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Benign Prostatic Hyperplasia (BPH)
CARDURA is indicated for the treatment of the signs and symptoms of BPH.
CARDURA is 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 this drug.
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 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.
CARDURA may be used alone or in combination with other antihypertensives.
DOSAGE AND ADMINISTRATION
Following the initial dose and with each dose increase of CARDURA, monitor blood pressure for at least 6 hours following administration. If CARDURA administration is discontinued for several days, therapy should be restarted using the initial dosing regimen.
Benign Prostatic Hyperplasia
The recommended initial dosage of CARDURA is 1 mg given once daily either in the morning or evening.
Depending on the individual patient's urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily.
Routinely monitor blood pressure in these patients.
The initial dosage of CARDURA is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired reduction in blood pressure.
Dosage Forms And Strengths
Tablets (scored): 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green).
Storage And Handling
CARDURA (doxazosin mesylate) is available as scored tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green) of the active constituent, doxazosin.
|Bottle of 100:||1 mg||NDC 0049-2750-66|
|2 mg||NDC 0049-2760-66|
|4 mg||NDC 0049-2770-66|
|8 mg||NDC 0049-2780-66|
|Unit Dose Package of 100:||1 mg||NDC 0049-2750-41|
|2 mg||NDC 0049-2760-41|
|4 mg||NDC 0049-2770-41|
|8 mg||NDC 0049-2780-41|
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Distributed by: Roerig Division of Pfizer Inc., NY, NY 10017. Revised: June 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/24/2016
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