Pediatric Safety Profile
The safety profile of OraVerse in children is well demonstrated and provides doctors both an age and weight determinant for the use of the product.
OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
OraVerse safety was studied in a multicenter, double-blinded, randomized controlled clinical trial with 152 pediatric patients aged 4-11 and in two adult and adolescent trials with patients 12 and over.† The safety, but not the efficacy, of OraVerse has been evaluated in pediatric patients under the age of 6 years old.
Consistent with adult and adolescent trials, OraVerse was well tolerated among pediatric patients and similar to control for:
- Adverse events
- Pain or post-treatment analgesic use
- Vital signs or oral mucosa assessments
†Tavares M, Goodson JM, Studen-Pavlovich D, and colleagues. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. JADA 2008;139(8):1095-1104. Copyright ©2008 American Dental Association. All rights reserved. Excerpted by permission.
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.
