Generic Name and Formulations:
Avanafil 50mg, 100mg, 200mg; tabs.
Indications for STENDRA:
Take 1 dose as needed approx. 15 mins before sexual activity at frequency of up to once daily. Initially 100mg. May reduce dose to 50mg taken approx. 30 mins before activity or increase to 200mg taken approx. 15 mins before activity. Concomitant moderate CYP3A4 inhibitors: max 50mg once every 24hrs. Concomitant α-blockers (patients should be stable on α-blocker therapy before starting): initially 50mg.
<18yrs: not established.
Concomitant organic nitrates (if medically necessary, allow ≥12hrs to elapse after last avanafil dose before considering initiation). Concomitant guanylate cyclase (GC) stimulators (eg, riociguat).
Confirm diagnosis before therapy. Cardiovascular disease (eg, MI, stroke, life-threatening arrhythmia, or coronary revascularization within 6 months; BP<90/50 or >170/100; unstable angina, angina with intercourse, NYHA Class ≥2 CHF, LV outflow obstruction, impaired autonomic regulation of BP): not recommended. Anatomical penile deformation. Predisposition to priapism. History of non-arteritic anterior ischemic optic neuropathy (NAION) or those with "crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Bleeding disorders. Active peptic ulcer. Severe hepatic or renal impairment, on dialysis: not recommended. Pregnancy (Cat.C).
See Contraindications. Hypotension with nitrates, GC stimulators. Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin), CYP450 inducers, or other ED treatments: not recommended. Potentiated by moderate CYP3A4 inhibitors (eg, erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, verapamil), grapefruit juice. Additive hypotensive effects with concomitant α-blockers, antihypertensives (eg, amlodipine, enalapril). Increased orthostatic hypotension with substantial alcohol consumption (eg, >3 units); caution. May potentiate nitric oxide donors (eg, sodium nitroprusside), desipramine, omeprazole, rosiglitazone.
Phosphodiesterase type 5 inhibitor (cGMP-specific).
Headache, flushing, nasal congestion, nasopharyngitis, back pain; sudden vision or hearing loss; rare: cardiovascular events, prolonged erection, priapism.
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