Frequently Asked Questions

For Dental Patients

 

Q What is OraVerse?

OraVerse (phentolamine mesylate) is an injection that reverses the effects of local anesthetic with a vasoconstrictor (numbness after a dental procedure) and accelerates the return of normal sensation and function. It helps you reduce the unwanted and unnecessary lingering numbness in the lips and tongue after routine dental procedures. This loss of sensation can result in difficulty with smiling, drinking, and speaking and can cause uncontrolled drooling. These are unpleasant side effects of the local anesthetic with a vasoconstrictor (that tightens blood vessels). In 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 group, and in the lower lip was 70 minutes for OraVerse patients vs. 155 minutes for the control group.

 

Q How quickly will the numbess go away with OraVerse?

In 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 group, and in the lower lip was 70 minutes for OraVerse patients vs. 155 minutes for the control group.

 

Q What are the potential side effects with OraVerse?

In the clinical trials, the most common side effects with OraVerse compared to the control group were pain after the procedure (6% vs. 6%), injection site pain (5% vs. 4%), increase in heart rate (5% vs. 6%), headache (3% vs. 4%) and decrease in heart rate (2% vs. 0.3%). The majority of side effects were mild and went away within 48 hours.

 

Q Are there any drug interactions with OraVerse?

There are no known drug interactions with OraVerse but you should always inform your dental professional about all medications you are taking.

 

Q Is there anyone who should not receive OraVerse?

OraVerse is not recommended for use in children less than 6 years of age or weighing less than 33 lbs. In addition, OraVerse has not been studied in pregnant women, and it is not known if OraVerse is passed to the baby while nursing so caution should be exercised if a pregnant or nursing woman is considering using OraVerse. Please consult with your doctor or dentist.

 

Q Does the injection of OraVerse hurt?

Since OraVerse is given while you are still numb from the anesthetic, most patients don’t experience injection site pain. In clinical studies, the incidence of injection site pain in the OraVerse group was similar to that in the control group (5% vs 4%, respectively).

About OraVerse

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. OraVerse is indicated for use in adults and children 6 years of age or older and weighing at least 33 lbs.

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.

See full prescribing information for details.