Patient Medication Information: uses, side effects, how to take - Lidocaine Injection BP (Auro Pharma, PM 00039517)
ABOUT THIS MEDICATION
WHAT THE MEDICATION IS USED FOR:
LIDOCAINE INJECTION BP is used to anesthetize part of the body for surgical operations and also for pain relief and can be used:
- to anesthetise the area of the body where surgery is to be performed;
- to provide pain relief in labour and after surgery.
WHAT IT DOES:
LIDOCAINE INJECTION BP act by 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 anesthetised 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:
LIDOCAINE INJECTION BP should not be used in patients who:
- are allergic to lidocaine, any other "-caine" type anesthetics, or any of the non-medicinal ingredients in the product (see NONMEDICINAL INGREDIENTS below)
Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing LIDOCAINE INJECTION BP into the joint (i.e. by use of a post-operative “pain pump”).
WHAT THE MEDICINAL INGREDIENTS ARE:
Sterile solutions of 1%w/v and 2%w/v lidocaine hydrochloride contain 10 mg or 20 mg/mL lidocaine hydrochloride.
NONMEDICINAL INGREDIENTS:
LIDOCAINE INJECTION BP also contain sodium chloride, water for injection, and sodium hydroxide and/or hydrochloric acid.
Check with your doctor if you think you may be sensitive to any of the above ingredients.
WHAT DOSAGE FORMS IT COMES IN:
LIDOCAINE INJECTION BP 1% w/v (10 mg/mL) & 2% w/v (20 mg/mL) is available in single use glass ampoules.
WARNINGS AND PRECAUTIONS
You should talk to your doctor prior to surgery:
- about all health problems you have now or have had in the past;
- about other medicines you take, including ones you can buy without a prescription;
- if you are taking other medicines such as drugs used to treat irregular heart activity (anti-arrhythmics);
- if you think you may be allergic or sensitive to any ingredients in LIDOCAINE INJECTION BP (see above).
- if you have a severe heart, kidney or liver disease;
- if you have neurological disease, spinal deformities, septicaemia and severe hypertension (in case of Lumbar and caudal epidural anesthesia);
- if you have epilepsy;
- if you or someone in your family has been diagnosed with porphyria;
- if you are experiencing severe shock;
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 LIDOCAINE INJECTION BP may temporarily interfere with your reactions and muscle coordination.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor/dentist/pharmacist if you are taking or have recently taken any medicines even those that can be bought without a prescription.
Drugs that may interact with LIDOCAINE INJECTION BP include:
- anti-arrhythmic drugs for heart problems (e.g. mexiletine, amiodarone);
- other anesthetics;
- propranolol for heart problems or cimetidine for gastrointestinal problems;
- fluvoxamine for depression, if using high doses of LIDOCAINE INJECTION BP for long time and other medicines for depression;
- antimigraine therapy; antipsychotic therapy;
- medicines for high blood pressure.
Usage of such medicines at the same time as LIDOCAINE INJECTION BP may increase the risk of serious side effects.
PROPER USE OF THIS MEDICATION
USUAL DOSE:
LIDOCAINE INJECTION BP should be administered by a doctor. The dose to be given is decided by the doctor, based on the clinical need and your physical condition.
OVERDOSE:
| If you think you have taken too much LIDOCAINE INJECTION BP contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Serious side effects resulting from getting too much LIDOCAINE INJECTION BP need special treatment and the doctor treating you is trained to deal with these situations. Early signs that too much LIDOCAINE INJECTION BP has been given include:
- numbness of the lips and around the mouth,
- light-headedness or dizziness
- blurred vision
- hearing problems
- tingling in the ears
In the event of a serious overdosage or a misplaced injection, trembling, seizures or unconsciousness may occur.
If the early signs of overdosage are noticed and no further Xylocaine Parenteral Solutions is given, the risk of serious side effects occurring rapidly decreases. If you have any of these symptoms, or you think you have received too much LIDOCAINE INJECTION BP, tell your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, LIDOCAINE INJECTION BP 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. If any side effects bother you, or if you experience any unusual effects after exposure to LIDOCAINE INJECTION BP, check with your doctor as soon as possible.
LIDOCAINE INJECTION BP may temporarily interfere with your reactions and muscle co-ordination; therefore do not drive or use machines on the day of surgery.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||
|---|---|---|---|---|---|---|---|
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | |||||
| Only if severe | In all cases | ||||||
| Common | |||||||
Dizziness, abnormal sensations (pins and needles) | X | ||||||
Feeling of Sickness/nausea*, vomiting* | X | ||||||
| Decreased heart rate | X | ||||||
Increased blood pressure, decreased blood pressure* | X | ||||||
| Uncommon | |||||||
Toxicity symptoms such as: convulsions, seizures, light- headedness, numbness of the lips and around the mouth, numbness of the tongue, hearing disturbances , visual disturbances, speech disturbances, trembling and other signs of central nervous system depression. | X | ||||||
| Rare | |||||||
| Cardiac arrest and/or irregular heartbeat | X | ||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help |
|---|
Only if severe | In all cases | ||
|---|---|---|---|
Allergic reactions such as: facial swelling and difficulties with breathing/respiratory shock | X | ||
Nervous system disorders such as: nerve injury, paralysis or tingling of extremities | X | ||
| Double vision | X | ||
*These side effects occur more frequently after epidural block.
This is not a complete list of side effects. Consult your doctor immediately if any of these symptoms or any unexpected effects appear.
HOW TO STORE IT
Store at room temperature (15°C to 30°C).
Sterile solution for single use. Discard unused portion
Keep out of the reach and sight of children.
Your doctor or the hospital will normally store, LIDOCAINE INJECTION BP. The staff is responsible for storing, dispensing and disposing of, LIDOCAINE INJECTION BP in the correct way.
Reporting 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. |
MORE INFORMATION
If you want more information about LIDOCAINE INJECTION BP.:
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http:// www.auropharma.ca,, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of Preparation: March 10, 2017.