Ordiss, 16 mg, tablets, 30 pcs.


Ordiss®

Renal dysfunction.

During the use of the drug Ordiss®, as with the use of other drugs that inhibit the RAAS, in some cases, renal dysfunction may develop.

When using the drug Ordiss® in patients with arterial hypertension and severe renal failure (creatinine clearance less than 30 ml/min), it is recommended to regularly monitor the potassium content and creatinine concentration in the blood serum. Clinical experience with the drug in patients with end-stage renal failure (creatinine clearance less than 15 ml/min) is limited. When using the drug Ordiss® in such patients, it is necessary to select the dose of the drug Ordiss® under blood pressure control.

In patients with chronic kidney disease, renal function should be periodically monitored, especially in patients over 75 years of age and in patients with impaired renal function. When increasing the dose, it is also recommended to monitor the potassium content and creatinine concentration in the blood serum.

There is no data on the use of the drug Ordiss® for CHF with a creatinine concentration of more than 265 µmol/l (more than 3 mg/ml).

Hemodialysis

. During hemodialysis, blood pressure may be especially sensitive to AT1 receptor blockade as a result of a decrease in blood volume and activation of the RAAS. Therefore, patients on hemodialysis need to monitor blood pressure and individually select the dose of Ordiss® in accordance with blood pressure levels.

Simultaneous use with ACE inhibitors for CHF

. When used simultaneously with ACE inhibitors, the risk of side effects increases, especially renal dysfunction and hyperkalemia. The clinical condition of patients and relevant laboratory parameters should be monitored.

Renal artery stenosis

. Drugs that affect the RAAS (eg, ACE inhibitors) may lead to increased serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or solitary renal artery stenosis. A similar effect can be expected with the use of angiotensin II receptor antagonists.


Kidney
transplantation . There is no experience with the use of Ordiss® in patients who have recently undergone kidney transplantation.

Arterial hypotension

. In patients with CHF, arterial hypotension may develop when using the drug Ordiss®. It is also possible to develop arterial hypotension in patients with BCC deficiency, for example, when using large doses of diuretics. In this case, before using the drug Ordiss®, it is necessary to correct the blood volume.

General anesthesia and/or surgery

. In patients receiving angiotensin II antagonists, hypotension may develop during general anesthesia and during surgery as a result of blockade of the RAAS. In rare cases, hypotension may be severe, requiring intravenous fluids and/or vasopressors.

Stenosis of the aortic and/or mitral valves, HOCM

. When using the drug Ordiss® in patients with HOCM or hemodynamically significant stenosis of the aortic or mitral valves, caution should be exercised.

Primary hyperaldosteronism

. Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect the RAAS, so the use of Ordiss® in this group of patients is not recommended. Hyperkalemia. Concomitant use of Ordiss® with potassium-sparing diuretics, potassium preparations or salt substitutes containing potassium, or other drugs that can increase serum potassium levels (for example, heparin) may lead to the development of hyperkalemia in patients with arterial hypertension.

Hyperkalemia can also develop in patients with CHF taking the drug Ordiss®. During therapy with Ordiss® in patients with CHF, it is recommended to periodically monitor the potassium content in the blood serum, especially with the simultaneous use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene, amiloride).

Are common.

Patients whose vascular tone and renal function are predominantly dependent on the activity of the RAAS (for example, patients with severe chronic heart failure, kidney disease, including renal artery stenosis) are especially sensitive to drugs acting on the RAAS. The use of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria and, less commonly, acute renal failure. The possibility of developing the listed effects cannot be excluded when using angiotensin II receptor antagonists. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic origin when using any antihypertensive drugs can lead to the development of myocardial infarction or stroke.

Use in pediatrics

. The safety and effectiveness of using Ordiss® in people under 18 years of age have not been established.

Ordiss, 16 mg, tablets, 30 pcs.

Concomitant use of ACE inhibitors, ARB II or aliskiren increases the risk of developing arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure). Double blockade of the RAAS when using ACE inhibitors, ARB II or aliskiren is not recommended (see “Interaction”).

