INDICATIONS
Benign Prostatic Hyperplasia (BPH):
Doxazosin mesylate 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). Doxazosin mesylate
may be used in all BPH patients whether hypertensive or
normotensive. In patients with hypertension and BPH, both
conditions were effectively treated with doxazosin mesylate
monotherapy. Doxazosin mesylate provides rapid improvement
in symptoms and urinary flow rate in 66-71% of patients.
Sustained improvements with doxazosin mesylate were seen
in patients treated for up to 14 weeks in double-blind
studies and up to 2 years in open-label studies.
Hypertension: Doxazosin mesylate is
also indicated for the treatment of hypertension. Doxazosin
mesylate 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 doxazosin mesylate 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 doxazosin mesylate. 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 doxazosin mesylate administration is discontinued
for several days, therapy should be restarted using the
initial dosing regimen.
Benign Prostatic Hyperplasia 1-8 mg Once Daily:
The initial dosage of doxazosin mesylate 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.
Hypertension 1-16 mg Once Daily: The
initial dosage of doxazosin mesylate 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.
HOW SUPPLIED
Cardura 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 are available as 1 mg (white), 2 mg (yellow),
4 mg (orange) and 8 mg (green) scored tablets.
Recommended Storage: Store below 86°F
(30°C).
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