Duodart

Duodart

dutasteride + tamsulosin

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
Concise Prescribing Info
Contents
Dutasteride 500 mcg, tamsulosin HCl 400 mcg
Indications/Uses
Treatment & prevention of benign prostatic hyperplasia (BPH) progression by alleviation of symptoms, improvement of urinary flow rate, reduction of prostate size (vol) & risk of acute urinary retention & the need for BPH-related surgery.
Dosage/Direction for Use
Adult male (including elderly) 1 cap once daily.
Administration
Should be taken on an empty stomach: Take w/in 30 min after a meal. Take at the same time each day. Swallow whole, do not chew/open.
Contraindications
Hypersensitivity to dutasteride, other 5α-reductase inhibitors & tamsulosin HCl. Women. Pregnancy & lactation. Childn.
Special Precautions
Liver disease; cardiac failure. Perform digital rectal exam & other prostate cancer evaluations on BPH patients prior to therapy & periodically thereafter. Establish new prostate specific antigen (PSA) baseline after 6 mth of treatment. Regularly monitor & carefully evaluate any sustained increase of PSA values. Risk of prostate cancer & high grade tumor; orthostatic hypotension; intraoperative floppy iris syndrome. Discontinue therapy 1-2 wk prior to cataract surgery. Concomitant use w/ CYP3A4 & CYP2D6 inhibitors. Possible breast cancer in men. May affect ability to drive or operate machinery. Women & childn should avoid contact w/ leaking caps.
Adverse Reactions
Impotence, altered (decreased) libido, dizziness, ejaculation & breast disorders.
Drug Interactions
Dutasteride: Possible increase in blood conc & decrease in clearance w/ CYP3A4 inhibitors (eg, verapamil & diltiazem). Tamsulosin HCl: Enhanced hypotensive effects w/ BP-reducing drugs including anesth agents, PDE5 inhibitors & other α1-adrenergic blockers. Cmax & AUC may increase w/ ketoconazole & paroxetine, & reduce w/ furosemide. Significant increase in exposure w/ CYP3A4 & CYP2D6 inhibitors. Increased AUC & decreased clearance 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
30's;60's
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