Trade Names:Avodart- Capsules 0.5 mg
Inhibits the conversion of testosterone to 5-alpha-dihydrotestosterone, a potent androgen.
T max is 2 to 3 h; bioavailability is approximately 60%; administration with food decreased C max 10% to 15%.
Vd is 300 to 500 L; highly protein bound (99%).
Metabolized by CYP3A4 and CYP3A5.
Mainly excreted in feces (approximately 5% as unchanged dutasteride and approximately 40% as metabolites). The t ½ is approximately 5 wk.
Pharmacokinetics have not been studied; however, no dosage adjustment is anticipated for patients with renal function impairment.Hepatic Function Impairment
Pharmacokinetics have not been studied; however, because dutasteride is extensively metabolized, exposure could be higher in patients with hepatic function impairment.
Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of need for BPH-related surgery.
Women; children; hypersensitivity to 5-alpha-reductase inhibitors or any component of the product.
PO 0.5 mg once daily.
Store at controlled room temperature (59° to 86°F).
Plasma concentrations of dutasteride may be elevated, increasing the risk of adverse reactions.
Decreased prostate-specific antigen levels.
Decreased libido (3%).
Impotence (5%); ejaculation disorder, gynecomastia (1%).
Allergic reactions including angioedema, localized edema, pruritus, rash, urticaria (postmarketing).
Perform digital rectal exams, as well as other evaluations for prostate cancer prior to starting therapy and periodically thereafter. Assess patient to rule out other urologic diseases prior to treatment. Carefully monitor patients with large residual urine volume or severely diminished urinary flow for obstructive uropathy.
Category X .
Safety and efficacy not established.
Use with caution.
Men should not donate blood until at least 6 mo after the last dose of dutasteride.
Women who are pregnant or may be pregnant should not handle the capsules. Women who are not pregnant should use caution whenever handling the capsules. If contact is made with leaking capsules, wash the contacted area immediately with soap and water.
Patients with large residual urine volume or severely diminished urinary flow may not be good candidates for therapy.
Sperm count may be reduced in some patients.
Single doses of dutasteride 40 mg for 7 days have not produced safety concerns.
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