July 27, 2016
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OraVerse

Indications
Dosage
How Supplied

INDICATIONS

OraVerse, an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older 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

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)]
¼ Cartridge 0.1 %
½ Cartridge 0.2 %
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.

Dosing In Special Populations

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 3 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 4 years of age.)

HOW SUPPLIED

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 individual packaged in a separate compartment of a 10 cartridge blister pack.

NDC 0362-0101-50
NDC 0362-0101-10

Store at controlled room temperature, 20-25oC (68-77 oF) with brief excursions permitted between 15-30 oC (59-86 oF) (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. Rev. Mar 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/21/2016

Indications
Dosage
How Supplied

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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