Instructions for use VALSACOR®
Hyperkalemia
Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium and other substances that may increase potassium concentrations (heparin) is not recommended. Potassium concentrations should be monitored if necessary.
Renal dysfunction
In patients with creatinine clearance <10 ml/min and patients on hemodialysis, valsartan should be used with caution due to the fact that there is currently no data on the safety of use in this category of patients. Patients with CC >10 ml/min do not require dose adjustment.
Patients with liver failure
In patients with mild to moderate hepatic impairment without cholestasis, valsartan should be prescribed with caution.
Patients with sodium and/or fluid deficiency
In patients with severe sodium deficiency and/or reduced blood volume (for example, due to taking diuretics in high doses), in rare cases, severe arterial hypotension may develop at the beginning of valsartan therapy. Before starting treatment with valsartan, it is recommended to restore the electrolytes and fluid levels in the body, in particular by reducing the doses of diuretics.
Renal artery stenosis
In patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney, the safety of treatment with valsartan has not been established. Short-term administration of valsartan to 12 patients with secondary renovascular hypertension did not reveal significant changes in renal hemodynamics, creatinine concentrations, or blood urea nitrogen compared with patients with unilateral renal artery stenosis. However, other substances that affect the RAAS may increase blood urea and creatinine in patients with unilateral renal artery stenosis, so monitoring of renal function is recommended during treatment with valsartan.
Kidney transplant
There are currently no data on the use of valsartan in patients who have recently undergone kidney transplantation.
Primary hyperaldosteronism
Valsartan should not be prescribed to patients with primary hyperaldosteronism, because their RAAS is not active.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy
When using valsartan, as with other vasodilators, special caution should be exercised in patients suffering from aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy.
Recent myocardial infarction
Caution should be exercised when prescribing valsartan to patients who have recently suffered a myocardial infarction. The use of valsartan in such patients may lead to some reduction in blood pressure, but discontinuation of therapy due to ongoing symptomatic hypotension is usually not required, provided the dose is adjusted according to the instructions. The combination of captopril and valsartan does not have additional clinical benefits and increases the risk of side effects. Therefore, the combination of valsartan and ACE inhibitors is not recommended. The evaluation of patients after myocardial infarction should always include an assessment of renal function.
Heart failure
In patients with heart failure, the triple combination of an ACE inhibitor, beta blocker and valsartan has no clinical benefit, increases the risk of side effects and is therefore not recommended. Caution should be exercised when prescribing valsartan to patients with this pathology. Evaluation of patients with heart failure should always include assessment of renal function. The use of valsartan in such patients may lead to some reduction in blood pressure, but discontinuation of therapy due to ongoing symptomatic hypotension is usually not required, provided the dose is adjusted according to the instructions.
In patients whose renal function may be dependent on the activity of the RAAS (for example, patients with severe congestive heart failure), oliguria and/or progressive azotemia and, in rare cases, acute renal failure and/or death have been observed during treatment with ACE inhibitors. Because valsartan is an angiotensin II antagonist, it cannot be excluded that renal dysfunction may be associated with the use of valsartan.
The risk of adverse reactions, especially hypotension, hyperkalemia and decreased renal function (including acute renal failure), may increase when Valsacor® is used in combination with ACE inhibitors. The triple combination of ACE inhibitors, mineralocorticoid receptor antagonists and valsartan is also not recommended. The use of such combinations should be carried out under specialist supervision, subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE inhibitors and angiotensin II receptor antagonists should not be used concomitantly in patients with diabetic nephropathy.
Quincke's edema
In patients receiving valsartan, angioedema was observed, which was accompanied by swelling of the larynx, glottis, which led to airway obstruction, and/or swelling of the face, lips, pharynx and/or tongue; in some of these patients, angioedema was observed previously when taking other drugs, incl. ACE inhibitors. If there are signs of developing Quincke's edema, valsartan should be stopped immediately. In such patients, its repeated use is not allowed.
Double blockade of the RAAS
Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy.
Due to dual blockade of the RAAS, the combined use of ACE inhibitors, angiotensin II receptor antagonists or aliskiren is not recommended.
