Equapress, 5 mg+1.5 mg+10 mg 28 pcs.

Equapress is a fixed combination of the antihypertensive components amlodipine, indapamide and lisinopril, which have complementary mechanisms of action to control blood pressure (BP) and also have a synergistic cardioprotective effect.

The combination of amlodipine, indapamide, and lisinopril prevents possible side effects of the individual components of the drug. For example, by dilating the arterioles, slow calcium channel blockers (SCBs) can cause sodium and fluid retention in the body, which leads to activation of the renin-angiotensin-aldosterone system (RAAS). Angiotensin-converting enzyme (ACE) inhibitor blocks this process and normalizes the body’s response to salt load.

The ACE inhibitors significantly reduce hypokalemia caused by diuretics.

Amlodipine

The dihydropyridine derivative is a “slow” calcium channel blocker that has antihypertensive and antianginal effects. It blocks “slow” calcium channels, decreases transmembrane transition of calcium ions into cells (more in vascular smooth muscle cells than in cardiomyocytes). Antianginal action is due to the dilation of coronary and peripheral arteries and arterioles:

In angina, it reduces the severity of myocardial ischemia; by dilating the peripheral arterioles, it reduces total peripheral vascular resistance, reduces the afterload on the heart, and reduces myocardial oxygen demand;

– expanding coronary arteries and arterioles in unchanged and in ischemic areas of the myocardium, increases the flow of oxygen to the myocardium (especially in vasospastic angina); prevents spasm of coronary arteries (including those caused by smoking).Also caused by smoking.)

In patients with stable angina, a single daily dose increases exercise tolerance, delays the development of angina attacks and ST-segment depression by 1 mm, reduces the frequency of angina attacks and the consumption of nitroglycerin and other nitrates.

It has a long-term dose-dependent antihypertensive effect. The antihypertensive effect is due to a direct vasodilatory effect on the vascular smooth muscles. In arterial hypertension a single dose provides clinically significant reduction of BP during 24 hours (in “lying” and “standing” positions).

Orthostatic hypotension when using amlodipine is quite rare. Amlodipine does not cause a decrease in exercise tolerance, left ventricular ejection fraction. It reduces the degree of left ventricular myocardial hypertrophy. It has no effect on myocardial contractility and conduction, does not cause reflex increase of heart rate, inhibits platelet aggregation, increases glomerular filtration rate, has a weak natriuretic effect.

In diabetic nephropathy it does not increase microalbuminuria. It does not have any adverse effect on metabolism and blood plasma lipid concentration and may be used for therapy of patients with bronchial asthma, diabetes and gout. Significant decrease in BP is observed after 6-10 hours, the duration of effect is 24 hours.

In patients with diseases of the cardiovascular system (including coronary atherosclerosis with lesions of one vessel and up to stenosis of 3 or more arteries, atherosclerosis of the carotid arteries), who had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or in patients with angina pectoris, the use of amlodipine prevents the development of carotid intima-media thickening, reduces mortality from myocardial infarction, stroke, PTCA, aortocoronary bypass; leads to fewer hospitalizations for unstable angina and progression of chronic heart failure (CHF); reduces the frequency of interventions to restore coronary blood flow.

Does not increase risk of death or complications and lethal outcomes in patients with CHF (New York Heart Association (NYHA) Class III-IV functional class) during therapy with digoxin, diuretics and ACE inhibitors. In patients with CHF (functional class III-IV according to NYHA classification) of non-ischemic etiology, there is a possibility of pulmonary edema when using amlodipine.

Indapamide

Indapamide refers to sulfonamide derivatives with an indole ring and has pharmacological properties similar to thiazide diuretics, which inhibit sodium ion absorption in the cortical segment of the nephron loop. The renal excretion of sodium and chlorine ions and, to a lesser extent, potassium and magnesium ions increases, which is accompanied by increased diuresis and antihypertensive effect.

In clinical studies, a 24-hour antihypertensive effect has been demonstrated with indapamide in monotherapy in doses that have no pronounced diuretic effect.

The antihypertensive activity of indapamide is associated with improvement of elastic properties of large arteries, reduction of arteriolar and total peripheral vascular resistance.

Indapamide reduces left ventricular hypertrophy.

The thiazide and thiazide-like diuretics reach a plateau of therapeutic effect at a certain dose, whereas the incidence of side effects continues to increase with further increasing of the drug dose. Therefore, do not increase the dose of the drug if the therapeutic effect is not achieved at the recommended dose.

In short-, medium-, and long-term studies involving patients with arterial hypertension, it has been shown that indapamide:

– has no effect on lipid metabolism, including triglyceride, cholesterol, low and high density lipoprotein concentrations;

– has no effect on carbohydrate metabolism, including in patients with diabetes.

Lisinopril

Lisinopril is an ACE inhibitor and inhibits the transformation of angiotensin I into angiotensin II. Reducing the concentration of angiotensin II leads to a direct reduction of aldosterone secretion. Lisinopril inhibits bradykinin degradation and increases prostaglandin synthesis. It reduces total peripheral vascular resistance, BP, preload and pulmonary capillary pressure. In patients with CHF it increases the minute blood volume and increases myocardial resistance to stress.

Dilates the arteries to a greater extent than the veins. Some effects are explained by its effect on the tissue renin-angiotensin system. Long-term use reduces myocardial hypertrophy and resistive arterial wall hypertrophy.

Lisinopril improves the blood supply to the ischemic myocardium.

In patients with CHF, ACE inhibitors increase life expectancy; in patients with a history of myocardial infarction in the absence of clinical manifestations of heart failure, lisinopril slows the progression of left ventricular dysfunction.

In patients with CHF, lisinopril starts acting within 1 hour after oral administration. Maximum effect is achieved within 6-7 hours; the duration of effect is 24 hours. In patients with arterial hypertension the effect is seen during the first days after treatment start; stabilization of the effect occurs within 1-2 months of treatment. Cases of marked increase in BP after abrupt withdrawal of the drug have not been registered.

Lisinopril provides both BP reduction and albuminuria reduction. In patients with hyperglycemia the drug promotes restoration of function of damaged glomerular endothelium. In patients with diabetes, lisinopril has no effect on plasma glucose concentration; the drug does not lead to increased incidence of hypoglycemia.

Indications

Arterial hypertension (patients who require combination therapy).

