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GENITO URINARY SYSTEM AND SEX HORMONES › UROLOGICALS › DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY › Alpha-adrenoreceptor antagonists
alfuzosin and finasteride
G04CA51
Forms & Strengths
- Alfuzosin 10 mg extended-release / Finasteride 5 mg fixed-dose combination
- Separate oral formulations: Alfuzosin HCl 10 mg extended-release tablets; Finasteride 5 mg tablets
Adult Dosing
- Benign Prostatic Hyperplasia (BPH): One tablet (Alfuzosin 10 mg / Finasteride 5 mg) orally once daily
- Administer the combination product or individual components approximately 30 minutes after the same meal each day
- Swallow tablets whole; do not crush, split, or chew
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
- Not indicated for use in pediatric populations
Indications
- Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate
- Improvement of BPH symptoms, reduction in the risk of acute urinary retention, and reduction in the risk of the need for BPH-related surgery
Mechanism of Action
- Alfuzosin: Uroselective alpha-1 adrenergic receptor antagonist; relaxes smooth muscle in the bladder neck and prostate, reducing dynamic obstruction
- Finasteride: Competitive inhibitor of type II 5-alpha-reductase; blocks conversion of testosterone to dihydrotestosterone (DHT), reducing prostate size and static obstruction
Contraindications
- Hypersensitivity to alfuzosin, finasteride, other alpha-1 blockers, or any component of the formulation
- Moderate to severe hepatic impairment
- Co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
- Pregnancy, women of childbearing potential, and pediatric patients (due to teratogenic risks of finasteride via 5-alpha-reductase inhibition)
Adverse Reactions
- Dizziness, headache, fatigue
- Orthostatic hypotension, syncope
- Erectile dysfunction, decreased libido, ejaculation disorders (associated with finasteride)
- Upper respiratory tract infection, nasopharyngitis
- Floppy iris syndrome during cataract surgery
Drug Interactions
- Potent CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) significantly increase alfuzosin exposure; avoid co-administration
- Phosphodiesterase-5 (PDE-5) inhibitors (e.g., sildenafil, tadalafil): risk of additive blood pressure-lowering effects and symptomatic hypotension
- Other antihypertensive agents: potential for enhanced hypotensive effects
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may decrease alfuzosin plasma concentrations
Curated Content: Needs Vetting Before Put to Clinical Use