Duodart

Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg

Moderate to severe symptomatic benign prostatic hyperplasia (BPH) in men w/ enlarged prostate.

Adult males (including elderly) 1 cap once daily.

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

Hypersensitivity to dutasteride, other 5-α-reductase inhibitors & tamsulosin HCl. History of orthostatic hypotension. Severe hepatic impairment. Women, childn & adolescent.

Liver disease. Evaluate men for prostate cancer risk including prostate-specific antigen (PSA) testing regularly. Established new PSA baseline after 6 mth of treatment. Monitor PSA values regularly thereafter. Evaluate any confirmed increase from lowest PSA level or non-compliance to therapy. Perform digital rectal exam & other prostate cancer evaluations on BPH patients prior to therapy & periodically thereafter. Risk of cardiac failure; orthostatic hypotension; Intraoperative Floppy Iris syndrome. Possible male breast cancer; report any changes in the breast tissues eg, lumps or nipple discharge. Concomitant use w/ α-adrenergic blockers & phosphodiesterase-5 (PDE5) inhibitors; strong CYP3A4 eg, ketoconazole & CYP2D6 inhibitors eg, paroxetine; moderate CYP3A4 inhibitors eg, erythromycin in combination w/ either strong or moderate CYP2D6 inhibitors; patients known to be poor CYP2D6 metabolisers. Discontinue therapy 1-2 wk prior to cataract surgery. Possible occurrence of symptoms related to orthostatic hypotension eg, dizziness when taking Duodart. Women & childn must avoid contact w/ leaking cap.

Impotence, altered (decreased) libido, ejaculation & breast disorders, dizziness.

Dutasteride: Possible increase in blood conc & decrease in clearance w/ CYP3A4 inhibitors (eg, verapamil & diltiazem). Tamsulosin HCl: Theoretical risk of enhanced hypotensive effects w/ BP-reducing drugs including anesth agents, PDE5 inhibitors & other α₁ adrenergic blockers. Increased C_max & AUC w/ ketoconazole, paroxetine. Potential significant increase in exposure w/ CYP3A4 & CYP2D6 inhibitors. Decreased clearance & increased AUC w/ cimetidine. Concomitant use w/ warfarin.

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.