Lidocaine HCl Injection USP 1% (50mg/5mL): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

WHAT THE MEDICATION IS USED FOR:

Lidocaine hydrochloride parenteral solutions are used to anesthetize part of the body for surgical operations and also for pain relief.

WHAT IT DOES:

Lidocaine hydrochloride parenteral solutions 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 parenteral solutions 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 (used in some solutions)
• are allergic to methylparaben (preservative used in some solutions) or PABA

Lidocaine hydrochloride parenteral solutions containing methylparaben should not be used for epidural or spinal anaesthesia.

Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing Lidocaine HCl Injection USP 1% (50 mg/5mL) into the joint (i.e. by use of a post-operative “pain pump”).

WHAT THE MEDICINAL INGREDIENTS ARE:

lidocaine hydrochloride

NONMEDICINAL INGREDIENTS: Lidocaine HCl Injection USP 1% (50 mg/5mL) also contains 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 HCl Injection USP 1% (50 mg/5mL) is available in 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 HCl Injection USP 1% (50 mg/5mL) (see above). Sodium metabisulphite (used in some lidocaine solutions) 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, septicaemia 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 HCl Injection USP 1% (50 mg/5mL) may temporarily interfere with your reactions and muscle coordination.

INTERACTIONS WITH THIS MEDICATION

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 HCl Injection USP 1% (50 mg/5mL) 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 parenteral solutions 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 HCl Injection USP 1% (50 mg/5mL) may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

PROPER USE OF THIS MEDICATION

USUAL DOSE:

Lidocaine hydrochloride parenteral solutions 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 parenteral solutions need special treatment and the doctor treating you is trained to deal with these situations. Early signs that too much lidocaine hydrochloride parenteral solutions has been given include:

• numbness of the lips and around the mouth,
• lightheadedness or dizziness
• blurred vision
• hearing problems
• tingling in the ears

In the event of a serious overdosage, trembling, seizures or unconciousness may occur.

If the early signs of overdosage are noticed and no further lidocaine hydrochloride 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 HCl Injection USP 1% (50 mg/5mL), tell your doctor immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

THEM

Like any medication, Lidocaine HCl Injection USP 1% (50 mg/5mL) 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 HCl Injection USP, check with your doctor as soon as possible.

Lidocaine HCl Injection USP 1% (50 mg/5mL) 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 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: ------------------------------------------------------------------------

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• 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 0701D Ottawa, Ontario

    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.

SIDE

MORE INFORMATION

E 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 HCl Injection USP 1% (50 mg/5mL).

NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.

For the most current information, the Consumer Information Leaflet plus the full Package Insert, prepared for health professionals can be found by contacting the sponsor, Valesco Pharmaceuticals Inc. at:

514-332-6294

Valesco Pharmaceuticals Inc.

Montreal, QC, Canada

H4R 2J5

Last revised: December 19, 2012