Concise Prescribing Info
Contents
Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg
Indications/Uses
Moderate to severe symptomatic benign prostatic hyperplasia (BPH) in men w/ enlarged prostate.
Dosage/Direction for Use
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, tamsulosin HCl, other 5α-reductase inhibitors. History of orthostatic hypotension. Severe hepatic impairment. Women, children & adolescent.
Special Precautions
Liver disease; cardiac failure. Perform digital rectal exam & other prostate cancer evaluations on BPH patients prior to therapy & periodically thereafter. Established new PSA baseline after 6 mth of treatment. Regularly monitor & carefully evaluate any sustained increase of PSA. Risk of prostate cancer & high grade tumor; orthostatic hypotension; Intraoperative Floppy Iris syndrome. Discontinue therapy 1-2 wk prior to cataract surgery. May affect ability to drive or operate machinery.
Adverse Reactions
Impotence, decreased libido, dizziness; ejaculation & breast (including breast tenderness & enlargement) 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. 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
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