Uroxatral (alfuzosin hydrochloride)
Treatment of signs and symptoms of BPH.
Benign Prostatic Hypertrophy
Take w/ food and w/ the same meal each day
Do not chew or crush tab
Tab, Extended-Release: 10mg
Moderate or severe hepatic impairment (Child-Pugh categories B and C), concomitant use of potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir).
Postural hypotension with or without symptoms (eg, dizziness) may develop within a few hrs after administration; caution with symptomatic hypotension or in those who had a hypotensive response to other medications. Syncope may occur; caution to avoid situations in which injury could result should syncope occur. Prostate carcinoma and BPH frequently coexist and many of their symptoms are similar. D/C if symptoms of angina pectoris appear or worsen. Caution with severe renal impairment, mild hepatic impairment, or congenital/acquired QT prolongation. Intraoperative floppy iris syndrome (IFIS) observed in some patients during cataract surgery. Priapism reported (rare).
Dizziness, URTI, headache.
See Contraindications. Avoid use with other α-blockers. May increase risk of hypotension/postural hypotension and syncope with nitrates and other antihypertensives. Caution with medications that prolong the QT interval. Caution with PDE-5 inhibitors; may potentially cause symptomatic hypotension.
PREGNANCY AND LACTATION
Category B, safety not known in nursing.
MECHANISM OF ACTION
α1-antagonist; selectively inhibits α1-adrenergic receptors in lower urinary tract causing smooth muscle in bladder neck and prostate to relax, which results in improved urine flow and decreased symptoms of BPH.
Absorption: Absolute bioavailability (49%), Cmax=13.6ng/mL, Tmax=8 hrs, AUC0-24=194ng•hr/mL. Distribution: Vd=3.2L/kg (IV); plasma protein binding (82-90%). Metabolism: Liver (extensive) via CYP3A4; oxidation, O-demethylation, N-dealkylation. Elimination: Feces (69%), urine (24%, 11% unchanged); T1/2=10 hrs.
Assess for hypersensitivity to drug, symptomatic hypotension, history of QT prolongation, hepatic/renal impairment, cataract surgery, and possible drug interactions. Rule out the presence of prostate cancer prior to therapy.
Monitor for postural hypotension, syncope, hypersensitivity reactions, IFIS, QT prolongation, hepatic/renal impairment, and other adverse reactions. Monitor urine flow.
Inform about possible occurrence of symptoms related to postural hypotension when beginning therapy; caution about driving, operating machinery, or performing hazardous tasks during this period. Instruct to inform ophthalmologist about use of the product before cataract surgery or other procedures involving the eyes, even if no longer taking the medication. Advise about the possibility of priapism resulting from treatment and to seek immediate medical attention if it occurs.
25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light and moisture.
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