Pharmacological effect

Equapress is a fixed combination of antihypertensive components amlodipine, indapamide and lisinopril, which have complementary mechanisms of action that control blood pressure (BP) and also have a synergistic cardioprotective effect.

The combination of amlodipine, indapamide and lisinopril helps prevent the possible development of side effects that occur when prescribing individual components of the drug. For example, by dilating arterioles, slow calcium channel blockers (SCBCs) can cause sodium and fluid retention in the body, which leads to activation of the renin-angiotensin-aldosterone system (RAAS). An angiotensin-converting enzyme (ACE) inhibitor blocks this process and normalizes the body’s response to salt load.

ACE inhibitors significantly reduce hypokalemia caused by diuretics.

Amlodipine

A dihydropyridine derivative is a blocker of “slow” calcium channels, which has antihypertensive and antianginal effects. Blocks “slow” calcium channels, reduces the transmembrane transition of calcium ions into the cell (more into vascular smooth muscle cells than into cardiomyocytes). The antianginal effect is due to the expansion of coronary and peripheral arteries and arterioles:

– in case of angina pectoris, it reduces the severity of myocardial ischemia; expanding peripheral arterioles, reduces total peripheral vascular resistance, reduces afterload on the heart, reduces myocardial oxygen demand;

– expanding the coronary arteries and arterioles in unchanged and ischemic areas of the myocardium, increases the supply of oxygen to the myocardium (especially with vasospastic angina); prevents spasm of the coronary arteries (including those caused by smoking).

In patients with stable angina, a single daily dose increases exercise tolerance, slows the development of angina attacks and ST segment depression by 1 mm, reduces the frequency of angina attacks and the consumption of nitroglycerin and other nitrates.

It has a long-term dose-dependent antihypertensive effect. The antihypertensive effect is due to a direct vasodilating effect on vascular smooth muscle. For arterial hypertension, a single dose provides a clinically significant reduction in blood pressure over 24 hours (in the “lying” and “standing” positions).

Orthostatic hypotension with amlodipine is quite rare. Amlodipine does not cause a decrease in exercise tolerance or left ventricular ejection fraction. Reduces the degree of left ventricular myocardial hypertrophy. It has no effect on myocardial contractility and conductivity, does not cause a reflex increase in heart rate, inhibits platelet aggregation, increases the glomerular filtration rate, and has a weak natriuretic effect.

In diabetic nephropathy, it does not increase the severity of microalbuminuria. It does not have any adverse effect on metabolism and plasma lipid concentrations and can be used in the treatment of patients with bronchial asthma, diabetes mellitus and gout. A significant decrease in blood pressure is observed after 6-10 hours, the duration of the effect is 24 hours.

In patients with diseases of the cardiovascular system (including coronary atherosclerosis with damage to one vessel and up to stenosis of 3 or more arteries, atherosclerosis of the carotid arteries), who have had myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or in patients with angina pectoris, the use of amlodipine prevents the development of intima-media thickening of the carotid arteries, reduces mortality from myocardial infarction, stroke, PTCA, coronary artery bypass grafting; leads to a decrease in the number of hospitalizations for unstable angina and progression of chronic heart failure (CHF); reduces the frequency of interventions aimed at restoring coronary blood flow.

Does not increase the risk of death or the development of complications and deaths in patients with CHF (III-IV functional class according to the New York Heart Association (NYHA) classification) during therapy with digoxin, diuretics and ACE inhibitors. In patients with CHF (III-IV functional class according to the NYHA classification) of non-ischemic etiology, when using amlodipine, there is a risk of pulmonary edema.

Indapamide

Indapamide is a sulfonamide derivative with an indole ring and is similar in pharmacological properties to thiazide diuretics, which inhibit the absorption of sodium ions in the cortical segment of the nephron loop. At the same time, the kidneys excrete sodium and chloride ions and, to a lesser extent, potassium and magnesium ions, which is accompanied by an increase in diuresis and an antihypertensive effect.

In clinical studies, when indapamide was used as monotherapy in doses that did not have a pronounced diuretic effect, a 24-hour antihypertensive effect was demonstrated.

The antihypertensive activity of indapamide is associated with an improvement in the elastic properties of large arteries, a decrease in arteriolar and total peripheral vascular resistance.

Indapamide reduces left ventricular hypertrophy.

Thiazide and thiazide-like diuretics at a certain dose reach a plateau of therapeutic effect, while the frequency of side effects continues to increase with further increases in the dose of the drug. Therefore, you should not increase the dose of the drug if a therapeutic effect is not achieved when taking the recommended dose.

In short-, medium- and long-term studies in patients with hypertension, indapamide has been shown to:

– does not affect lipid metabolism, including the concentration of triglycerides, cholesterol, low and high density lipoproteins;

– does not affect carbohydrate metabolism, including in patients with diabetes.

Lisinopril

Lisinopril is an ACE inhibitor that suppresses the transformation of angiotensin I to angiotensin II. A decrease in angiotensin II concentration leads to a direct decrease in aldosterone secretion. Lisinopril inhibits the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces total peripheral vascular resistance, blood pressure, preload and pulmonary capillary pressure. In patients with CHF, it increases minute blood volume and increases the resistance of the myocardium to stress.

Dilates arteries more than veins. Some effects are attributed to its effects on the tissue renin-angiotensin system. With long-term use, hypertrophy of the myocardium and the walls of resistive arteries decreases.

Lisinopril improves blood supply to ischemic myocardium.

In patients with CHF, ACE inhibitors increase life expectancy; in patients with a history of myocardial infarction in the absence of clinical manifestations of heart failure, lisinopril slows the progression of left ventricular dysfunction.

In patients with CHF, lisinopril begins to act within 1 hour after oral administration. The maximum effect is achieved within 6-7 hours; duration of effect – 24 hours. In patients with arterial hypertension, the effect appears within the first days after the start of treatment; stabilization of the effect occurs within 1-2 months of treatment. Cases of a pronounced increase in blood pressure after abrupt discontinuation of the drug have not been recorded.

Lisinopril provides both a decrease in blood pressure and a decrease in albuminuria. In patients with hyperglycemia, the drug helps restore the function of damaged glomerular endothelium. In patients with diabetes mellitus, lisinopril has no effect on plasma glucose concentrations; taking the drug does not lead to an increase in cases of hypoglycemia.

Special instructions

If you are hospitalized, tell your doctor that you are taking Equapress.

