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Hypotension
in Volume- or Salt-Depleted Patients
In patients
with an activated renin-angiotensin system, such
as 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.
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Vasodilation
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.
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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.
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Congestive
Heart Failure
In
general, calcium channel blockers should be used with caution in patients
with heart failure.
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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.
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Hepatic
Impairment
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.
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Laboratory
Tests
There
was a greater decrease in hemoglobin and hematocrit
in the combination product compared to either component alone.
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Adverse
Reactions
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% (5/20 mg), 6.2% (5/40 mg), 13.3%
(10/20 mg), and 11.2% (10/40 mg). The edema incidence for placebo was
12.3%.
Adverse reactions seen at lower rates but at about the same or greater
incidence as in patients receiving placebo included hypotension,
orthostatic hypotension, rash, pruritus,
palpitation, urinary frequency, and nocturia.
In individual clinical trials of amlodipine
and olmesartan medoxomil,
other commonly reported adverse reactions included headache, dizziness and
flushing.
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