (creatinine clearance less than 10 ml/min), because There is insufficient data on the use of Accupro in such patients, with severe autoimmune systemic connective tissue diseases (including SLE, scleroderma), with impaired liver function (especially when used simultaneously with a diuretic), with combination therapy with a potassium-sparing diuretic, with diabetes mellitus , extensive surgical interventions and general anesthesia, while taking other antihypertensive drugs, as well as mTOR and DPP-4 enzyme inhibitors.

Directions for use and doses

When conducting monotherapy for arterial hypertension, the recommended initial dose of quinapril in patients not receiving diuretics is 10 mg or 20 mg 1 time / day. Depending on the clinical effect, the dose can be increased to a maintenance dose of 20 mg or 40 mg/day, which is usually prescribed in 1 dose or divided into 2 parts. As a rule, the dose should be changed at intervals of 4 weeks. In most patients, it is possible to achieve adequate blood pressure control during long-term treatment by using the drug once a day. In some patients, the dose of quinapril reached 80 mg/day.

Storage conditions

At a temperature not exceeding 25 C

Best before date

3 years

special instructions

Caution must be exercised when prescribing to patients with reduced blood volume (including as a result of diuretic therapy, limiting NaCl intake, hemodialysis, diarrhea and vomiting) due to the increased risk of developing a sudden decrease in blood pressure after using even the initial dose of ACE. Transient hypotension is not a contraindication for continuing treatment with the drug after stabilization of blood pressure (the dose should be reduced). In case of an excessive decrease in blood pressure, the patient is transferred to a horizontal position with a low head, and, if necessary, saline solution is infused (to increase the volume of the bcc). Before starting treatment, 2-3 days before starting treatment, it is necessary to cancel previous diuretic therapy, except for patients with malignant or difficult-to-treat hypertension. In these patients, the use of quinapril can be started immediately, at a reduced dose, under close medical supervision (within 2 hours after administration and an additional 1 hour until blood pressure stabilizes) and a careful increase in dose. Patients with malignant arterial hypertension or concomitant severe heart failure should begin treatment in a hospital setting. Before starting therapy with ACE inhibitors, it is necessary to count the total number of leukocytes, as well as monitor the leukocyte formula once a month in the first 3-6 months of treatment, and at periodic intervals up to 1 year in patients with an increased risk of neutropenia (with impaired renal function, systemic diseases connective tissue in those receiving high doses, at the first signs of infection). Before and during treatment, monitoring of blood pressure, renal function, K+ content in plasma, control of Hb content in peripheral blood, creatinine, urea, control of the concentration of electrolytes and liver enzymes in the blood is necessary. The use of AN69 dialysis membranes in combination with ACE inhibitors is not recommended (due to the possibility of developing anaphylactoid reactions in patients). It is recommended that neonates exposed in utero to ACE inhibitors be closely monitored for hypotension, oliguria, and hyperkalemia. In oliguria, it is necessary to maintain blood pressure and renal perfusion by administering appropriate fluids and vasoconstrictors. In neonates and infants, the risk of developing oliguria and neurological disorders is associated with a decrease in renal and cerebral blood flow due to the decrease in blood pressure caused by ACE inhibitors, in which case lower initial doses and careful monitoring are recommended. Care must be taken when driving vehicles or performing other work that requires increased attention, because Dizziness is possible, especially after the initial dose of an ACE inhibitor in patients taking diuretics. Caution should be exercised during exercise or hot weather due to the risk of dehydration and hypotension due to decreased fluid volume. Before surgery (including dentistry), the surgeon/anesthesiologist must be warned about the use of ACE inhibitors.

Conditions for dispensing from pharmacies

Available with prescription

Side effects

From the central nervous system and peripheral nervous system: possible dizziness, weakness, headache, rarely - paresthesia, mood and sleep disturbances.

From the cardiovascular system: arterial hypotension is possible, rarely - tachycardia.

