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doxazosin tablet

1 INDICATIONS AND USAGE Doxazosin tablets are an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of HypertensionTreatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin 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 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. Doxazosin tablets may be used alone or in combination with other antihypertensives.

apotex corp.


3 years ago OVAL WHITE 094 doxazosin tablet

OVAL WHITE 094

3 years ago OVAL WHITE 094 doxazosin tablet

094 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

DOXAZOSIN tablets, USP are available as white to off-white tablets for oral administration. Each tablet contains

DOXAZOSIN mesylate equivalent to 1 mg, 2 mg, 4 mg or 8 mg of the active constituent,

DOXAZOSIN.

DOXAZOSIN tablets, USP are available as 1 mg (white to off-white, round, scored tablets, imprinted "APO" on one side and "093" with a partial bisect on the other side), 2 mg (white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "094" with a partial bisect on the other side), 4 mg (white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "095" with a partial bisect on the other side) and 8 mg (white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "096" with a partial bisect on the other side). Bottles of 100: 1 mg (NDC 60505-0093-0) 2 mg (NDC 60505-0094-0) 4 mg (NDC 60505-0095-0) 8 mg (NDC 60505-0096-0) Bottles of 1,000: 1 mg (NDC 60505-0093-1) 2 mg (NDC 60505-0094-1) 4 mg (NDC 60505-0095-1) 8 mg (NDC 60505-0096-1) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].


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