Source: FDA, National Drug Code (US) Revision Year: 2018
OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older 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.
The recommended dose of OraVerse is based on the number of cartridges of local anesthetic with vasoconstrictor administered:
| Amount of Local Anesthetic Administered | Dose of OraVerse [mg] | Dose of OraVerse [Cartridge(s)] |
|---|---|---|
| ¼ Cartridge | 0.1 | ¼ |
| ½ Cartridge | 0.2 | ½ |
| 1 Cartridge | 0.4 | 1 |
| 2 Cartridges | 0.8 | 2 |
OraVerse should be administered following the dental procedure using the same location(s) and technique(s) (infiltration or block injection) employed for the administration of the local anesthetic.
Chemically disinfect the carpule cap by wiping with either isopropyl alcohol (91%) or ethyl alcohol (70%). Many commercially available brands of isopropyl (rubbing) alcohol, as well as solutions of ethyl alcohol not of U.S.P. grade, contain denaturants that are injurious to rubber and therefore are not to be used. Inspect carpules visually prior to administration and do not use if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.
Note: Do not administer OraVerse if particulate matter, discoloration, cracks in the glass, protruding plungers or other defects are observed.
In pediatric patients weighing between ≥15 kg and <30 kg, the maximum dose of OraVerse recommend is ½ cartridge (0.2 mg).
(Note: Use in pediatric patients under 3years of age or weighing less than15 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 4 years of age.)
No deaths due to acute poisoning with phentolamine have been reported.
Overdosage with parenterally administered phentolamine is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. In addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances, nausea, vomiting, diarrhea, or hypoglycemia.
There is no specific antidote; treatment consists of appropriate monitoring and supportive care. Substantial decreases in blood pressure or other evidence of shock-like conditions should be treated vigorously and promptly.
Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F) (see USP Controlled Room Temperature)
Protect from direct heat and light. Do not permit to freeze.
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