Duodart

Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg

Moderate to severe benign prostatic hyperplasia (BPH) symptoms; reduces risk of acute urinary retention & need for surgery in patients w/ moderate to severe BPH symptoms.

Adult >21 yr (including elderly) 1 cap daily.

Should be taken with food: Take w/in 30 min after a meal. Take at the same time each day. Swallow whole, do not chew/open.

Hypersensitivity to tamsulosin, dutasteride or other 5α-reductase inhibitors. History of orthostatic hypotension. Severe hepatic impairment. Women; patients ≤21 yr.

CHD, orthostatic hypotension; patients w/ excessive haemodynamic reaction on previous α₁-blocker treatment & receiving antihypertensives; swallowing disorders eg, stenosing oesophageal changes or neurological disorders accompanied by impaired oesophageal motility. Intraoperative floppy iris syndrome (IFIS). Changes in breast tissue eg, lumps or nipple discharge; male breast cancer. Monitor for acute/chronic urinary retention in patients w/ large residual urinary vol &/or severely impaired urine flow. Perform digital rectal exam & PSA level for prostate cancer detection. Not to be co-administered w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, clarithromycin, indinavir, nelfinavir, ritonavir, saquinavir. Co-administration w/ moderate CYP3A4 inhibitors eg, erythromycin, fluconazole, verapamil, diltiazem. May affect ability to drive & use machines. Mild to moderate hepatic & severe renal impairment. Avoid use during pregnancy. Lactation. Not indicated in patients ≤21 yr.

Decreased libido; dizziness; impotence, ejaculation disorders, gynaecomastia, breast tenderness.

Increased tamsulosin exposure w/ CYP3A4 or CYP2D6 inhibitors. Monitor INR values for 2-3 mth w/ oral anticoagulants.

Drugs for Bladder & Prostate Disorders

G04CA52 - tamsulosin and dutasteride ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

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