Due to its absolute necessity, the prescription of dual RAAS blockade therapy should only occur under the supervision of a specialist and subject to frequent careful monitoring of renal function, electrolytes and blood pressure. Carrying out double blockade of the RAAS under the careful supervision of a specialist and mandatory monitoring of renal function, water-electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistence of symptoms of chronic heart failure, despite other adequate therapy .
Dual blockade of the RAAS using an ACE inhibitor, angiotensin II receptor antagonist, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.
Use in pediatrics
There is no data on the use of valsartan in children with creatinine clearance <30 ml/min and on dialysis. Patients with CC >30 ml/min do not require dose adjustment. During treatment with valsartan, renal function and serum potassium concentrations should be carefully monitored, especially in conditions that impair renal function (fever, dehydration).
As in adults, valsartan is contraindicated in children with severe liver dysfunction, biliary cirrhosis and cholestasis. There is limited experience with the use of valsartan in pediatrics in patients with moderate to severe liver dysfunction. In such patients, the dose of valsartan should not exceed 80 mg.
Excipients
Valsacor® contains lactose, therefore the drug is not recommended for patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Impact on the ability to drive vehicles and operate machinery
There is no data on the effect on the ability to drive a car or drive potentially dangerous machinery. When driving or operating machinery, be aware that while taking valsartan there may be a risk of dizziness or fatigue.
Valsacor®
When using Valsacor® in patients with hypertension, regular monitoring of laboratory parameters is not required.
Double blockade of the RAAS
In some patients, double blockade of the RAAS was accompanied by the development of severe arterial hypotension, syncope, stroke, hyperkalemia and renal dysfunction (including acute renal failure).
The simultaneous use of ARB II, including valsartan, with drugs that affect the RAAS, such as ACE inhibitors or aliskiren, is not recommended; if such therapy is necessary, blood pressure, renal function, and blood plasma electrolyte levels should be carefully monitored. Concomitant use of ARB II, including valsartan, 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.
The simultaneous use of ARB II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.
Hyponatremia and/or dehydration
In patients with severe hyponatremia and/or dehydration, for example, due to taking large doses of diuretics, in rare cases, arterial hypotension with clinical manifestations may develop at the beginning of therapy with Valsacor®. Before starting treatment, it is recommended to restore sodium levels and/or replenish blood volume, in particular by reducing the doses of diuretics.
If arterial hypotension with clinical manifestations develops, the patient must be placed in a horizontal position and, if necessary, a 0.9% sodium chloride solution should be administered intravenously. Therapy with Valsacor® can be continued only after stabilization of hemodynamic parameters.
Hyperkalemia
Concomitant use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium supplements, potassium-containing nutritional supplements or other drugs that can increase serum potassium levels (for example, heparin) is not recommended. It is necessary to monitor the potassium content in the blood plasma.
Renal artery stenosis
Short-term use of valsartan in patients with renovascular hypertension, which developed secondary to unilateral stenosis of the artery of a single kidney, was not accompanied by significant changes in renal hemodynamics, creatinine concentrations or serum urea nitrogen. Because other drugs that affect the RAAS can increase serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or solitary renal artery stenosis, continuous monitoring of these values is recommended as a precaution.
Condition after kidney transplantation
The safety of Valsacor® in patients who have recently undergone kidney transplantation has not been established.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, therefore the use of Valsacor® is not recommended for such patients.
Stenosis of the aortic and/or mitral valves, HOCM
The drug Valsacor® should be used with caution in patients with hemodynamically significant stenosis of the aortic and/or mitral valves or with HOCM.
Renal dysfunction
In patients with impaired renal function, no change in drug doses is required, since there is no data on the use of the drug Valsacor® in severe renal failure (creatinine clearance less than 10 ml/min or 0.167 ml/s) and in patients on hemodialysis, in such cases In cases, the drug is recommended to be used with caution. Concomitant use of ARB II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with impaired renal function (GFR less than 60 ml/min/1.73 m2 body surface area).
Liver dysfunction
For patients with impaired liver function, biliary cirrhosis and cholestasis, Valsacor® at a dosage of 320 mg is contraindicated, since the maximum daily dose should not exceed 80 mg.
