Alfuzocin HCL 2.5mg Tabs 60s
INDICATIONS AND USAGE
Alfuzosin hydrochloride is an alpha-adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.
Important Limitations of Use:
Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension.
Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.
DOSAGE AND ADMINISTRATION
10 mg once daily with food and with the same meal each day.
Tablets should not be chewed or crushed
DOSAGE FORMS AND STRENGTHS
Extended-release tablet: 10 mg
- Moderate or severe hepatic impairment
- Coadministration with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir)
- Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients
WARNINGS AND PRECAUTIONS
- Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates
- Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min)
- Use with caution in patients with mild hepatic impairment
- Should not be used in combination with other alpha-adrenergic antagonists
- Prostate carcinoma should be ruled out prior to treatment
- Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique
- Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen
- Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval
- Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue.