From the FDA Drug Label
Caution should be exercised when UROXATRAL is administered in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12. 3)]. In phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies Safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 mL/min; therefore, caution should be exercised when UROXATRAL is administered in patients with severe renal impairment [see Warnings and Precautions (5.2)].
The safety of Alfuzosin (Uroxatral) on renal function, specifically in patients with impaired renal function, is a concern. Caution is advised when administering UROXATRAL to patients with severe renal impairment.
- Systemic exposure is increased by approximately 50% in patients with mild, moderate, and severe renal impairment.
- The safety profile of patients with mild or moderate renal impairment is similar to those with normal renal function.
- However, safety data is limited for patients with creatinine clearance below 30 mL/min, and therefore, caution should be exercised in these patients 1, 1, 1.
From the Research
Alfuzosin can be safely administered to patients with impaired renal function without the need for dosage adjustment, as evidenced by a study published in the Journal of Clinical Pharmacology in 2002 2. The study found that the pharmacokinetics of alfuzosin were not significantly altered in patients with mild to severe renal impairment, and that the medication was well-tolerated in these patients. Key findings from the study include:
- Mean Cmax values increased by a factor of 1.20,1.52, and 1.20 in subjects with mild, moderate, or severe renal impairment, respectively, compared with controls.
- Values for AUC(0-infinity) were 1.46,1.47, and 1.44, respectively.
- The t(1/2z) was increased only in the group with severe renal impairment.
- Emergent vasodilatory adverse events were reported by 4 of 26 subjects, and no discontinuations due to adverse events occurred.
- Laboratory parameters were satisfactory in all groups. It is essential to note that while alfuzosin is primarily metabolized by the liver, patients with kidney issues should still be monitored closely when starting alfuzosin treatment, and any changes in kidney function should be reported to their healthcare provider promptly. In terms of dosage, the standard dose of alfuzosin for treating benign prostatic hyperplasia is 10 mg once daily, and this dose may not need to be reduced in patients with significant kidney dysfunction, according to the study 2. However, as with any medication, the benefits of alfuzosin should be weighed against potential risks in patients with compromised kidney function. Other studies, such as those published in 1995 3, 2012 4, 2014 5, and 1998 6, provide information on the use of various medications in patients with renal impairment, but the study published in 2002 2 is the most relevant to the safety of alfuzosin in patients with impaired renal function.