DUSTA 0.5/MG SOFT CAP 30/CAP

Indications

Approved Uses

Treatment of symptomatic benign prostatic hyperplasia (BPH) in adult men with an enlarged prostate; reduces risk of acute urinary retention and need for BPH-related surgery; may be used alone or in combination with an alpha-blocker (e.g., tamsulosin).

Dosage & Administration

Dosing by Condition

BPH: dutasteride 0.5 mg orally once daily; may be used in combination with an alpha-blocker (e.g., tamsulosin 0.4 mg once daily) in appropriate patients.

Initial Dose

0.5 mg once daily

Maintenance Dose

0.5 mg once daily

Maximum Dose

0.5mg once daily.

Children's Dosage

Not approved for children.

How to Take

Swallow the capsule whole with water. Do not chew, crush, or open it, as the contents can irritate the mouth and throat. Can be taken with or without food.

Side Effects

Common Side Effects

Impotence (erectile dysfunction), decreased libido, ejaculation disorders (including decreased semen volume), gynecomastia (breast enlargement and tenderness).

Side Effect Frequency

Common (1-10%): erectile dysfunction, decreased libido, ejaculation disorders, breast disorders (gynecomastia/breast tenderness). Uncommon (<1%): testicular pain/swelling, depressed mood/depression, dizziness; hypersensitivity reactions are rare.

Safety & Warnings

Contraindications

Contraindicated in: women (including pregnancy and women of childbearing potential), pediatric patients, and patients with hypersensitivity to dutasteride or other 5-alpha-reductase inhibitors (or any excipients).

Warnings & Precautions

Key warnings/precautions: may increase detection/risk of high-grade prostate cancer; lowers PSA ~50% after ~6 months (adjust PSA interpretation and evaluate rises from nadir); women who are pregnant/may become pregnant and children must not handle leaking/broken capsules (dermal absorption risk); assess BPH (DRE/PSA) before and during therapy; do not donate blood during treatment and for 6 months after stopping.

Age Restriction

Not indicated/approved for pediatric patients; use is for adult men (typically for BPH).

Drug Interactions

Drug Interactions

CYP3A4 inhibitors (especially potent inhibitors such as ketoconazole and ritonavir; also inhibitors like verapamil/diltiazem) can increase dutasteride exposure-use caution/monitor; no major interaction expected with most other drugs.

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children.

Elderly

Standard adult dosing; no dose adjustment required based on age alone

Storage & Patient Advice

Patient Counseling

Take 0.5 mg once daily at the same time each day, with or without food; swallow capsule whole (do not open/crush/chew); pregnant women or those who may become pregnant must not handle leaking/broken capsules; do not donate blood during therapy and for at least 6 months after stopping; inform clinicians before PSA testing because PSA is lowered (~50%); expect symptom improvement over months (often 3-6+ months); report breast changes (lump/pain/nipple discharge) and any allergic reactions.

Monitoring Requirements

Monitor PSA and clinical response; establish a new PSA baseline after ~3-6 months and interpret subsequent PSA values by considering ~50% PSA reduction (i.e., roughly double measured PSA for comparison to untreated reference); continue routine prostate cancer evaluation (e.g., DRE as clinically indicated).

Pharmacology

Mechanism of Action

Inhibits both type 1 and type 2 5-alpha-reductase, reducing conversion of testosterone to dihydrotestosterone (DHT) and thereby lowering DHT and reducing prostate volume over time.

Product Information

Available Dosage Forms

Capsule, soft (oral soft gelatin capsule).

Composition per Dose

Each soft capsule: 0.5 mg dutasteride

OTC Alternatives

No OTC alternative

Urological Condition

BPH

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 19-07-2026