Oraverse (Phentolamine Mesylate) - Indications and Dosage

INDICATIONS AND USAGE

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]
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.

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 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.)

DOSAGE FORMS AND STRENGTHS

0.4 mg/1.7 mL solution per cartridge

HOW SUPPLIED/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.

NDC 1500-0101-01

NDC 1500-0101-02

Store at controlled room temperature, 20-25C (68-77F) with brief excursions permitted between 15-30C (59-86F) (see USP Controlled Room Temperature).

Protect from direct heat and light. Do not permit to freeze.

Manufactured

by Novocol Pharmaceutical of Canada, Incorporated
Cambridge, Ontario, Canada

for Novalar Pharmaceuticals, Inc.
San Diego, CA, 92130

US Patent Nos.: 6,764,678; 6,872,390; 7,229,630

Trademark of Novalar Pharmaceuticals, Inc.