Oraverse
Loading...Oraverse Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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).
History
There is currently no drug history available for this drug.
Other Information
Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1 H-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-, methanesulfonate (salt), a non-specific alpha adrenergic blocker.
Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46. It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C 17H19N3O•CH4O3S, and the chemical structure is:
OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH.
Sources
Oraverse Manufacturers
-
Novalar Pharmaceuticals
![Oraverse (Phentolamine Mesylate) Injection, Solution For Submucosal Use [Novalar Pharmaceuticals]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Oraverse | Novalar Pharmaceuticals
2.1 General Dosing InformationThe 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 2OraVerse 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.
2.2 Dosing in Special PopulationsIn 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.)
-
Septodont, Inc.
Oraverse | Septodont, Inc.
2.1 General Dosing informationThe 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)] ½ Cartridge 0.2 ½ 1 Cartridge 0.4 1 2 Cartridges 0.8 2OraVerse 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.
2.2 Dosing in Special PopulationsIn 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.)
![Oraverse (Phentolamine Mesylate) Injection, Solution [Septodont, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4025cf98-ea87-4531-b0fc-6283c84f63f3&name=oraverse-04.jpg)
Login To Your Free Account