Since the vasodilation attributable to amlodipine in AZOR is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering AZOR, particularly in patients with severe aortic stenosis.
Severe Obstructive Coronary Artery Disease
Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Congestive Heart Failure
In general, calcium channel blockers should be used with caution in patients with heart failure.
Impaired Renal Function
In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with AZOR because of the olmesartan medoxomil component.
Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment.
There was a greater decrease in hemoglobin and hematocrit in the combination product compared to either component alone.
The only adverse reaction that occurred in greater than or equal to 3%
of patients treated with AZOR and more frequently than placebo was edema.
The placebo-subtracted incidence was 5.7% (5
|SOURCE Daiichi Sankyo, Inc.|
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