Dutasteride

Dutasteride

Approved uses

• Dutasteride capsules are a 5 alpha-reductase inhibitor indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for BPH-related surgery.
• Limitations of Use: Dutasteride capsules are not approved for the prevention of prostate cancer.

Forms and strengths

• 0.5 mg, yellow opaque oblong capsule filled with clear transparent solution and printed with "SZ31" in red ink. 0.5 mg soft gelatin capsules

How it is taken

• The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. Dutasteride capsules may be administered with or without food. Monotherapy: 0.5 mg once daily.
• Combination with tamsulosin: 0.5 mg once daily and tamsulosin 0.4 mg once daily.
• Dosing considerations: Swallow whole. May take with or without food.

Must not be used when

• Dutasteride capsules are contraindicated for use in: Pregnancy.
• Dutasteride use is contraindicated in women who are pregnant.
• In animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia.
• Therefore, dutasteride may cause fetal harm when administered to a pregnant woman.

Interactions

• Use with caution in patients taking potent, chronic cytochrome P450 (CYP)3A4 enzyme inhibitors (e.g., ritonavir).

Warnings and precautions

• Dutasteride reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on dutasteride capsules may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for untreated men.
• Dutasteride may increase the risk of high-grade prostate cancer.
• Prior to initiating treatment with dutasteride, consideration should be given to other urological conditions that may cause similar symptoms.
• Women who are pregnant or may be pregnant should not handle dutasteride capsules due to potential risk to a male fetus.
• Patients should not donate blood until 6 months after their last dose of dutasteride.

Common side effects

• most common adverse reactions, reported in ≥1% of subjects treated with dutasteride and more commonly than in subjects treated with placebo, are impotence, decreased libido, ejaculation disorders, and breast disorders.
• most common adverse reactions reported in subjects receiving combination therapy (dutasteride plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.
• most common adverse reaction leading to trial withdrawal was impotence (1%).

Pregnancy

Dutasteride is contraindicated for use in pregnancy because it may cause harm to the male fetus. Dutasteride is not indicated for use in women. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.

How it acts

Dutasteride inhibits the conversion of testosterone to DHT. DHT is the androgen primarily responsible for the initial development and subsequent enlargement of the prostate gland. Testosterone is converted to DHT by the enzyme 5 alpha-reductase, which exists as 2 isoforms, type 1 and type 2.

Label holder:

Aurobindo Pharma Limited

Label version:

11 September 2025

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.