What Sensorcaine is used for and how to use it
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Sensorcaine - Consumer Medicine Information

Manufacture: AstraZeneca
Country: Canada
Condition: Local Anesthesia, Surgery
Class: Local injectable anesthetics
Form: Liquid solution
Ingredients: bupivacaine hydrochloride, bupivacaine hydrochloride with epinephrine, sodium chloride, sodium hydroxide and/or hydrochloric acid and water for injection, sodium metabisulphite

SENSORCAINE

Bupivacaine Hydrochloride Injection USP

SENSORCAINE with Epinephrine

Bupivacaine Hydrochloride and Epinephrine Injection USP

About this Medication

What the medication is used for

SENSORCAINE/SENSORCAINE with Epinephrine are used to anaesthetise part of the body for surgical operations and also for pain relief, and can be used:

  • to anaesthetise the area of the body where surgery is to be performed;
  • to provide pain relief in labour and after surgery or acute injury.

What it does

SENSORCAINE/SENSORCAINE with Epinephrine act 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 anaesthetised/numbed 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

SENSORCAINE/SENSORCAINE with Epinephrine should not be used in patients who are allergic to:

  • bupivacaine hydrochloride;
  • any other "-caine" type anaesthetics;
  • sodium metabisulfite;
  • any of the non-medicinal ingredients in the product (see WHAT THE NONMEDICINAL INGREDIENTS ARE below).

What the medicinal ingredients are

Bupivacaine hydrochloride.
Bupivacaine hydrochloride with epinephrine.

What the nonmedicinal ingredients are

SENSORCAINE contains sodium chloride, sodium hydroxide and/or hydrochloric acid and water for injection.

SENSORCAINE with Epinephrine contains sodium chloride, sodium hydroxide and/or hydrochloric acid, sodium metabisulphite and water for injection.

What dosage forms it comes in

SENSORCAINE is available as 0.25% (2.5 mg/mL) and 0.5% (5 mg/mL) in plastic ampoules (Polyamp Duofit) and in single-use glass vials.

SENSORCAINE with Epinephrine is available in single-use glass vials as SENSORCAINE 0.25% (2.5 mg/mL) or 0.5% (5mg/mL) with epinephrine (as bitartrate) 5 mcg/mL (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 think you may be allergic or sensitive to any ingredients in SENSORCAINE/SENSORCAINE with Epinephrine (see above). Sodium metabisulphite 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 SENSORCAINE/SENSORCAINE with Epinephrine may temporarily interfere with your reactions and muscular coordination.

Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing SENSORCAINE into the joint (i.e. by use of a post-operative "pain pump").

SENSORCAINE is not recommended to be used in children under 2 years of age.

Interactions with this Medication

Many drugs interact with SENSORCAINE/ SENSORCAINE with Epinephrine. Tell your doctor about all prescription, over-the-counter and natural health products that you are using (See WARNINGS AND PRECAUTIONS above).

Drugs that may interact with SENSORCAINE/SENSORCAINE with Epinephrine include:

  • anti-arrhythmic drugs for heart problems (e.g. mexiletine, amiodarone);
  • other local anaesthetics;
  • drugs to treat heartburn such as cimetidine and ranitidine.

Additional drugs that may interact with SENSORCAINE with Epinephrine include:

  • medicines for depression;
  • ergot-type antimigraine therapy;
  • antipsychotic therapy;
  • medicines for high blood pressure.

Usage of such medicines at the same time as SENSORCAINE/SENSORCAINE with Epinephrine may increase the risk of serious side effects.

Proper use of this Medication

Usual dose

SENSORCAINE/SENSORCAINE with 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

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 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 SENSORCAINE/SENSORCAINE with Epinephrine has been given usually take the form of lightheadedness, numbness of the lips and around 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 SENSORCAINE/SENSORCAINE with Epinephrine is stopped as soon as early signs of overdose appear, the risk of serious adverse effects rapidly decreases.

Side Effects and what to do about them

Like any medication, SENSORCAINE/SENSORCAINE with 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.

Serious side effects, how often they happen and what to do about them

Symptom / effectTalk with your
doctor
Seek
immediate
emergency
assistance
Only if
severe
In all
cases
Very
Common
Feeling of
sickness/nausea
X
Lowering of
blood pressure
X
CommonAbnormal
sensations (pins
and needles)
X
Decreased heart
rate
X
Difficulties in
urinating
X
DizzinessX
Elevated blood
pressure*
X
VomitingX
RareAllergic
reactions such
as:
facial
swelling,
difficulties in
breathing
X
double visionX
heart rate is
irregular or skips
a beat
X
nerve injury,
paralysis or
tingling of the
extremities,
weakness
X

* To determine if you have elevated blood pressure stop by your local pharmacy to take a reading with their machine.

This is not a complete list of side effects. For any unexpected effects while taking SENSORCAINE/SENSORCAINE with Epinephrine, contact your doctor.

How to Store it

Your doctor or the hospital will normally store, SENSORCAINE/SENSORCAINE with Epinephrine. The staff is responsible for storing, dispensing and disposing of SENSORCAINE 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:

  • 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 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

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

The Consumer Information Leaflet plus the full Product Monograph, prepared for health professionals can be found at:

www.astrazeneca.ca,

or by contacting the sponsor, AstraZeneca Canada Inc. at:

Customer Inquiries – 1 (800) 668-6000

Renseignements – 1 (800) 461-3787