Patient Medication Information: uses, side effects, how to take - Bupivacaine Hydrochloride Injection USP (Formative Pharma)
What is Bupivacaine Hydrochloride Injection USP used for?
Bupivacaine Hydrochloride Injection USP is used to numb (anaesthetise) part of the body during surgery and also for pain relief. Bupivacaine Hydrochloride Injection USP 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.
How does Bupivacaine Hydrochloride Injection USP work?
Bupivacaine Hydrochloride Injection USP 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.
What are the ingredients in Bupivacaine Hydrochloride Injection USP?
Medicinal ingredients:
bupivacaine hydrochloride.
Non-medicinal ingredients:
Bupivacaine Hydrochloride Injection USP contains sodium chloride, sodium hydroxide and/or hydrochloric acid and water for injection.
Bupivacaine Hydrochloride Injection USP comes in the following dosage forms:
Bupivacaine Hydrochloride Injection USP is available as a solution: 0.25% (2.5 mg/mL) and 0.5% (5 mg/mL).
Do not use Bupivacaine Hydrochloride Injection USP 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)
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Bupivacaine Hydrochloride Injection USP. 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 Hydrochloride Injection USP 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 Hydrochloride Injection USP.
Liver Injury: Serious cases of liver injury including drug-induced liver injury (DILI), liver failure and increased liver enzymes have been reported in people being treated with bupivacaine, the medicinal ingredient in Bupivacaine Hydrochloride Injection USP. This is more likely to happen in people being treated with Bupivacaine Hydrochloride Injection USP repeatedly or for a long time. These side effects happened in people with and without a history of previous liver problems. For more information and this and other serious side effects, see the Serious side effects and what to do about them table, below.
Joint Damage: Because of the potential for irreversible joint damage, Bupivacaine Hydrochloride Injection USP should not be used to treat pain following joint surgery.
Use in Children:
- Bupivacaine Hydrochloride Injection USP is not to be used in children under 2 years of age.
- It is not known if Bupivacaine Hydrochloride Injection USP is safe and effective in children 2 - 12 years of age. Bupivacaine Hydrochloride Injection USP 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.
The following may interact with Bupivacaine Hydrochloride Injection USP:
- other local anaesthetics, such as lidocaine, ropivacaine, mepivacaine, prilocaine, chloroprocaine
- medicines used to treat heartburn, such as cimetidine and ranitidine
- sedatives
Additional medicines that may interact with Bupivacaine Hydrochloride Injection USP include:
- medicines used to treat depression such as monoamine oxidase (MAO) inhibitors, triptyline, imipramine
- ergot-type medicines used to treat migraines
- phenothiazines used to treat mental health problems
- medicines used to treat high blood pressure, such as propranolol
How to take Bupivacaine Hydrochloride Injection USP:
Usual dose:
Your healthcare professional will decide how much Bupivacaine Hydrochloride Injection USP to give you.
Overdose:
If you think you, or a person you are caring for, have taken too much Bupivacaine Hydrochloride Injection USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
The first signs that too much Bupivacaine Hydrochloride Injection USP 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.
What are possible side effects from using Bupivacaine Hydrochloride Injection USP?
These are not all the possible side effects you may have when taking Bupivacaine Hydrochloride Injection USP. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- feeling sick, nausea
- vomiting
- dizziness
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
VERY COMMON Low Blood Pressure: dizziness, fainting, lightheadedness May occur when you go from lying or sitting to standing up. | X | ||
COMMON Slow heart beat | X | ||
| Trouble urinating, unable to pass urine | X | ||
| High Blood Pressure: headache, fatigue, vision problems, irregular heart beat | X | ||
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 | X | ||
| Double vision | X | ||
| Irregular heart beat or heart skips a beat (heart palpitations) | X | ||
Nerve Problems: nerve injury, paralysis, numbness or tingling of the extremities, weakness | X | ||
| Central Nervous System Problems: restlessness, anxiety, dizziness, ringing in the ears, blurred vision, tremors, seizures or fits | X | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| 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 | X | ||
| Liver Injury (including Drug Induced Liver Injury, liver failure): yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
Your healthcare professional or the hospital will store Bupivacaine Hydrochloride Injection USP.
Keep out of reach and sight of children.
If you want more information about Bupivacaine Hydrochloride Injection USP:
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 (canada.ca/drug-device-reporting) 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.
- 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/services/drugs-health-products/drug-products/drug- product-database.html; or by calling
1-855-808-9528.
Formative Pharma Inc.