TAMSULOSIN CAP,ORAL
Clinical Criteria Summary
Indication & Patient Population
- Benign prostatic hypertrophy/hyperplasia (BPH) with moderate to severe symptoms
- Patients currently receiving alpha-blocker monotherapy at maintenance doses (e.g., alfuzosin 10 mg qd) or highest tolerated dose if maintenance dose was not achieved
- Alpha-blocker naive patients presenting with BPH symptoms
Clinical Criteria for Combination Therapy Initiation/Continuation
- Large prostate volume (typically >40ml, approximately the size of a golf ball)
- Clinical progression of BPH symptoms evidenced by:
- Increase in AUA symptom score ≥4 points from baseline
- History of acute urinary retention
- Persistently bothersome symptoms despite adequate alpha-blocker therapy
- Baseline AUA symptom score ≥12 for patients not previously treated with alpha-blockers
- High risk for intervention or urinary retention due to large prostate volume (>40ml)
Safety, Monitoring & Precautions
- Discuss risks and benefits of long-term finasteride therapy with the patient prior to initiation
- Finasteride is not recommended for prevention of prostate cancer based on the Prostate Cancer Prevention Trial
- Patients must be reevaluated on a regular basis
- Monitor PSA levels; double values after more than 6 months of finasteride therapy to approximate actual off-therapy levels
- Referral to a local expert is strongly advised for severe unrelenting symptoms, very large prostates, or smaller prostate mass with poor response to alpha-blockers
Adverse Event Profile
- Alpha-blockers: dizziness, postural hypotension, asthenia
- Finasteride (monotherapy or combination): erectile dysfunction, decreased libido, abnormal ejaculation
- Combination therapy: increased frequency of abnormal ejaculation, peripheral edema, dyspnea; breast cancer diagnosed in a small number of patients
Drug Interactions (PDE5 Inhibitors)
- Sildenafil: Do not administer within 4 hours of an alpha-blocker; 25mg dose may be taken at any time
- Tadalafil: Concomitant administration with alpha-blockers other than tamsulosin 0.4mg is not recommended
- Vardenafil: Concomitant administration with any alpha-blocker is contraindicated