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Co-Perindopril, tablets coated. captivity. about. 2.5 mg+8 mg, 30 pcs.

Common to INDAPAMIDE and PERINDOPRIL

The use of the drug Co-PERINDOPRIL is not accompanied by a significant reduction in the frequency of side effects, with the exception of hypokalemia, compared to taking the individual components of the drug in the lowest approved doses. When initiating therapy with two antihypertensive drugs that the patient has not previously received, an increased risk of idiosyncrasy cannot be excluded. Careful monitoring of the patient can minimize this risk.

Lithium preparations

The simultaneous use of the drug Co-PERINDOPRIL with lithium preparations is usually not recommended.

Renal dysfunction

Therapy with the drug Co-PERINDOPRIL is contraindicated in patients with moderate (creatinine clearance less than 60 ml/min.) and severe renal failure (creatinine clearance less than 30 ml/min.). In some patients with arterial hypertension without previous obvious renal impairment, laboratory signs of functional renal failure may appear during therapy. In this case, treatment with Co-PERINDOPRIL should be discontinued. In the future, you can resume combination therapy using low doses of a combination of indapamide and perindopril, or use only one of the drugs. Such patients require regular monitoring of the content of potassium ions and creatinine concentration in the blood serum - 2 weeks after the start of therapy and then every 2 months.

Renal failure occurs more often in patients with severe chronic heart failure or underlying renal impairment, including renal artery stenosis.

The drug Co-PERINDOPRIL is not recommended for use in cases of bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney.

Arterial hypotension and water-electrolyte imbalance

In the case of initial hyponatremia, there is a risk of sudden development of arterial hypotension (especially in patients with renal artery stenosis). Therefore, during dynamic monitoring of patients, attention should be paid to possible symptoms of dehydration and decreased electrolyte levels in the blood plasma, for example, after diarrhea or vomiting. Such patients require regular monitoring of electrolyte levels in the blood plasma.

In case of severe arterial hypotension, intravenous administration of 0.9% sodium chloride solution may be required.

Transient arterial hypotension is not a contraindication for continued therapy. After restoration of circulating blood volume (CBV) and blood pressure, therapy can be resumed using low doses of a combination of indapamide and perindopril, or use only one of the drugs.

Potassium content

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

Excipients

It should be taken into account that the excipients of the drug include lactose monohydrate. The drug Co-PERINDOPRIL should not be prescribed to patients with hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Childhood

The drug Co-PERINDOPRIL should not be prescribed to children and adolescents under the age of 18 years due to the lack of data on the effectiveness and safety of the use of indapamide and perindopril, both in monotherapy and in combination use in patients of this age group.

INDAPAMIDE

Hepatic encephalopathy

In the presence of liver dysfunction, taking thiazide and thiazide-like diuretics can lead to the development of hepatic encephalopathy. In such a situation, you should immediately stop taking the diuretic.

Photosensitivity

Cases of photosensitivity reactions have been reported while taking thiazide and thiazide-like diuretics. If a photosensitivity reaction develops while taking the drug, treatment should be discontinued. If it is necessary to continue diuretic therapy, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays.

Water and electrolyte balance

The content of sodium ions in the blood plasma must be determined before starting treatment, and then regularly monitored while taking the drug. Hyponatremia at the initial stage may not be accompanied by clinical symptoms, so regular laboratory monitoring is necessary. More frequent monitoring of sodium ion levels is indicated for patients with liver cirrhosis and elderly patients. Treatment with any diuretics can cause hyponatremia, sometimes with very serious consequences. Hyponatremia accompanied by hypovolemia can lead to dehydration and orthostatic hypotension. A simultaneous decrease in the content of chloride ions can lead to the development of secondary compensatory metabolic alkalosis: the frequency of its occurrence and severity are insignificant.

Content of potassium ions in blood plasma

Therapy with thiazide and thiazide-like diuretics is associated with a high risk of developing hypokalemia. Hypokalemia (less than 3.4 mmol/L) should be avoided in the following high-risk patients: elderly patients, malnourished patients (both those receiving and not receiving concomitant drug therapy), patients with cirrhosis (with edema and ascites) , coronary heart disease, chronic heart failure. Hypokalemia in these patients increases the toxic effect of cardiac glycosides and increases the risk of developing arrhythmia.

Patients with a prolonged QT interval, either congenital or drug-induced, are also at increased risk.

Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, especially arrhythmias, which can be fatal. In all the cases described above, more frequent monitoring of the content of potassium ions in the blood plasma is necessary. The first measurement of potassium ion content should be carried out within the first week from the start of therapy.

If hypokalemia is detected, appropriate correction should be made.

Content of potassium ions in blood plasma

Thiazide and thiazide-like diuretics can reduce the excretion of calcium ions by the kidneys, leading to a slight and temporary increase in the content of calcium ions in the blood plasma. Severe hypercalcemia may be a consequence of previously undiagnosed hyperparathyroidism. Before studying the function of the parathyroid glands, you should stop taking diuretics.

Plasma glucose concentration

It is necessary to monitor blood glucose concentrations in patients with diabetes mellitus, especially in the presence of hypokalemia.

