1 INDICATIONS AND USAGE
Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Hypertension (1.1)
Amlodipine besylate tablets, USP 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.
Coronary Artery Disease (1.2)
Chronic Stable Angina
Vasospastic Angina (Prinzmetals or Variant Angina)
Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
1.1 Hypertension
Amlodipine besylate tablets, USP 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 amlodipine besylate tablets.
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
Programs 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 cardiovascular risk,
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 pressure goal.
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 Disease (CAD)
Chronic Stable Angina
Amlodipine besylate tablets, USP 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, USP are indicated for the treatment of confirmed
or suspected vasospastic angina. Amlodipine besylate tablets, USP 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, USP are
indicated to reduce the risk of hospitalization for angina and to reduce the risk
of a coronary revascularization procedure.