AVANAFIL

Mean avanafil plasma concentrations measured after the administration of a single oral dose of 50 or 200 mg to healthy male volunteers are depicted in Figure 4. The pharmacokinetics of avanafil are dose proportional from 12.5 to 600 mg. Figure 4: Plasma Avanafil Concentrations (mean ± SD) Following a Single 50 mg or 200 mg Avanafil Dose Absorption and

DistributionAvanafil is rapidly absorbed after oral administration, with a median T max of 30 to 45 minutes in the fasted state. When avanafil (2...

Avanafil was evaluated in four randomized, double-blind, placebo-controlled, parallel trials of 2 to 3 months in duration. Avanafil was taken as needed at doses of 50 mg, 100 mg, and 200 mg (Study 1) and 100 mg and 200 mg (

Study 2Study 3 and Study 4). Patients were instructed to take 1 dose of study drug approximately 30 minutes (Study 1 and Study 2) or approximately 15 minutes (Study 4) prior to initiation of sexual activity. Food and alcohol intake was not restricted. In addition, a subset of patients from 2 of these trials were enrolled into an open-label extension trial. In the open-labe...

Most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical ...

• Administration of avanafil tablet to patients using any form of organic nitrate is contraindicated ( 4.1 )
• Hypersensitivity to any component of the avanafil tablet ( 4.2 )
• Administration with guanylate cyclase (GC) stimulators such as riociguat and vericiguat ( 4.3 ) 4.1 Nitrates Administration of avanafil tablets with any form of organic nitrates, either regularly and/or intermittently, is ...

Evaluation of erectile dysfunction (ED) should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing avanafil, it is important to note the following:

• Patients should not use avanafil if sexual activity is inadvisable due to cardiovascular status or any other reason ( 5.1 )
• Use of avanafil with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension (...

7 DRUG INTERACTIONS

• Avanafil can potentiate the hypotensive effect of nitrates, alpha-blockers, antihypertensives, and alcohol ( 7.1 )
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase avanafil exposure ( 7.2 ) 7.1 Potential for Pharmacodynamic Interactions with Avanafil Nitrates Administration of avanafil to patients who are using any form of organic nitrate, is contrai...