Perindopril PLUS Indapamide, 30 pcs., 0.625 mg+2 mg, film-coated tablets

Perindopril-Teva tablets 5 mg 30 pcs. in Moscow

Inside,

1 table each 1 time per day, preferably in the morning, before meals.

The tablet should be placed on the tongue and after it disintegrates on the surface of the tongue, swallow it with saliva.

When choosing a dose, one should take into account the characteristics of the clinical situation and the degree of reduction in blood pressure during therapy.

Arterial hypertension

Can be used both in monotherapy and as part of combination therapy.

The recommended starting dose is 5 mg once daily.

In patients with severe activation of the RAAS system (especially with renovascular hypertension, hypovolemia and/or decreased plasma electrolytes, decompensated chronic heart failure or severe arterial hypertension), a marked decrease in blood pressure may develop after taking the first dose of the drug. At the beginning of therapy, such patients should be under close medical supervision. The recommended starting dose for such patients is 2.5 mg once daily. If necessary, a month after the start of therapy, you can increase the dose of the drug to 10 mg 1 time per day.

At the beginning of drug therapy, symptomatic arterial hypotension may occur. In patients simultaneously receiving diuretics, the risk of developing arterial hypotension is higher due to possible hypovolemia and a decrease in plasma electrolytes. Caution should be exercised when using the drug in this group of patients.

It is recommended, if possible, to stop taking diuretics 2-3 days before the intended start of drug therapy.

If it is impossible to cancel diuretics, the initial dose of the drug should be 2.5 mg. In this case, it is necessary to monitor kidney function and potassium levels in the blood serum. In the future, if necessary, the dose of the drug can be increased. If necessary, diuretics can be resumed.

In elderly patients

treatment should begin with a dose of 2.5 mg/day. If necessary, a month after the start of therapy, the dose can be increased to 5 mg/day, and then to a maximum dose of 10 mg/day, taking into account the state of renal function (see Table 1).

The maximum daily dose is 10 mg.

Heart failure

Treatment of patients with chronic heart failure with the drug in combination with non-potassium-sparing diuretics and/or digoxin and/or beta-blockers is recommended to begin under close medical supervision, prescribing the drug at an initial dose of 2.5 mg 1 time per day, in the morning. After 2 weeks of treatment, the dose of the drug can be increased to 5 mg 1 time per day, provided that the dose of 2.5 mg is well tolerated and the response to therapy is satisfactory.

In patients at high risk of developing symptomatic arterial hypotension, for example, with reduced electrolyte levels with or without hyponatremia, hypovolemia, or taking diuretics, these conditions should, if possible, be corrected before starting the drug.

Indicators such as blood pressure, renal function and potassium levels in the blood plasma should be monitored both before and during therapy.

Prevention of recurrent stroke (combination therapy with indapamide)

In patients with a history of cerebrovascular disease, therapy with the drug should be started with a dose of 2.5 mg during the first two weeks, then increasing the dose to 5 mg over the next two weeks before using indapamide.

Therapy should begin at any time (from two weeks to several years) after a stroke.

IHD: reducing the risk of cardiovascular complications in patients who have previously had myocardial infarction and/or coronary revascularization

In patients with stable ischemic heart disease, drug therapy should be started with a dose of 5 mg once a day.

After 2 weeks, if the drug is well tolerated and taking into account the state of renal function, the dose can be increased to 10 mg 1 time per day.

Elderly patients

Therapy should be started with a dose of 2.5 mg 1 time per day for 1 week, then 5 mg 1 time per day over the next week. Then, taking into account the state of renal function, the dose can be increased to 10 mg 1 time per day (see Table 1). The dose of the drug can be increased only if it is well tolerated at the previously recommended dose.

Special patient groups:

Kidney failure

In patients with renal failure, the dose of the drug should be adjusted taking into account creatinine Cl.

Table 1

Dosage of the drug for renal failure

*Dialysis clearance of perindoprilate is 70 ml/min. The drug should be taken after the dialysis procedure.

Liver failure

In patients with impaired liver function, no dose adjustment is required.

Age up to 18 years

It should not be prescribed to children and adolescents under 18 years of age due to the lack of data on the effectiveness and safety of the drug in patients in this age group.

Perindopril PLUS Indapamide, 30 pcs., 0.625 mg+2 mg, film-coated tablets

Perindopril PLUS Indapamide

The simultaneous use of Perindopril PLUS Indapamide with lithium preparations is not recommended.

Therapy with Perindopril PLUS Indapamide is contraindicated in patients with severe renal failure (creatinine clearance less than 30 ml/min). In some patients with arterial hypertension without previous renal impairment, symptoms of acute renal failure may occur during therapy with Perindopril PLUS Indapamide. In this case, treatment with Perindopril PLUS Indapamide should be discontinued. In the future, you can resume combination therapy using low doses of Perindopril PLUS Indapamide, or use perindopril and indapamide in monotherapy. Such patients require regular monitoring of potassium levels and creatinine concentrations in the blood serum every 2 weeks after the start of therapy and every subsequent 2 months of therapy with Perindopril PLUS Indapamide.