When using the drug Equapress, it is necessary to take into account special instructions regarding the individual components of the drug.

Amlodipine related

Maintaining dental hygiene and monitoring by a dentist is necessary (to prevent pain, bleeding and gum hyperplasia).

In elderly patients, T1/2 may increase and amlodipine clearance may decrease. Dose changes are not required, but more careful monitoring of patients in this category is necessary.

The effectiveness and safety of amlodipine in hypertensive crisis have not been established.

In vitro studies have shown that amlodipine does not affect the degree of binding of digoxin, phenytoin, warfarin or indomethacin to human plasma proteins.

Despite the absence of withdrawal syndrome in BMCC, it is advisable to discontinue treatment with amlodipine by gradually reducing the dose of the drug.

During the use of amlodipine in patients with NYHA class III and IV CHF of non-ischemic origin, an increase in the incidence of pulmonary edema was observed, despite the absence of signs of worsening heart failure.

Effect on fertility

Some patients treated with calcium channel blockers have had reversible biochemical changes in the sperm head, which may be clinically significant during in vitro fertilization (IVF).

However, there is currently insufficient clinical data regarding the potential effects of amlodipine on fertility. A preclinical study identified undesirable effects on fertility in males.

Indapamide related

Liver dysfunction

When thiazide and thiazide-like diuretics are prescribed to patients with impaired liver function, hepatic encephalopathy may develop, especially in the presence of electrolyte imbalance. In this case, it is necessary to stop using diuretics.

Photosensitivity

When using thiazide and thiazide-like diuretics, cases of photosensitivity have been reported. With the development of photosensitivity, discontinuation of these drugs is indicated. If it is necessary to continue treatment, it is recommended to protect the skin from sunlight or artificial UV radiation.

Water and electrolyte balance

Sodium content in blood plasma

Before starting treatment, the sodium content in the blood plasma should be determined and this indicator should be regularly monitored. All diuretics can cause hyponatremia, which can lead to extremely serious consequences. Constant monitoring of sodium content in blood plasma is necessary, since initially its decrease may not have clinical manifestations. Sodium levels should be monitored especially carefully in patients with cirrhosis and the elderly.

All diuretic drugs can cause hyponatremia, sometimes leading to extremely serious consequences. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in chloride ions can lead to secondary compensatory metabolic alkalosis: the frequency and severity of this effect are insignificant.

Potassium content in blood plasma

During therapy with thiazide and thiazide-like diuretics, a sharp decrease in the potassium content in the blood plasma, as well as the development of hypokalemia, is possible. It is necessary to prevent the risk of developing hypokalemia (<3.4 mmol/l) in the following groups of patients: elderly, debilitated patients and/or those receiving concomitant drug therapy, patients with liver cirrhosis, peripheral edema and ascites, coronary heart disease, heart failure.

In such patients, hypokalemia enhances the toxic effects of cardiac glycosides and increases the risk of arrhythmias. In addition, patients with a prolonged QT interval are at high risk, and it does not matter whether this increase is caused by congenital causes or the effect of drugs.

Hypokalemia, like bradycardia, contributes to the development of severe arrhythmias, especially cardiac arrhythmias, which can be fatal. The first measurement of potassium content in the blood plasma should be carried out within the first week from the start of treatment. If hypokalemia is detected, appropriate therapy is indicated.

Calcium content in blood plasma

Thiazide and thiazide-like diuretics reduce the excretion of calcium in the urine, which leads to a slight temporary increase in calcium levels in the blood plasma. Clinical hypercalcemia may result from previously undiagnosed hyperparathyroidism.

Diuretics should be discontinued until parathyroid function is examined.

Blood plasma glucose

Monitoring glucose concentrations is indicated in patients with diabetes mellitus, especially in the presence of hypokalemia.

Uric acid

Patients suffering from gout may experience an increase in the frequency of gout attacks or an exacerbation of its course.

Diuretics and kidney function

Thiazide and thiazide-like diuretics are most effective in patients with normal or slightly reduced renal function (plasma creatinine in adults <25 mg/l or 220 µmol/l). Plasma creatinine concentrations in elderly patients are assessed depending on age, body weight and gender.

At the beginning of treatment, patients may experience a decrease in glomerular filtration rate due to hypovolemia, which may be associated with loss of water and sodium due to the action of diuretics. This may be associated with an increase in the concentration of uric acid and creatinine in the blood plasma. With preserved renal function, such transient functional renal failure, as a rule, resolves without complications. However, in the presence of renal failure, the general condition of patients may worsen.

Athletes

Indapamide may give a positive result in doping tests in athletes.

Related to lisinopril

Symptomatic hypotension

Most often, a pronounced decrease in blood pressure is associated with hypovolemia caused by the use of diuretics, reducing the amount of salt in food, dialysis, diarrhea or vomiting. In patients with CHF, regardless of whether it is associated with renal failure, arterial hypotension may develop. It has been found that in patients with severe heart failure, this condition occurs more often due to the administration of high doses of diuretics, hyponatremia or impaired renal function. In such patients, careful medical monitoring is required (dosages of lisinopril and diuretics must be carefully selected). The same instructions apply to patients with coronary heart disease and cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

If there is a significant decrease in blood pressure, it is recommended to place the patient in a supine position and, if necessary, administer a 0.9% sodium chloride solution intravenously.

A transient hypotensive reaction is not a contraindication for taking the next dose of lisinopril.

In patients with CHF, but with normal or reduced blood pressure, the use of lisinopril may lead to a decrease in blood pressure; this usually does not serve as a reason to discontinue the drug. If arterial hypotension becomes symptomatic, it is necessary to reduce the dose of the drug or discontinue treatment with the drug. In patients at risk of developing symptomatic arterial hypotension (on a low-salt or salt-free diet), regardless of the presence of hyponatremia, as well as in patients receiving high-dose diuretics, it is necessary to compensate for hypovolemia or sodium deficiency before starting treatment.

It is necessary to monitor blood pressure when taking the first dose of lisinopril.

Acute myocardial infarction

Standard treatment is recommended (thrombolytics, acetylsalicylic acid, beta-blockers). Lisinopril can be used concomitantly with intravenous nitroglycerin or transdermal nitroglycerin.

