1
INDICATIONS
AND USAGE
Amlodipine besylate tablets are a calcium channel blocker and may be use d alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension(1.1) Amlodipine besylate tablets are indicate d for the treatment of hypertension, to lower blood pressure. Lowe ring blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Coronary Artery Disease(1.2) Chronic Stable Angina Vasospastic Angina (Prinzmetals or VariantAngina) AngiographicallyDocumented Coronary Artery Diseaseinpatientswithoutheart failureoranejectionfraction< 40%.
1.1
Hypertension
Amlodipine Besylate Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipinebesylate.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous
antihypertensive
drugs, from a variety of pharmacologic
classes
and
with different mechanisms
of action, have
been shown in randomized controlled trials
to
reduce
cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic
property of
the
drugs, that is
largely responsible
for
those
benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascularrisk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute
benefit is greater in patients
who are at higher risk independent of their hypertension (for example, patients with diabetes
or hyperlipidemia), and such patients would be expected to benefit from more
aggressive
treatment to
a lower
blood pressuregoal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents.
1.2
Coronary
Artery
Dis
eas
e
(CAD)
Chronic Stable Angina
Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina. Amlodipine besylate tablets may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetals or Variant Angina)
Amlodipine
besylate
tablets
are
indicated
for
the
treatment
of
confirmed
or
suspected
vasospastic angina. Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reducethe risk of a coronary revascularization procedure.