Bupivacaine Hydrochloride Injection USP (Mylan Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

• to anaesthetize 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:

Bupivacaine Hydrochloride Injection USP 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 anesthetized / 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:

Bupivacaine Hydrochloride Injection USP 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)

Bupivacaine Hydrochloride Injection USP (multi-dose vials) should not be used in patients who are allergic to methylparaben, other parabens or PABA.

Because of the potential for irreversible joint damage, pain following joint surgery should not be managed by infusing Bupivacaine Hydrochloride Injection USP into the joint (i.e. by use of a post-operative “pain-pump”).

What the medicinal ingredient is:

Bupivacaine Hydrochloride

What the non-medicinal ingredients are:

Bupivacaine Hydrochloride Injection USP contains sodium chloride, Sodium hydroxide and/or Hydrochloric acid added to adjust the pH and water for injection. Multidose vials contain methylparaben as a preservative.

What dosage form it comes in:

Bupivacaine Hydrochloride Injection USP is available as follows:

• Bupivacaine Hydrochloride Injection USP, 2.5 mg/mL
• Single-dose vials of 10 mL (without preservative) box of 5
• Single- dose vials of 30 mL (without preservative) box of 5
• Multiple-dose vials of 50 mL (with methylparaben as preservative) box of 1
• Bupivacaine Hydrochloride Injection USP, 5 mg/mL
• Single- dose vials of 10 mL (without preservative) box of 5
• Single- dose vials of 30 mL (without preservative) box of 5
• Multiple-dose vials of 50 mL (with methylparaben as preservative) box of 1
• Bupivacaine Hydrochloride Injection USP, 7.5 mg/mL
• Single- dose vials of 10 mL (without preservative) box of 5
• Single- dose vials of 30 mL (without preservative) box of 5

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 Hydrochloride Injection USP (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 Bupivacaine

• Hydrochloride Injection USP may temporarily interfere with your reactions and muscular coordination.

INTERACTIONS WITH THIS MEDICATION

Many drugs interact with Bupivacaine Hydrochloride Injection USP. 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 Hydrochloride Injection USP may increase the risk of serious side effects.

PROPER USE OF THIS MEDICATION

Usual dose:

Bupivacaine Hydrochloride Injection USP 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 hand such situations.

The first signs that too much Bupivacaine Hydrochloride Injection USP 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 misplaced injection, trembling, seizures or unconsciousness may occur.

If the administration of Bupivacaine Hydrochloride Injection USP 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, Bupivacaine 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.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT 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 Hydrochloride Injection USP is causing an allergic reaction, tell your doctor immediately.

There are other possible side effects that have been reported for Bupivacaine Hydrochloride Injection USP. Tell your doctor or anesthesia professional if you experience any of the following side effects:

Other possible side effects include:

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

Possible side effects seen with other local anesthetics which might also be caused by Bupivacaine Hydrochloride Injection USP include:

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

If too much Bupivacaine Hydrochloride Injection USP is given into the spinal fluid, the whole body may become numbed (anesthetized).

This is not a complete list of side effects. For any unexpected effects while taking Bupivacaine Hydrochloride Injection USP, contact your doctor or pharmacist.

HOW TO STORE IT

• Store Bupivacaine Hydrochloride Injection USP at 20-25°C. Do not freeze.
• Do not use if solution is coloured or contains a precipitate.
• Do not use product if solution shows haziness, particulate matter, discolouration, or leakage

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379

Mylan Pharmaceuticals ULC

Etobicoke, Ontario M8Z 2S6

1-800-575-1379

www.mylan.ca

Last revised: September 08, 2014