ORAVERSE- phentolamine mesylate injection, solution
OraVerse is indicated for reversal of the 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).
| Amount of Local |
| Dose of OraVerse |
| Dose of OraVerse |
(Note: Use in pediatric patients under 6 years of age or weighing less than 15 kg (33 lbs) is not recommended. A dose of more than 1 cartridge [0.4 mg] of OraVerse has not been studied in children less than 12 years of age.)
Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the parenteral administration of phentolamine. These events usually occurred in association with marked hypotensive episodes producing shock-like states.
Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents. Although such effects are uncommon after administration of OraVerse, clinicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of cardiovascular disease.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Dental patients were administered a dose of either 0.2, 0.4 or 0.8 mg of OraVerse. The majority of adverse reactions were mild and resolved within 48 hours. There were no serious adverse reactions and no discontinuations due to adverse reactions.
| 0.2 mg |
(N = 83)
| 0.4 mg |
(N = 284)
| 0.8 mg |
(N = 51)
| Total |
(N = 418)
| Total |
(N = 359)
|N (%)||N (%)||N (%)||N (%)||N (%)|
|Patients with AEs||15 (18)||82 (29)||20 (39)||117 (28)||96 (27)|
|Tachycardia||0 (0)||17 (6)||2 (4)||19 (5)||20 (6)|
|Bradycardia||0 (0)||5 (2)||2 (4)||7 (2)||1 (0.3)|
|Injection site pain||5 (6)||15 (5)||2 (4)||22 (5)||14 (4)|
|Post procedural pain||3 (4)||17 (6)||5 (10)||25 (6)||23 (6)|
|Headache||0 (0)||10 (4)||3 (6)||13 (3)||14 (4)|
Results from the pain assessments in Study 1 and Study 2, involving mandibular and maxillary procedures, respectively, indicated that the majority of dental patients in both OraVerse and control groups experienced no or mild oral pain, with less than 10% of patients in each group reporting moderate oral pain with a similar distribution between the OraVerse and control groups. No patient experienced severe pain in these studies.
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