Can Numbness Be Reversed

poster-top-WEB poster-chart1-WEB poster-chart2-WEB

Frequently Asked Questions:

Oraverse
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. OraVerse is the first and only local anesthesia reversal agent that allows you to bring patients back to normal sensation twice as fast.
Phentolamine mesylate, the active ingredient in OraVerse, has been used in medical applications since 1952.

Q. What is OraVerse?
A. OraVerse (phentolamine mesylate) is an injection that reverses the effectsof 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?
A. 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?
A. 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. Is there anyone who should not receive OraVerse?
A. 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?
A. 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).

OraVerse is the first and only local anesthesia reversal agent that allows you to bring patients back to normal sensation twice as fast. Phentolamine mesylate, the active ingredient in OraVerse, has been used in medical applications since 1952. As you’ll see below, the clinical trials for OraVerse have yielded positive results.

Median Time to Normal Lip Sensation (Adult and Adolescent Clinical Trials)
These trials showed that on average, OraVerse patients not only return to normal sensation faster, but they can speak, smile and drink sooner and drooling is minimized.

Median Time to Recovery of Normal Function
OraVerse is indicated for 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. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).

Important Safety Information
In clinical trials, the most common adverse events with OraVerse (phentolamine mesylate) vs. control were post procedural pain (6% vs. 6%), injection site pain (5% vs. 4%), tachycardia (5% vs. 6%), bradycardia (2% vs. 0.3%) and headache (3% vs. 4%). Following parenteral use of phentolamine in non-dental indications, myocardial infarction and cerebrovascular spasm and occlusion have been reported, usually in association with marked hypotensive episodes producing shock-like states. Although such effects are uncommon with OraVerse, clinicians should be alert to the signs and symptoms of tachycardia and cardiac arrhythmias, particularly in patients with a history of cardiovascular disease, as these symptoms may occur with the use of phentolamine or other alpha-adrenergic blocking agents. See full prescribing information for details.

*Hersh EV, Moore PA, Papas AS, and colleagues. Reversal of soft-tissue anesthesia with phentolamine mesylate in adolescents and adults. JADA 2008;139(8):1080-1093. Copyright ©2008 American Dental Association. All rights reserved. Excerpted by permission.

DOWNLOAD THE ORAVERSE BROCHURE:
Oraverse-Brochure-THUMB

DOWNLOAD THE ORERVERS PRESCRIBING INFORMATION:
Oraverse-prescribing-info-THUMB