In patients with acute myocardial infarction and the risk of further deterioration of hemodynamics, worsening of symptoms after the administration of vasodilators, lisinopril therapy should not be started. These are patients with systolic blood pressure ≤100 mm Hg. Art. and patients with cardiogenic shock. In patients with systolic blood pressure < 120 mm Hg. Art. During the first three days after myocardial infarction, a dose reduction is indicated. In patients with systolic blood pressure ≤100 mm Hg. Art. The maintenance dose should be reduced to 5 mg (or temporarily to 2.5 mg). In patients with persistent arterial hypotension (systolic blood pressure <90 mm Hg for 1 hour or more), discontinuation of lisinopril is indicated.

Renal dysfunction

In patients with CHF, a significant decrease in blood pressure during the administration of ACE inhibitors can lead to increased renal dysfunction. Cases of acute renal failure have been reported.

In patients with bilateral renal artery stenosis or renal artery stenosis of a single kidney, an increase in serum urea and creatinine concentrations was observed during the use of ACE inhibitors; Typically, such disturbances were transient and ceased after discontinuation of therapy. They were more common in patients with renal failure.

In patients with acute myocardial infarction and severe renal impairment (serum creatinine concentration >177 µmol/l and/or proteinuria >500 mg/day), lisinopril should not be prescribed. If renal dysfunction develops during treatment (serum creatinine concentration >265 µmol/l or doubling compared to the initial value), discontinuation of lisinopril is indicated.

Hypersensitivity, angioedema

In rare cases, during the use of ACE inhibitors, including lisinopril, the development of angioedema of the face, extremities, lips, tongue, epiglottis and/or larynx has been observed. In such cases, immediate discontinuation of lisinopril is required; Monitoring the condition of patients until symptoms are completely resolved is indicated. Typically, angioedema of the face and lips is temporary and does not require treatment; however, antihistamines may be prescribed.

Angioedema of the larynx can lead to death. Swelling of the tongue, epiglottis, or larynx can lead to secondary airway obstruction. In this case, it is necessary to immediately administer 0.3-0.5 ml of a 1:1000 solution of adrenaline subcutaneously, and also ensure airway patency.

In rare cases, angioedema of the intestine has developed during therapy with ACE inhibitors. In this case, patients experienced abdominal pain as an isolated symptom or in combination with nausea or vomiting, in some cases without previous angioedema of the face and with normal levels of C1-esterase.

The diagnosis was made using computed tomography of the abdominal organs, ultrasound, or during surgery. Symptoms disappeared after stopping the ACE inhibitors. Therefore, in patients with abdominal pain receiving ACE inhibitors, when carrying out differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.

In patients with a history of angioedema not associated with taking ACE inhibitors, the risk of its development when using ACE inhibitors is higher.

Anaphylactic reactions associated with desensitization to hymenoptera insects

In very rare cases, patients taking ACE inhibitors may develop life-threatening anaphylactic reactions during desensitization to hymenoptera, so it is necessary to temporarily discontinue ACE inhibitors before desensitization.

Patients on hemodialysis

Anaphylactic reactions have also occurred in patients undergoing hemodialysis using high-flux dialysis membranes (eg, AN69) while receiving ACE inhibitors. In such patients, the use of other dialysis membranes or other antihypertensive drugs is indicated.

Cough

Therapy with ACE inhibitors may cause cough, which should be taken into account when carrying out differential diagnosis. A prolonged dry cough usually stops when ACE inhibitors are discontinued.

Surgery/general anesthesia

The use of antihypertensive drugs during major surgery or during general anesthesia can lead to inhibition of angiotensin II formation due to compensatory secretion of renin.

The significant decrease in blood pressure associated with this effect can be prevented by increasing circulating blood volume.

Patients taking ACE inhibitors should inform the surgeon/anesthesiologist before undergoing surgery (including dental procedures).

Serum potassium

Cases of hyperkalemia have been reported.

Risk factors for hyperkalemia include renal failure, diabetes mellitus, therapy with potassium-sparing diuretics (spironolactone, triamterene and amiloride), use of potassium supplements and potassium-based salt substitutes, especially in patients with impaired renal function.

If combined use of lisinopril and these drugs is necessary, regular monitoring of potassium concentrations in the blood serum is indicated.

Double blockade of the RAAS

It has been proven that the simultaneous administration of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure). Thus, the combined administration of ACE inhibitors, angiotensin II receptor blockers or aliskiren for dual blockade of the RAAS is not recommended.

If there are absolute indications for double blockade of the RAAS, then it should be carried out under the careful supervision of a specialist with frequent monitoring of renal function, electrolyte levels and blood pressure.

The simultaneous use of ACE inhibitors with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or with moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) and is not recommended in other patients;

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

Neutropenia/ agranulocytosis/ thrombocytopenia/ anemia

While taking ACE inhibitors, neutropenia/agranulocytosis, thrombocytopenia and anemia may occur. In patients with normal renal function and in the absence of other aggravating factors, neutropenia rarely develops. Equapress should be prescribed with extreme caution to patients with systemic connective tissue diseases, while taking immunosuppressants, allopurinol or procainamide, or a combination of these risk factors, especially patients with impaired renal function.

Some patients developed severe infections, in some cases resistant to intensive antibiotic therapy. When prescribing Equapress to such patients, it is recommended to periodically monitor the number of leukocytes in the blood plasma. Patients should report any signs of infectious diseases (eg, sore throat, fever) to their doctor.

Mitral stenosis/aortic stenosis/hypertrophic cardiomyopathy

ACE inhibitors should be prescribed with caution to patients with mitral stenosis, as well as to patients with left ventricular outflow tract obstruction (aortic stenosis, hypertrophic cardiomyopathy).

Liver failure

Very rarely, cholestatic jaundice occurs while taking ACE inhibitors. As this syndrome progresses, fulminant liver necrosis develops, sometimes with death. The mechanism of development of this syndrome is unclear. If jaundice or a significant increase in the activity of liver enzymes occurs while taking ACE inhibitors, Equapress should be discontinued and the patient should be carefully monitored.

Ethnic differences

In patients of the Negroid race, angioedema develops more often than in representatives of other races while taking ACE inhibitors. ACE inhibitors may have a less pronounced antihypertensive effect in patients of the Black race compared to representatives of other races. This difference may be due to the fact that black patients with arterial hypertension are more likely to have low renin activity.

