OraVerse (Phentolamine Mesylate) injection is the first and only local dental anesthesia reversal agent.
OraVerse is indicated for the reversal of soft tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor. It accelerates the return to normal sensation and function following restorative and periodontal maintenance procedures. In randomized, controlled clinical trials, the median time to recovery of normal sensation in the upper lip was 50 minutes for OraVerse patients vs 133 minutes for the control and in the lower lip was 70 minutes vs 155 minutes. Use in pediatric patients less than 3 years of age or <15 kg (33lbs) has not been established.
The most common adverse reaction with OraVerse is injection-site pain.
Important Safety Information
Tachycardia, bradycardia, and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents. Although such effects are uncommon with OraVerse (phentolamine mesylate), clinicians should be alert to the signs and symptoms of these events, particularly in patients with a history of cardiovascular disease. Following parenteral use of phentolamine at doses between 5 to 15 times higher than the recommended dose of OraVerse, myocardial infarction, and cerebrovascular spasm and occlusion have been reported, usually in association with marked hypotensive episodes producing shock-like states.