Tuesday, May 15, 2012

FDA Approvals: Avanafil for Erectile Dysfunction


CLINICAL CONTEXT

Avanafil is the fifth branded oral drug for erectile dysfunction (ED) approved by the US Food and Drug Administration (FDA). Like tadalafil, vardenafil (Levitra,Staxyn), and sildenafil, avanafil is a phosphodiesterase type 5 (PDE5) inhibitor. Although this class of drugs is effective for ED by increasing blood flow to the penis, it can also cause hypotension in men taking nitrates and may cause rare, but serious, adverse events including color vision changes, a sudden loss of vision or hearing, and erections lasting more than 4 hours.

CLINICAL IMPLICATIONS

§  For most men, the starting dose of avanafil is 100 mg taken as needed for ED, not more than once a day, approximately 30 minutes before sexual activity. The dose may be increased to 200 mg or decreased to 50 mg based on efficacy and/or tolerability. Patients should use the lowest dose that is effective. Avanafil may be taken with or without food.
§  Avanafil is contraindicated in patients using any form of organic nitrate because of the risk for hypotension. Hypotension may also occur in patients taking avanafil with alpha-blockers, other antihypertensive drugs, or more than 3 units of alcohol. Patients should seek emergency treatment if an erection lasts longer than 4 hours or if they experience a sudden loss of vision in 1 or both eyes.
§  Common adverse events associated with avanafil may include headache, flushing in the face and other areas, nasal congestion, symptoms of nasopharyngitis, and back pain.
More information about avanafil is available on the FDA Web site.


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