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 5 α-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 w/ childbearing potential. Men should not donate blood until at least 6 mth following last dose. Lactation is contraindicated.
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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