Benign prostatic hyperplasia/urinary retention:

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 Dosage:

Swallow whole. Monotherapy: 0.5mg once daily. Combination therapy: 0.5mg once daily with tamsulosin 0.4mg once daily.

Children Dosage:

Not indicated.

AVODART Contraindications:

Pregnant women.

AVODART Warnings/Precautions:

Not for use in women. 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. Advise pregnant women to avoid handling caps; may cause potential risk to male fetus. Men should avoid donating blood until at least 6months after last dose.

AVODART Classification:

Type I and II 5 alpha-reductase inhibitor.

AVODART 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).

Metabolism:

Extensively metabolized (eg, CYP3A4 and CYP3A5).

Drug Elimination:

Fecal (primarily). Half-life: 5 weeks.

Generic Drug Availability:

YES

How Supplied:

Caps—30, 90