Uroka

Uroka

dutasteride

Manufacturer:

Mega Lifesciences

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dutasteride
Indications/Uses
Alone or in combination w/ α-adrenergic antagonist for the treatment of symptomatic benign prostatic hyperplasia in men w/ enlarged prostate.
Dosage/Direction for Use
1 cap once daily. In combination w/ α-adrenergic antagonist 1 cap once daily + 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 5α-reductase inhibitors. Pregnancy. Women of childbearing potential. Ped patients.
Special Precautions
Establish new prostate-specific antigen (PSA) baseline at least 3 mth after starting treatment & monitor PSA periodically thereafter during therapy. Increased risk of high-grade prostate cancer development. Consider for other urological conditions that may cause similar symptoms prior to initiation of treatment. Should not be handled by pregnant women or women of childbearing potential. Men should not donate blood until at least 6 mth following last dose. Lactation.
Adverse Reactions
Impotence, decreased libido, breast disorders (eg, breast enlargement & tenderness), ejaculation disorders, dizziness. Erectile dysfunction.
Drug Interactions
Increased blood conc w/ CYP3A4/5 inhibitors eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, troleandomycin, & ciprofloxacin.
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
Uroka soft-gelatin cap 0.5 mg
Packing/Price
30's
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