Duactam

Tadalafil 5 mg, tamsulosin HCl 400 mcg

Lower urinary tract symptoms associated w/ benign prostatic hyperplasia (BPH).

1 cap daily.

May be taken with or without food: Swallow whole. Do not crush/chew.

Hypersensitivity. History of orthostatic hypotension. Patients who are using any form of organic nitrate. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class ≥2 heart failure in the last 6 mth; uncontrolled arrhythmias, hypotension (<90/50 mmHg), or uncontrolled HTN; stroke w/in the last 6 mth. Patients who have loss of vision in 1 eye because of non-arteritic anterior ischemic optic neuropathy. Co-administration w/ guanylate cyclase stimulators eg, riociguat. Severe hepatic insufficiency.

Not indicated for use in women. Symptomatic/orthostatic hypotension in patients taking α1-blockers (eg, doxazosin). Concomitant use w/ CYP3A4 inhibitors (eg, ritonavir, saquinavir, ketoconazole, itraconazole & erythromycin). May affect ability to drive & use machine as drowsiness, blurred vision, dizziness & syncope can occur. Severe hepatic impairment (Child-Pugh Class C). Severe renal impairment (CrCl <10 mL/min). Avoid use during pregnancy. Not to be used during lactation. Childn <18 yr. Tadalafil: Potentiates hypotensive effects of nitrates. Examine patients to rule out the presence of carcinoma of prostate & assess CV conditions carefully prior to initiating treatment for BPH. May induce BP decrease in patients receiving concomitant antihypertensives. Discontinue in case of sudden visual defect. Priapism-predisposing conditions (eg, sickle cell anemia, multiple myeloma or leukemia) or patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease). Tamsulosin: Examine patient to exclude presence of other conditions which can cause same symptoms as BPH before therapy is initiated. Perform digital rectal exam & determine PSA before treatment & at regular intervals afterwards. Intraoperative floppy iris syndrome. Discontinue therapy 1-2 wk prior to cataract or glaucoma surgery. Not to be given w/ strong CYP3A4 inhibitors (eg, ketoconazole) in patients w/ poor metabolizer CYP2D6 phenotype.

Tadalafil: Headache; flushing; nasal congestion; dyspepsia, gastroesophageal reflux; back pain, myalgia, pain in extremity. Tamsulosin: Dizziness; ejaculation disorders including retrograde ejaculation & ejaculation failure.

Increased exposure (AUC) & C_max w/ selective/strong CYP3A4 inhibitor eg, ketoconazole. Tadalafil: Increased exposure (AUC) w/ ritonavir, other PIs (eg, saquinavir) & other CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Reduced exposure (AUC) & decreased efficacy w/ CYP3A4 inducers eg, rifampicin. Decreased plasma conc w/ other CYP3A4 inducers eg, phenobarb, phenytoin & carbamazepine. Increased BP-lowering effects of anti-hypertensives (including Ca channel blockers) & α-blockers (eg, doxazosin). Additive systemic BP lowering effect w/ riociguat. Exercise caution w/ 5-α reductase inhibitors (eg, finasteride) & CYP1A2 substrates (eg, theophylline). Increased oral bioavailability of ethinylestradiol & terbutaline. Tamsulosin: May increase elimination rate w/ diclofenac & warfarin. Use w/ caution w/ moderate CYP3A4 moderate inhibitors (eg, erythromycin). Theoretical risk of enhanced hypotensive effect w/ drugs, which may reduce BP, including anesth agents & other α1-adrenoceptor antagonists.

Drugs for Bladder & Prostate Disorders / Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04CA54 - tamsulosin and tadalafil ; Belongs to the class of alpha-adrenoceptor antagonist and other urological drug. Used in the treatment of benign prostatic hypertrophy and other urological disease.

Rx