Navafil

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Avanafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction

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Administration of Avanafil to patients using any form of organic nitrate is contraindicated. Hypersensitivity to any component of the Avanafil tablet

Avanafil is a selective phosphodiesterase 5 (PDE5) enzyme inhibitor used for the treatment of erectile dysfunction caused by diabetes, age induced oxidative stress or other complications. Avanafil inhibits the cGMP specific phosphodiesterase type 5 (PDE5) which is responsible for degradation of cGMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) by avanafil enhances erectile function by increasing the amount of cGMP.

Avanafil can potentiate the hypotensive effect of nitrates, alphablockers, antihypertensives, and alcohol. CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase Avanafil exposure

Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain

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.

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 hypotensionPatients should seek emergency treatment if an erection lasts greater than 4 hoursPatients 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 NAIONPatients 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