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Drug Catalog - Product Detail

DOXAZOSIN MESYLATE TB 4MG 1000

NDC Mfr Size Str Form
67253-0382-11 PAR PHARMACEUTICAL 1000 4MG TABLET
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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 is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Doxazosin mesylate is available as colored tablets for oral use and contains 1 mg (white), 2 mg (yellow), 4 mg (orange) and 8 mg (green) of doxazosin as the free base. The inactive ingredients for all tablets are: microcrystalline cellulose, NF; lactose, NF; sodium starch glycolate, NF; magnesium stearate, NF and sodium lauryl sulfate, NF. The 2 mg tablet contains D&C yellow #10 Aluminum Lake and FD&C yellow #6 Aluminum Lake; the 4 mg tablet contains FD&C yellow #6 Aluminum Lake; the 8 mg tablet contains FD&C blue #2 Aluminum Lake and D&C yellow #10 Aluminum Lake. Image of the chemical structure of doxazosin mesylate.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Doxazosin mesylate tablets, USP are available as 1 mg, white tablet, oval shape, partially bisected on one side, debossed with "1" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P16" on the other side; 2 mg, yellow tablet, oval shape, partially bisected on one side, debossed with "2" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P17" on the other side; 4 mg, orange tablet, oval shape, partially bisected on one side, debossed with "4" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P18" on the other side; and 8 mg, green tablet, oval shape, partially bisected on one side, debossed with "8" to the left and "mg" to the right of the partial bisection; and debossed with "ML-P19" on the other side. Bottles of 100: 1 mg NDC 67253-380-10 2 mg NDC 67253-381-10 4 mg NDC 67253-382-10 8 mg NDC 67253-383-10 Bottles of 1000: 1 mg NDC 67253-380-11 2 mg NDC 67253-381-11 4 mg NDC 67253-382-11 8 mg NDC 67253-383-11 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]
Indications & Usage
1 INDICATIONS AND USAGE Doxazosin mesylate is an alpha 1 adrenergic antagonist indicated for: Signs and symptoms of Benign Prostatic Hyperplasia (BPH) Treatment of Hypertension 1.1 Benign Prostatic Hyperplasia (BPH) Doxazosin mesylate tablets are indicated for the treatment of the signs and symptoms of BPH. 1.2 Hypertension Doxazosin mesylate 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 mesylate tablets 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 mesylate tablets, monitor blood pressure for at least 6 hours following administration. If doxazosin mesylate tablets 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 mesylate tablets 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 mesylate tablets 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.