In patients who are intravascular volume or salt depleted (e.g., those treated with diuretics, dietary salt restriction, diarrhea or vomiting), symptomatic hypotension may occur, especially after the first dose. Such conditions should be corrected before starting therapy.
Because the renin-angiotensin-aldosterone system appears to contribute substantially to maintenance of glomerular filtration in patients with heart failure in whom renal perfusion is severely compromised, renal function may deteriorate markedly (e.g., oliguria, progressive azotemia, renal failure) in these patients during therapy with an ACE inhibitor or an angiotensin II receptor antagonist (e.g., Olmesartan medoxomil). Renal artery stenosis also is a risk factor for renal impairment during therapy with drugs that inhibit the RAA system.
Use with caution in patients with unilateral/bilateral renal artery stenosis due to the elevated risk of deterioration in renal function and severe hypotension.
When Olmesartan medoxomil is used in patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. Use of Olmesartan medoxomil is not recommended in patients with severe renal impairment (CrCl < 20 mL/min).
Sprue-like enteropathy, an intestinal condition characterized by severe chronic diarrhea with substantial weight loss, has been reported during postmarketing experience in patients receiving Olmesartan medoxomil; may develop months to years after initiation of Olmesartan medoxomil therapy. If symptoms of sprue-like enteropathy develop during Olmesartan medoxomil therapy, if no other causative factor can be identified, discontinuance of the drug and consider other antihypertensive treatment.
Olmesartan inhibits renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalaemia. Monitor serum electrolytes periodically.
Use of Olmesartan medoxomil in patient with hepatic impairment is not recommended.
Hyperkalemia may occur, risk factors include renal dysfunction, heart failure. Use cautiously and monitor potassium closely.
The combination of lithium and Olmesartan medoxomil is not recommended.
Use caution in patients with significant aortic/mitral stenosis or obstructive hypertropic cardiomyopathy.
Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of Olmesartan medoxomil is not recommended in such patients.
As with all other angiotensin II antagonists, the blood pressure lowering effect of Olmesartan medoxomil is somewhat less in black patients than in non-black patients, possibly because of a higher prevalence of low-renin status in the black hypertensive population.
As with any antihypertensive agent, excessive blood pressure decrease in patients with ischemic heart disease or ischemic cerebrovascular disease could result in myocardial infarction or stroke.
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