Tamzor Duo

Dutasteride 500 mcg, tamsulosin HCl 400 mcg

Moderate to severe symptoms of benign prostatic hyperplasia (BPH). Reduction in the risk of acute urinary retention & surgery in patients w/ moderate to severe symptoms of BPH.

Adult including elderly 1 cap daily.

Should be taken with food: Take approx 30 min after the same meal each day. Swallow whole, do not chew/open.

Hypersensitivity to dutasteride, tamsulosin HCl, other 5α-reductase inhibitors, soya or peanut. History of orthostatic hypotension. Severe hepatic impairment. Women. Childn & adolescents <18 yr.

Not recommended in patients w/ scheduled cataract surgery. High incidence of cardiac failure. Breast neoplasia; instruct patients to promptly report any changes in the breast tissue eg, lumps or nipple discharge. Hypotension (orthostatic or symptomatic). Regularly evaluate for prostate cancer. Establish a new PSA baseline after 6 mth of treatment & monitor PSA values regularly thereafter. Perform digital rectal exam & other evaluations for prostate cancer or other conditions causing same symptoms as BPH prior to therapy & periodically thereafter. Not recommended in concomitant use w/ strong CYP3A4 inhibitor. Concomitant use w/ moderate CYP3A4 inhibitor, strong or moderate CYP2D6 inhibitor, combination of both CYP3A4 & CYP2D6 inhibitors or in patients known to be poor CYP2D6 metabolisers. May affect ability to drive & use machines due to possible occurrence of dizziness. Severe renal impairment (CrCl <10 mL/min). Mild to moderate hepatic impairment. Possibility of reduced male fertility. Avoid contact w/ leaking cap in women, childn & adolescents. Tamsulosin: Co-administration w/ PDE5 inhibitors eg, sildenafil, tadalafil, vardenafil.

Dizziness; impotence, altered (decreased) libido, ejaculation & breast disorders.

Dutasteride: Increased serum conc w/ verapamil or diltiazem. Serum conc may be increased w/ potent CYP3A4 inhibitors eg, ritonavir, indinavir, nefazodone, itraconazole, ketoconazole. Tamsulosin: Enhanced hypotensive effects w/ drugs reducing BP including anesth agents, PDE5 inhibitors & other α₁-adrenoceptor antagonists. Increased C_max & AUC w/ ketoconazole & paroxetine & in CYP2D6 poor metabolisers. Potential significant increase in exposure w/ CYP3A4 & CYP2D6 inhibitors. Decreased clearance & increased AUC w/ cimetidine. Elimination rate may be increased w/ diclofenac & warfarin. Fall in plasma levels w/ furosemide.

Drugs for Bladder & Prostate Disorders

G04CA52 - tamsulosin and dutasteride ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.

Rx