CARDURA XL Safety Information
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.