API

Dutasteride, Tamsulosin Hydrochloride

Drug classification

Dutasteride: 5-alpha reductase inhibitor; Tamsulosin HCl: Alpha blocker.

Dosage form

Capsule, Hard

API strength per dosage

0.5mg / 0.4mg

Dose

The recommended dose for Duodart Capsules (Dutasteride 0.5 mg / Tamsulosin HCl 0.4 mg) in adults is one capsule daily, approximately 30 minutes after the same meal each day. Not indicated for use in pediatric populations or women. Adjustments may be needed for severe renal impairment.

Mechanism of action

Dutasteride inhibits 5-alpha-reductase types I and II, reducing dihydrotestosterone levels, which decreases prostate growth. Tamsulosin selectively antagonizes alpha-1A adrenergic receptors in prostatic smooth muscle, leading to muscle relaxation and improved urinary flow.

Indications

Benign prostatic hyperplasia (BPH) with associated symptoms, urinary retention risk reduction, and surgical intervention need reduction in patients with an enlarged prostate.

Side effects

Ejaculation disorders, dizziness, impotence, decreased libido, breast tenderness or enlargement, orthostatic hypotension, headache, gastrointestinal discomfort, rhinitis, rash, palpitations, syncope.

Pregnancy category

Category X

Precautions

Orthostatic hypotension risk, potential for prostate cancer masking, pregnancy category X (teratogenic effects), caution in severe hepatic impairment, possible intraoperative floppy iris syndrome during cataract surgery, monitor for signs of angioedema, adjust dose in severe renal impairment, potential interaction with CYP3A4 and CYP2D6 inhibitors.

Contraindications

Hypersensitivity to dutasteride, tamsulosin, or any capsule components, pregnancy, pediatric patients, severe hepatic impairment, history of orthostatic hypotension, concurrent strong CYP3A4 inhibitors use.