c Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14CLINICAL STUDIES
14.1 Effects in Hypertension
14.2 Effects in Chronic Stable Angina
14.3 Effects in Vasospastic Angina
14.4 Effects in Documented Coronary Artery Disease
14.5 Studies in Patients with Heart Failure
16HOW SUPPLIED/STORAGE AND HANDLING
*Sections or subsections omitted from the full prescribing information are notlisted
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Hypertension
KATERZIA is indicated for the treatment of hypertension in adults and children 6 years andolder, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatalcardiovascular events, primarily strokes and myocardial infarctions. These benefits have beenseen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classesincluding amlodipine.
Control of high blood pressure should be part of comprehensive cardiovascular riskmanagement, including, as appropriate, lipid control, diabetes management, antithrombotictherapy, smoking cessation, exercise, and limited sodium intake. Many patients will requiremore than one drug to achieve blood pressure goals. For specific advice on goals andmanagement, see published guidelines, such as those of the National High Blood Pressure
Education Program’s Joint National Committee on Prevention, Detection, eva luation, andTreatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with differentmechanisms of action, have been shown in randomized controlled trials to reduce cardiovascularmorbidity and mortality, and it can be concluded that it is blood pressure reduction, and not someother pharmacologic property of the drugs, that is largely responsible for those benefits. Thelargest and most consistent cardiovascular outcome benefit has been a reduction in the risk ofstroke, but reductions in myocardial infarction and cardiovascular mortality also have been seenregularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute riskincrease per mmHg is greater at higher blood pressures, so that even modest reductions of severehypertension can provide substantial benefit. Relative risk reduction from blood pressurereduction is similar across populations with varying absolute risk, so the absolute benefit isgreater 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 moreaggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in blackpatients, and many antihypertensive drugs have additional approved indications and effects(e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guideselection of therapy.
KATERZIA may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD)
Chronic Stable Angina
KATERZIA is indicated for the symptomatic treatment of chronic stable angina. KATERZIAmay b |