Uric acid

When the concentration of uric acid in the blood plasma increases during therapy, the frequency of gout attacks may increase.

Diuretics and kidney function

Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly impaired renal function (plasma creatinine concentration in adult patients below 25 mg/l or 220 µmol/l). In elderly patients, plasma creatinine levels should be assessed taking into account age, weight and sex, according to the Cockcroft-Gault formula:

Creatinine clearance (CC) = (140 - age) x weight / 0.814 x plasma creatinine concentration,

where: age - in years; weight - in kg; plasma creatinine concentration - in µmol/l.

The formula is suitable for older men; for older women, the result should be multiplied by 0.85.

At the beginning of treatment with diuretics, patients due to hypovolemia (due to the excretion of water and sodium ions) may experience a temporary decrease in glomerular filtration rate and an increase in the concentration of urea and creatinine in the blood plasma. This transient functional renal failure is not dangerous for patients with initially normal renal function, but its severity may increase in patients with renal failure.

Athletes

Indapamide may give a positive reaction during doping control.

Acute myopia and secondary angle-closure glaucoma

Sulfonamides and their derivatives can cause the development of idiosyncratic reactions leading to temporary (transient) myopia and acute angle-closure glaucoma. Without proper treatment, acute angle-closure glaucoma can lead to vision loss. First of all, you need to stop taking the drug as soon as possible. If intraocular pressure continues to be high, immediate medical or surgical treatment may be required. Risk factors that may lead to the development of acute angle-closure glaucoma include a history of allergies to sulfonamides or penicillin.

PERINDOPRIL

Double blockade of the renin-angiotensin-aldosterone system (RAAS).

There is evidence of an increased risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure) with simultaneous use of ACE inhibitors and ARB II or aliskiren. Therefore, double blockade of the RAAS by combining an ACE inhibitor and an ARB II or aliskiren is not recommended.

If a double blockade is absolutely necessary, it should be performed under the strict supervision of a specialist with regular monitoring of renal function, plasma electrolytes and blood pressure.

The use of ACE inhibitors in combination with angiotensin receptor antagonists (ARBs) is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Potassium-sparing diuretics, potassium supplements, potassium-containing table salt substitutes and food supplements

The simultaneous administration of perindopril and potassium-sparing diuretics, as well as potassium preparations and potassium-containing substitutes for table salt and food additives is not recommended.

Neutropenia/agranulocytosis/thrombocytopenia

There are reports of the development of neutropenia/agranulocytosis, thrombocytopenia and anemia while taking ACE inhibitors. In patients with normal renal function and without concomitant risk factors, neutropenia rarely occurs. Perindopril should be used with extreme caution against the background of systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), as well as while taking immunosuppressants, allopurinol, procainamide, or a combination of these factors, especially in patients with initially impaired renal function.

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

Anemia

Anemia may develop in patients after kidney transplantation or in patients undergoing hemodialysis. In this case, the decrease in hemoglobin is greater, the higher its initial value. This effect does not appear to be dose-dependent, but may be related to the mechanism of action of ACE inhibitors.

A slight decrease in hemoglobin occurs during the first 6 months, then it remains stable and is completely restored after discontinuation of the drug. In such patients, treatment can be continued, but hematological tests should be performed regularly.

Hypersensitivity/angioedema

When taking ACE inhibitors, including perindopril, in rare cases, the development of angioedema of the face, extremities, lips, tongue, vocal folds and/or larynx may occur. This can happen at any time during therapy. If symptoms appear, the drug Co-PERINDOPRIL should be stopped immediately and the patient should be observed until signs of edema completely disappear. If the swelling affects only the face and lips, it usually goes away on its own, although antihistamines can be used as symptomatic therapy.

Angioedema, accompanied by swelling of the larynx, can be fatal. Swelling of the tongue, vocal folds, or larynx can lead to airway obstruction. If such symptoms appear, appropriate therapy should be started immediately, for example, epinephrine (adrenaline) administered subcutaneously at a dilution of 1:1000 (0.3 or 0.5 ml) and/or ensure airway patency.

A higher risk of developing angioedema has been reported in black patients.

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 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 activity of the C-1 esterase enzyme. The diagnosis is made using computed tomography of the abdominal region, ultrasound, or at the time of surgery.

Symptoms disappear after stopping ACE inhibitors. 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.

mTOR (mammalian target of rapamycin) inhibitors (eg, sirolimus, everolimus, temsirolimus): Patients receiving concomitant therapy with mTOR inhibitors may have an increased risk of developing angioedema (including swelling of the airways or tongue with or without respiratory dysfunction).

Anaphylactoid reactions during desensitization

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 with a history of allergies or a tendency to allergic reactions undergoing desensitization procedures. The use of an ACE inhibitor should be avoided in patients receiving immunotherapy with hymenoptera venom. However, an anaphylactoid reaction can be avoided by temporarily discontinuing the ACE inhibitor at least 24 hours before the start of the desensitization procedure.

Anaphylactoid reactions during LDL apheresis

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

Hemodialysis

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 agent of a different pharmacotherapeutic group.

