Potenflo

Treatment & prevention of benign prostatic hyperplasia (BPH) progression by alleviation of symptoms, improvement of urinary flow rate, reduction of prostate size (vol), risk of acute urinary retention, & the need for BPH-related surgery.

Adult male (including elderly) 1 cap once 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, other 5α-reductase inhibitors, or tamsulosin HCl. Women. Childn.

Orthostatic hypotension. Risk of intraoperative floppy iris syndrome during cataract surgery. Regularly evaluate men for prostate cancer risk including PSA testing. Establish new PSA baseline after 6 mth of treatment & monitor PSA values regularly thereafter. Perform digital rectal exam & other prostate cancer evaluations in patients w/ BPH prior to initiating therapy & periodically thereafter. Promptly report any changes in breast tissue eg, lumps or nipple discharge. Concomitant use w/ PDE5 inhibitors; strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, paroxetine) inhibitors; moderate CYP3A4 inhibitor (eg, erythromycin), moderate CYP2D6 inhibitor, combination of both CYP3A4 & CYP2D6 inhibitor. Poor CYP2D6 metabolisers. May affect ability to drive & use machines due to possible occurrence of symptoms related to orthostatic hypotension eg, dizziness. Effect of renal & hepatic impairment on pharmacokinetics has not been studied. Women & childn must avoid contact w/ leaking cap.

Impotence, altered (decreased) libido, ejaculation & breast disorders, dizziness.

Dutasteride: Blood conc may be increased w/ CYP3A4 inhibitors. Tamsulosin: Theoretical risk of enhanced hypotensive effects w/ drugs that can reduce BP including anesth agents, PDE5 inhibitors & other α₁-adrenoceptor antagonists. Increased C_max & AUC w/ ketoconazole (strong CYP3A4 inhibitor) & paroxetine (strong CYP2D6 inhibitor). Potential increase in exposure w/ strong CYP3A4 inhibitor in CYP2D6 poor metabolisers; w/ both CYP3A4 & CYP2D6 inhibitors. Decreased clearance & increased AUC w/ cimetidine. Concomitant use w/ warfarin.

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