Generic Name and Formulations:
Dutasteride 0.5mg; caps.
Indications for AVODART:
BPH, as monotherapy to improve symptoms and reduce risks of acute urinary retention and need for prostate surgery; or in combination with tamsulosin. Limitation of use: not approved for preventing prostate cancer.
Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily.
Not for use in children or women. Pregnant women and those of childbearing potential should avoid handling caps.
Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values (establish new baseline PSA after at least 3months 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 6months after last dose.
Type I and II 5 alpha-reductase inhibitor.
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).
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