Lactose

The drug contains lactose monohydrate, so it should not be taken by patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Impact on the ability to drive vehicles. Wed and fur.:

There is no data on the effect of the drug Equapress on the ability to drive vehicles and operate machinery. Considering the possibility of a decrease in blood pressure, the risk of dizziness, drowsiness and similar side effects, patients should be careful when performing potentially dangerous activities that require special attention and quick reaction (driving, working with moving mechanisms, working as a dispatcher and operator, etc.).

Active ingredient

Amlodipine, Indapamide, Lisinopril

Composition

Active ingredients:

amlodipine besilate – 6.934 mg (equivalent to amlodipine 5 mg),

indapamide – 1.5 mg,

lisinopril dihydrate – 10.888 mg (equivalent to lisinopril 10 mg).

Excipients: lactose monohydrate, hypromellose, calcium hydrogen phosphate dihydrate, mannitol, corn starch, microcrystalline cellulose, croscarmellose sodium, talc, magnesium stearate, colloidal silicon dioxide, Opadry II white (contains: polyvinyl alcohol, titanium dioxide, macrogol-3350, talc), hard gelatin capsule (contains: yellow iron oxide dye, titanium dioxide, water, gelatin).

Contraindications

– Hypersensitivity to amlodipine or other dihydropyridine derivatives.

– Hypersensitivity to lisinopril or other ACE inhibitors.

– Hypersensitivity to indapamide or other sulfonamide derivatives.

– Hypersensitivity to the excipients of the drug.

– Severe arterial hypotension (systolic blood pressure below 90 mm Hg).

– Angioedema in the past, including associated with the use of ACE inhibitors.

– Hereditary or idiopathic angioedema.

– Severe renal failure (creatinine clearance <30 ml/min).

– Hepatic encephalopathy or severe liver dysfunction.

– Hypokalemia.

– Hemodynamically significant obstruction of the left ventricular outflow tract (for example, in severe aortic stenosis, hypertrophic obstructive cardiomyopathy), hemodynamically significant mitral stenosis.

– Hemodynamically unstable heart failure after myocardial infarction.

– Shock (including cardiogenic).

– Unstable angina (with the exception of Prinzmetal’s angina).

– Concomitant use of Equapress and drugs containing aliskiren in patients with diabetes mellitus and/or moderate or severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 body surface area).

– Concomitant use with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy.

– Pregnancy and breastfeeding.

– Age up to 18 years (efficacy and safety have not been established).

– Hereditary lactose intolerance, galactosemia, glucose-galactose malabsorption syndrome.

Side Effects

The most common adverse reactions reported during treatment with amlodipine, indapamide and lisinopril as monotherapy were: dizziness, headache, drowsiness, visual disturbances, tinnitus, palpitations, flushing of the face, decreased blood pressure (and effects associated with hypotension), cough, shortness of breath, gastrointestinal disorders (abdominal pain, constipation, diarrhea, nausea, dyspepsia, vomiting), maculopapular rash, muscle cramps, swelling in the ankle area, asthenia, edema and fatigue.

The following adverse drug reactions (ADRs) were reported during separate use of amlodipine – 1, indapamide – 2 and lisinopril – 3.

The frequency is determined as follows:

Very often – 1/10 prescriptions (≥10%).

Often – 1/100 prescriptions (≥1% and <10%).

Uncommon – 1/1000 prescriptions (≥0.1% and <1%).

Rarely – 1/10000 prescriptions (≥0.01% and <0.1%).

Very rare – less than 1/10,000 prescriptions (<0.01%).

Frequency unknown (frequency cannot be estimated from available data).

Within each frequency group, adverse reactions are presented in decreasing order of importance.

Blood and lymphatic system disorders

decrease in hemoglobin3(rare), decrease in hematocrit3(rare), inhibition of bone marrow hematopoiesis3(very rare), leukopenia1,2,3(very rare), thrombocytopenia1,2,3(very rare), agranulocytosis2,3(very rare), aplastic anemia2(very rare), hemolytic anemia2,3(very rare), neutropenia3(very rare), anemia3 (very rare), lymphadenopathy3 (very rare).

Immune system disorders

allergic reactions1 (very rare), autoimmune disorders3 (very rare).

Endocrine system disorders

syndrome of inappropriate secretion of antidiuretic hormone3 (rare).

Metabolic and nutritional disorders

hyperglycemia1 (very rare), hypoglycemia3 (very rare), hypercalcemia2 (very rare), decreased potassium levels and the development of hypokalemia2 (frequency unknown), especially significant for patients at risk; hyponatremia2 (frequency unknown).

Mental disorders

mood lability1,3 (infrequent), sleep disturbances3 (infrequent), hallucinations3 (infrequent), insomnia1 (infrequent), anxiety1 (infrequent), depression1 (infrequent),3 (frequency unknown), confusion1,3 (rare).

Nervous system disorders

dizziness 1.3 (often), headache 1.3 (often), 2 (rare), drowsiness 1 (often), fatigue 2 (rare), vertigo 2 (rare), 3 (infrequent), paresthesia 2 (rare), 1.3 (infrequent), dysgeusia 1.3 (infrequent), fainting 1 (infrequent), 2.3 (frequency unknown), tremor 1 (infrequent), hypoesthesia1 (uncommon), parosmia (impaired sense of smell)3 (rare), muscle hypertonicity1 (very rare), peripheral neuropathy1 (very rare), extrapyramidal disorders1 (frequency unknown).

Visual disorders

visual impairment (including diplopia) 1 (common), 2 (frequency unknown), myopia 2 (frequency unknown), blurred vision 2 (frequency unknown).

Hearing and balance disorders

tinnitus1 (infrequently).

Heart disorders

palpitations 1 (often), 3 (infrequent), myocardial infarction 3 (infrequent), 1 (very rare), tachycardia 3 (infrequent), ventricular tachycardia 1 (infrequent), arrhythmia 1 (infrequent), 2 (very rare), polymorphic ventricular tachycardia of the pirouette type (potentially fatal) 2 (frequency unknown), bradycardia 1 (infrequently), atrial fibrillation 1 (uncommon).

Vascular disorders

orthostatic hypotension and associated symptoms3 (common), flushing of the face1 (common), acute cerebrovascular accident3 (uncommon) (due to a pronounced decrease in blood pressure in high-risk patient groups), Raynaud’s syndrome3 (infrequently), vasculitis1 (very rare), hypotension 1 (infrequently), marked decrease in blood pressure2 (very rare).

