Candesartan

Pregnancy Pregnancy: The use of ARBs is not recommended during the first trimester of pregnancy.‍‍‍‍‍‍​​​‍​​​​​​ The use of ARBs is contraindicated during the second and third trimesters of pregnancy. Breastfeeding Breastfeeding: Therapy with Candesartan is not recommended during breastfeeding. Hepatic Impairment Hepatic Impairment: Reduce dose by half in mild hepatic impairment; avoid in severe hepatic impairment. Renal Impairment Renal Impairment: Reduce dose by 50% in moderate renal impairment; avoid in severe renal impairment. Driving Driving: Some people may experience dizziness or fatigue during treatment with Candesartan. If this occurs, do not drive or operate any tools or machinery. Renal function impairment As with all other agents that inhibit the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible patients treated with Candesartan. When Candesartan is used in hypertensive patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended. Experience in patients with very severe or end-stage renal impairment is limited (creatinine clearance <15 ml/min). In these patients, Candesartan should be carefully titrated with blood pressure monitoring. Assessment of patients with heart failure should include periodic evaluation of renal function, particularly in elderly patients aged 75 years and over and in patients with renal impairment. During dose adjustment of Candesartan, 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). Concomitant therapy with an ACEI in heart failure The risk of adverse reactions, particularly renal impairment and hyperkalaemia, may increase when Candesartan is used in combination with an ACEI. Patients receiving this therapy should be regularly and carefully monitored. Haemodialysis During dialysis, blood pressure may be particularly sensitive to AT1 receptor blockade as a consequence of reduced plasma volume and activation of the renin-angiotensin-aldosterone system. Therefore, Candesartan should be carefully titrated with blood pressure monitoring in patients on haemodialysis. Renal artery stenosis Medicinal products that affect the renin-angiotensin-aldosterone system, including angiotensin II receptor antagonists (ARBs), may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Renal transplantation There is no experience with the administration of Candesartan in patients with a recent renal transplant. Hypotension Hypotension may occur during treatment with Candesartan in patients with heart failure. It may also occur in hypertensive patients with intravascular volume depletion, particularly those treated with high doses of diuretics. Caution should be exercised when initiating therapy and hypovolaemia should be corrected in a timely manner. 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 enough to warrant the use of intravenous fluids and/or vasopressors. Aortic and mitral valve stenosis (hypertrophic obstructive cardiomyopathy) As with all other vasodilators, special caution is indicated in patients with haemodynamically significant aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy. Primary hyperaldosteronism Patients with primary hyperaldosteronism generally do not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the use of Candesartan is not recommended in this population. Hyperkalaemia Concomitant use of Candesartan with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (e.g. heparin) may lead to increases in serum potassium in hypertensive patients. Potassium levels should be monitored as appropriate. In patients with heart failure treated with Candesartan, hyperkalaemia may occur. Periodic monitoring of serum potassium is recommended. The combination of ACEIs, a potassium-sparing diuretic (e.g. spironolactone), and Candesartan is not recommended and should only be considered after careful evaluation of the potential benefits and risks. General In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (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 with ARBs cannot be excluded. As with any other antihypertensive agent, excessive blood pressure reduction in patients with ischaemic heart disease or ischaemic cerebrovascular disease may result in myocardial infarction or stroke. The antihypertensive effect of candesartan may be potentiated by other medicinal products with the ability to lower blood pressure, whether prescribed as antihypertensives or for other indications. Pregnancy ARBs should not be initiated during pregnancy. Unless continued ARB therapy is considered essential, patients planning pregnancy should be switched to an alternative antihypertensive treatment with an established safety profile during pregnancy. When pregnancy is diagnosed, treatment with ARBs should be discontinued immediately and, if appropriate, alternative therapy should be initiated. Candesartan may affect the way other medicines work, and some medicines may have an effect on Candesartan. If you are taking certain medicines, your doctor may request blood tests from time to time. In particular, tell your doctor if you are taking any of the following medicines: Other medicines to help lower your blood pressure, including beta-blockers, diazoxide, and ACE inhibitors such as enalapril, captopril, lisinopril, or ramipril. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines for pain relief and inflammation). Acetylsalicylic acid (if taking more than 3 g per day) (a medicine for pain relief and inflammation). Potassium supplements or salt substitutes containing potassium (medicines to increase the amount of potassium in your blood). Heparin (a medicine to thin the blood). Medicines that increase urine production (diuretics). Lithium (a medicine for mental health disorders).