* Treatment-emergent adverse events occurring in ≥1% of BPH patients treated with CARDURA XL and more frequently than with placebo in the 2 controlled clinical studies. † Immediate release.
Important Safety Information
CARDURA XL is contraindicated in patients with a known sensitivity to other quinazolines (eg, prazosin, terazosin),
doxazosin, or any of the inert ingredients.
Postural hypotension with or without symptoms (eg, dizziness) may develop within a few hours
following administration of CARDURA XL. However, infrequently, symptomatic postural hypotension has also been reported more than a few hours after dosing.
As with other alpha blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength.
Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur.
Prior to commencing therapy with CARDURA XL, carcinoma of the prostate should be ruled out. Intraoperative floppy iris syndrome (IFIS) has
been observed during cataract surgery in some patients on or previously treated with alpha1 blockers.
Caution should be used when administering CARDURA XL to patients with preexisting severe gastrointestinal tract narrowing, chronic
constipation, or evidence of mild or moderate hepatic dysfunction. Use in patients with severe hepatic impairment is not recommended.
The most commonly reported adverse events occurring in >2% of patients were: headache, dizziness, respiratory tract infection,
asthenia, and back pain.
This product information is intended only for residents of the United States.
