Apo-Dutasteride

Apo-Dutasteride

dutasteride

Manufacturer:

Apotex

Distributor:

Hind Wing
/
Four Star
Concise Prescribing Info
Contents
Dutasteride
Indications/Uses
Monotherapy for symptomatic benign prostatic hyperplasia (BPH) in men w/ enlarged prostates. In combination w/ tamsulosin, for moderate to severe symptomatic BPH in men w/ enlarged prostates.
Dosage/Direction for Use
Monotherapy 0.5 mg once daily. Combination therapy 0.5 mg once daily w/ tamsulosin 0.4 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/open.
Contraindications
Hypersensitivity to dutasteride or other α-reductase inhibitors. Women & childn.
Special Precautions
Presence or history of liver problems; prostate cancer or urinary tract disease. Do not donate blood during treatment & for at least 6 mth after stopping treatment. Perform regular checkups including digital rectal exam & prostate specific antigen (PSA) exam. Prior to treatment, perform urological evaluation to determine severity of condition & to rule out the need for immediate surgery or possibility of prostate cancer. Not approved for use in the prevention of prostate cancer. Can lower PSA test result. Pregnant women or those who may become pregnant should not handle Apo-Dutasteride. May affect normal development of the external genital organs in a male baby.
Adverse Reactions
Impotence, decreased libido, changes or problems w/ ejaculation, breast swelling or tenderness; dizziness.
Drug Interactions
Potential interaction w/ verapamil or diltiazem, ritonavir, ketoconazole, ciprofloxacin or troleandomycin, cimetidine, certain herbal medicines eg, St. John's Wort or milk thistle.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04CB02 - dutasteride ; Belongs to the class of testosterone-5-alpha reductase inhibitors. Used in the treatment of benign prostatic hypertrophy.
Presentation/Packing
Form
Apo-Dutasteride cap 0.5 mg
Packing/Price
30's
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