Acute renal failure often develops in patients with severe chronic heart failure or underlying renal impairment, incl. with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney. Taking the drug Perindopril PLUS Indapamide is not recommended for patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney.

Hyponatremia is associated with a risk of a sudden decrease in blood pressure (especially in patients with bilateral renal artery stenosis or arterial stenosis of a single functioning kidney). Therefore, during dynamic monitoring of patients, attention should be paid to possible symptoms of dehydration and a decrease in plasma electrolytes, for example, after prolonged diarrhea or vomiting. Such patients require regular monitoring of plasma electrolytes.

With a pronounced decrease in blood pressure, intravenous administration of 0.9% sodium chloride solution may be required.

Transient arterial hypotension is not a contraindication for further continuation of therapy. After restoration of blood volume and blood pressure, you can resume therapy with Perindopril PLUS Indapamide, using low doses of the drug, or using perindopril and indapamide in monotherapy.

The combined use of perindopril and indapamide does not prevent the development of hypokalemia, especially in patients with diabetes mellitus or renal failure. As in the case of the combined use of antihypertensive drugs and a diuretic, regular monitoring of potassium levels in the blood plasma is necessary.

Perindopril

In patients taking ACE inhibitors, cases of neutropenia/agranulocytosis, thrombocytopenia and anemia may develop. In patients with normal renal function in the absence of other complications, neutropenia rarely develops and resolves spontaneously after discontinuation of ACE inhibitors.

Perindopril should be used with extreme caution in patients with connective tissue diseases and concomitantly receiving immunosuppressive therapy, allopurinol or procainamide, especially with existing renal impairment. Such patients may develop a severe infection that does not respond to intensive antibiotic therapy. If perindopril is prescribed, it is recommended to periodically monitor the number of leukocytes in the blood. The patient should be warned that if any signs of an infectious disease appear (sore throat, fever), consult a doctor immediately.

When taking ACE inhibitors, incl. perindopril, in rare cases, the development of angioedema of the face, lips, tongue, uvula, and/or larynx may occur. If these symptoms appear, the drug should be stopped immediately. The patient's condition should be monitored until signs of edema completely disappear.

If angioedema affects only the face and lips, its symptoms usually resolve on their own, or antihistamines can be used to treat symptoms. Angioedema, accompanied by swelling of the tongue or larynx, can lead to airway obstruction and death.

If symptoms of angioedema appear, you should immediately administer subcutaneous epinephrine (adrenaline) at a dilution of 1:1000 (0.3 or 0.5 ml) and/or ensure airway patency.

Patients with a history of angioedema not associated with taking ACE inhibitors may have an increased risk of developing it when taking drugs of this group. In patients of the Negroid race, angioedema develops more often than in patients of other races.

In rare cases, angioedema of the intestine develops during therapy with ACE inhibitors. In this case, patients experience abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without previous angioedema of the face and with normal C-1-esterase levels. The diagnosis is made using computed tomography of the abdominal cavity, ultrasound, or at the time of surgery. Symptoms disappear after stopping ACE inhibitors. In patients with abdominal pain receiving ACE inhibitors, the possibility of developing angioedema of the intestine must be taken into account when making a differential diagnosis.

There are isolated reports of the development of prolonged, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with hymenoptera venom (bees, wasps). ACE inhibitors should be used with caution in patients prone to allergic reactions undergoing desensitization procedures. Prescription of an ACE inhibitor should be avoided in patients receiving immunotherapy with hymenoptera venom. However, the development of anaphylactoid reactions can be avoided by temporarily discontinuing the ACE inhibitor at least 24 hours before the start of the desensitization procedure.

In rare cases, life-threatening anaphylactoid reactions may occur in patients receiving ACE inhibitors during LDL apheresis using dextran sulfate. To prevent an anaphylactoid reaction, ACE inhibitor therapy should be discontinued before each LDL apheresis procedure using high-flux membranes.

Anaphylactoid reactions have been reported in patients receiving ACE inhibitors during hemodialysis using high-flux membranes (eg, AN69®). Therefore, it is advisable to use a different type of membrane or use an antihypertensive drug of a different pharmacotherapeutic group.

During therapy with an ACE inhibitor, a dry cough may occur, which disappears after discontinuation of drugs in this group. If a dry cough appears, you should be aware of the possible connection of this symptom with taking an ACE inhibitor. If the doctor believes that ACE inhibitor therapy is necessary for the patient, Perindopril PLUS Indapamide can be continued.