If double blockade of the RAAS is considered absolutely necessary, then treatment should only occur under the supervision of a physician and should be accompanied by careful and regular monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and ARB II should not be used simultaneously in patients with diabetic nephropathy.

Renal dysfunction.

During the use of the drug Ordiss®, as with the use of other drugs that inhibit the RAAS, in some cases, renal dysfunction may develop.

When using the drug Ordiss® in patients with arterial hypertension and severe renal failure (GFR less than 30 ml/min/1.73 m2), it is recommended to regularly monitor the potassium content and creatinine concentration in the blood serum. Clinical experience with the drug in patients with end-stage renal failure (GFR less than 15 ml/min/1.73 m2) is limited. In such patients, it is necessary to select the dose of Ordiss® under blood pressure control.

In patients with CHF, renal function should be periodically monitored, especially in patients over 75 years of age and patients with impaired renal function. When increasing the dose, it is also recommended to monitor the potassium content and creatinine concentration in the blood serum.

There is no data on the use of the drug Ordiss® for CHF with a creatinine concentration of more than 265 µmol/l (more than 3 mg/ml).

Hemodialysis.

During hemodialysis, blood pressure may be especially sensitive to AT1 receptor blockade as a result of a decrease in blood volume and activation of the RAAS. Therefore, patients on hemodialysis need to monitor blood pressure and individually select the dose of Ordiss® in accordance with blood pressure levels.

Simultaneous use with ACE inhibitors for CHF. When used simultaneously with ACE inhibitors, the risk of side effects increases, especially renal dysfunction and hyperkalemia. The clinical condition of patients and relevant laboratory parameters should be monitored.

Renal artery stenosis.

Drugs that affect the RAAS (eg ACE inhibitors) may cause increases in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney. A similar effect can be expected when using ARA II.

Kidney transplantation.

There is no experience with the use of Ordiss® in patients who have recently undergone kidney transplantation.

Arterial hypotension.

In patients with CHF, arterial hypotension may develop when using Ordiss®. It is also possible to develop arterial hypotension in patients with BCC deficiency, for example, when using large doses of diuretics. In this case, before using the drug Ordiss®, it is necessary to correct the blood volume.

General anesthesia and/or surgical interventions.

In patients receiving angiotensin II antagonists, hypotension may develop during general anesthesia and during surgery as a result of blockade of the RAAS. In rare cases, arterial hypotension may be severe, requiring IV fluids and/or vasopressors.

Stenosis of the aortic and/or mitral valves, HOCM.

When using the drug Ordiss® in patients with HOCM or hemodynamically significant stenosis of the aortic or mitral valves, caution should be exercised.

Primary hyperaldosteronism.

Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect the RAAS, so the use of Ordisc® in this group of patients is not recommended.

Hyperkalemia.

Concomitant use of Ordiss® with potassium-sparing diuretics, potassium preparations or salt substitutes containing potassium, or other drugs that can increase serum potassium levels (for example, heparin) may lead to the development of hyperkalemia in patients with arterial hypertension.

Hyperkalemia can also develop in patients with CHF taking the drug Ordiss®. During therapy with Ordiss® in patients with CHF, it is recommended to periodically monitor the potassium level in the blood serum, especially with the simultaneous use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone (spironolactone derivative).

Are common.

Patients whose vascular tone and renal function primarily depend on the activity of the RAAS (for example, patients with severe CHF, kidney disease, including renal artery stenosis) are especially sensitive to drugs acting on the RAAS. The use of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria and, less commonly, acute renal failure. The possibility of developing the listed effects is not excluded when using ARA II. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic origin when using any antihypertensive drugs can lead to the development of myocardial infarction or stroke.

Application in pediatrics.

The safety and effectiveness of using Ordiss® in people under 18 years of age have not been established.

Impact on the ability to drive vehicles and machinery.

If undesirable effects from the central nervous system occur during therapy with Ordiss®, caution should be exercised when performing actions that require increased concentration and speed of psychomotor reactions.