History of angioedema
Among patients with angioedema (swelling of the larynx and vocal cords, causing obstruction of the airways and/or swelling of the face, lips, pharynx and/or tongue) during treatment with Valsacor®, cases of development of angioedema in the anamnesis were observed, including when taking ACE inhibitors. If angioedema develops, the drug should be immediately discontinued and the possibility of its re-use should be excluded.
Arterial hypertension
For hypertension, the drug Valsacor® can be used in monotherapy or simultaneously with other antihypertensive drugs, in particular with diuretics.
CHF/increasing survival of patients with acute myocardial infarction
It is possible to use the drug Valsacor® in combination with other drugs used for acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers and HMG-CoA reductase inhibitors (statins)).
The simultaneous use of Valsacor® and ACE inhibitors in this category of patients is not recommended, since this combination therapy does not lead to additional clinical effect and is accompanied by an increased risk of developing AEs compared to therapy with the two drugs separately.
In patients with CSP, triple combination therapy (with Valsacor®, an ACE inhibitor and a beta-blocker) is not recommended, since it does not lead to additional clinical effect and is accompanied by an increased risk of developing AEs.
The use of Valsacor® in patients with CHF or acute myocardial infarction often leads to a slight decrease in blood pressure. As a rule, discontinuation of the drug is not required if dosing instructions are followed.
In patients whose renal function may depend on the activity of the RAAS (for example, in patients with CHF II-IV FC according to the NYHA classification), therapy with ACE inhibitors and ARB II is accompanied by oliguria and/or an increase in azotemia, and in rare cases, AKI and/or death outcome. Since valsartan is a II ARA, the possibility of deterioration of renal function with its use cannot be excluded.
Initiation of therapy in patients with XCII or acute myocardial infarction should be done with caution. Renal function should always be assessed when assessing patients.
Special information on excipients
The drug Valsacor® contains lactose, therefore the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption syndrome.
Valsacor, 30 pcs., 160 mg, film-coated tablets
Hyperkalemia.
Caution should be exercised when using potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium supplements, potassium-containing salt substitutes or other drugs that can increase plasma potassium levels (for example, heparin). It is necessary to regularly monitor the potassium content in the blood plasma.
Renal dysfunction.
In patients with impaired renal function, no dose changes are required. Because There are no data on the use of the drug in severe renal failure (creatinine Cl less than 10 ml/min or 0.167 ml/s) and in patients on hemodialysis; in such cases, the drug is recommended to be used with caution.
The simultaneous use of valsartan with aliskiren in patients with moderate and severe renal impairment (creatinine clearance less than 60 ml/min) is contraindicated.
Liver dysfunction.
In patients with mild to moderate liver dysfunction without cholestasis, Valsacor® should be used with caution.
Patients with hyponatremia and/or dehydration.
In patients with severe hyponatremia and/or dehydration, for example due to taking large doses of diuretics, in rare cases, arterial hypotension with clinical manifestations may develop at the beginning of therapy with Valsacor®. Before starting treatment, it is recommended to restore sodium and/or bcc levels, in particular by reducing the doses of diuretics.
Renal artery stenosis.
The use of valsartan in a short course in patients with renovascular hypertension, which developed secondary to stenosis of the artery of a single kidney, does not cause significant changes in renal hemodynamics, creatinine concentration or urea nitrogen in the blood serum. However, given that other drugs that affect the RAAS may cause an increase in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney, it is necessary to regularly monitor the concentrations of creatinine and residual urea nitrogen in the blood serum.
Condition after kidney transplantation.
The safety of using Valsacor® in patients who have recently undergone kidney transplantation has not been established.
Primary hyperaldosteronism.
Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, therefore the use of Valsacor® is not recommended for such patients.
Stenosis of the aortic and/or mitral valves, HOCM.
The drug Valsacor® should be used with caution in patients with hemodynamically significant stenosis of the aortic and/or mitral valves or with HOCM.
The period after an MI.
Concomitant use with ACE inhibitors is not recommended, because has no additional clinical benefits over monotherapy and increases the risk of adverse events.
