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).
DOSAGE AND ADMINISTRATION
General Dosing information
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)]|
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.
Note: Do not administer OraVerse if the product is discolored or contains particulate matter.
Dosing in Special Populations
In pediatric patients weighing 15-30 kg, the maximum dose of OraVerse recommended is 1/2 cartridge (0.2 mg).
(Note: Use in pediatric patients under 6 years 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 12 years of age.)
Dosage Forms And Strengths
0.4 mg/1.7 mL solution per cartridge
Storage And Handling
OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7 mL is supplied in a dental cartridge, in cartons of 10 and 50 cartridges. Each cartridge is individually packaged in a separate compartment of a 10 cartridge blister pack.
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.
Manufactured by : Novocol Pharmaceutical of Canada, Inc. Cambridge, Ontario, Canada for Septodont, Inc, Louisville, CO 80027. Revised: April 2011
Last reviewed on RxList: 9/20/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional OraVerse Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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