Durotam

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

Adult (including elderly) 1 cap (0.5 mg/0.4 mg) once daily.

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

Hypersensitivity to dutasteride, other 5-α reductase inhibitors, tamsulosin (including tamsulosin-induced angioedema), soya, peanut. History of orthostatic hypotension. Severe hepatic impairment. Women, childn, & adolescents.

Patients beginning treatment should be cautioned to sit or lie down at 1st signs of orthostatic hypotension (dizziness, weakness) until symptoms have resolved. Patient should be hemodynamically stable on an α₁-adrenoceptor antagonist prior to PDE5 inhibitor initiation. Can potentially cause symptomatic hypotension. Regularly evaluate men taking dutasteride for prostate cancer. Instruct patients to promptly report any changes in breast tissue eg, lumps or nipple discharge. Risk of intraoperative floppy iris syndrome; initiation of therapy in patients for whom cataract surgery is scheduled is not recommended. Patients w/ severe renal impairment (CrCl <10 mL/min); mild to moderate hepatic impairment. Patient should avoid exposure of his partner who is pregnant or potentially pregnant to semen by use of a condom. Dutasteride may affect semen characteristics (reduction in sperm count, vol, & motility). Avoid contact w/ leaking cap in women, childn, & adolescents.

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

Dutasteride: Increased serum conc w/ verapamil or diltiazem (moderate CYP3A4 inhibitors & P-gp inhibitors); potent CYP3A4 inhibitors (eg, ritonavir, indinavir, nefazodone, itraconazole, orally administered ketoconazole). Tamsulosin: Enhanced hypotensive effects w/ drugs that can reduce BP, including anesth agents, PDE5 inhibitors, & other α-adrenoceptor antagonists. Not to be used in combination w/ other α₁-adrenoceptor antagonists. Increased C_max & AUC w/ strong CYP3A4 inhibitor eg, ketoconazole & CYP2D6 inhibitor eg, paroxetine. Decreased clearance & increased AUC w/ cimetidine. Possible increased elimination rate w/ diclofenac & 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