Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection is used to anaesthetize the mouth for surgical operations and also for pain relief, and can be used:

• to anaesthetize the area of the mouth where surgery is

  to be performed.

What it does:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection acts by temporarily 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/numbed 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:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection should not be used in patients who are allergic to:

• bupivacaine hydrochloride
• any other “-caine” type anaesthetics

• any of the non-medicinal ingredients in the product)

  see WHAT THE NON-MEDICINAL INGREDIENT ARE below)

• sodium metabisulfite

What the medicinal ingredients are:

Bupivacaine hydrochloride with epinephrine.

What the non-medicinal ingredients are:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection contains sodium chloride, sodium hydroxide and/or hydrochloric acid, monothioglycerol, ascorbic acid, sodium lactate 60% solution, edetate calcium disodium, sodium metabisulfite and water for injection.

What dosage forms it comes in:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection is available in single –dose glass cartridges as 0.5% (5 mg/mL) with epinephrine (as bitartrate) (1:200,000).

WARNINGS AND PRECAUTIONS

You should talk to your doctor prior to surgery:

• about 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 have ever had a bad, unusual allergic reaction to bupivacaine or any other medicines ending with “-caine”,
• if you are allergic to methylparaben, other parabens or PABA.

• if you think you may be allergic or sensitive to any ingredients in Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection ^.

  Sodium metabisulfite might cause allergic reactions (e.g. itching, hives, facial swelling and breathing difficulties) in susceptible people, especially those with a history of asthma or allergy;

• if you have heart, liver or kidney disease;

• 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 Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection may temporarily interfere with your reactions and muscular coordination.

INTERACTIONS WITH THIS MEDICATION

Many drugs interact with Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection

Tell your doctor about all prescription, over the counter and natural health products that you are using (See WARNINGS AND PRECAUTIONS above).

Usage of such medicines at the same time as Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

Usual dose:

Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection 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 an overdose are extremely rare and need special treatment. The doctor is trained and equipped to handle such situations.

The first signs that too much Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injectionhas been given usually take the form of lightheadedness, numbness of the lips and round the mouth, numbness of the tongue, hearing disturbances, tingling in the ears, and visual disturbances. Tell your doctor immediately if you notice any of these symptoms. Speech symptoms, muscular twitching or tremors are more serious.

In the event of serious overdose or a misplaced injection, trembling, seizures or unconsciousness may occur.

If the administration of Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection is stopped as soon as early signs of overdose appears, the risk of serious adverse effects rapidly decreases.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like any medication, Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection 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.

Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting less than 1 in 1,000 people. Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. If you think that Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection is causing an allergic reaction, tell your doctor immediately.

There are other possible side effects that have been reported for Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection. Tell your doctor or anesthesia professional if you experience any of the following side effects:

Frequency Symptoms/Effect

Other possible side effects include:

Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.

Possible side effects with other local anaesthetics which might also be caused by Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection

include:

Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent problems.

This is not a complete list of side effects. For any unexpected effects while taking Bupivacaine HCl 0.5% and Epinephrine 1:200,000 Injection, contact your doctor or pharmacist.

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

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

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Septodont, Inc.

at 1-800-647-0643

Septodont, Inc.

205 Granite Run Dr.

Suite 150

Lancaster, PA 17601

Last revised: March 15, 2012