OraVerse

What is OraVerse used for?

OraVerse is a prescription medicine that is used during a test for pheochromocytoma. It is used to treat high blood pressure due to pheochromocytoma. OraVerse is also used to treat skin problems from some drugs. It is used to reverse the effects of some drugs. OraVerse may be given to you for other reasons.

Description

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.

Mechanism of Action

The mechanism by which OraVerse accelerates reversal of soft-tissue anesthesia and the associated functional deficits is not fully understood. 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. In an animal model, OraVerse increased local blood flow in submucosal tissue of the dog when given after an intraoral injection of lidocaine 2% with 1:100,000 epinephrine.

Before taking OraVerse, tell your doctor:

• If you are allergic to OraVerse; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had any of these health problems: Chest pain or pressure, diseased arteries in the heart, or heart attack.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take OraVerse with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take OraVerse?

For all uses of OraVerse:

• Tell all of your health care providers that you take OraVerse. This includes your doctors, nurses, pharmacists, and dentists.
• Heart attack and blood vessel problems in the brain have happened after OraVerse was given. Most of the time, this happened in people with low blood pressure. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using OraVerse while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Mouth:

• Do not eat or drink while your mouth feels numb.

How is OraVerse best taken?

Use OraVerse as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of OraVerse that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Very bad headache.

What are some other side effects of OraVerse?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling tired or weak.
• Dizziness.
• Flushing.
• Stuffy nose.
• Upset stomach or throwing up.
• Diarrhea.
• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out OraVerse?

• If you need to store OraVerse at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 10 PACK OF 0.4MG/1.7 ML CARTON