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All about: Dutasteride

Big Image Pronouncation: (Doo-TASS-teer-ide)
Class: Androgen hormone inhibitor

Trade Names:
Avodart
- Capsules 0.5 mg

Mechanism of Action

Pharmacology

Inhibits the conversion of testosterone to 5-alpha-dihydrotestosterone, a potent androgen.

Pharmacokinetics

Absorption

T max is 2 to 3 h; bioavailability is approximately 60%; administration with food decreased C max 10% to 15%.

Distribution

Vd is 300 to 500 L; highly protein bound.

Metabolism

Metabolized by CYP3A4.

Elimination

Mainly excreted in feces (approximately 5% as unchanged dutasteride and approximately 40% as metabolites). The t ½ is approximately 5 wk.

Indications and Usage

Treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

Contraindications

Women; children; hypersensitivity to 5-alpha-reductase inhibitors or any component of the product.

Dosage and Administration

Adults

PO 0.5 mg once daily.

General Advice

  • Swallow capsules whole. Do not crush, cut, or chew.
  • Do not use capsules that are cracked or leaking.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from light.

Drug Interactions

CYP-450 3A4 inhibitors (eg, cimetidine, ciprofloxacin, diltiazem, ketoconazole, ritonavir, verapamil)

Plasma concentrations of dutasteride may be elevated, increasing the risk of adverse reactions.

Laboratory Test Interactions

Decreased prostate-specific antigen levels.

Adverse Reactions

Genitourinary

Impotence; decreased libido; ejaculation disorder; gynecomastia.

Precautions

Pregnancy

Category X .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hepatic Function

Use with caution.

Handling capsules

Women who are not pregnant should use caution whenever handling dutasteride capsules. If contact is made with leaking capsules, wash the contacted area immediately with soap and water.

Obstructive uropathy

Carefully monitor patients with large residual urine volume or severely diminished urinary flow.

Patient Information

  • Advise patient to read the patient information leaflet before starting dutasteride and with each refill.
  • Advise patient that prescribed dose is to be taken once daily without regard to meals and to try to take the dose at about the same time each day.
  • Advise patient that if a dose is missed to take as soon as remembered but to never take 2 doses the same day.
  • Advise patient that drug does not work immediately and that it may take 3 to 6 mo to experience maximum benefit.
  • Advise patient that ejaculate volume may be decreased during treatment but that this decrease does not interfere with normal sexual function.
  • Instruct patient to not stop taking dutasteride when symptoms have improved.
  • Caution patient that women who are or may be pregnant should not handle the medication because of risk of absorption though the skin and risk to developing male fetus.
  • Caution patient that a woman who is not pregnant can handle the capsules with caution but if contact is made with a leaking capsule to wash the contacted area immediately with soap and water.
  • Advise patient that impotence, decreased libido, and ejaculation disorder may occur with therapy but that these symptoms should lessen as treatment continues.
  • Advise patient against donating blood for at least 6 mo following discontinuation of therapy to prevent pregnant women from receiving dutasteride through a blood transfusion.

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