From the digestive system: possible dyspeptic symptoms (including dry mouth, loss of appetite), rarely - stomatitis, abdominal pain, pancreatitis, cholestatic jaundice.

Metabolism: possible hyperkalemia, hyponatremia, rarely - proteinuria, increased levels of urea and creatinine in the blood (mainly in patients with impaired renal function).

From the respiratory system: dry cough, bronchitis, rhinitis are possible.

From the hematopoietic system: rarely - neutropenia, agranulocytosis, thrombocytopenia, anemia.

From the urinary system: possible renal dysfunction.

From the reproductive system: rarely - impotence.

Allergic reactions: skin rash, angioedema, and other hypersensitivity reactions are possible.

Dermatological reactions: rarely - alopecia.

Other: rarely - muscle spasms.

Interaction

Antihypertensive, diuretic, opioid analgesics, and general anesthesia agents enhance the hypotensive effect. NSAIDs, table salt - weaken the effect. Potassium supplements, potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of developing hyperkalemia. Enhances the effect of ethanol, slows down the excretion of Li+. Enhances the hypoglycemic effect of sulfonylurea derivatives and insulin. Increases the risk of developing leukopenia when used simultaneously with allopurinol, cytostatic agents, immunosuppressants, procainamide. Estrogens weaken the hypotensive effect due to fluid retention. Drugs that cause bone marrow suppression increase the risk of neutropenia and/or agranulocytosis, including death.

Overdose

Symptoms: marked decrease in blood pressure, dizziness, weakness, visual impairment.

Treatment is symptomatic. The patient should take a horizontal position; it is advisable to carry out an intravenous infusion using 0.9% sodium chloride solution (to increase the volume of blood volume). Hemodialysis and peritoneal dialysis are not effective.

Interactions of the drug Accupro

Taking tetracycline with quinapril reduces the absorption of tetracycline by approximately 28–37%. The decrease in absorption is due to the presence of magnesium carbonate as a filler in Accupro. Elevated serum lithium levels and symptoms of lithium toxicity have been reported in patients taking lithium and ACE inhibitors concomitantly. The combination of these drugs should be used with caution; Frequent monitoring of serum lithium levels is recommended. Additional use of a diuretic increases the risk of lithium intoxication. No clinically significant pharmacokinetic interactions were observed when quinapril was administered with propranolol, hydrochlorothiazide, digoxin or cimetidine. The anticoagulant effect with a single dose of warfarin (measured by prothrombin time) does not change significantly with simultaneous administration of quinapril 2 times a day. Concomitant therapy with thiazide diuretics and/or beta-adrenergic blockers enhances the antihypertensive effect of quinapril. When quinapril is co-administered with potassium-sparing diuretics (spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes, they should be used with caution and with appropriate monitoring of serum potassium levels. In patients taking quinapril (as well as other ACE inhibitors), serum potassium levels may increase. When used concomitantly, quinapril may reduce hypokalemia caused by thiazide diuretics. Due to the risk of further increases in serum potassium levels, combination therapy with potassium-sparing diuretics should be initiated with caution and regular monitoring of serum potassium levels. Some patients with impaired renal function who are taking NSAIDs may experience further deterioration in renal function after starting ACE inhibitors. This condition is usually reversible. The therapeutic effect of quinapril may be reduced when administered concomitantly with NSAIDs. ACE inhibitors, including quinapril, may increase sensitivity to insulin or oral hypoglycemic agents, which may lead to hypoglycemia in patients with diabetes mellitus. In this case, additional observations are necessary.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Accupro, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

Are you interested in Accupro? Do you want to know more detailed information or do you need a doctor's examination? Or do you need an inspection? You can make an appointment with a doctor - the Euro lab is always at your service! The best doctors will examine you, advise you, provide the necessary assistance and make a diagnosis. You can also call a doctor at home . Euro lab clinic is open for you around the clock.

** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Accupro is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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