Respiratory, thoracic and mediastinal disorders

shortness of breath 1 (often), cough 1 (infrequent), 3 (often), rhinitis 1, 3 (infrequent), bronchospasm 3 (very rare), allergic alveolitis 3 (very rare), eosinophilic pneumonia 3 (very rare), sinusitis 3 (very rare).

Gastrointestinal disorders

abdominal pain1 (often), 3 (infrequent), nausea1 (often), 2 (rare), 3 (infrequent), dyspepsia1 (often), 3 (infrequent), change in the rhythm of bowel movements1 (often), diarrhea1.3 (often), constipation1 (often), 2 (rare), vomiting1.2 (infrequent), 3 (often), dry mouth1 (infrequent), 2.3 (rare), pancreatitis1,2,3(very rare), gastritis1 (very rare), interstitial angioedema3(very rare), gingival hyperplasia1(very rare).

Disorders of the liver and biliary tract

hepatitis 1 (very rare), 2 (frequency unknown), hepatitis (including hepatocellular or cholestatic) 3 (very rare), jaundice 1, 3 (very rare), liver failure 3 (very rare), possible development of hepatic encephalopathy in case of liver failure 2 (frequency unknown), impaired liver function 2 (very rare), increased activity of liver enzymes * 1 (very rare).

(*- mainly due to cholestasis)

Skin and subcutaneous tissue disorders

alopecia 1 (uncommon), 3 (rare), hypersensitivity reactions 2 (common), maculopapular rash 2 (common), exanthema 1 (infrequent), purpura 1,2 (infrequent), skin depigmentation 1 (infrequent), hyperhidrosis 1 (infrequent), 3 (very rare), pruritus 1,3 (infrequent), rash 1,3 (infrequent), urticaria1 (infrequent), 2 (very rare), 3 (rare), Psoriasis 3 (rare), erythema multiforme 1, 3 (very rare), angioedema 1, 2 (very rare), 3 (rare), exfoliative dermatitis 1 (very rare), toxic epidermal necrolysis 2, 3 (very rare), Stevens-Johnson syndrome 1, 2, 3 (very rare), Quincke’s edema 1 (very rare), photosensitivity1(very rare), 2(frequency unknown), pemphigus vulgaris3(very rare), benign cutaneous lymphadenosis*3(very rare), exacerbation of existing acute systemic lupus erythematosus2(frequency unknown), hypersensitivity/angioedema of the face, arms and legs, lips, tongue, glottis and/or larynx3(rare).

(* – a symptom complex has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibody (ANA), increased erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, skin rash, photosensitivity or other skin changes).

Musculoskeletal and connective tissue disorders

muscle cramps1 (common), swelling in the ankles1 (common), arthralgia1 (uncommon), myalgia1 (uncommon), back pain1 (uncommon).

Renal and urinary tract disorders

impaired renal function 3 (common), urinary disorder 1 (infrequent), nocturia 1 (infrequent), frequent urination 1 (infrequent), acute renal failure 1 (rare), renal failure 2 (very rare), uremia 3 (rare), oliguria 3 (very rare), anuria 3 (very rare).

Disorders of the genital organs and breast

gynecomastia1(infrequently), 3(rarely), impotence1,3(infrequently).

General and administration site disorders

swelling 1 (very common), fatigue 1 (often), 3 (infrequent), asthenia 1 (often), 3 (infrequent), chest pain 1 (infrequent), pain 1 (infrequent), malaise 1 (infrequent).

Influence on the results of laboratory and instrumental studies:

increased concentrations of creatinine and urea3 (infrequently), hyperkalemia3 (infrequently), hyperbilirubinemia3 (rarely), increased activity of liver enzymes2 (frequency unknown), 3 (infrequently), hyponatremia3 (rarely), prolongation of the QT interval on the ECG2 (frequency unknown), increased concentration of uric acid2 (frequency unknown), increased concentration of glucose in the blood2 (frequency unknown), decreased or weight gain1 (uncommon).

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Amlodipine

Contraindicated combinations of drugs

Dantrolene (intravenous administration)

In laboratory animals, cases of ventricular fibrillation with death and collapse have been reported during the use of verapamil and intravenous administration of dantrolene. accompanied by hyperkalemia. Due to the risk of hyperkalemia, concomitant use of Equapress containing amlodipine, a calcium channel blocker, should be avoided in patients susceptible to malignant hyperthermia, as well as during the treatment of malignant hyperthermia.

Not recommended drug combinations

Grapefruit juice

Taking amlodipine with grapefruit or grapefruit juice is not recommended as the bioavailability of amlodipine may increase in some patients, resulting in increased blood pressure-lowering effects.

Combinations of drugs that require special caution when used

Inducers of the CYP3A4 isoenzyme

There are no data on the effect of inducers of the CYP3A4 isoenzyme on the pharmacokinetics of amlodipine. Concomitant use of inducers of the CYP3A4 isoenzyme (for example, rifampicin, St. John’s wort preparations) and amlodipine may lead to a decrease in the plasma concentration of amlodipine. Caution should be exercised when using Equapress simultaneously with inducers of the CYP3A4 isoenzyme.

CYP3A4 isoenzyme inhibitors

Concomitant use of amlodipine and strong or moderate CYP3A4 inhibitors (protease inhibitors, for example, ritonavir, azole antifungals, macrolides, for example, erythromycin or clarithromycin, verapamil or diltiazem) can lead to a significant increase in amlodipine concentrations. Clinical manifestations of these pharmacokinetic abnormalities may be more pronounced in elderly patients. In this regard, monitoring of the clinical condition and dose adjustment of Equapress may be required.

Combinations of drugs that require caution when used

Simvastatin

Repeated administration of amlodipine at a dose of 10 mg in combination with simvastatin at a dose of 80 mg resulted in an increase in simvastatin exposure by 77% compared with simvastatin monotherapy. Therefore, patients receiving amlodipine should take simvastatin at a daily dose of no more than 20 mg.

Calcium preparations

May reduce the effect of BMCC.

Lithium preparations

When BMCC is used together with lithium preparations (no data are available for amlodipine), their neurotoxicity (nausea, vomiting, diarrhea, ataxia, tremor or tinnitus) may increase.

Baclofen

Strengthening the antihypertensive effect. Blood pressure and renal function should be monitored and the dose of amlodipine adjusted if necessary.

Amifostin

The antihypertensive effect of amlodipine may be enhanced.

