Duodart特尿通

Duodart

dutasteride + tamsulosin

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Dutasteride 0.5 mg, tamsulosin HCl 0.4 mg
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 BPH symptoms. Not approved for prevention of prostate cancer.
Dosage/Direction for Use
Adult & elderly 1 cap once daily.
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, other 5α-reductase inhibitors, tamsulosin, soya or peanut. History of orthostatic hypotension. Severe hepatic impairment. Women, childn & adolescents.
Special Precautions
Regular evaluation of PSA values for possible risk of prostate cancer is encouraged. Perform digital rectal examination & other evaluations for prostate cancer or other conditions which can cause the same symptoms as BPH prior to initiation, & periodically thereafter. Risk of cardiac failure & CHF; breast neoplasia; hypotension (orthostatic or symptomatic); intraoperative floppy iris syndrome (IFIS) during cataract surgery. Concomitant use w/ CYP3A4 & CYP2D6 inhibitors. Contains sunset yellow (E110). Impaired ability to drive & use machines due to possible occurrence of dizziness. End stage renal disease (CrCl <10 mL/min). Mild to moderate hepatic impairment. Possible effect on male fertility. Women, childn & adolescents must avoid contact w/ leaking cap.
Adverse Reactions
Dizziness; impotence, decreased libido, ejaculation disorders, breast tenderness & enlargement.
Drug Interactions
Dutasteride: Increased serum conc w/ moderate CYP3A4 & P-gp inhibitors (eg, verapamil, diltiazem) & CYP3A4 inhibitors (eg, ritonavir, indinavir, itraconazole, nefazodone, oral ketoconazole). Tamsulosin: Enhanced hypotensive effects w/ anaesthetic agents, PDE5 inhibitors & other α1- adrenoceptor antagonists. Increased Cmax & AUC w/ strong CYP3A4 inhibitors (eg, ketoconazole), strong CYP2D6 inhibitors (eg, paroxetine). Decreased clearance & increased AUC w/ cimetidine. Possible increased elimination rate w/ warfarin & diclofenac.
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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