Generic
Tamsulosin + Dutasteride
18 brands available in the market
At a glance
Tamsulosin + Dutasteride is a combination medicine used for moderate to severe symptoms of benign prostatic hyperplasia (BPH). It improves urine flow and reduces prostate size.
Description
Tamsulosin is a selective alpha-1 adrenoceptor blocker that relaxes smooth muscle in the prostate and bladder neck, improving urine flow. Dutasteride is a 5-alpha reductase inhibitor that blocks conversion of testosterone to DHT, reducing prostate size. This combination targets both the dynamic and static components of BPH.
Indications
- Moderate to severe symptoms of Benign Prostatic Hyperplasia (BPH)
- Reduction in risk of acute urinary retention and surgery
Therapeutic class
BPH/Urinary Retention/Urinary Incontinence
Pharmacological class
Alpha-1 Blocker + 5-Alpha Reductase Inhibitor
Pharmacology
Tamsulosin blocks alpha-1 adrenoceptors in the prostate, prostatic capsule, urethra, and bladder neck, relaxing smooth muscle and improving urine flow. Dutasteride inhibits Type I and II 5-alpha reductase enzymes, preventing testosterone conversion to DHT, reducing prostate size and improving the static component of BPH.
Mechanism of action
Improves urine flow and reduces prostate size.
Dosage
Adult Dose (Oral):
- 1 capsule (Tamsulosin 0.4 mg + Dutasteride 0.5 mg) once daily
- Take approximately 30 minutes after the same meal each day
- Swallow capsule whole; do not chew or open
Administration
- Take approximately 30 minutes after the same meal each day
- Swallow capsule whole; do not chew, crush, or break
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Impotence (erectile dysfunction)
- Decreased libido
- Breast pain and enlargement
- Ejaculation disorders
- Dizziness
Precautions & warnings
- Risk of cardiac failure (with dutasteride + alpha-blocker combination)
- PSA levels decrease by approximately 50%; establish new baseline after 6 months
- Intraoperative Floppy Iris Syndrome (IFIS) – discontinue before cataract surgery
- Do not use in severe hepatic impairment
- Contraindicated in women, children, and adolescents
Contraindications
- Hypersensitivity to any component
- Severe hepatic impairment
- Pregnancy, lactation, children, adolescents
- History of orthostatic hypotension
Drug interactions
- CYP3A4/5 inhibitors (ritonavir, ketoconazole, verapamil, diltiazem, cimetidine): Increase dutasteride levels
- CYP2D6 inhibitors (fluoxetine): Increase tamsulosin levels
- PDE5 inhibitors (sildenafil, tadalafil): Risk of symptomatic hypotension
- Other alpha-1 blockers: Additive hypotensive effects
Food interactions
Alcohol is unsafe with Tamsulosin + Dutasteride (excessive dizziness).
Use in pregnancy
Use in Pregnancy: Highly unsafe; contraindicated in women; male patients with pregnant partners should use condoms; consult your doctor.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Information not available; contraindicated in women; consult your doctor.
Pediatric use
Contraindicated in children and adolescents
Geriatric use
Indicated for elderly (no dose adjustment needed)
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; dose adjustment may not be needed; caution in severe renal impairment; consult your doctor.
Hepatic Impairment: Mild-moderate: caution; severe: do not use; consult your doctor.
Overdose effects
No overdose data available; tamsulosin overdose may cause acute hypotension, vomiting, diarrhea; dutasteride up to 40 mg/day is tolerated; provide symptomatic and supportive treatment.
Storage conditions
Store in a cool and dry place, protected from light; keep out of reach of children.
Chemical structure
Tamsulosin + Dutasteride