Cough

During therapy with an ACE inhibitor, a dry persistent cough may occur. The cough persists for a long time while taking drugs of this group and disappears after their discontinuation. If a patient develops a dry cough, one should be aware of the possible iatrogenic nature of this symptom associated with taking an ACE inhibitor. If the doctor believes that ACE inhibitor therapy is necessary for the patient, the drug may be continued.

Risk of arterial hypotension and/or renal failure (in patients with chronic heart failure, fluid and electrolyte imbalance, etc.)

In some pathological conditions, significant activation of the RAAS may be observed, especially with severe hypovolemia and a decrease in the content of electrolytes in the blood plasma (due to a salt-free diet or long-term use of diuretics), in patients with initially low blood pressure, renal artery stenosis, chronic heart failure or cirrhosis of the liver with edema and ascites.

The use of ACE inhibitors causes blockade of the RAAS and therefore may be accompanied by a sharp decrease in blood pressure and/or an increase in the concentration of creatinine in the blood plasma, indicating the development of functional renal failure. These phenomena are more often observed when taking the first dose of the drug or during the first two weeks of therapy. In rare cases, these conditions develop acutely and during other periods of therapy. In such cases, it is recommended to restart therapy at a lower dose and then gradually increase the dose.

Elderly age

Before starting to take perindopril, it is necessary to assess the functional activity of the kidneys and the content of potassium ions in the blood plasma. At the beginning of therapy, the dose of the drug is selected taking into account the degree of reduction in blood pressure, especially in the case of dehydration and loss of electrolytes. Such measures help to avoid a sharp decrease in blood pressure.

Atherosclerosis

The risk of arterial hypotension exists in all patients, however, special care should be taken when using the drug in patients with coronary heart disease and cerebrovascular insufficiency. In such patients, treatment should begin with low doses of the drug.

Renovascular hypertension

The treatment method for renovascular hypertension is revascularization. However, the use of ACE inhibitors may have a beneficial effect in patients both awaiting surgery and in cases where surgery is not possible.

Treatment with the drug Co-PERINDOPRIL is not indicated in patients with diagnosed or suspected renal artery stenosis, because therapy should be started in a hospital setting with lower doses of the combination of perindopril and inadpamide

Heart failure/severe heart failure

In patients with chronic heart failure (functional class IV according to the UNHA classification), treatment with the drug Co-PERINDOPRIL should begin with a low dose of the drug, and under close medical supervision.

Patients with arterial hypertension and coronary heart disease should not stop taking beta-blockers: an AG1F inhibitor should be added to beta-blocker therapy.

Diabetes

In patients with type 1 diabetes mellitus, a spontaneous increase in potassium levels in the blood is possible. Treatment of such patients with the drug Co-PERINDOPRIL should begin with minimal doses and take place under constant medical supervision. Patients receiving oral hypoglycemic agents or insulin require regular monitoring of plasma glucose concentrations during the first month of therapy with ACE inhibitors.

Ethnic differences

Perindopril, like other ACE inhibitors, has a clearly less pronounced antihypertensive effect in patients of the Negroid 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.

Surgery / General anesthesia

Carrying out general anesthesia while taking ACE inhibitors can lead to a significant decrease in blood pressure, especially when using general anesthesia agents that have an antihypertensive effect. It is recommended, if possible, to stop taking long-acting ACE inhibitors, including perindopril, the day before surgery. It is necessary to warn the anesthesiologist that the patient is taking ACE inhibitors.

Aortic or mitral stenosis / Hypertrophic obstructive cardiomyopathy

ACE inhibitors should be prescribed with caution to patients with left ventricular outflow tract obstruction.

Liver failure

In rare cases, cholestatic jaundice occurs while taking ACE inhibitors. As this syndrome progresses, fulminant liver necrosis may develop, sometimes with death. The mechanism of development of this syndrome is unclear. If jaundice appears or a significant increase in liver enzyme activity occurs while taking ACE inhibitors, the patient should stop taking ACE inhibitors and consult a doctor.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, including perindopril. Risk factors for hyperkalemia are renal failure, impaired renal function, old age over 70 years, diabetes mellitus, some concomitant conditions (dehydration, acute decompensation of chronic heart failure, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene , amiloride, etc.), as well as potassium preparations or potassium-containing substitutes for table salt, as well as the use of other drugs that help increase the content of potassium ions in the blood plasma (for example, heparin, ACE inhibitors, angiotensin II receptor antagonists, acetylsalicylic acid in a dose of 3 g /day or more, cyclooxygenase-2 (COX-2) inhibitors and non-selective NSAIDs, immunosuppressants such as cyclosporine or tacrolimus, trimethoprim.

The use of potassium supplements, potassium-sparing diuretics, potassium-sparing table salt substitutes can lead to a significant increase in potassium levels in the blood, especially in patients with reduced renal function. Hyperkalemia can lead to serious, sometimes fatal, heart rhythm disturbances. If a combination of the above drugs is necessary, treatment should be carried out with caution, against the background of regular monitoring of the content of potassium ions in the blood serum.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of indapamide + perindopril on the ability to drive vehicles and operate machinery when used in therapeutic doses, however, it must be borne in mind that dizziness may occur, so caution should be exercised.