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Phosphodiesterase-5 (PDE-5) inhibitor
Initial: 100mg prn, as early as 15 min before sexual activityTitrate: May increase to 200mg as early as 15 min before, or decrease to 50mg 30 min before sexual activity, based on individual efficacy and tolerabilityMax Dosing Frequency: qd
Use lowest effective doseSexual stimulation is required for response to treatment
Concomitant Medicationsα-Blocker:Initial: 50mg
Moderate CYP3A4 Inhibitors (eg, Erythromycin, Amprenavir, Diltiazem):Max: 50mg/24 hrsStrong CYP3A4 Inhibitors (eg, Ketoconazole, Ritonavir, Atazanavir):Do not use
Take w/ or w/o food.
Tab: 50mg, 100mg, 200mg
Concomitant use (regularly and/or intermittently) w/ organic nitrates. Known hypersensitivity to any component of the tablet. Do not use in patients who are using a guanylate cyclase stimulator (eg, riociguat).
In a patient who has taken avanafil, where nitrate administration is necessary, allow at least 12 hrs to elapse after the last dose of therapy before considering nitrate administration; only administer under close medical supervision w/ appropriate hemodynamic monitoring. Potential for cardiac risk during sexual activity in patients w/ preexisting cardiovascular (CV) disease; avoid if sexual activity is inadvisable due to underlying CV status. Patients w/ left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those w/ severely impaired autonomic control of BP may be sensitive to therapy. Not recommended in patients w/ MI, stroke, life-threatening arrhythmia, or coronary revascularization w/in the last 6 months; resting hypotension (BP <90/50mmHg) or HTN (BP >170/100mmHg), or unstable angina, angina w/ sexual intercourse, or NYHA Class 2 or greater CHF. Has vasodilatory properties resulting in transient decreases in sitting BP. Prolonged erection >4 hrs and priapism may occur; caution w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, Peyronie's disease), or conditions that may predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia). Nonarteritic anterior ischemic optic neuropathy (NAION) reported (rare); d/c if sudden loss of vision in 1 or both eyes occurs. Caution w/ underlying NAION risk factors; increased risk w/ previous history of NAION and in individuals w/ "crowded" optic disc. Sudden decrease or loss of hearing that may be accompanied by tinnitus or dizziness reported; d/c if this occurs. Avoid in patients w/ severe renal disease, on renal dialysis, or w/ severe hepatic disease.
Headache, flushing, nasopharyngitis, nasal congestion, back pain, URI, ECG abnormal.
See Contraindications and Dosage. Not recommended w/ other PDE-5 inhibitors or ED therapy combinations. Not recommended w/ CYP inducers. Caution w/ α-blockers; may augment BP-lowering effect of α-blockers and other antihypertensives. May increase BP-lowering effect of each compound w/ concomitant alcohol use and the risk of orthostatic signs/symptoms w/ substantial alcohol consumption. Do not use w/ strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, nefazodone). Increased levels w/ strong, moderate, and likely w/ other CYP3A4 inhibitors (eg, grapefruit juice). May increase levels of desipramine or omeprazole. May affect rosiglitazone levels. Amlodipine may increase levels and prolong T1/2. May decrease amlodipine levels. May potentiate the antiaggregatory effect of sodium nitroprusside.
Pregnancy: Category C.Lactation: Safety not known in nursing.
PDE-5 inhibitor; enhances effect of nitric oxide, which activates the enzyme guanylate cyclase resulting in increased levels of cGMP, producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Absorption: Rapid; (fasted) Tmax=30-45 min (median). Distribution: Plasma protein binding (99%). Metabolism: Liver (extensive); CYP3A4 (major), CYP2C (minor); M4 and M16 (major circulating metabolites). Elimination: Feces (62% metabolites), urine (21% metabolites); T1/2=5 hrs.
Assess for hypersensitivity to the drug, CV disease, left ventricular outflow obstruction, anatomical deformation of the penis, conditions that predispose to priapism, potential underlying causes of ED, risk for NAION, renal/hepatic impairment, any other conditions where treatment is contraindicated/cautioned, and possible drug interactions. Obtain baseline BP.
Monitor for hypersensitivity reactions, CV risk, priapism, changes in vision/hearing, and other adverse reactions.
Instruct to take ud and explain that sexual stimulation is required for an erection to occur. Inform about the contraindication of avanafil w/ regular and/or intermittent use of organic nitrates; instruct patients who experience anginal chest pain after taking medication to seek immediate medical attention. Inform patients w/ preexisting CV risk factors of the potential cardiac risk of sexual activity; advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention. Advise to contact prescribing physician if new medications that may interact w/ therapy are prescribed by another healthcare provider. Instruct to seek emergency medical attention if erection persists >4 hrs; inform that priapism, if not treated promptly, may result in irreversible erectile tissue damage. Inform of the increased risk of NAION w/ history of NAION in 1 eye and in patients w/ a "crowded" optic disc. Instruct to d/c and seek medical attention in the event of sudden loss of vision in 1 or both eyes, or if a sudden decrease or loss of hearing that may be accompanied by tinnitus and dizziness occurs. Inform that substantial alcohol consumption (eg, >3 units) in combination w/ medication may increase the potential for orthostatic signs/symptoms. Inform that drug does not protect against STDs; counsel about protective measures necessary to guard against STDs, including HIV. Inform about the contraindication of avanafil w/ the use of guanylate cyclase stimulators.
20-25°C (68-77°F); excursions permitted to 30°C (86°F). Protect from light.