Details for: VIVACAINE (BUPIVACAINE HCL 0.5% & EPINEPHRINE 1:200,000 INJ, USP)
Company: SEPTODONT INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02305135 | VIVACAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 5 MG / ML; 0.0091 MG / ML | SOLUTION | BLOCK/INFILTRATION |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Vivacaine™ is used to anaesthetize the mouth for surgical operations and also for pain relief, and can be used:
- to anaesthetize the area of the mouth where surgery is to be performed.
What it does
Vivacaine™ acts by temporarily preventing the nerves in the injected area from transmitting sensations of pain, heat or cold. However, you may still experience sensations such as pressure and touch. In this way the nerve(s) is anaesthetized/numbed in the part of the mouth, which will be subjected to surgery. In many cases this means that the nerves to the muscles in the area will also be blocked, causing temporary weakness or paralysis.
When it should not be used
Vivacaine™ should not be used in patients who are allergic to:
- bupivacaine hydrochloride
- any other “-caine” type anaesthetics
- any of the non-medicinal ingredients in the product) see WHAT THE NON-MEDICINAL INGREDIENT ARE below)
- sodium metabisulfite
What the medicinal ingredient is
Bupivacaine hydrochloride with epinephrine.
What the non-medicinal ingredients are
Vivacaine™ contains sodium chloride, sodium hydroxide and/or hydrochloric acid, monothioglycerol, ascorbic acid, sodium lactate 60% solution, edetate calcium disodium, sodium metabisulfite and water for injection.
What dosage form it comes in
Vivacaine™ is available in single –dose glass cartridges as 0.5% (5 mg/mL) with epinephrine (as bitartrate) (1:200,000).
Warnings and precautions
You should talk to your doctor prior to surgery:
- about health problems you have now or have had in the past.
- about other medicines you take, including ones you can buy without prescription.
- if you are taking other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
- if you have ever had a bad, unusual allergic reaction to bupivacaine or any other medicines ending with “-caine”,
- if you are allergic to methylparaben, other parabens or PABA.
- if you think you may be allergic or sensitive to any ingredients in Vivacaine™ . Sodium metabisulfite might cause allergic reactions (e.g. itching, hives, facial swelling and breathing difficulties) in susceptible people, especially those with a history of asthma or allergy;
- if you have heart, liver or kidney disease;
- if you are pregnant, plan to become pregnant or are breastfeeding;
- if you are planning to drive or operate any tools or machinery on the day of surgery, because Vivacaine™ may temporarily interfere with your reactions and muscular coordination.
Interactions with this medication
Many drugs interact with Vivacaine™. Tell your doctor about all prescription, over the counter and natural health products that you are using (See WARNINGS AND PRECAUTIONS above).
Usage of such medicines at the same time as Vivacaine™ may increase the risk of serious side effects.
Proper use of this medication
Usual Dose
Vivacaine™ should be administered by a doctor. The dose given is decided by the doctor based on the clinical need and your physical condition.
Overdose
Serious adverse effects resulting from an overdose are extremely rare and need special treatment. The doctor is trained and equipped to handle such situations.
The first signs that too much Vivacaine™ has been given usually take the form of lightheadedness, numbness of the lips and round the mouth, numbness of the tongue, hearing disturbances, tingling in the ears, and visual disturbances. Tell your doctor immediately if you notice any of these symptoms. Speech symptoms, muscular twitching or tremors are more serious.
In the event of serious overdose or a misplaced injection, trembling, seizures or unconsciousness may occur.
If the administration of Vivacaine™ is stopped as soon as early signs of overdose appears, the risk of serious adverse effects rapidly decreases.
Side effects and what to do about them
Like any medication, Vivacaine™ may cause side effects in some people.
Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them.
Serious side effects, how often they happen and what to do about them
Sudden life-threatening allergic reactions (such as
anaphylaxis) are rare, affecting less than 1 in 1,000
people. Possible symptoms include sudden onset of
rash, itching or lumpy rash (hives); swelling of the
face, lips, tongue or other parts of the body; and
shortness of breath, wheezing or difficulty breathing.
If you think that Vivacaine™ is causing an
allergic reaction, tell your doctor immediately.
There are other possible side effects that have been reported for Vivacaine™. Tell your doctor or anesthesia professional if you experience any of the following side effects:
| Frequency Symptom / effect |
|
|---|---|
| Very Common | |
| Low blood pressure (hypertension). This might make you feel dizzy or light headed. | |
| Feeling sick (nausea). | |
| Common | |
| Pins and needles | |
| Feeling dizzy | |
| Headache | |
| Slow or fast heart beat (bradycardia, tachycardia) | |
| High blood pressure (hypertension) | |
| Being sick (vomiting) | |
| Difficulty in passing urine. | |
| High temperature (fever) or stiffness (rigor) | |
| Back pain | |
| Uncommon | |
| Anxiety | |
| Decreased sensitivity or feeling in the skin | |
| Fainting | |
| Difficulty breathing | |
| Low body temperature (hypothermia) | |
| Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Vivacaine™.(see also OVERDOSE section above). These inlcude fits (seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech, stiff muscles, and trembling. | |
| Rare | |
| Heart attack (cardiac arrest) | |
| Uneven heart beat (arrhythmias). | |
Other possible side effects include
Numbness, due to nerve irritation caused by the
needle or the injection. This does not usually last for
long.
Possible side effects with other local anaesthetics which might also be caused by Vivacaine™ include:
Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent problems.
This is not a complete list of side effects. For any unexpected effects while taking Vivacaine™, , contact your doctor or pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
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.
More information
NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.
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
This leaflet was prepared by
Septodont, Inc.
205 Granite Run Dr.
Suite 150
Lancaster, PA 17601
Last revised: February 9, 2012