The use of valsartan in patients after a myocardial infarction often leads to a slight decrease in blood pressure, but discontinuation of therapy due to arterial hypotension is usually not required if drug dosage recommendations are followed.
Treatment with Valsacor® should be initiated cautiously. Assessment of the condition of patients after acute myocardial infarction should include monitoring of renal function.
Possible simultaneous use in acute MI with other drugs: thrombolytics, acetylsalicylic acid, beta-blockers and HMG-CoA reductase inhibitors (statins).
CHF.
In patients with CHF, the simultaneous use of three classes of drugs is not recommended: ACE inhibitors, beta-blockers and valsartan, because this therapy did not provide additional clinical effect, and the risk of adverse events increased. Use in patients with CHF is usually accompanied by a decrease in blood pressure, however, if recommendations for dose selection are followed, treatment rarely requires discontinuation due to arterial hypotension. Treatment with Valsacor® in patients with CHF should be initiated with caution. Due to the suppression of RAAS activity in some patients (for example, in patients with CHF III–IV functional class according to the NYNA classification, whose kidney function depends on the state of the RAAS) during therapy with ACE inhibitors, a change in renal function is possible: the development of oliguria and/or progressive azotemia, and in in rare cases - acute renal failure and/or death. The drug Valsacor® blocks angiotensin II receptors, so patients with CHF require regular monitoring of renal function.
History of angioedema.
Among patients with angioedema during therapy with Valsacor®, there were cases of a history of angioedema, incl. and ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.
Special information on excipients
The drug Valsacor® contains lactose, so it should not be used for the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving, working with moving mechanisms).
Due to the possibility of dizziness or weakness while using the drug Valsacor®, care must be taken when driving vehicles and engaging in potentially hazardous activities.
Valsacor
When using the drug Valsacor in patients with hypertension, regular monitoring of laboratory parameters is not required.
Hyponatremia and/or dehydration.
In patients with severe hyponatremia and/or dehydration, for example due to taking large doses of diuretics, in rare cases, arterial hypotension with clinical manifestations may develop at the beginning of therapy with Valsacor. Before starting treatment, it is recommended to restore the sodium content and/or replenish the volume of blood volume, in particular by reducing the doses of diuretics.
If arterial hypotension with clinical manifestations develops: the patient must be placed in a horizontal position and, if necessary, injected intravenously with a 09% sodium chloride solution. Therapy with Valsacor can be continued only after stabilization of hemodynamic parameters.
Hyperkalemia.
The simultaneous use of potassium-sparing diuretics (spironolactone eplerenone triamterene amiloride), potassium preparations, potassium-containing nutritional supplements or other drugs that can increase the level of potassium in the blood serum (for example, heparin) is not recommended. It is necessary to monitor the potassium content in the blood plasma.
Renal artery stenosis.
Short-term use of valsartan in patients with renovascular hypertension developed secondary to unilateral stenosis of the artery of a solitary kidney was not accompanied by significant changes in renal hemodynamic parameters, creatinine or urea nitrogen concentrations in the blood serum. Since other drugs acting on the RAAS can increase the concentrations of urea and creatinine in the blood serum in patients with bilateral renal artery stenosis or stenosis of the artery of a solitary kidney, it is recommended as a precaution to constantly monitor these indicators.
Condition after kidney transplantation.
The safety of Valsacor in patients who have recently undergone kidney transplantation has not been established.
Primary hyperaldosteronism.
Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS; therefore, the use of Valsacor is not recommended for such patients.
Stenosis of the aortic and/or mitral valves HOCM.
Valsacor should be used with caution in patients with hemodynamically significant stenosis of the aortic and/or mitral valves or with HOCM.
Renal dysfunction.
In patients with impaired renal function, no dose changes are required. Since there is no data on the use of the drug in severe renal failure (creatinine clearance less than 10 ml/min or 0167 ml/s) and in patients on hemodialysis in such cases the drug is recommended to be used with caution.
The simultaneous use of ARB II including valsartan or ACE inhibitors with aliskiren is contraindicated in patients with impaired renal function (creatinine clearance less than 60 ml/min).
Liver dysfunction.
For patients with mild or moderate liver dysfunction of non-biliary origin without cholestasis, the drug Valsacor at a dosage of 320 mg is contraindicated since the maximum daily dose should not exceed 80 mg.
