Sife 50/Sife 100

Sildenafil citrate

Erectile dysfunction.

Adult 50 mg as needed approx 1 hr before sexual activity. May be increased to 100 mg or decreased to 25 mg. Max dose: 100 mg daily. Max frequency: Once daily. Patient receiving concomitant therapy w/ ritonavir Max: Single dose of 25 mg in a 48-hr period. Patient receiving concomitant treatment w/ CYP3A4 inhibitors Initially 25 mg dose. Patients w/ severe renal (CrCl <30 mL/min) & hepatic impairment 25 mg dose. Elderly Initially 25 mg.

May be taken with or without food.

Hypersensitivity. Patients concurrently using nitric oxide donors, organic nitrates/nitrites in any form, either regularly or intermittently. Co-administration w/ guanylate cyclase stimulators eg, riociguat. Severe hepatic impairment, hypotension (BP <90/50 mmHg), recent history of stroke or MI, known hereditary degenerative retinal disorders eg, retinitis pigmentosa. Men for whom sexual activity is inadvisable due to CV risk factors eg, severe CV disease (eg, established cardiac failure & unstable angina pectoris). Loss of vision in 1 eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not w/ previous PDE-5 inhibitor exposure.

Obtain thorough medical history & perform physical exam to diagnose erectile dysfunction, & consider CV status prior to initiating treatment. Not to be used in men for whom sexual activity is inadvisable. Patients w/ increased susceptibility to vasodilators include those w/ left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy) or those w/ rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of BP. Discontinue use in case of sudden visual loss; potentially, sudden decrease or loss of hearing. Increased risk of recurrence in patients who have experienced NAION. Prolonged erections >4 hr & priapism. Patients w/ retinitis pigmentosa; bleeding disorders or active peptic ulceration; anatomical penis deformation (eg, angulation, cavernosal fibrosis or Peyronie's disease) or conditions predisposing to priapism (eg, sickle cell anemia, multiple myeloma or leukemia); resting HTN (BP >170/110); history of life-threatening arrhythmia w/in the last 6 mth, history of cardiac failure or CAD causing unstable angina. Co-administration w/ α-blockers. Not recommended in combination w/ other PDE-5 inhibitors, other pulmonary arterial HTN treatments containing sildenafil, or other treatments for erectile dysfunction. Not indicated for use in women. Not for childn <18 yr.

Headache. Dizziness; blurred vision, visual disturbance, cyanopsia; hot flush, flushing; nasal congestion; nausea, dyspepsia.

Reduced clearance w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin, cimetidine). Increased plasma conc w/ cimetidine. Increased AUC w/ erythromycin. Increased AUC & C_max w/ HIV PI (saquinavir & ritonavir). Increased plasma levels w/ grapefruit juice. Decreased AUC & C_max w/ endothelin antagonist (bosentan). Decreased plasma conc w/ strong CYP3A4 inducers (eg, rifampin). Potentiated hypotensive effect of acute & chronic nitrates. Potential symptomatic hypotension w/ α-blockers.

Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.