In liver cirrhosis, accompanied by edema and ascites, arterial hypotension, chronic heart failure, significant activation of the renin-angiotensin-aldosterone system (RAAS) is possible, especially with severe hypovolemia and a decrease in the content of electrolytes in the blood plasma (against the background of a salt-free diet or long-term use of diuretics).

The use of an ACE inhibitor causes blockade of the RAAS, and therefore a sharp decrease in blood pressure and/or an increase in serum creatinine is possible, indicating the development of acute renal failure, which is more often observed when taking the first dose of Perindopril PLUS Indapamide or during the first 2 weeks of therapy.

When prescribing Perindopril PLUS Indapamide to patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose concentrations should be regularly monitored during the first month of therapy.

Perindopril (like other ACE inhibitors) has a less pronounced antihypertensive effect in patients of the Negroid race compared to representatives of other races.

The use of ACE inhibitors in patients undergoing surgery under general anesthesia can lead to a significant decrease in blood pressure, especially when using general anesthetic agents that have an antihypertensive effect.

It is recommended to stop taking ACE inhibitors, incl. perindopril, 12 hours before surgery, warning the anesthesiologist about the use of ACE inhibitors.

ACE inhibitors should be used with caution in patients with left ventricular outflow tract obstruction and with aortic and/or mitral stenosis and HOCM (hypertrophic obstructive cardiomyopathy).

In rare cases, while taking ACE inhibitors, cholestatic jaundice occurs, with the progression of which fulminant liver necrosis develops, sometimes with a fatal outcome. If jaundice or a significant increase in the activity of liver transaminases occurs while taking ACE inhibitors, Perindopril PLUS Indapamide should be discontinued.

In patients after kidney transplantation or in patients on hemodialysis, anemia may develop.

During treatment with ACE inhibitors, incl. and perindopril may develop hyperkalemia. Risk factors for hyperkalemia are renal failure, old age, diabetes mellitus, some concomitant conditions (decrease in blood volume, acute heart failure in the stage of decompensation, metabolic acidosis), simultaneous use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as drugs potassium or potassium-containing substitutes for table salt and the use of other drugs that increase the content of potassium in the blood plasma (for example, heparin). Hyperkalemia can cause serious heart rhythm problems, sometimes fatal. The combined use of the drugs listed above is not recommended; if their use is necessary, therapy should be carried out with extreme caution.

Indapamide

There are reports of cases of increased photosensitivity while taking thiazide and thiazide-like diuretics. If a photosensitivity reaction develops while taking Perindopril PLUS Indapamide, treatment should be discontinued. If it is necessary to resume the use of Perindopril PLUS Indapamide, you should protect exposed skin from direct exposure to sunlight and artificial ultraviolet rays.

Before starting treatment with Perindopril PLUS Indapamide, it is necessary to determine the sodium content in the blood plasma and, while taking the drug, regularly monitor electrolytes in the blood plasma (especially in elderly patients). All diuretics can cause hyponatremia, leading to serious complications.

Therapy with thiazide and thiazide-like diuretics is associated with a risk of developing hypokalemia (less than 3.4 mmol/l) in elderly patients, malnourished patients, patients with liver cirrhosis, patients with peripheral edema, ascites, coronary artery disease, and chronic heart failure. Hypokalemia in these patients increases the toxic effect of cardiac glycosides and increases the risk of developing arrhythmia. The high-risk group includes patients with an increased QT interval on the ECG. Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, especially ventricular arrhythmias, which can be fatal. In all the described cases, regular monitoring of potassium levels in the blood plasma is necessary. The first determination of potassium in the blood plasma should be carried out within the first week of starting therapy with Perindopril PLUS Indapamide.

Thiazide and thiazide-like diuretics reduce the excretion of calcium by the kidneys, leading to a slight and temporary increase in calcium levels in the blood plasma. Severe hypercalcemia may be a consequence of latent hyperparathyroidism. Before studying the function of the parathyroid glands, you should stop taking the drug Perindopril PLUS Indapamide.

Glucose concentrations should be monitored in patients with diabetes mellitus.

In patients with increased concentrations of uric acid in the blood plasma during therapy with Perindopril PLUS Indapamide, the frequency of exacerbations of gout may increase.

Hypovolemia as a result of a decrease in blood volume or hyponatremia caused by taking diuretics at the beginning of treatment with Perindopril PLUS Indapamide can lead to a decrease in glomerular filtration rate and be accompanied by an increase in creatinine and urea in the blood plasma.

Indapamide may give a false-positive reaction during doping control.

Use in pediatrics

The drug Perindopril PLUS Indapamide is contraindicated in children and adolescents under 18 years of age due to the lack of data on the effectiveness and safety of its use.

Impact on the ability to drive vehicles and operate machinery

Care must be taken when driving vehicles and other technical devices that require increased attention and speed of psychomotor reactions (risk of dizziness and fainting).