Dutasteride


Concise Prescribing Info
Indications/Uses
Benign prostatic hyperplasia.
Dosage/Direction for Use
Adult : PO 500 mcg once daily.
Dosage Details
Oral
Benign prostatic hyperplasia
Adult: 500 mcg once daily for at least 6 mth.
Child: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Administration
May be taken with or without food.
Contraindications
Women, childn and adolescents. Severe hepatic impairment. Pregnancy and lactation.
Special Precautions
Mild to moderate hepatic impairment.
Adverse Reactions
Impotence, decreased libido, ejaculation disorder, breast disorders (e.g. tenderness, enlargement), breast cancer, hypersensitivity reactions (e.g. rash, pruritus, urticaria, localised oedema, serious skin reactions, angioedema), depressed mood, testicular pain and swelling, decreased prostate-specific antigen (PSA) concentration.
Patient Counseling Information
Avoid donating blood during treatment and for at least 6 mth following treatment cessation.
MonitoringParameters
Monitor prostate-specific antigen (PSA) levels.
Drug Interactions
Plasma concentrations may be increased when used concomitantly w/ moderate or potent CYP3A4 inhibitors.
Lab Interference
May interfere with interpretation of prostate-specific antigen test results.
Action
Description: Dutasteride, a 4-azo analog of testosterone, is a selective inhibitor of steroid 5α-reductase isoenzymes type 1 (skin and hepatic) and type 2 (reproductive tissues). This results in inhibition of the conversion of testosterone to dihydrotestosterone and markedly suppresses serum dihydrotestosterone levels.
Pharmacokinetics:
Absorption: Absorbed from the GI tract. Bioavailability: Approx 60%. Time to peak plasma concentration: 1-3 hr.
Distribution: Plasma protein binding: >99.5%.
Metabolism: Undergoes hepatic metabolism by CYP3A4 and CYP3A5 isoenzymes.
Excretion: Via faeces (40% as metabolites; approx 5% as unchanged drug) and urine (<1% as unchanged drug). Elimination half-life: Approx 3-5 wk.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Dutasteride, CID=6918296, https://pubchem.ncbi.nlm.nih.gov/compound/Dutasteride (accessed on Jan. 21, 2020)

Storage
Store at 25°C.
References
Anon. Dutasteride. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 12/11/2014.

Anon. Dutasteride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/11/2014.

Avodart- Dutasteride Capsule, Liquid filled. DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 12/11/2014.

Buckingham R (ed). Dutasteride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com . Accessed 12/11/2014.

Disclaimer: This information is independently developed by MIMS based on Dutasteride from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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