Glucocorticosteroids

Decreased antihypertensive effect (retention of fluid and sodium ions as a result of the action of corticosteroids).

Tricyclic antidepressants, neuroleptics, isoflurane

There is an increased risk of orthostatic hypotension and increased antihypertensive effect (additive effect).

Tacrolimus

When used simultaneously with amlodipine, there is a risk of increasing the concentration of tacrolimus in the blood plasma. To avoid toxicity of tacrolimus when used concomitantly with amlodipine, the concentration of tacrolimus in the blood plasma of patients should be monitored and the dose of tacrolimus should be adjusted if necessary.

Tasonermin

With simultaneous use, amlodipine may increase the systemic exposure of tasonermin in blood plasma. In such cases, regular monitoring of tasonermin in the blood and dose adjustment if necessary is necessary.

Other interactions with amlodipine

For the treatment of arterial hypertension, amlodipine can be safely used with thiazide diuretics, alpha-blockers, beta-blockers and ACE inhibitors. In patients with stable angina, simultaneous use of amlodipine with other antianginal drugs, such as long- and short-acting nitrates, beta-blockers, is possible.

It is likely that the antianginal and antihypertensive effects of BMCC are enhanced when used simultaneously with thiazide and loop diuretics, ACE inhibitors, beta-blockers and nitrates, as well as their antihypertensive effect is enhanced when prescribed with alpha-1-blockers and antipsychotics.

Amlodipine does not cause a negative inotropic effect. However, some CBMCs may increase the negative inotropic effect of antiarrhythmic drugs that cause QT prolongation (eg, amiodarone and quinidine)

Unlike other BMCCs, no significant interaction was detected between amlodipine (3rd generation BMCC) and NSAIDs, including indomethacin.

It is safe to administer amlodipine with oral hypoglycemic agents. A single dose of sildenafil 100 mg in patients with essential arterial hypertension had no effect on the pharmacokinetics of amlodipine. Combined repeated administration of amlodipine at a dose of 10 mg and atorvastatin at a dose of 80 mg led to an insignificant change in the pharmacokinetic parameters of atorvastatin at equilibrium concentration.

Ethanol (drinks containing alcohol): amlodipine does not have a significant effect on the pharmacokinetics of ethanol with single or repeated use at a dose of 10 mg. Interaction studies between cyclosporine and amlodipine have not been conducted in healthy volunteers or in special groups of patients, with the exception of patients after kidney transplantation.

Various studies of the interaction of amlodipine with cyclosporine in patients after kidney transplantation show that the use of this combination may either not lead to any effect or increase the minimum concentration of cyclosporine to varying degrees, up to 40%. Cyclosporine concentrations should be monitored in patients after kidney transplantation.

With simultaneous use of amlodipine and digoxin, the renal clearance and concentration of digoxin in the blood serum do not change.

With simultaneous use of warfarin with amlodipine, the prothrombin time does not change.

When used simultaneously with cimetidine, the pharmacokinetics of amlodipine does not change.

Amlodipine does not affect the degree of binding of digoxin, phenytoin, warfarin and indomethacin to plasma proteins in vitro.

Aluminum and magnesium-containing antacids: a single dose of such antacids together with amlodipine does not have a significant effect on the pharmacokinetics of amlodipine.

Indapamide

Contraindicated drug combinations

Lithium preparations

With the simultaneous use of indapamide and lithium preparations, as well as when following a salt-free diet, an increase in the concentration of lithium in the blood plasma may be observed due to a decrease in its excretion, accompanied by the appearance of signs of overdose. If necessary, diuretics can be used in combination with lithium preparations, and the lithium content in the blood plasma should be carefully monitored and the dose of the drug should be adjusted accordingly.

Combinations of drugs requiring special caution when used

Drugs that can cause polymorphic ventricular tachycardia of the “pirouette” type

– Class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide).

– Class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide).

– Some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, evomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol).

– Others: bepridil, cisapride, difemanil, erythromycin (intravenous), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, astemizole, vincamine (intravenous).

Increased risk of ventricular arrhythmias, especially polymorphic ventricular tachycardia of the “pirouette” type (risk factor – hypokalemia).

The concentration of potassium in the blood plasma should be determined and, if necessary, adjusted before starting combination therapy with indapamide and the above drugs. It is necessary to monitor the patient’s clinical condition, monitor the level of electrolytes in the blood plasma, and ECG indicators.

In patients with hypokalemia, it is necessary to use drugs that do not cause polymorphic ventricular tachycardia of the “pirouette” type.

Nonsteroidal anti-inflammatory drugs (for systemic use), including selective COX-2 inhibitors, high doses of salicylic acid (≥3 g/day)

The antihypertensive effect of indapamide may be reduced.

There is a risk of developing acute renal failure due to decreased glomerular filtration. Patients need to compensate for fluid loss and carefully monitor renal function at the beginning of treatment.

ACE inhibitors

Prescribing ACE inhibitors to patients with an initially reduced concentration of sodium ions in the blood (especially patients with renal artery stenosis) is accompanied by a risk of sudden arterial hypotension and/or acute renal failure. Patients with arterial hypertension and possibly reduced levels of sodium ions in the blood plasma due to diuretics should:

– 3 days before starting treatment with an ACE inhibitor, stop taking the diuretic. In the future, if necessary, taking a non-potassium-sparing diuretic can be resumed;

– or start ACE inhibitor therapy with low doses, followed by a gradual increase in dose if necessary.

In chronic heart failure, treatment with ACE inhibitors should be prescribed from the lowest doses with a possible preliminary reduction in the doses of diuretics. In all cases, in the first weeks of taking ACE inhibitors in patients, it is necessary to monitor renal function (plasma creatinine content).

Other drugs that can cause hypokalemia: amphotericin B (when administered intravenously), gluco- and mineralocorticosteroids (when administered systemically), tetracosactide, laxatives that stimulate intestinal motility

Increased risk of hypokalemia (additive effect).

Constant monitoring of potassium concentration in the blood plasma is necessary, and, if necessary, its correction. Particular attention should be paid to patients concomitantly receiving cardiac glycosides. It is recommended to use laxatives that do not stimulate intestinal motility.

Baclofen

There is an increase in the antihypertensive effect.

Patients need to compensate for fluid loss and carefully monitor renal function at the beginning of treatment.

Cardiac glycosides

Hypokalemia enhances the toxic effect of cardiac glycosides.

