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Drug reference

Dutasteride

5-alpha-reductase inhibitor (type 1 and 2) · Benign Prostatic Hyperplasia agent; Androgen inhibitor

Also known as Avodart, Dutasterid

START
0.5 mg PO once daily (± tamsulosin 0.4 mg)
TYPICAL MAX
0.5 mg/day
STOP IF
Significant depression/suicidality, suspected breast malignancy, planned conception (long washout)
WATCH
PSA — establish new baseline at 6 months and double measured PSA when screening; mood; sexual function
CDSCO approvedSchedule HATC G04CB02
Renal dose adjustmenteGFR mL/min/1.73m²
FULLNo dose adjustment at any eGFR (negligible renal excretion)90

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours
38minONSET2.5hPEAK5w1dDURATION
ONSET
38min · absorption onset
PEAK
2.5h · Cmax
5w · steady-state t½ (~5 weeks)
DURATION
1d · once-daily dosing
EXCRETION
Hepatic CYP3A4; faecal metabolites, negligible renal
route + CYP
INTERACTIONS
none in our sources
PREGNANCY
Contraindicated — risk of male-fetus genital abnormalities; women must not handle leaking capsules
FDA category + note
Available in India

50 branded formulations. Look up specific brands in the Drugs workspace.

Mechanism

Dual inhibition of 5-alpha-reductase types 1 and 2, blocking conversion of testosterone to dihydrotestosterone (>90% serum DHT suppression), reducing prostate volume and androgenetic hair loss.

Indications

Symptomatic benign prostatic hyperplasia (alone or with tamsulosin)Androgenetic alopecia (off-label/region-dependent)

Dosing

Adult
0.5 mg PO once daily (monotherapy or with tamsulosin 0.4 mg).
Pediatric
Contraindicated.
Renal adjustment
No adjustment (minimal renal excretion).
Hepatic adjustment
No data in hepatic impairment — use with caution (extensive hepatic metabolism).
Geriatric
No specific adjustment.
Max dose
0.5 mg/day

Pharmacokinetics

Onset
DHT suppression within days; clinical benefit 3–6 months
Peak effect
~2–3 h (Cmax); clinical 6 months
Duration
Long (accumulates)
Half-life
~5 weeks at steady state
Bioavailability
~60%
Protein binding
>99%
Metabolism
Hepatic CYP3A4/3A5
Excretion
Faecal (metabolites); negligible renal unchanged

Contraindications

  • Pregnancy and women of childbearing potential (teratogenic — male fetus)
  • Children
  • Hypersensitivity to dutasteride or other 5-ARIs

Side effects

Common
Decreased libidoErectile dysfunctionEjaculation disordersGynaecomastia/breast tenderness
Serious
  • Persistent sexual dysfunction (may continue after stopping)
  • Depressed mood/suicidality (reported)
  • Possible increased high-grade prostate cancer (class signal)
  • Male breast cancer (rare)

Pregnancy & lactation

Pregnancy

Contraindicated — risk of male-fetus genital abnormalities; women must not handle leaking capsules

Lactation

Not indicated in women

Drug interactions

Carbamazepine
Moderate
Textbook

Reduced plasma levels and potentially decreased efficacy of dutasteride.

Interactions with CYP3A4 inducers are possible; dose adjustments or monitoring may be required.

Source: KDT 7e · p303

Ketoconazole
Moderate
Database

Increased plasma levels and potential for adverse effects of dutasteride.

Interactions with CYP3A4 inhibitors are possible; dose adjustments or monitoring may be required.

Source: DDInter

Strong Cyp3a4 Inhibitors
Moderate
Database

Increased dutasteride exposure

Consider dose interval reduction with long-term potent inhibitors

Source: Kimi deep-research + Cla

Tamsulosin
Moderate
Database

Intended combination — additive BPH benefit; additive hypotension/ejaculatory effects

Standard combination; counsel on orthostasis/IFIS

Source: Kimi deep-research + Cla

Testosterone
Moderate
Database

Opposing hormonal effect; confounds therapy

Avoid concurrent unless clinically justified

Source: Kimi deep-research + Cla

7 additional low-confidence interactions hidden — those rows lack a documented mechanism or management plan in our sources.

Related guidelines

Ask House about Dutasteride

Continue into a citation-backed clinical answer with the drug context already attached.

Sources: KD Tripathi 7e, Goodman & Gilman 14e, Katzung, BNF·Verified: 2026-05-19 · House clinical team·Cockpit curated: 2026-05-19