Casey 5

Adult males w/ erectile dysfunction (sexual stimulation is required); signs & symptoms of benign prostatic hyperplasia including those w/ erectile dysfunction.

Adult men Erectile dysfunction Take 10 mg prior to anticipated sexual activity. Patient in whom 10 mg has inadequate effect May be increased to 20 mg at least 30 min prior to sexual activity. Max dosing frequency: Once daily. Patient who anticipate frequent use (ie, at least twice wkly) 5 mg once daily, may be decreased to 2.5 mg once daily based on individual tolerability. Benign prostatic hyperplasia including those w/ erectile dysfunction Take 5 mg approx at the same time of the day. Consider alternative therapy in patients unable to tolerate 5-mg treatment. Severe renal impairment Max recommended dose: 10 mg. Hepatic impairment using on-demand therapy 10 mg prior to anticipated sexual activity.

May be taken with or without food.

Hypersensitivity. Men w/ cardiac disease for whom sexual activity is inadvisable. Patients w/ MI w/in the last 90 days; unstable angina or angina occurring during sexual intercourse; NYHA class ≥2 heart failure, or stroke w/in the last 6 mth; uncontrolled arrhythmias & HTN, or hypotension (<90/50 mmHg); who have vision loss in 1 eye due to non-arteritic anterior ischaemic optic neuropathy (NAION) w/ or w/o previous PDE5 inhibitor exposure. Concomitant use w/ any form of organic nitrates; guanylate cyclase stimulators eg, riociguat.

Not indicated for use by women. Discontinue use in case of sudden visual defect, acuity impairment &/or distortion; sudden decrease or loss of hearing. Serious CV events including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations & tachycardia. Visual defects including central serous chorioretinopathy & NAION. Prolonged erections ≥4 hr. May cause dizziness. Patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy; conditions which may predispose to priapism eg, sickle cell anaemia, multiple myeloma or leukaemia; w/ anatomical deformation of penis (angulation, cavernosal fibrosis, or Peyronie's disease). Assess CV status prior to therapy. Perform medical history & physical exam, & determine potential underlying causes before treatment. Rule out presence of prostate carcinoma prior to treatment. Concomitant use w/ antihypertensives; α₁-blockers; potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, & erythromycin); other PDE5 inhibitors or treatments for erectile dysfunction. Not recommended in combination w/ doxazosin. Not to be taken in patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Severe hepatic impairment (Child-Pugh Class C). Avoid use during pregnancy. Not to be used during lactation.

Headache; flushing; nasal congestion; dyspepsia; back pain, myalgia, pain in extremity. SJS.

Increased AUC & C_max w/ ketoconazole. Increased AUC w/ ritonavir. Increased plasma conc w/ other PIs (eg, saquinavir); CYP3A4 inhibitors eg, erythromycin, clarithromycin, itraconazole & grapefruit juice. Reduced AUC w/ rifampicin. Decreased plasma conc w/ other CYP3A4 inducers eg, phenobarb, phenytoin & carbamazepine. Augmented hypotensive effect of nitrates. Increased BP lowering effect of doxazosin. Additive systemic BP lowering effect w/ riociguat. Concomitant use w/ 5-α reductase inhibitors; CYP1A2 substrates (eg, theophylline). Increased oral bioavailability of ethinylestradiol & terbutaline.

Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04BE08 - tadalafil ; Belongs to the class of drugs used in erectile dysfunction.

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