Classes
DEA Class; Rx
Common Brand Names; Stendra
- Phosphodiesterase-5 Enzyme Inhibitors
Description
An oral phosphodiesterase type 5 (PDE5) inhibitor
Used for erectile dysfunction (ED) and taken prior to anticipated sexual activity
As with other PDE5 inhibitors, contraindicated for use with nitrates because the combination can cause a sudden drop in blood pressure
Indications
Indicated for the treatment of erectile dysfunction (ED).
Contraindications
Hypersensitivity
Soluble guanylate cyclase (sGC) stimulators (eg, riociguat or vericiguat); concomitant use can cause hypotension
Adverse Effects
- Headache (5.6%)
- Flushing (3.5%)
- Nasal congestion (2.1%)
- Nasopharyngitis (3.4%)
- Back pain (2.5%)
- Upper respiratory infection (<2%)
- Bronchitis (<2%)
- Influenza (<2%)
- Sinusitis (<2%)
- Sinus congestion (<2%)
- Hypertension (<2%)
- Dyspepsia (<2%)
- Nausea (<2%)
- Constipation (<2%)
- Rash (<2%)
Warnings
Potential for cardiovascular risk during sexual activity in patients with underlying cardiovascular conditions
Monitor patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis)
Dose should not exceed 50 mg/24hr when taking avanafil concomitantly with moderate CYP3A4 inhibitors
Initiate therapy at 50 mg/24hr if coadministered with antihypertensive medications like alpha-blockers
Priapism may occur especially in patients with predisposed conditions (eg, sickle cell anemia, multiple myeloma, or leukemia)
Discontinue therapy if sudden loss of vision in one or both eyes occur (could be a sign of non-arteritic anterior ischemic optic neuropathy)
Safety and efficacy not established in patients with hereditary retinal disorders, including retinitis pigmentosa (use not recommended)
Sudden hearing loss may occur; discontinue therapy if tinnitus symptoms occur
Alcohol may increase risk for orthostatic hypotension; may increase heart rate and cause dizziness and headache
Pregnancy and Lactation
Pregnancy Category: C
Lactation: Safety and efficacy not established
Maximum Dosage
200 mg/day PO.
200 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Avanafil
tablets
- 50mg
- 100mg
- 200mg