INDICATIONS AND USAGE
A. Benign Prostatic Hyperplasia (BPH)
CARDURA is indicated for the treatment of both the urinary outflow obstruction and obstructive and irritative symptoms associated with BPH: obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning). CARDURA may be used in all BPH patients whether hypertensive or normotensive. In patients with hypertension and BPH, both conditions were effectively treated with CARDURA monotherapy. CARDURA provides rapid improvement in symptoms and urinary flow rate in 66–71% of patients. Sustained improvements with CARDURA were seen in patients treated for up to 14 weeks in double-blind studies and up to 2 years in open-label studies.
CARDURA (doxazosin mesylate) is also indicated for the treatment of hypertension. CARDURA may be used alone or in combination with diuretics, beta-adrenergic blocking agents, calcium channel blockers or angiotensin-converting enzyme inhibitors.
DOSAGE AND ADMINISTRATION
DOSAGE MUST BE INDIVIDUALIZED. The initial dosage of CARDURA in patients with hypertension and/or BPH is 1 mg given once daily in the a.m. or p.m. This starting dose is intended to minimize the frequency of postural hypotension and first dose syncope associated with CARDURA. Postural effects are most likely to occur between 2 and 6 hours after a dose. Therefore, blood pressure measurements should be taken during this time period after the first dose and with each increase in dose. If CARDURA administration is discontinued for several days, therapy should be restarted using the initial dosing regimen.
A. BENIGN PROSTATIC HYPERPLASIA 1–8 mg once daily.
The initial dosage of CARDURA is 1 mg, given once daily in the a.m. or p.m. Depending on the individual patient's urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and 8 mg once daily, the maximum recommended dose for BPH. The recommended titration interval is 1–2 weeks. Blood pressure should be evaluated routinely in these patients.
B. HYPERTENSION 1–16 mg once daily.
The initial dosage of CARDURA is 1 mg given once daily. Depending on the individual patient's standing blood pressure response (based on measurements taken at 2–6 hours post-dose and 24 hours post-dose), dosage may then be increased to 2 mg and thereafter if necessary to 4 mg, 8 mg and 16 mg to achieve the desired reduction in blood pressure. Increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, postural dizziness/vertigo and postural hypotension. At a titrated dose of 16 mg once daily the frequency of postural effects is about 12% compared to 3% for placebo.
CARDURA (doxazosin mesylate) is available as colored 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.
CARDURA TABLETS (doxazosin mesylate) are available as 1 mg (white), 2 mg (yellow), 4 mg (orange) and 8 mg (green) scored tablets.
|Bottles 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 Packages 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)|
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
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