Dutasteride

AVODART

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What it isDual 5-alpha reductase inhibitor of both type 1 and type 2; benign prostatic hyperplasia.

Why this oneIt blocks both isoenzymes, giving more complete DHT suppression than finasteride.

What limits itA half-life of weeks means effects and teratogenic risk persist long after stopping — no blood donation for six months. It halves PSA.

FDA-approved for

BPH (2001)

FDA label

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FDA dosing	Population	Start	Target	Max
Benign prostatic hyperplasia	Adult men	0.5 mg QD	0.5 mg QD	0.5 mg QD

Renal No adjustment needed

Hepatic Undefined (not studied; exposure may be higher)

May be given with tamsulosin 0.4 mg QD (same dutasteride dose)

Instructions

Swallow whole; do not chew or open (contents may irritate oropharyngeal mucosa)
Take with or without food
Do not donate blood until at least 6 months after the last dose

Contraindications

Pregnancy; women who are or may become pregnant (risk to male fetus)

Cautions

Reduces serum PSA by ~50% (interpret PSA accordingly; any confirmed rise may signal prostate cancer)
May increase risk of high-grade prostate cancer
Evaluate for other urological conditions before treatment
Pregnant/potentially pregnant women should not handle capsules
No blood donation for 6 months after last dose
Reduces sperm count/semen volume/motility

Adverse reactions

Impotence
Decreased libido
Ejaculation disorders
Breast disorders (enlargement/tenderness)

Pregnancy Contraindicated; may cause harm to a male fetus.

Lactation Not indicated for use in women; no data.

NO BOXED WARNINGS

Principal riskSexual dysfunction; halves PSA

Cost, est. cash$4–$300/month

Generic entry2010

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk4 / 4

Legacy pregnancy categoryX

Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.