Generic Name and Formulations:
Dutasteride 0.5mg, tamsulosin HCl 0.4mg; caps.
Benign prostatic hyperplasia (BPH). Limitations of use: not approved for preventing prostate cancer.
Swallow whole. Take 1 cap daily approx. 30mins after the same meal each day.
Type I and II 5 alpha-reductase inhibitor + alpha-1A blocker.
Not for use in children. Pregnant women and those of childbearing potential should avoid handling caps. Pregnancy (Cat.X). Nursing mothers.
Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values (set new baseline PSA after 3–6 months of treatment); double PSA levels to compare with normal values. Rule out prostate cancer and other urological disorders prior to treatment. Syncope. End-stage renal disease. Severe hepatic impairment. Cataract surgery (intraoperative floppy iris syndrome possible); do not initiate tamsulosin-containing products. Poor metabolizers (low CYP2D6 activity). Sulfa allergy. Avoid donating blood until at least 6 months after last dose.
Concomitant strong inhibitors of CYP3A4 (eg, ketoconazole): not recommended; caution with strong CYP2D6 inhibitors (eg, paroxetine). Do not use with other alpha-blockers. Potentiated by cimetidine. Dutasteride may be potentiated by moderate CYP3A4/5 inhibitors (eg, diltiazem, erythromycin). Tamsulosin may be potentiated by a concomitant combination of CYP3A4 and CYP2D6 inhibitors (eg, terbinafine). Caution with PDE-5 inhibitors (may increase orthostatic hypotension). Monitor warfarin.
Ejaculation disorders, impotence, decreased libido, dizziness, breast disorders, orthostatic hypotension and/or syncope; rare: priapism.