Dutasteride Teva

Dutasteride Teva

dutasteride

Manufacturer:

Teva Pharma

Distributor:

DKLL

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
Dutasteride
Indications/Uses
Moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention (AUR) & surgery in patients w/ moderate to severe symptoms of BPH.
Dosage/Direction for Use
Can be administered alone or in combination w/ α-blocker tamsulosin (0.4 mg). Adult (including elderly) 1 cap once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/open cap.
Contraindications
Hypersensitivity to dutasteride, other 5-α reductase inhibitors. Patients w/ severe hepatic impairment. Women, childn & adolescents.
Special Precautions
Regularly evaluate men for prostate cancer while receiving treatment. Patients receiving treatment should have a new prostate-specific antigen (PSA) baseline established after 6 mth of treatment; monitor PSA values regularly thereafter. Perform digital rectal exam prior to initiating therapy & periodically thereafter. Higher incidence of cardiac failure (primarily cardiac failure & congestive cardiac failure) in concomitant use w/ an α-blocker, primarily tamsulosin. Mild to moderate hepatic impairment. Women, childn & adolescents should avoid contact w/ leaking cap. Avoid exposure of pregnant or potentially pregnant female partner to semen.
Adverse Reactions
Impotence, altered (decreased) libido, ejaculation & breast disorders.
Drug Interactions
May increase serum conc in long-term combination w/ potent CYP3A4 enzyme inhibitors eg, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole).
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
Dutasteride Teva soft cap 0.5 mg
Packing/Price
10 × 3's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in