Frequently Asked Questions

For Dental Professionals

 

Q What is OraVerse?

OraVerse (phentolamine mesylate) is a local dental anesthesia reversal agent that accelerates the return to normal sensation and function after routine dental procedures where a local anesthetic with a vasoconstrictor was used.

 

Q What is the clinical indication for OraVerse?

OraVerse is indicated for the reversal of soft-tissue anesthesia, ie, 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).

 

Q What are the most common adverse events with OraVerse?

The most common adverse events with OraVerse that were equal to or greater than 3% in any dose group, and equal to or exceeded the control group, were post-procedural pain (6% vs. 6%), injection site pain (5% vs. 4%), tachycardia (5% vs. 6%), headache (3% vs. 4%) and bradycardia (2% vs. 0.3%).

 

Q How does OraVerse work?

The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, is a vasodilator that has been used in other medical indications since 1952.

 

Q With which anesthetics was OraVerse tested?

In clinical trials, OraVerse was used with four leading anesthetics containing a vasoconstrictor: lidocaine 2% with epinephrine 1:100,000, articaine 4% with epinephrine 1:100,000, prilocaine 4% with epinephrine 1:200,000, and mepivacaine 2% with levonordefrin 1:20,000.

 

Q What are the contraindications for OraVerse?

There are no contraindications for OraVerse. In clinical trials, OraVerse was tested in patients able to receive routine dental restorative and periodontal maintenance procedures involving a local anesthetic with vasoconstrictor. Pregnant women were excluded from study. OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).

 

Q Are there any drug interactions with OraVerse?

There are no known drug interactions with OraVerse.

 

Q How is OraVerse supplied, and how is it dosed?

OraVerse is supplied in boxes of 10 and 50 cartridges. The 50-cartridge box contains 5 trays with 10 cartridges each. Each cartridge contains 0.4 mg of phentolamine mesylate in 1.7 mL of solution.

OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic. Maximum recommended dose:

  • 2 cartridges for adults and adolescents 12 years of age and older
  • 1 cartridge for patients 6-11 years of age and over 66 lbs.
  • 1/2 cartridge for children 6-11 years of age weighing 33-66 lbs.

 

Q When should I administer OraVerse?

OraVerse should be given at the end of the procedure, when there is no longer any need for pulpal and/or gingival anesthesia.

 

Q Will my patients experience more pain if the anesthesia wears off faster?

In clinical trials, the effect of OraVerse on pain and post-treatment analgesic use was similar to the control group. In these trials, patients underwent routine restorative and periodontal maintenance procedures (eg, crown preparation, cavity preparation, scaling and root planing) which are not typically associated with significant post-procedural pain.

 

Q Will a second injection cause my patient to experience more pain?

The injection for OraVerse is typically given while the soft tissue is still anesthetized. In clinical trials, the reported incidence of injection site pain in the OraVerse group was 5% compared to 4% in the control group.

 

Q Does OraVerse have an effect on vital signs?

The effect of OraVerse on vital signs in clinical trials was comparable to the control group.

 

Q Can I use OraVerse as an antidote for an overdose of anesthetic?

No. OraVerse is indicated for accelerating the recovery of soft tissue sensation and function following the administration of a local dental anesthetic with a vasoconstrictor. In cases of overdose of anesthetic, customary medical emergency procedures should be promptly implemented.

 

Q Is there any increased risk for injection site complications?

In clinical trials, the incidence of injection site complications was similar between OraVerse patients and the control group.

 

Q What is the half-life of OraVerse?

Clinical trials conducted with children and adults assessed the pharmacokinetics of phentolamine and its effect on lidocaine. In these studies, the half-life of OraVerse was 2 to 3 hours.

 

Q Will OraVerse be reimbursed by dental insurance plans?

OraVerse is the first and only local anesthesia reversal agent, and there is no distinct Current Dental Terminology (CDT) code for the product. The ADA recommends using the local anesthesia designation, code D9215.

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.