Hepatic Impairment When Eprosartan is used in patients with mild to moderate hepatic impairment, special care should be exercised due to the fact that there is limited experience in this patient population. Renal impairment No dose adjustment is required in patients with mild to moderate renal insufficiency (creatinine clearance ≥30 ml/min).
Caution is recommended for use in patients with creatinine clearance < 30 ml/min or in patients undergoing dialysis. , patients with severe cardiac insufficiency [NYHA-classification: class IV], bilateral renal artery stenosis, or renal artery stenosis of a solitary kidney) have risks of developing oliguria and/or progressive azotaemia and rarely acute renal failure during therapy with an angiotensin converting enzyme (ACE) inhibitor.
These events are more likely to occur in patients treated concomitantly with a diuretic. Angiotensin II receptor blockers such as eprosartan have not had adequate therapeutic experience to determine if there is a similar risk of developing renal function compromise in these susceptible patients.
When eprosartan is to be used in patients with renal impairment, renal function should be assessed before starting treatment with eprosartan and at intervals during the course of therapy. If worsening of renal function is observed during therapy, treatment with eprosartan should be reassessed.
g. high dose diuretic therapy). These conditions should be corrected before commencing therapy. Coronary heart disease There is limited experience in patients with coronary heart disease. Aortic and mitral valve stenosis / hypertrophic cardiomyopathy As with other vasodilators, eprosartan should be used with caution in patients with aortic and mitral valve stenosis or hypertrophic cardiomyopathy.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Primary hyperaldosteronism Patients with primary hyperaldosteronism are not recommended to be treated with eprosartan. Renal transplantation There is no experience in patients with recent kidney transplantation. Hyperkalaemia During treatment with other medicinal products which affect the renin- angiotensin-aldosterone system hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure.
Adequate monitoring of serum potassium in patients at risk is recommended. g. heparin) may lead to an increase in serum potassium and should therefore be co-administered cautiously with Eprosartan. Pregnancy Angiotensin II receptor blockers should not be initiated during pregnancy.