DUODART 0.5/0.4/MG CAP 30/CAP

Indications

Approved Uses

Treatment of moderate to severe symptomatic benign prostatic hyperplasia (BPH) in adult men, including reduction in the risk of acute urinary retention (AUR) and BPH-related surgery.

Dosage & Administration

Dosing by Condition

Benign Prostatic Hyperplasia (BPH): One capsule (0.5mg/0.4mg) taken orally once daily, approximately 30 minutes after the same meal each day.

Initial Dose

One capsule once daily (dutasteride 0.5mg + tamsulosin 0.4mg)

Maintenance Dose

One capsule once daily

Maximum Dose

One capsule (dutasteride 0.5mg + tamsulosin 0.4mg) once daily

Children's Dosage

Not approved for children or adolescents under 18 years

Dose Adjustment Notes

Renal impairment: no dosage adjustment generally required. Hepatic impairment: use caution in mild to moderate impairment; avoid/contraindicated in severe hepatic impairment. No dose titration required (fixed-dose capsule).

How to Take

Swallow capsule whole with water approximately 30 minutes after the same meal each day. Do not crush, chew, or open the capsule. Capsule contents can irritate the oropharyngeal mucosa.

Side Effects

Common Side Effects

Erectile dysfunction, decreased libido, ejaculation disorders, dizziness/orthostatic hypotension, and breast tenderness/enlargement (gynecomastia); rhinitis and headache can also occur.

Side Effect Frequency

Common (≥1% to <10%): ejaculation disorders, impotence/erectile dysfunction, decreased libido, dizziness. Breast disorders (tenderness/enlargement/gynecomastia) are typically uncommon (<1%) with the combination (though can be reported with dutasteride).

Safety & Warnings

Contraindications

Contraindicated in: women (including pregnancy and breastfeeding) and children/adolescents; hypersensitivity to dutasteride, other 5‑alpha‑reductase inhibitors, tamsulosin, or any excipients (including soya lecithin/peanut/soy allergy where applicable); severe hepatic impairment; history of orthostatic hypotension.

Warnings & Precautions

Key warnings/precautions: women who are pregnant or may become pregnant must not handle leaking/broken capsules (transdermal absorption of dutasteride); PSA decreases ~50% after 3-6 months-establish a new baseline and interpret PSA accordingly; risk of orthostatic hypotension especially at initiation; IFIS risk-inform ophthalmologist before cataract surgery; monitor for breast changes; consider the 5‑ARI high-grade prostate cancer signal; excipients may include soya lecithin (relevant to soy/peanut allergy depending on local formulation).

Age Restriction

Not indicated/approved for use in children or adolescents (<18 years); intended for adult men with BPH.

Driving Warning

Caution with activities requiring alertness due to risk of dizziness and orthostatic hypotension

Drug Interactions

Drug Interactions

Clinically important interactions: strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, itraconazole) and CYP2D6 inhibitors (e.g., paroxetine) can increase tamsulosin exposure; other alpha-blockers and PDE5 inhibitors can cause additive hypotension; antihypertensives may enhance hypotension-avoid/monitor. Co-administration with other alpha-blockers should generally be avoided (not routinely listed as an absolute contraindication in all labels).

Interaction Severity

MAJOR: strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) can markedly increase tamsulosin exposure-avoid. MODERATE: PDE5 inhibitors and other antihypertensives (additive hypotension). AVOID/CONTRAINDICATED: concomitant use with other alpha-blockers due to additive hypotension/syncope risk.

Food Interaction

Take once daily about 30 minutes after the same meal each day; avoid taking on an empty stomach.

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. Monitor for orthostatic hypotension more closely in elderly patients.

Kidney Impairment

No dose adjustment is generally required in mild-moderate renal impairment; in severe renal impairment (CrCl <10 mL/min) use with caution due to limited data.

Liver Impairment

Mild to moderate hepatic impairment: use with caution (no established dose adjustment); severe hepatic impairment: contraindicated.

Storage & Patient Advice

Missed Dose

If a dose is missed, take it when remembered the same day; if it is close to the next dose, skip the missed dose and resume the regular schedule-do not double the dose.

Stopping the Medicine

Can be stopped without tapering, but should be done in consultation with the prescriber; BPH symptoms may recur after discontinuation.

Overdose

Overdose is expected to present mainly with tamsulosin-related hypotension (dizziness/syncope); no specific antidote-manage with supportive care (supine positioning, IV fluids/vasopressors as needed) and urgent medical evaluation.

Patient Counseling

Take 1 capsule once daily ~30 minutes after the same meal; swallow whole (do not open/crush). Expect possible dizziness/orthostatic hypotension-rise slowly. Inform clinicians about PSA suppression while on dutasteride and before cataract surgery (IFIS risk with tamsulosin). Pregnant women or those who may become pregnant must not handle leaking/broken capsules. Report breast changes/lumps. Do not donate blood during therapy and for 6 months after stopping.

Monitoring Requirements

Baseline and periodic assessment for prostate cancer (DRE and PSA); interpret PSA with awareness that dutasteride lowers PSA by ~50% and establish a new PSA baseline after ~6 months; monitor blood pressure/orthostatic symptoms especially at initiation and dose changes.

Pharmacology

Mechanism of Action

Dutasteride inhibits type 1 and type 2 5-alpha-reductase, reducing conversion of testosterone to DHT and shrinking prostate over time; tamsulosin selectively antagonizes alpha-1A (and alpha-1D) receptors in prostate/bladder neck to relax smooth muscle and improve urinary flow.

Onset of Action

Tamsulosin: symptom improvement may begin within days and is typically noticeable within 1-2 weeks. Dutasteride: clinically meaningful symptom improvement/prostate volume reduction typically requires ~3-6 months of continuous daily therapy.

Duration of Effect

Tamsulosin: approximately 24 hours per dose for symptom control. Dutasteride: DHT suppression is sustained with continuous daily therapy; clinical benefits (symptom/prostate size and risk reduction) are maintained only while treatment is continued and diminish gradually after discontinuation (over weeks to months).

Half-Life

Dutasteride: ~5 weeks (range ~3-5 weeks). Tamsulosin: ~9-13 hours (can be up to ~15 hours depending on formulation/conditions).

Bioavailability

Dutasteride: Approximately 60%. Tamsulosin: >90%.

Metabolism

Dutasteride: hepatic metabolism mainly via CYP3A4 and CYP3A5. Tamsulosin: hepatic metabolism mainly via CYP3A4 and CYP2D6.

Excretion

Dutasteride: eliminated mainly via feces as metabolites with minimal renal excretion. Tamsulosin: excreted mainly in urine (predominantly as metabolites) with a smaller fecal component.

Protein Binding

Dutasteride: >99.5%. Tamsulosin: 94-99%.

Product Information

Available Dosage Forms

Capsule, hard (oral).

Composition per Dose

Each hard capsule: Dutasteride 0.5mg + Tamsulosin hydrochloride 0.4mg

OTC Alternatives

No OTC alternative

Urological Condition

BPH

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