Patient Medication Information: uses, side effects, how to take - Bupivacaine Hydrochloride in Dextrose Injection USP (Formative Pharma)
ABOUT THIS MEDICATION
What the medication is used for:
Bupivacaine Hydrochloride in Dextrose Injection USP is used to anesthetize part of the lower body for pain relief or in surgical operations.
What it does:
Bupivacaine Hydrochloride in Dextrose Injection USP 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 anesthetized/ numbed in the part of the body, 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:
Bupivacaine Hydrochloride in Dextrose Injection USP 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)
Bupivacaine Hydrochloride in Dextrose Injection USP should not be used;
- in severe shock and in heart block
- when there is inflammation and/or sepsis near the site of the proposed injection
What the medicinal ingredients are:
Bupivacaine hydrochloride. What the non-medicinal ingredients are:
Bupivacaine Hydrochloride in Dextrose Injection USP contains dextrose anhydrous, sodium hydroxide and/or hydrochloride acid and water for injection.
What dosage forms it comes in:
Bupivacaine Hydrochloride in Dextrose Injection USP is a sterile solution available in single-dose glass ampoules as 0.75% (7.5 mg/mL).
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 think you may be allergic or sensitive to any ingredients in Bupivacaine Hydrochloride in Dextrose Injection USP (see above).
- 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 Bupivacaine Hydrochloride in Dextrose Injection USP may temporarily interfere with your reactions and muscular coordination.
INTERACTIONS WITH THIS MEDICATION
Many drugs interact with Bupivacaine Hydrochloride in Dextrose Injection USP. 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 Bupivacaine Hydrochloride in Dextrose Injection USP may increase the risk of serious side effects.
PROPER USE OF THIS MEDICATION
Usual dose:
Bupivacaine Hydrochloride in Dextrose Injection USP should be administered by a doctor. The dose given is decided by the doctor based on the clinical need and your physical condition.
Overdose:
| If you think you, or a person you are caring for, have taken too much Bupivacaine Hydrochloride in Dextrose Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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 Bupivacaine Hydrochloride in Dextrose Injection USP 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.
IMPORTANT: PLEASE READ
If the administration of Bupivacaine Hydrochloride in Dextrose Injection USP is stopped as soon as early signs of overdose appear, the risk of serious adverse effects rapidly decreases.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, Bupivacaine Hydrochloride in Dextrose Injection USP 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 |
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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 Bupivacaine Hydrochloride in Dextrose Injection USP is causing an allergic reaction, tell your doctor immediately.
There are other possible side effects that have been reported for Bupivacaine Hydrochloride in Dextrose Injection USP. Tell your doctor or anesthesia professional if you experience any of the following side effects:
| Frequency | Symptom/ Effect |
|---|---|
| Very Common | Low blood pressure (hypotension). 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 Bupivacaine Hydrochloride in Dextrose Injection USP (see also “OVERDOSE” section above). These include 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 seen with other local anesthetics which might also be caused by Bupivacaine Hydrochloride in Dextrose Injection USP include:
Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent problems.
If too much Bupivacaine Hydrochloride in Dextrose Injection USP is given into the spinal fluid, the whole body may become numbed (anesthetised).
This is not a complete list of side effects. For any unexpected effects while taking Bupivacaine Hydrochloride in Dextrose Injection USP, contact your doctor or pharmacist.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
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MORE INFORMATION
If you want more information about Bupivacaine Hydrochloride in Dextrose Injection USP:
- 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; the manufacturer’s website www.formativepharma.com or by calling 1-855-808-9528
Formative Pharma Inc.
Burlington, Ontario, L7L 6A3
Last Prepared: March 27, 2023