Lidocaine 2% and Epinephrine 1:100,000: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Lidocaine Hydrochloride and Epinephrine are used to anesthetize part of the mouth for surgical operations and also for pain relief.

WHAT IT DOES:

Lidocaine Hydrochloride and Epinephrine 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 anaesthetized in the part of the mouth, 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 and Epinephrine 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 sodium metabisulfite

WHAT THE MEDICINAL INGREDIENTS ARE:

Lidocaine hydrochloride 2% with epinephrine 0.010 mg/mL (1:100,000) or 0.02 mg/mL (1:50,000)

NON-MEDICINAL INGREDIENTS:

Lidocaine Hydrochloride and Epinephrine contains sodium chloride, sodium metabisulfite, 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 Hydrochloride and Epinephrine is available in single –dose glass cartridges.

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 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 and Epinephrine (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, liver or kidney disease;
• if you have poorly controlled hyperthyroidism and diabetes;
• 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 and Epinephrine may temporarily interfere with your reactions and muscular 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 and Epinephrine include:

• anti-arrhythmic drugs for heart problems

  (e.g. mexiletine, amiodarone);

• other anesthetics;
• proranolol for heart problems or cimetidine for gastrointestinal problems;
• fluvoxamine for depression, if using high doses of Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

USUAL DOSE:

Lidocaine Hydrochloride and Epinephrine should be administered by a doctor. The dose given is decided by the doctor based on the clinical need and your physical condition.

Overdose:

Serious adverse effects resulting from getting too much Lidocaine Hydrochloride and Epinephrine need special treatment and the doctor treating you is trained to deal with these situations. Early signs that too much Lidocaine Hydrochloride and Epinephrine 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 unconsciousness may occur.

If the early signs of overdosage are noticed and no further Lidocaine Hydrochloride and Epinephrine 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 and Epinephrine , tell your doctor immediately.

In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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

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

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 of the following 3 ways:

Report Online at www.healthcanada.gc.ca/medeffect Call toll free telephone: 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 0701E

  OTTAWA ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Medeffect^TM 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 and Epinephrine Solutions.

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 manufacturer, Novocol Pharmaceutical of Canada, Inc.

at 1-800-647-0643

Novocol Pharmaceutical of Canada, Inc. 25 Wolseley Court.

Cambridge ON

NIR 6X3

Last revised: December 22, 2011