AVODART 0.5/MG SOFT CAP 30/CAP

Indications

Approved Uses

Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate; reduces risk of acute urinary retention and need for BPH-related surgery.

Off-Label Uses

Androgenetic alopecia (male pattern hair loss) is a common off-label use; other dermatologic uses (e.g., female pattern hair loss, frontal fibrosing alopecia) are reported but off-label with limited evidence and require specialist oversight; not recommended for prostate cancer risk reduction as a routine off-label indication.

Dosage & Administration

Dosing by Condition

BPH: 0.5 mg orally once daily; may be used alone or in combination with an alpha-blocker (e.g., tamsulosin 0.4 mg daily) when clinically indicated.

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 or adolescents under 18 years

Dose Adjustment Notes

No dosage adjustment is required in renal impairment; no adjustment is recommended for mild-to-moderate hepatic impairment, but use caution/avoid in severe hepatic impairment due to extensive hepatic metabolism.

How to Take

Swallow the capsule whole with water. Do not chew, crush, or open it as the contents may irritate the oropharyngeal mucosa. Can be taken with or without food.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): erectile dysfunction/impotence, decreased libido, ejaculation disorders, gynecomastia/breast tenderness or enlargement; Uncommon/Rare: hypersensitivity reactions (rash, pruritus, urticaria, angioedema); Frequency not known/very rare: depressed mood, testicular pain/swelling; male breast cancer: very rare/postmarketing.

Safety & Warnings

Contraindications

Contraindicated in: pregnancy; women who are or may become pregnant (including handling of leaking capsules); and patients with known hypersensitivity to dutasteride or other 5-alpha-reductase inhibitors (or any component).

Warnings & Precautions

Key warnings: women who are pregnant or may become pregnant must not handle leaking/broken capsules (skin absorption/teratogenicity); PSA decreases ~50% after ~6 months-interpret PSA accordingly; possible increased risk of high-grade prostate cancer; avoid blood donation during therapy and for 6 months after the last dose; sexual adverse effects may occur/persist.

Age Restriction

Not approved/indicated for patients <18 years; indicated for adult men with BPH.

Driving Warning

Safe

Drug Interactions

Drug Interactions

CYP3A4 inhibitors (especially strong/moderate inhibitors such as ketoconazole, ritonavir, verapamil, diltiazem) can increase dutasteride exposure; use caution/monitor-no routine dose adjustment is specified.

Interaction Severity

MODERATE: Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) can increase dutasteride exposure; moderate inhibitors (e.g., verapamil, diltiazem) may also increase levels-generally monitor rather than avoid. MINOR: No consistently clinically significant minor interactions beyond CYP3A inhibition effects.

Food Interaction

No food restrictions; may be taken with or without food.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Contraindicated

Children

Not approved for children or adolescents under 18 years

Elderly

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

Kidney Impairment

No adjustment needed.

Liver Impairment

No specific dose adjustment is established; use with caution in hepatic impairment, particularly severe impairment.

Storage & Patient Advice

Stopping the Medicine

Do not discontinue without prescriber advice; stopping may lead to gradual return/worsening of BPH symptoms over time.

Overdose

No specific overdose syndrome identified; manage with symptomatic/supportive care and seek medical attention/poison center guidance if overdose is suspected.

Patient Counseling

Swallow capsule whole (do not open/crush/chew); take once daily consistently; expect delayed benefit (often 3-6+ months); women who are pregnant or may become pregnant must not handle leaking/broken capsules; inform clinicians PSA will be lowered (~50%); do not donate blood during therapy and for 6 months after stopping; report sexual adverse effects and any breast changes (lumps/pain/nipple discharge).

Monitoring Requirements

PSA at baseline and periodically (expect ~50% reduction after ~3-6 months; establish a new baseline and investigate any confirmed PSA rise), plus routine BPH/prostate cancer evaluation (e.g., DRE per clinician).

Pharmacology

Mechanism of Action

Dual inhibitor of type 1 and type 2 5-alpha-reductase, reducing conversion of testosterone to dihydrotestosterone (DHT) and thereby decreasing DHT-driven prostate growth.

Onset of Action

Symptom improvement may begin within ~1-3 months, with maximal benefit typically requiring ~6 months or longer.

Duration of Effect

Clinical benefit persists only with continued therapy; due to a long terminal half-life (~3-5 weeks), DHT suppression and drug levels decline gradually after stopping and prostate/symptoms may worsen over time.

Half-Life

Terminal half-life approximately 3-5 weeks.

Bioavailability

Approximately 60%.

Metabolism

Extensively hepatic metabolism primarily via CYP3A4, with minor contribution from CYP3A5, to multiple metabolites (mostly inactive).

Excretion

Eliminated primarily via feces (mostly as metabolites; small amount unchanged); urinary excretion is minimal (<1%).

Protein Binding

>99.5%.

Product Information

Available Dosage Forms

Oral capsule, liquid-filled (soft gelatin capsule).

Composition per Dose

Each soft gelatin capsule: 0.5 mg dutasteride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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