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.
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.
Type I and II 5 alpha-reductase inhibitor + alpha-1A blocker.
Ejaculation disorders, impotence, decreased libido, dizziness, breast disorders, orthostatic hypotension and/or syncope; rare: priapism.
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