Duoflow

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

Adult male (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, other 5α-reductase inhibitors & tamsulosin HCl. Women & childn.

May affect ability to drive & use machine. Liver function abnormalities. May inhibit development of external genital organs in a male foetus carried by a woman exposed to dutasteride. Ped patients. Dutasteride: Increased incidence of high-grade prostate cancer. Breast cancer in men. Decreased serum PSA in presence of prostate cancer. Changes in semen characteristics (total sperm count, semen vol, sperm motility). Avoid blood donation at least 6 mth following last dose. Assess patients to rule out other urological diseases, including prostate cancer, prior to treatment & periodically thereafter. Establish new PSA baseline at least 3 mth after starting treatment & periodically monitor PSA thereafter. Promptly report any changes in breast tissue eg, lumps or nipple discharge. Women should avoid contact w/ crushed or broken cap & semen from male partner exposed to 5-α reductase inhibitors due to risk on fetal development. Tamsulosin: Serious or life-threatening sulfa sensitivity. Allergic reactions eg, rash, pruritus, urticaria, & angioedema of the tongue, lips & face. Postural hypotension, dizziness, or vertigo; syncope may occur. Risk of priapism can lead to permanent impotence if not promptly treated. Intra-op floppy iris syndrome during phacoemulsification cataract surgery. Exclude possibility of prostate cancer prior to initiation of therapy.

Ejaculation disorders, decreased libido. Dutasteride: Impotence, breast disorders (including breast tenderness & enlargement). Tamsulosin: Headache, infection, asthenia, back & chest pain, dizziness, somnolence, insomnia, rhinitis, pharyngitis, increased cough, sinusitis, diarrhea, nausea, tooth disorder, abnormal ejaculation, blurred vision.

Dutasteride: Decreased clearance & increased serum conc w/ drugs affecting hepatic microsomal enzymes (eg, ritonavir, ketoconazole, verapamil, diltiazem, cimetidine, ciprofloxacin). Tamsulosin: Additive effects w/ α-adrenergic blockers. Increased plasma conc w/ cimetidine. Concomitant use w/ warfarin. Increased bioavailability & peak conc w/ fasting.

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.

D