Alfuzosin
Regulatory sources consulted
- aemps-cima-ft-67605
- ansm-bdpm-rcp-69490193
- CredibleMeds.org
- RxNorm rxcui 17300 ↗
Approved indications
- Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH).
- Adjunctive therapy to urethral catheterization for acute urinary retention (AUR) related to BPH.
Contraindications
Absolute
- Hypersensitivity to alfuzosin or to any of the excipients.
- History of orthostatic hypotension.
- Combination with other alpha-1 receptor blockers.
- Hepatic insufficiency.
Clinical warnings
- Major warning · Risk of orthostatic hypotension, especially in the first hours after administration. Use with caution in patients treated with antihypertensives or nitrates. — ANSM
- 'Intraoperative Floppy Iris Syndrome' (IFIS) has been observed during cataract surgery in patients on or previously treated with alpha-blockers. — ANSM
- Major warning · Risk of priapism. If not treated properly, it can lead to permanent tissue damage and impotence. — ANSM
Drug interactions
- HighKetoconazoleJ02AB02
Mechanism: Potent inhibition of CYP3A4, significantly increasing alfuzosin plasma concentrations.
Recommendation: Association not recommended. Avoid concomitant use with potent CYP3A4 inhibitors.
ANSM SPC
- HighOther alpha-1 blockersG04CA
Mechanism: Additive class effect, increased risk of orthostatic hypotension.
Recommendation: Concomitant use is contraindicated.
ANSM SPC
Adverse events
Common (≥1%)
dizziness · headache · asthenia · nausea · abdominal pain
Rare but serious
priapism · severe orthostatic hypotension · angina pectoris · atrial fibrillation · hepatocellular injury · intraoperative floppy iris syndrome · neutropenia · thrombocytopenia
Pregnancy and lactation
FDA category: NA
Not applicable. The indication for alfuzosin is for the treatment of benign prostatic hyperplasia in men.