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Drug Catalog - Product Detail

DOXAZOSIN TAB 1MG 100CT

NDC Mfr Size Str Form
68382-0783-01 ZYDUS PHARMACEUTICALS (USA) 100 1MG TABLET
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Generic Name
DOXAZOSIN
Substance Name
DOXAZOSIN MESYLATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA208719
Description
11 DESCRIPTION Doxazosin mesylate is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4 benzodioxan-2-ylcarbonyl)piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 • CH 4 O 3 S and the molecular weight is 547.6. It has the following structure: Doxazosin mesylate, USP is white to off white powder. It is freely soluble in formic acid; very slightly soluble in methanol and in water. Doxazosin is available as tablets for oral use and contains 1 mg (white), 2 mg (pink), 4 mg (pink) and 8 mg (purple) of doxazosin as the free base. Each doxazosin tablet, USP for oral administration contains 1 mg or 2 mg or 4 mg or 8 mg of doxazosin as 1.213 mg or 2.426 mg or 4.852 mg or 9.703 mg of doxazosin mesylate, respectively and inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate (botanical source: potato) and sodium lauryl sulphate. Additionally 8 mg tablet contains FD&C red #40 aluminum lake, FD&C blue #2 aluminum lake and 2 mg and 4 mg tablet contains ferric oxide red. Doxazosin Tablets, USP
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Each doxazosin tablet, USP for oral administration contains 1 mg or 2 mg or 4 mg or 8 mg of doxazosin as 1.213 mg or 2.426 mg or 4.852 mg or 9.703 mg of doxazosin mesylate, respectively. Doxazosin tablets USP, 1 mg are white to off-white, round biconvex scored tablets debossed with '783' on one side and score line on another side and are supplied as: NDC 68382-783-06 in bottle of 30 tablets with child-resistant closure NDC 68382-783-01 in bottle of 100 tablets with child-resistant closure NDC 68382-783-10 in bottle of 1,000 tablets NDC 68382-783-77 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 2 mg are light pink to pink, mottled, round biconvex scored tablets debossed with '784' on one side and score line on another side and are supplied as: NDC 68382-784-06 in bottle of 30 tablets with child-resistant closure NDC 68382-784-01 in bottle of 100 tablets with child-resistant closure NDC 68382-784-10 in bottle of 1,000 tablets NDC 68382-784-77 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 4 mg are light pink to pink, mottled, capsule shaped, biconvex scored tablets debossed with '785' on one side and score line on another side and are supplied as: NDC 68382-785-06 in bottle of 30 tablets with child-resistant closure NDC 68382-785-01 in bottle of 100 tablets with child-resistant closure NDC 68382-785-10 in bottle of 1,000 tablets NDC 68382-785-77 in cartons of 100 tablets (10 x 10 unit-dose) Doxazosin tablets USP, 8 mg are light purple to purple, mottled, round biconvex scored tablets debossed with '786' on one side and score line on another side and are supplied as: NDC 68382-786-06 in bottle of 30 tablets with child-resistant closure NDC 68382-786-01 in bottle of 100 tablets with child-resistant closure NDC 68382-786-10 in bottle of 1,000 tablets NDC 68382-786-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Indications & Usage
1 INDICATIONS AND USAGE Doxazosin tablets are an alpha1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment 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 are may be used alone or in combination with other antihypertensives.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For the treatment of BPH: Initiate therapy at 1 mg once daily. Dose maybe titrated at 1 to 2 week intervals, up to 8 mg once daily.( 2.2 ) For the treatment hypertension: Initiate therapy at 1 mg once daily. Dose may be titrated as needed, up to 16 mg once daily. ( 2.3 ) 2.1 Dosing Information Following the initial dose and with each dose increase of doxazosin, monitor blood pressure for at least 6 hours following administration. If doxazosin administration is discontinued for several days, therapy should be restarted using the initial dosing regimen. 2.2 Benign Prostatic Hyperplasia The recommended initial dosage of doxazosin 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. 2.3 Hypertension The initial dosage of doxazosin 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.