Details for: BUPIVACAINE INJECTION BP
Company: STERIMAX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02443686 | BUPIVACAINE INJECTION BP | BUPIVACAINE HYDROCHLORIDE | 2.5 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 02443686 | BUPIVACAINE INJECTION BP | BUPIVACAINE HYDROCHLORIDE | 2.5 MG / ML | SOLUTION | EPIDURAL |
| 02443694 | BUPIVACAINE INJECTION BP | BUPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 02443694 | BUPIVACAINE INJECTION BP | BUPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | EPIDURAL |
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
BUPIVACAINE INJECTION BP is used to numb (anaesthetise) part of the body during surgery and also for pain relief. BUPIVACAINE INJECTION BP can be used to:
- numb the area of the body where surgery is to be performed.
- provide pain relief in labour.
- provide pain relief after surgery.
- provide pain relief after an injury.
What it does
BUPIVACAINE INJECTION BP works by temporarily blocking the nerves in the area it is injected so you do not feel pain, heat or cold. This makes the area numb and relieves pain. You may still feel pressure and touch. In many cases the nerves to the muscles in the area will also be blocked. This can cause temporary weakness or paralysis.
When it should not be used
Do not use BUPIVACAINE INJECTION BP if you are allergic (hypersensitive) to:
- bupivacaine hydrochloride
- any other “-caine” type anaesthetics
- any of the non-medicinal ingredients in the product, or component of the container (see above)
What the medicinal ingredient is
Bupivacaine hydrochloride.
What the non-medicinal ingredients are
Sodium chloride, sodium hydroxide and/or hydrochloric acid and water for injection.
What dosage form it comes in
Sterile solution packed in single-use glass vials available in two strengths:
- 0.25% (2.5 mg/mL).
- 0.5% (5 mg/mL).
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BUPIVACAINE INJECTION BP. Talk about any health conditions or problems you may have, including if you:
- have heart problems
- have high blood pressure
- have problems with the blood flow to your brain
- have Peripheral Vascular Disease or problems with your blood circulation
- have thyroid problems
- have diabetes
- have liver problems
- have kidney problems
- have asthma
- are pregnant
- are breastfeeding or planning to breastfeed
Other warnings you should know about
Driving and using machines: BUPIVACAINE INJECTION BP can affect your level of alertness, your reactions and your coordination. You should use caution driving and when operating tools or machinery on the day you receive BUPIVACAINE INJECTION BP.
Because of the potential for irreversible joint damage, BUPIVACAINE INJECTION BP should not be used to treat pain following joint surgery.
BUPIVACAINE INJECTION BP is not to be used in children under 2 years of age.
The safety and efficacy of BUPIVACAINE INJECTION BP has not been established in children 2 - 12 years of age. BUPIVACAINE INJECTION BP should only be used in this age group if the benefit outweighs the risk.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- medicines used to treat heart problems, such as mexiletine, amiodarone, procainamide, disopyramide, tocainide, flecainide
- other local anaesthetics, such as lidocaine, ropivacaine, mepivacaine, prilocaine, chloroprocaine
- medicines used to treat heartburn, such as cimetidine and ranitidine
- sedatives
Proper use of this medication
Your healthcare professional will decide how much BUPIVACAINE INJECTION BP to give you.
Overdose
If you think you have taken too much BUPIVACAINE INJECTION BP contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
The first signs that too much BUPIVACAINE INJECTION BP has been given are: lightheadedness, numbness of the lips and around the mouth, numbness of the tongue, hearing disturbances, ringing in the ears, and visual disturbances. Symptoms that are more serious include speech problems, muscle twitching and tremors. Tell your healthcare professional immediately if you notice any of these symptoms.
In the case of a serious overdose or a misplaced injection, trembling, seizures or unconsciousness may occur.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking BUPIVACAINE INJECTION BP. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- feeling sick, nausea
- vomiting
- dizziness
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| VERY COMMON | |||
| Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up. | ✔ | ||
| COMMON | |||
| Slow heart beat | ✔ | ||
| Trouble urinating, unable to pass urine | ✔ | ||
| High Blood Pressure: headache, fatigue, vision problems, irregular heart beat | ✔ | ||
| Rare | |||
| Allergic Reaction: rash, hives, itching, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, fast heart rate, sneezing, nausea, vomiting, fainting, sweating | ✔ | ||
| Double vision | ✔ | ||
| Irregular heart beat or heart skips a beat (heart palpitations) | ✔ | ||
| Nerve Problems: nerve injury, paralysis, numbness or tingling of the extremities, weakness | ✔ | ||
| Central Nervous System Problems: restlessness, anxiety, dizziness, ringing in the ears, blurred vision, tremors, seizures or fits | ✔ | ||
| Heart Attack or Cardiovascular Collapse: chest pain or tightness, pain spreading to the neck, jaw or back, nausea, indigestion, shortness of breath, cold sweat, fatigue, lightheadedness, fast heart beat, fainting | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Your healthcare professional or the hospital will store BUPIVACAINE INJECTION BP.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website (www.sterimaxinc.com), or by calling 1-800-881-3550.
This leaflet was prepared by:
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Last revised: November 18, 2019