DOXAZOSIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXAZOSIN MESYLATE (UNII: 86P6PQK0MU) (DOXAZOSIN - UNII:NW1291F1W8)

Available from:

direct rx

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin tablets, USP are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin 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 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, Detectio

Product summary:

Doxazosin tablets, USP are available as functionally scored tablets for oral administration. Each tablet contains doxazosin mesylate equivalent to 1 mg (white to off white), 2 mg (cream to yellow), 4 mg (cream to yellow) or 8 mg (white to off white) of the active constituent, doxazosin. 1 mg: White to off white, round, biconvex uncoated tablets, debossed with “C3” on one side and breakline on other side and supplied as follows: 2 mg: Cream to yellow colored, round, biconvex uncoated tablets, debossed with “C7” on one side and breakline on other side, may have mottled appearance and supplied as follows: 4 mg: Cream to yellow colored, round, biconvex uncoated tablets, debossed with “C4” on one side and breakline on other side, may have mottled appearance and supplied as follows: 8 mg: White to off white, round, biconvex uncoated tablets, debossed with “C5” on one side and breakline on other side and supplied as follows: Recommended Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXAZOSIN- DOXAZOSIN TABLET
DIRECT RX
----------
DOXAZOSIN
1.1 Benign Prostatic Hyperplasia (BPH)
Doxazosin tablets, USP are indicated for the treatment of the signs
and symptoms of BPH.
1.2 Hypertension
Doxazosin 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 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 popul