Tamsulosin Hydrochloride + Dutasteride

Generic Details

Generic Name

Tamsulosin Hydrochloride Dutasteride

Other Names

  • Tamsulosin Dutasteride Combination

Drug Class

  • Alpha-1 adrenergic receptor antagonist
  • 5-alpha reductase inhibitor

Chemical Formula

C20H28N2O5S • HCl, C27H30F6N2O2

Molecular Weight

499.008 g/mol, 528.53 g/mol

Mechanism of Action

  • Tamsulosin relaxes the muscles in the prostate gland and the bladder neck, making it easier to urinate.
  • Dutasteride inhibits the conversion of testosterone to dihydrotestosterone which helps shrink the prostate gland.

Indications

  • Benign Prostatic Hyperplasia (BPH)

Common Dosage Forms

  • Capsules

Typical Dosage

  • 0.4 mg tamsulosin/0.5 mg dutasteride once daily

Pediatric Dosage

  • Not recommended for use in children

Geriatric Dosage

  • Dosage adjustment may be required in elderly patients with impaired renal function.

Side Effects

  • Orthostatic hypotension
  • Dizziness
  • Headache
  • Ejaculation disorders
  • Decreased libido

Contraindications

  • Hypersensitivity to tamsulosin, dutasteride or other components of the formulation
  • Severe hepatic impairment

Pregnancy Category

  • Category X (dutasteride can cause fetal harm and should not be handled by pregnant women)

Lactation Safety

  • Not recommended for use during breastfeeding

Drug Interactions

  • Concomitant use with strong CYP3A4 inhibitors may increase exposure to tamsulosin

Overdose Symptoms

  • Hypotension
  • Dizziness
  • Fainting

Antidote for Overdose

  • Supportive measures and symptomatic treatment

Storage Conditions

  • Store at controlled room temperature between 20°C to 25°C (68°F to 77°F)

Pharmacokinetics

  • Absorption: Well absorbed after oral administration
  • Distribution: Extensively distributed in the body
  • Metabolism: Primarily hepatic via CYP3A4 and CYP3A5 enzymes
  • Excretion: Mainly excreted in the feces and urine

Precautions

  • Caution in patients with renal or hepatic impairment
  • Monitor for signs of orthostatic hypotension

Warnings

  • Not indicated for the treatment of hypertension

Others

  • May take several weeks to months to see the full benefits on symptoms of BPH.