With the simultaneous use of indapamide and cardiac glycosides, the content of potassium in the blood plasma, ECG parameters should be monitored and, if necessary, therapy should be adjusted.

Combinations of drugs requiring caution when used

Potassium-sparing diuretics (amiloride, spironolactone, triamterene, eplerenone) Combination therapy with indapamide and potassium-sparing diuretics is advisable in some patients, but the possibility of hypokalemia or hyperkalemia cannot be excluded (especially in patients with diabetes mellitus or in patients with renal failure).

It is necessary to monitor the concentration of potassium in the blood plasma, ECG indicators and, if necessary, adjust therapy.

Metformin

Functional renal failure, which can occur against the background of diuretics, especially loop diuretics, with simultaneous administration of metformin increases the risk of developing lactic acidosis.

Metformin should not be used if plasma creatinine levels exceed 15 mg/L (135 µmol/L) in men and 12 mg/L (110 µmol/L) in women.

Iodinated contrast agents

With dehydration caused by diuretics, the risk of acute renal failure increases, especially when using high doses of iodinated contrast agents.

Before using iodinated contrast agents, patients need to compensate for fluid loss.

Tricyclic antidepressants, antipsychotics (neuroleptics)

Drugs in these classes enhance the antihypertensive effect of indapamide and increase the risk of orthostatic hypotension (additive effect).

Calcium salts

With simultaneous use, the risk of hypercalcemia increases due to a decrease in the excretion of calcium ions by the kidneys.

Cyclosporine, tacrolimus

It is possible to increase the creatinine content in the blood plasma without changing the concentration of circulating cyclosporine, even with normal circulating blood volume and sodium content in the blood plasma.

Glucocorticosteroid drugs, tetracosactide (for systemic use)

Reduced antihypertensive effect (fluid and sodium ion retention caused by corticosteroids).

Lisinopril

Contraindicated drug combinations

Aliskiren

Concomitant use of ACE inhibitors with aliskiren and aliskiren-containing drugs in patients with diabetes mellitus and/or moderate or severe renal impairment (GFR less than 60 ml/min/1.73 m2 body surface area) is contraindicated.

The administration of ACE inhibitors with angiotensin II receptor antagonists is contraindicated in patients with diabetic nephropathy.

Not recommended drug combinations

Angiotensin II receptor antagonists (ARA II)

It has been reported in the literature that in patients with established atherosclerotic disease, chronic heart failure, or diabetes mellitus with end-organ damage, concomitant therapy with an ACE inhibitor and an ARB II 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. Dual blockade (for example, when combining an ACE inhibitor with an ARB II) should be limited to selected cases with careful monitoring of renal function, potassium levels and blood pressure.

Potassium supplements, potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone) or potassium-containing salt substitutes

Hyperkalemia may develop (with possible death), especially if renal function is impaired (additional effects associated with hyperkalemia). ACE inhibitors should not be used concomitantly with substances that increase plasma potassium levels, except in cases of hypokalemia. The combination of lisinopril and the above agents is not recommended. If, however, concomitant use is indicated, they should be used with caution and regular monitoring of serum potassium levels.

Lithium preparations

With the simultaneous use of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and associated toxic effects may be observed. The simultaneous use of lisinopril and lithium preparations is not recommended. If such therapy is necessary, the concentration of lithium in the blood serum should be regularly monitored.

Combinations of drugs that require special caution when used

Insulin and oral hypoglycemic agents

Epidemiological studies have shown that the combined use of ACE inhibitors and hypoglycemic agents (insulins, oral hypoglycemic agents) can enhance their hypoglycemic effect up to the development of hypoglycemia. This effect is most likely to be observed during the first weeks of concomitant therapy, as well as in patients with impaired renal function. Baclofen

Enhances the antihypertensive effect of ACE inhibitors. Blood pressure levels should be carefully monitored and, if necessary, the dose of antihypertensive drugs should be adjusted.

Diuretics

In patients taking diuretics, especially those that remove fluid and/or salts, a significant decrease in blood pressure may be observed when initiating therapy with an ACE inhibitor. The risk of developing antihypertensive effects can be reduced by discontinuing the diuretic and replacing fluid or salt losses before starting ACE inhibitor therapy. For arterial hypertension in patients with previous diuretic therapy, which could lead to excessive excretion of fluid and/or salts, diuretics should be discontinued before using Equapress.

Renal function (creatinine concentration) should be monitored during the first weeks of using Equapress.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid at a dose of ≥3 g/day

The simultaneous use of ACE inhibitors with NSAIDs (acetylsalicylic acid in a dose that has an anti-inflammatory effect, cyclooxygenase-2 (COX-2) inhibitors and non-selective NSAIDs) may lead to a decrease in the antihypertensive effect of ACE inhibitors.

Overdose

Amlodipine overdose

Symptoms: significant decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (there is a risk of developing significant and persistent hypotension, with the development of shock and death).

Treatment: gastric lavage, administration of activated charcoal (especially during the first 2 hours after an overdose), placing the patient in a horizontal position with raised lower limbs, active support of the function of the cardiovascular system, monitoring indicators of heart and lung function, monitoring circulating blood volume and diuresis.

In the absence of contraindications, it may be advisable to prescribe vasoconstrictors to restore vascular tone and blood pressure. Intravenous injections of calcium gluconate can help reverse the effects of calcium channel blockade. Since amlodipine is highly bound to serum proteins, hemodialysis is not effective in treating amlodipine overdose.

Indapamide overdose

No toxic effects of indapamide were noted in case of overdose, even in very high doses (up to 40 mg, i.e. 27 times higher than the therapeutic dose).

Signs of acute indapamide poisoning are primarily associated with water and electrolyte imbalance (hyponatremia, hypokalemia). Clinical symptoms of overdose may include nausea, vomiting, decreased blood pressure, convulsions, dizziness, drowsiness, confusion, polyuria or oliguria leading to anuria (due to hypovolemia).

Emergency measures include removing the drug from the body, gastric lavage and/or taking activated charcoal to restore water&electrolyte balance.

Lisinopril overdose

Symptoms: significant decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.

Treatment: symptomatic therapy, intravenous administration of 0.9% sodium chloride solution and, if possible, vasopressors, blood pressure control, control of water and electrolyte balance. Hemodialysis is possible.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiration date stated on the package.

Manufacturer

Gedeon Richter, Hungary