Duodart

Duodart

dutasteride + tamsulosin

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg
Indications/Uses
Treatment & prevention of benign prostatic hyperplasia (BPH) progression through alleviating symptoms, reducing prostate size (vol), improving urinary flow rate & reducing the risk of acute urinary retention & the need for BPH-related surgery.
Dosage/Direction for Use
Adult males (including elderly) 1 cap once daily.
Administration
Should be taken with food: Take approx 30 min after the same meal each day. Swallow whole, do not chew/open.
Contraindications
Hypersensitivity to dutasteride, other 5-α-reductase inhibitors & tamsulosin HCl. Women & childn.
Special Precautions
Perform digital rectal exam & other evaluations for prostate cancer risk including PSA testing prior to initiation of therapy & periodically thereafter. Establish new prostate-specific antigen (PSA) baseline after 6 mth of treatment. Risk of prostate cancer, orthostatic hypotension, intraoperative floppy iris syndrome. Consider to discontinue use for 1-2 wk prior to cataract surgery. Possible occurence of breast cancer in men. Concomitant use w/ α-adrenergic blockers & 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. Liver disease. May impair ability to drive or operate machinery.
Adverse Reactions
Impotence, altered (decreased) libido, ejaculation disorders, breast disorders, dizziness.
Drug Interactions
Dutasteride: Increased blood conc w/ CYP3A4 inhibitors (verapamil, diltiazem). Tamsulosin HCl: Theoretical risk of enhanced hypotensive effects w/ anesth agents, PDE5 inhibitors & other α-1 adrenergic blockers. Increased Cmax & AUC w/ ketoconazole, paroxetine. Potential significant increase in exposure w/ CYP3A4 & CYP2D6 inhibitors. Decreased clearance & increased AUC w/ cimetidine. Warfarin.
MIMS Class
Drugs for Bladder & Prostate Disorders
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
1 × 30's
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