Oraverse

What is Oraverse?

• Oraverse (Phentolamine mesylate), an alpha adrenergic blocker used for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia.

Phentolamine

Phentolamine Structural Formulae

What are the uses of this medicine?

• Oraverse (Phentolamine mesylate) is used 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.

How does this medicine work?

• Phentolamine mesylate, the active ingredient in OraVerse, produces an alpha-adrenergic block of relatively short duration resulting in vasodilatation when applied to vascular smooth muscle.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Hypersensitivity to the active substance or to any ingredients in the formulation.

What drug interactions can this medicine cause?

• There are no known drug interactions with OraVerse.

Is this medicine FDA approved?

• Initial U.S. Approval: 1952

How should this medicine be used?

Recommended dosage:

• 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)]
1/4 Cartridge	0.1	1/4
½ Cartridge	0.2	½
1 Cartridge	0.4	1
2 Cartridges	0.8	2

Administration:

• OraVerse is administered using the same location(s) and same technique(s) (infiltration or block injection) used for the administration of local anesthetic.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 0.4 mg/1.7 mL solution per cartridge

This medicine is available in fallowing brand namesː

• OraVerse

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection-site pain

What special precautions should I follow?

• Myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the intravenous or intramuscular administration of phentolamine, usually in association with marked hypotensive episodes or shock-like states which occasionally follow parenteral administration.
• Tachycardia and cardiac arrhythmias may occur with the use of phentolamine or other alpha-adrenergic blocking agents.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock.
• excitation
• headache
• sweating
• pupillary contraction
• visual disturbances
• nausea
• vomiting
• diarrhea
• hypoglycemia

Treatment of overdosage:

• 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.

Can this medicine be used in pregnancy?

• There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and efficacy of OraVerse has not been established in patients younger than 3 years.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Phentolamine Mesylate

Inactive ingredients:

• Edetate Disodium
• Mannitol
• Sodium Acetate
• Water
• Acetic Acid
• Sodium Hydroxide
• Nitrogen

Who manufactures and distributes this medicine?

Manufactured by: Novocol Pharmaceutical of Canada, Inc. Cambridge, Ontario, Canada

Manufactured for:

• Septodont, Inc
• Louisville, CO

What should I know about storage and disposal of this medication?

• Store at controlled room temperature, 20-25°C (68-77°F) with brief excursions permitted between 15-30°C (59-86°F).
• Protect from direct heat and light.
• Do not permit to freeze.

• Dailymed label info on Oraverse
• FDA Oraverse

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