Patient Medication Information: uses, side effects, how to take - Lidocaine Hydrochloride Injection USP 0.5%
ABOUT THIS MEDICATION
What the medication is used for:
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP are 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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);
- are allergic to sodium metabisulfite;
- are allergic to methylparaben (preservative used in some solutions) or PABA.
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP containing methylparaben should not be used for epidural or spinal anesthesia.
Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP into the joint (i.e., by use of a post-operative “pain pump”).
What the medicinal ingredients are:
- Sterile solutions of 0.5%, 1% and 2% lidocaine hydrochloride injection USP contain 5, 10 and 20 mg/mL lidocaine hydrochloride, respectively.
- Sterile solutions of 1% and 2% lidocaine hydrochloride with epinephrine contain 0.010 mg/mL (1:100 000) epinephrine.
- Sterile solutions of 0.5%, 1.5% and 2% lidocaine hydrochloride with epinephrine contain 0.005 mg/mL (1:200 000) epinephrine.
Nonmedicinal ingredients:
Lidocaine Hydrochloride Injection USP also contains sodium chloride, water for injection, and sodium hydroxide and/or hydrochloric acid.
Lidocaine Hydrochloride and Epinephrine Injection USP also contains sodium chloride, sodium metabisulfite, water for injection, and sodium hydroxide and/or hydrochloric acid. Certain vial presentations may contain citric acid. Please refer to the product label.
Multidose vials contain methylparaben.
Check with your doctor if you think you may be sensitive to any of the above ingredients.
What dosage forms it comes in:
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP are available in single-use and multidose vials, and 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP (see above). Sodium metabisulfite might cause allergic reactions (e.g., facial swelling and respiratory difficulties) in susceptible people, especially those with a history of asthma or allergy;
- if you have a severe heart, kidney or liver disease;
- if you have neurological disease, spinal deformities, septicemia and severe hypertension (in case of lumbar and caudal epidural anesthesia);
- if you have poorly controlled hyperthyroidism and diabetes (in case of use of solutions with epinephrine);
- 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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 Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP may increase the risk of serious side effects.
PROPER USE OF THIS MEDICATION
Usual dose:
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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:
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
Serious side effects resulting from getting too much Lidocaine Hydrochloride Injection USP or Lidocaine Hydrochloride and Epinephrine Injection USP need special treatment and the doctor treating you is trained to deal with these situations. Early signs that too much Lidocaine Hydrochloride Injection USP or Lidocaine Hydrochloride and Epinephrine Injection USP 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 Lidocaine Hydrochloride Injection USP or Lidocaine Hydrochloride and Epinephrine Injection USP 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 Hydrochloride Injection USP or Lidocaine Hydrochloride and Epinephrine Injection USP, tell your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like any medication, Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine 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. If any side effects bother you, or if you experience any unusual effects after exposure to Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP, check with your doctor as soon as possible.
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP 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 doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Common | |||
| Dizziness, abnormal sensations (pins and needles) | X | ||
| Feeling of sickness/nausea*, vomiting* | X | ||
| Decreased heart rate | X | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking the drug and call your doctor or pharmacist |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| 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 | ||
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
Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP should be stored at controlled room temperature (15 to 30°C). Lidocaine Hydrochloride and Epinephrine Injection USP containing epinephrine should be protected from light. Protect from freezing. Keep out of the reach and sight of children.
Your doctor or the hospital will normally store, Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP. The staff is responsible for storing, dispensing and disposing of Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP in the correct way.
REPORTING SUSPECTED 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 3 ways:
- 1. Report online at www.healthcanada.gc.ca/medeffect
- 2. Call toll-free at 1-866-234-2345
- 3.
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 MedEffect™ 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
Important Note: This leaflet alerts you to some of the times you should call your doctor. Other situations which cannot be predicted may arise. Nothing about this leaflet should stop you from calling your doctor with any questions or concerns you have about using Lidocaine Hydrochloride Injection USP and Lidocaine Hydrochloride and Epinephrine Injection USP.
NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.
This document, plus the full Prescribing Information prepared for health professionals, can be found by contacting the sponsor, Hospira Healthcare Corporation, at:
1-866-488-6088.
Hospira Healthcare Corporation
Montreal, Québec H4M 2X6