Zenavil

Erectile dysfunction; signs & symptoms of benign prostatic hyperplasia (BPH) in adult males.

Erectile dysfunction 10 mg prior to anticipated sexual activity as needed. Patient whom tadalafil 10 mg does not produce adequate effect Max daily dose: 20 mg. May be taken from 30 min to 36 hr pior to sexual activity. Patient who anticipate a frequent use of Zenavil (ie, at least 2x wkly) 2.5 mg once daily at approx same time every day w/o regard to timing of sexual activity. BPH 5 mg at approx same time every day. Therapy initiated w/ finasteride: 5 mg at approx same time every day up to 26 wk. Erectile dysfunction & BPH 5 mg at approx same time every day w/o regard to timing of sexual activity. Moderate renal impairment (CrCl 31-50 mL/min) Initially 5 mg once daily. Max dose: 10 mg not more than once in every 48 hr. Severe renal impairment (CrCl <30 mL/min or on hemodialysis) Max dose: 5 mg not more than once in every 72 hr. Hepatic impairment 10 mg prior to anticipated sexual activity. Patient taking CYP3A4 inhibitors (eg, ketoconazole or ritonavir) Max dose: 10 mg not to exceed once every 72 hr when used as needed. Max once daily dose: 2.5 mg.

May be taken with or without food.

Hypersensitivity. Patients w/ cardiac disease for whom sexual activity is inadvisable (eg, 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 vision loss in one eye because of non-arteritic anterior ischaemic optic neuropathy. Concomitant use w/ any form of organic nitrate.

Take a medical history & physical exam to diagnose erectile dysfunction or BPH prior to treatment. Consider CV status prior to treatment initiation for erectile dysfunction. Assess for CV conditions & examine to rule out presence of prostate carcinoma prior to treatment initiation for BPH. Patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Possible serious CV events including MI, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations & tachycardia. Concomitant use w/ α₁-blockers may lead to symptomatic hypotension. May decrease BP; consider possible dose adjustment of antihypertensive therapy. Discontinue use in case of sudden visual defect. Not recommended in patients w/ known hereditary degenerative retinal disorders including retinitis pigmentosa. Patients who experience erections lasting ≥4; may result to penile tissue damage & permanent loss of potency if priapism is not treated immediately. Patients w/ anatomical deformation of penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in those who have predisposing conditions to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia). Concomitant use w/ potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazone & erythromycin); other PDE5 inhibitors or other treatments for erectile dysfunction. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Possible dizziness; may affect the ability to drive & use machines. Not recommended in patients w/ severe renal impairment. Severe hepatic impairment. Not indicated for women. Not to be used in childn <18 yr.

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

Increased AUC & C_max w/ selective CYP3A4 inhibitor (eg, ketoconazole). Increased AUC w/ ritonavir. May increase plasma conc w/ other PIs (eg, saquinavir) & other CYP3A4 inhibitors (eg, erythromycin, clarithromycin, itraconazole & grapefruit juice). Possible interaction mediated by transporter (eg, P-glycoprotein) inhibition. Reduced AUC w/ rifampicin. May decrease plasma conc w/ other CYP3A4 inducers (eg, phenobarb, phenytoin & carbamazepine). May augment the hypotensive effects of nitrates. Increased BP-lowering effect of doxazosin. Additive systemic BP-lowering effect w/ riociguat. Small increase in heart rate w/ 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.

POM