In volume- and/or salt-depleted patients, symptomatic hypotension due particularly to the olmesartan component may occur after initiation of treatment with AZOR. Treatment should start under close medical supervision.
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.
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.
The only adverse events that occurred in greater than 3% of patients treated with AZOR and more frequently than placebo were edema (22.2% vs 12.3%).
IMPORTANT SAFETY INFORMATION ABOUT BENICAR
Benicar is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
USE IN PREGNANCY
When used in pregnancy, during the second and third trimester, drugs
that act directly on the renin-angiotensin system can cause injury and even
death to the developing fetus. When pregnancy is detected, Benicar should
be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity
and Mortality in the prescribing in
|SOURCE Daiichi Sankyo, Inc.|
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