Duodart

Duodart

tamsulosin + dutasteride

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg
Indications/Uses
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.
Dosage/Direction for Use
Adult >21 yr (including elderly) 1 cap daily.
Administration
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.
Contraindications
Hypersensitivity to tamsulosin, dutasteride or to other 5α-reductase inhibitors. History of orthostatic hypotension. Severe hepatic impairment. Women; patients ≤21 yr.
Special Precautions
Monitor for acute/chronic urinary retention in patients w/ large residual urinary vol &/or severely impaired urine flow. Perform digital rectal exam & prostate-specific antigen level for prostate cancer detection. Changes in breast tissue eg, lumps or nipple discharge; male breast cancer. 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). Co-administration w/ CYP3A4 inhibitors. May impair ability to drive & use machines. Mild to moderate hepatic & severe renal impairment. Not to be used during pregnancy & potential pregnancy. Lactation. Not to be used in patients ≤21 yr.
Adverse Reactions
Decreased libido; dizziness; impotence, ejaculation disorders, gynaecomastia, breast tenderness.
Drug Interactions
Increased tamsulosin exposure w/ CYP3A4 or CYP2D6 inhibitors.
ATC Classification
G04CA52 - tamsulosin and dutasteride ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
Presentation/Packing
Form
Duodart cap
Packing/Price
30's
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