History of angioedema.
Among patients with angioedema (swelling of the larynx and vocal cords causing obstruction of the airways and/or swelling of the face, lips, pharynx and/or tongue) during treatment with Valsacor, cases of a history of angioedema development were observed, including in response to ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.
Arterial hypertension.
For hypertension, the drug Valsacor can be used in monotherapy or simultaneously with other antihypertensive drugs, in particular diuretics.
CHF/increasing survival of patients with acute myocardial infarction.
It is possible to use the drug Valsacor in combination with other drugs used for acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers and HMG-CoA reductase inhibitors (statins)). The simultaneous use of Valsacor and ACE inhibitors in this category of patients is not recommended because this combination therapy does not lead to an additional clinical effect and is accompanied by an increased risk of adverse events compared to therapy with the two drugs separately.
In patients with CHF, triple combination therapy: Valsacor with an ACE inhibitor and a beta-blocker is not recommended because it does not lead to additional clinical effect and is accompanied by an increased risk of adverse events.
The use of the drug Valsacor in patients with CHF or acute myocardial infarction often leads to a slight decrease in blood pressure, usually without discontinuation of the drug when dosing instructions are followed.
In patients whose renal function may depend on the activity of the RAAS (for example, in patients with CHF II-IV FC according to the NYNA classification), therapy with ACE inhibitors and ARA II is accompanied by oliguria and/or an increase in azotemia and, in rare cases, acute renal failure and/or death . Since valsartan is an ARA II, the possibility of deterioration of renal function with its use cannot be excluded.
Initiation of therapy in patients with CHF or acute myocardial infarction should be done with caution. Renal function should always be assessed when assessing patients.
Special information on excipients.
The drug Valsacor contains lactose; therefore, the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption syndrome.
Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions, as dizziness or weakness may develop due to arterial hypotension.
Valsacor®
Heart failure
Use in patients with heart failure is usually accompanied by a decrease in blood pressure, however, if recommendations for dose selection are followed, treatment rarely requires discontinuation due to arterial hypotension. Treatment with Valsacor in patients with heart failure should be initiated cautiously. Due to suppression of RAAS activity, changes in renal function may occur in some patients.
In severe heart failure, oliguria and/or progressive azotemia may develop, up to (rarely) acute renal failure and/or death. In patients with heart failure, constant monitoring of renal function is necessary when simultaneously prescribing a combination of three classes of drugs - ACE inhibitors, beta-blockers and angiotensin II AT1 receptor antagonists.
It may be prescribed in combination with other drugs prescribed after myocardial infarction: thrombolytics, acetylsalicylic acid, beta-blockers and statins.
Sodium and/or fluid deficiency
In patients with severe sodium deficiency and/or reduced blood volume, for example, due to taking large doses of diuretics, in rare cases, severe arterial hypotension may develop at the beginning of valsartan therapy. Before starting treatment with Valsacor, it is recommended to restore the content of electrolytes and fluid in the body, in particular, by reducing the doses of diuretics.
If arterial hypotension with clinical manifestations develops: the patient should be placed on his back and, if necessary, a 0.9% sodium chloride solution should be administered intravenously. Therapy with Valsacor can be continued only after blood pressure levels have stabilized.
Renal artery stenosis
In patients with bilateral or unilateral renal artery stenosis, it is necessary to constantly monitor serum creatinine and urea nitrogen.
Renal dysfunction
In patients with impaired renal function, no dose changes are required. Due to the lack of data on the use of the drug in severe renal failure (creatinine clearance <10 ml/min or 0.167 ml/s), in such cases the drug is recommended to be prescribed with caution.
Liver dysfunction
In patients with impaired liver function, no dose changes are required.
Valsacor® is excreted primarily in bile. In patients with obstructive biliary tract diseases, a decrease in the clearance of valsartan was observed, so in such cases the drug should be prescribed with caution.
Special information on excipients
Valsacor® contains lactose, therefore the drug is contraindicated in patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.
Impact on the ability to drive vehicles and operate machinery
Patients should be careful when driving a car and other mechanisms that require increased attention.
