Important Safety Information for UROXATRAL
UROXATRAL is contraindicated in patients with moderate or severe hepatic insufficiency
(Childs-Pugh categories B and C) and therefore should not be used in these patients.
UROXATRAL should not be administered with potent CYP3A4 inhibitors and therefore
should not be used in combination with drugs such as ketoconazole, itraconazole,
or ritonavir.
Postural hypotension with or without symptoms (eg, dizziness) may develop within
a few hours following administration of UROXATRAL. As with all alpha adrenergic
antagonists, there is a potential for syncope. Patients should be warned of the
possible occurrence of such events and should avoid situations where injury could
result should syncope occur. There may be an increased risk of hypotension/postural
hypotension and syncope when taking UROXATRAL concomitantly with anti-hypertensive
medication or nitrates, or PDE5 inhibitors.
Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery
in some patients on or previously treated with alpha adrenergic antagonists.
UROXATRAL should be used with caution in patients with severe renal insufficiency
(Cr Cl < 30 mL/min) or mild hepatic impairment. Caution should be exercised when
prescribing to patients with a known history of QT prolongation or to patients who
are taking medication known to prolong QT.
Patients should be assessed to rule out prostate cancer prior to beginning treatment
with UROXATRAL.
The most common side effects are dizziness, upper respiratory tract infection, headache,
and fatigue.