Patient Medication Information: uses, side effects, how to take - Oraverse
ABOUT THIS MEDICATION
What the medication is used for:
OraVerse is used in adults and children, 6 years of age and older, to reverse the numbness in the lip caused by the injection of local anesthetic containing a vasoconstrictor. OraVerse is given by your dentist after a routine dental procedure (such as teeth cleaning, scaling and planing, cavity filling, and crowns).
What it does:
OraVerse increases blood flow in the blood vessels at the injection site. The return of normal sensation in the lip is accelerated after OraVerse injection.
When it should not be used:
OraVerse should not be used if you:
- are allergic (hypersensitive) to phentolamine mesylate or to any non-medicinal ingredientin the formulation.
What the medicinal ingredient is:
Phentolamine Mesylate
What the non-medicinal ingredients are:
edetate disodium, mannitol, sodium acetate, water for injection (acetic acid or sodium hydroxide).
What dosage forms it comes in:
Solution for Injection: 0.4 mg/1.7 mL
WARNINGS AND PRECAUTIONS
BEFORE you use OraVerse talk to your dentist, doctor, nurse, or pharmacist if you:
- have history of heart disease;
- are at increased risk for bleeding or are taking blood thinning medications;
are pregnant; OraVerse is not recommended for use during pregnancy;
- are breastfeeding; It is not known whether OraVerse passes into breast milk.
OraVerse is not recommended for use in children less than 6 years of age or weighing less than 15 kg (33 lbs).
You should not eat or drink until normal oral sensation returns.
OraVerse will speed up the return of normal lip sensation, but can increase the feeling of pain in the mouth.
INTERACTIONS WITH THIS MEDICATION
As with most medicines, interactions with other drugs are possible. Tell your dentist, doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
The following may interact with OraVerse:
- Drugs used to lower blood pressure.
- Drugs used to thin the blood (anti-coagulant medications)
- Antipsychotic drugs.
PROPER USE OF THIS MEDICATION
OraVerse is to be administered by injection into the mouth by a dentist.
OraVerse will be given to you at the end of the dental procedure, when the numbing effect of the local anesthetic is no longer needed.
OraVerse is injected in the mouth at the same location(s) and using the same technique(s) used for the injection of the local anesthetic.
You should not eat or drink until normal oral sensation returns.
Usual dose (adults and children 6 years and older):
- The dentist decides the dose based on your age and weight, as well as on the dose of local anesthetic used.
- The maximum dose is 2 cartridges for patients 18 years and older and 1/2 cartridge for patients aged 6-11 years.
| If you think you have been given too much OraVerse which can lead to low blood pressure (dizziness, fainting) contact your dentist, doctor, nurse, pharmacist, hospital emergency department or regional Poison control Centre immediately. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- pain at the site of the injection
- pain in the area of the dental procedure
- pain and/or tenderness in the mouth and jaw
- headache
- itching, tingling, prickling and burning
- stomach pain, diarrhea, vomiting
If any of these affects you seriously, tell your dentist, doctor, nurse or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
This is not a complete list of side effects. For any unexpected effects while taking OraVerse, contact your dentist, or doctor, nurse or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Septodont, Inc.
at 1-800-647-0643
Septodont
58 Rue Du Pont De Creteil
Saint-Maur Des Fosses
France 94100
Last revised: February 24, 2014
| Symptom / effect | Talk with your dentist, doctor, nurse, or pharmacist | Seek immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Uncommon | Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
| Fast, slow or irregular heart beat | √ | |||
| High Blood Pressure: headache, vision disorders, nausea and vomiting | √ | |||
Low Blood Pressure: dizziness, fainting, lightheadedness. May occur when you go from lying or sitting to standing up | √ | |||
| Swelling of the face | √ | |||
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by of the following 3 ways: Report Online at www.healthcanada.gc.ca/medeffect Call toll free telephone: 1-866-234-2345 Complete a Canada Vigilance Reporting Form and:
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedeffectTM Canada Web site at www.healthcanada.gc.ca/medeffect NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |