Frepan Special Precautions

Renal impairment: As with other agents inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function may be anticipated in susceptible patients treated with candesartan cilexetil.
When candesartan cilexetil is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended. There is limited experience in patients with very severe or end-stage renal impairment (Cl_creatinine <15 mL/min). In these patients, candesartan cilexetil should be carefully titrated with thorough monitoring of blood pressure.
Evaluation of patients with heart failure should include periodic assessments of renal function, especially in elderly patients 75 years or older, and patients with impaired renal function. During dose titration of candesartan cilexetil, monitoring of serum creatinine and potassium is recommended. Clinical trials in heart failure did not include patients with serum creatinine >265 μmol/L (>3 mg/dL).
Use in paediatric patients, including patients with renal impairment: Candesartan cilexetil has not been studied in children with a glomerular filtration rate less than 30 mL/min/1.73m² (see Dosage & Administration).
For children with possible intravascular volume depletion (e.g. patients treated with diuretics, particularly those with impaired renal function), candesartan cilexetil treatment should be initiated under close medical supervision and a lower starting dose should be considered (see Dosage & Administration).
The use of AIIRAs, including candesartan cilexetil, or of ACE inhibitors with aliskiren should be avoided in patients with severe renal impairment (GFR <30 mL/min) (see Interactions).
Concomitant therapy with an ACE inhibitor in heart failure: The risk of adverse reactions, especially renal function impairment and hyperkalaemia, may increase when candesartan cilexetil is used in combination with an ACE inhibitor (see Adverse Reactions). Patients with such treatment should be monitored regularly and carefully.
Haemodialysis: During dialysis, the blood pressure may be particularly sensitive to AT₁-receptor blockade as a result of reduced plasma volume and activation of the renin-angiotensin-aldosterone system (RAAS). Therefore candesartan cilexetil should be carefully titrated with thorough monitoring of blood pressure in patients on haemodialysis.
Renal artery stenosis: Medicinal products that affect the RAAS, including angiotensin II receptor antagonists (AIIRAs), may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney.
Kidney transplantation: There is limited clinical evidence regarding candesartan cilexetil use in patients who have undergone renal transplant.
Hypotension: Hypotension may occur during treatment with candesartan cilexetil in heart failure patients. It may also occur in hypertensive patients with intravascular volume depletion such as those receiving high dose diuretics. Caution should be observed when initiating therapy and correction of hypovolemia should be attempted.
Anaesthesia and surgery: Hypotension may occur during anaesthesia and surgery in patients treated with angiotensin II antagonists due to blockade of the renin-angiotensin system. Very rarely, hypotension may be severe such that it may warrant the use of intravenous fluids and/or vasopressors.
Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy): As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary hyperaldosteronism: Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the RAAS. Therefore, the use of candesartan cilexetil is not recommended in this population.
Hyperkalaemia: Concomitant use of candesartan cilexetil with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin, co-trimoxazole also known as trimethoprim/sulfamethoxazole) may lead to increases in serum potassium in hypertensive patients. Monitoring of potassium should be undertaken as appropriate.
In heart failure patients treated with candesartan cilexetil, hyperkalaemia may occur. Periodic monitoring of serum potassium is recommended. The combination of an ACE inhibitor, a potassium-sparing diuretic (e.g. spironolactone) and candesartan cilexetil is not recommended and should be considered only after careful evaluation of the potential benefits and risks.
Dual blockade of the RAAS: Caution is required while co-administering AIIRAs, including candesartan cilexetil, with other agents blocking the RAAS such as ACE inhibitors or aliskiren (see Interactions).
General: In patients whose vascular tone and renal function depend predominantly on the activity of the RAAS (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded with AIIRAs. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic cardiopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
The antihypertensive effect of candesartan may be enhanced by other medicinal products with blood pressure lowering properties, whether prescribed as an antihypertensive or prescribed for other indications.
Paediatric population: In post-menarche patients, the possibility of pregnancy should be evaluated on a regular basis. Appropriate information should be given and/or action taken to prevent the risk of exposure during pregnancy (see Contraindications and Use in Pregnancy & Lactation).
Effects on ability to drive and use machines: No studies on the effects of candesartan on the ability to drive and use machines have been performed. However, it should be taken into account that occasionally dizziness or weariness may occur during treatment with candesartan cilexetil.