Generic Name and Formulations:
Dutasteride 0.5mg; caps.

Company:
GlaxoSmithKline Pharmaceuticals

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.

Adult Dose for AVODART:
Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily.

Children's Dose for AVODART:
See Contraindications.

Pharmacological Class:
Type I and II 5 alpha-reductase inhibitor.

Contraindications:
Not for use in children or women. Pregnant women and those of childbearing potential should avoid handling caps.

Warnings/Precautions:
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.

Interactions:
May be potentiated by CYP3A4/5 inhibitors (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, ciprofloxacin); caution.

Adverse Reactions:
Impotence, decreased libido, ejaculation disorder, gynecomastia, dizziness (with tamsulosin).

How Supplied:
Caps—30, 90