Lidocaine Hydrochloride Injection USP (Pfizer Canada, PM 00052009): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Lidocaine Hydrochloride Injection USP is used to anesthetize part of the body for surgical operations and also for pain relief and can be used:

• To anesthetize 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 acts 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 anesthetized 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 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 Non-medicinal ingredients below);
• are allergic to methylparaben (preservative used in some solutions) or PABA.

Lidocaine Hydrochloride 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 into the joint (i.e., by use of a post-operative “pain pump”).

What the medicinal ingredients are:

Sterile solutions of Lidocaine Hydrochloride Injection USP contains 10 mg/mL and 20 mg/mL lidocaine hydrochloride.

Non-medicinal ingredients:

Lidocaine Hydrochloride Injection USP also contains sodium chloride, water for injection, and sodium hydroxide and/or hydrochloric acid.

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 is available in single-use ampoules and multidose vials.

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 (see above);
• 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 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 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 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 for a 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 may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

Usual dose:

Lidocaine Hydrochloride 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:

Serious side effects resulting from getting too much Lidocaine Hydrochloride 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 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 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, tell your doctor immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medication, Lidocaine Hydrochloride 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, check with your doctor as soon as possible.

Lidocaine Hydrochloride Injection USP may temporarily interfere with your reactions and muscle co-ordination; therefore do not drive or use machines on the day of surgery.

* 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.

Reporting Side Effects

HOW TO STORE IT

Lidocaine Hydrochloride Injection USP should be stored at controlled room temperature (20°C to 25°C). Protect from freezing. Keep out of the reach and sight of children.

Your doctor or the hospital will normally store Lidocaine Hydrochloride Injection USP. The staff is responsible for storing, dispensing and disposing of Lidocaine Hydrochloride Injection USP in the correct way.

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.

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, Pfizer Canada ULC, at:

1-800-463-6001.

Pfizer Canada ULC

Kirkland, Québec H9J 2M5

Last revised: July 2, 2019