Generic Name and Formulations:
Dutasteride 0.5mg; caps.
Company:
GlaxoSmithKline Pharmaceuticals
BPH, as monotherapy to improve symptoms and reduce risks of acute urinary retention and need for prostate surgery; or in combination with tamsulosin.
Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily.
Not applicable.
Type I and II 5 alpha-reductase inhibitor.
Not for use in children or women. Pregnant women and those of childbearing potential should avoid handling capsules.
Not for use in preventing prostate cancer. Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values (establish 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. Hepatic dysfunction. Avoid donating blood until at least six months after last dose.
May be potentiated by CYP3A4/5 inhibitors (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, ciprofloxacin); caution.
Impotence, decreased libido, ejaculation disorder, gynecomastia, dizziness (with tamsulosin).
Caps—30, 90