Administration of Avanafil to patients using any form of organic nitrate is contraindicated. Hypersensitivity to any component of the Avanafil tablet
Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain
Pregnancy Category C. Avanafil is not indicated for use in women. There are no adequate and well-controlled studies of Avanafil in pregnant women.
Patients should not use Avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason
Use of Avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension
Patients should seek emergency treatment if an erection lasts greater than 4 hours
Patients should stop Avanafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss with patients the increased risk of NAION in patients with a history of NAION
Patients should stop taking Avanafil and seek prompt medical attention in the event of sudden decrease or loss of hearing
Pediatric Use: STENDRA is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years has not been established.
Geriatric Use: Of the total number of subjects in clinical studies of avanafil, approximately 23% were 65 and over. No overall differences in efficacy and safety were observed between subjects over 65 years of age compared to younger subjects; therefore no dose adjustment is warranted based on age alone. However, a greater sensitivity to medication in some older individuals should be considered
Renal & hepatic impairment patients: Do not use in patients with severe renal & hepatic impairment
Single doses up to 800 mg have been given to healthy subjects, and multiple doses up to 300 mg have been given to patients. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance because avanafil is highly bound to plasma proteins and is not significantly eliminated in the urine.
