Candetens Special Precautions

Dual blockade of the Renin-Angiotensin-Aldosterone (RAA) system with drugs containing aliskiren: Dual blockade of the Renin-Angiotensin-Aldosterone (RAA) system in combination therapy with CANDETENS and aliskiren is not recommended because of the increased risk of hypertension, hyperkalemia, and altered renal function.
The use of CANDETENS with aliskiren is contraindicated in patients with diabetes or moderate to severe kidney impairment (GFR˂60ml/min/1.73 m²).
Kidney failure: As with other Renin-Angiotensin-Aldosterone system inhibitors, changes in renal function can be anticipated in certain patients treated with CANDETENS.
The use of CANDETENS in hypertensive patients with kidney failure is recommended through periodic examination of serum potassium and creatinine levels. The experience of using CANDETENS in patients with terminal renal failure (creatinine Cl 15 ml/min) is very limited.
In such patients, increasing the dose should be done carefully accompanied by blood pressure checks.
Evaluation of patients with heart failure should include regular checks of renal function, especially in elderly patients 75 years of age or older, and patients with impaired renal function.
When increasing the dose of CANDETENS it is recommended to check serum creatinine and potassium levels. Clinical trials in heart failure did not include patients with serum creatinine 265 mol/L (˃3 mg/dl).
Combination therapy with ACE inhibitors in heart failure: The risks and undesirable effects, particularly hypotension, hyperkalemia, and impaired renal function (including acute renal failure), may be increased when CANDETENS is used in combination with ACE inhibitors.
Patients on this medication should be monitored regularly and carefully.
Hemodialysis: During dialysis, blood pressure can become very sensitive to AT receptor blockers, as a result of a decrease in plasma volume and activation of the Renin-Angiotensin-Aldosterone system. Therefore, CANDETENS titration should be carried out with care by carefully checking blood pressure in hemodialysis patients.
Renal artery stenosis: Renal function may deteriorate in patients with renal artery stenosis. Other drugs that affect the Renin-Angiotensin-Aldosterone system, eg ACE inhibitors can increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the arteries of one kidney. The same effect can be anticipated with angiotensin II receptor blockers.
Kidney transplant: There is no experience associated with administering CANDETENS in patients with kidney transplantation.
Hypotension: Hypotension may occur during treatment with CANDETENS in patients with heart failure. As described for other drugs acting on the Renin-Angiotensin-Aldosterone system, hypotension can also occur in hypertensive patients with reduced intravascular volume as in those receiving high-dose diuretics. Therefore, it is necessary to start treatment with caution and hypovolemia must be overcome before administering CANDETENS.
Anesthesia and surgery: Hypotension can occur during anesthesia and surgery in patients receiving angiotensin II inhibitors due to blockers of the Renin-Angiotensin system. Very rarely, severe hypotension may develop requiring intravenous fluids and/or vasopressors.
Stenosis of the aortic and mitral valves (obstructive hypertrophic cardiomyopathy): As with the use of vasodilators, special attention is paid to patients suffering from hemodynamic consequences associated with aortic and mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary hyperaldosteronism: Patients with primary hyperaldosterone generally will not respond to antihypertensive drugs that act by inhibiting the Renin-Angiotensin-Aldosterone system. Therefore, the use of CANDETENS is not recommended.
Hyperkalemia: Coadministration with potassium-sparing diuretics may result in increased potassium levels. Experience with use with other drugs that affect the Renin-Angiotensin-Aldosterone system Co-administration of CANDETENS with potassium-sparing diuretics, potassium supplements, salt substitutes using potassium, or other drugs that increase potassium levels (eg heparin) can cause elevated levels of potassium, serum potassium in hypertensive patients.
Hyperkalemia can occur in heart failure patients who are given CANDETENS and it is recommended to periodically check serum potassium, especially when used concomitantly with ACE inhibitors and potassium-sparing diuretics such as spironolactone.
General: In patients in whom renal function and vascular tone are highly dependent on the activity of the Renin-Angiotensin-Aldosterone system (such as patients with congestive heart failure or renal disease, including renal artery stenosis), treatment with other drugs that affect this system has been associated with the development of acute hypotension, azotemia, oliguria, or, rarely, acute renal failure. The same possible effect cannot be excluded with angiotensin II receptor blockers. As with other antihypertensives, excessive reduction in blood levels in ischemic cardiopathies or cerebrovascular ischemia can lead to myocardial infarction or stroke. Do not administer this drug in patients with rare hereditary problems namely galactose intolerance, "The Lapp lactase" deficiency or glucose-galactose malabsorption.