Ordiss

Concomitant use of ACE inhibitors, ARB II or aliskiren increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure). Double blockade of the RAAS when using ACE inhibitors, ARB II or aliskiren is not recommended.

If double blockade of the RAAS is considered absolutely necessary, then treatment should only occur under the supervision of a physician and should be accompanied by careful and regular monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and ARB II should not be used simultaneously in patients with diabetic nephropathy.

Renal dysfunction.

During the use of the drug, as with the use of other drugs that inhibit the RAAS, in some cases renal dysfunction may develop.

When using the drug in patients with arterial hypertension and severe renal failure (GFR less than 30 ml/min/1.73 m2 body surface area), it is recommended to regularly monitor the potassium content and creatinine concentration in the blood serum. Clinical experience with the drug in patients with end-stage renal failure (GFR less than 15 ml/m2/1.73 m2 body surface area) is limited.

When using the drug in such patients, it is necessary to select the dose of the drug under blood pressure control.

In patients with CHF, renal function should be periodically monitored, especially in patients over 75 years of age and patients with impaired renal function. When increasing the dose, it is also recommended to monitor the potassium content and creatinine concentration in the blood serum. There is no data on the use of the drug for CHF with a creatinine concentration of more than 265 µmol/l (more than 3 mg/ml).

Hemodialysis.

During hemodialysis, blood pressure may be especially sensitive to AT1 receptor blockade as a result of a decrease in blood volume and activation of the RAAS. Therefore, patients on hemodialysis need to monitor blood pressure and individually select the dose of the drug in accordance with blood pressure levels.

Simultaneous use with ACE inhibitors for CHF.

When used simultaneously with ACE inhibitors, the risk of side effects increases, especially renal dysfunction and hyperkalemia. The clinical condition of patients and relevant laboratory parameters should be monitored.

Renal artery stenosis.

Drugs that affect the RAAS (eg, ACE inhibitors) may cause increases in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney. A similar effect can be expected with the use of angiotensin II receptor antagonists.

Kidney transplantation.

There is no experience with the use of the drug in patients who have recently undergone kidney transplantation.

Arterial hypotension.

In patients with CHF, arterial hypotension may develop when using the drug. It is also possible to develop arterial hypotension in patients with BCC deficiency, for example, when using large doses of diuretics. In this case, before using the drug, it is necessary to correct the blood volume.

General anesthesia and or surgical interventions.

In patients receiving angiotensin II antagonists, hypotension may develop during general anesthesia and during surgery as a result of blockade of the RAAS. In rare cases, hypotension may be severe, requiring intravenous fluids and/or vasopressors.

Stenosis of the aortic or mitral valves. GOKMP.

When using the drug in patients with HOCM or hemodynamically significant stenosis of the aortic or mitral valves, caution should be exercised.

Primary hyperaldosteronism.

Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect the RAAS, so the use of the drug in this group of patients is not recommended.

Hyperkalemia.

Concomitant use with potassium-sparing diuretics, potassium supplements or salt substitutes containing potassium, or other drugs that can increase serum potassium levels (for example, heparin) may lead to the development of hyperkalemia in patients with arterial hypertension.

Hyperkalemia can also develop in patients with CHF taking the drug. During drug therapy in patients with CHF, it is recommended to periodically monitor the potassium content in the blood serum, especially with the simultaneous use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone).

Are common.

Patients whose vascular tone and renal function are predominantly dependent on the activity of the RAAS (for example, patients with severe chronic heart failure, kidney disease, including renal artery stenosis) are especially sensitive to drugs acting on the RAAS. The use of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria and, less commonly, acute renal failure. The possibility of developing the listed effects cannot be excluded when using angiotensin II receptor antagonists. A sharp decrease in blood pressure in patients with ischemic cardiopathy, cerebrovascular diseases of ischemic origin when using any antihypertensive drugs can lead to the development of myocardial infarction or stroke.

Application in pediatrics.

The safety and effectiveness of the drug in people under 18 years of age have not been established.

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