Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Bupivacaine Injection BP.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Bupivacaine Injection BP against the benefits this medicine is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about receiving this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Bupivacaine Injection BP is used for

Bupivacaine is used to prevent or relieve pain, but it will not put you to sleep. Bupivacaine Injection BP is used during or after surgery to relieve pain. It can also be used to make childbirth less painful.

Bupivacaine Injection BP belongs to a group of medicines known as local anaesthetics. It is injected into the body where it will either totally stop pain or will cause partial loss of feeling (numbness), depending on the amount used.

Your doctor will have explained why you are being treated with Bupivacaine Injection BP and what dose you will be given.

Follow all the directions and advice given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This product is available only on a doctor's prescription.

Before you are given Bupivacaine Injection BP

When you must not be given it:

Do not use Bupivacaine Injection BP if you have an allergy to:

• any medicine containing bupivacaine or other local anaesthetics e.g. lidocaine (lignocaine)
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

You should not be given Bupivacaine Injection BP if:

• you have an infection or swelling (redness) where the injection will be given
• you have uncorrected low blood pressure.

If you are not sure whether any of these apply to you, check with your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. It is not known if it is safe for you to receive bupivacaine while you are pregnant. It may affect your baby if you receive it early in pregnancy or in the last weeks before your baby is due. However, bupivacaine may be used during childbirth. Your doctor will discuss with you the benefits and risks of being given it during pregnancy.

Tell your doctor if you are breastfeeding or plan to breast feed. Your baby can absorb bupivacaine in very small amounts from breast milk if you are breastfeeding. Your doctor will discuss with you the benefits and risks of being given it whilst you are breastfeeding.

Tell your doctor if you have or have had any medical conditions, especially the following:

• problems with your blood pressure or circulation (especially low blood pressure)
• problems with clotting of your blood
• blood poisoning
• acidosis, or too much acid in the blood
• diseases of the brain, spine or nerves
• muscle disease or weakness such as myasthenia gravis
• kidney, liver, heart, or thyroid problems
• epilepsy.

It may not be safe for you to be given Bupivacaine Injection BP if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and bupivacaine may interfere with each other. These include:

• medicines used to help control your heart beat, such as mexiletine
• medicines to help prevent blood clots such as heparin
• medicines for depression.

These medicines may affect the way bupivacaine works or be affected by bupivacaine. You may need different amounts of your medicine, or you may need to take a different medicine.

Your doctor will advise you about continuing to take other medicines while you are receiving Bupivacaine Injection BP.

If you have not told your doctor about any of these things, tell them before you are given any bupivacaine.

How Bupivacaine Injection BP is given

How it is given

Bupivacaine Injection BP must only be given by a doctor or nurse.

It is given by injection into the skin, near a single nerve, or into an area which contains a large number of nerves (e.g. if you are given an epidural injection which is an injection around the spinal cord). This causes an area of numbness at the site of injection or in an area that may seem unrelated to the site of injection. The last will be the case if you are given an epidural injection and will result in a feeling of numbness in your lower body.

If you are receiving an epidural infusion it will be injected by your doctor into the epidural space, near your spinal cord, through a space between vertebrae in your lower back. A thin tube will be inserted so a continuous dose can be given over a period of time.

Bupivacaine Injection BP should not be injected directly into the blood.

How much is given

Your doctor will decide what dose, how often and how long you will receive it. This depends on the type of pain relief required, your condition and other factors, such as your weight, age, how well your liver and kidneys are working, and whether or not other medicines are being given at the same time.

If you are given too much (overdose)

This rarely happens as Bupivacaine Injection BP is administered under the care of an experienced anaesthetist. Your condition will be carefully monitored following administration of bupivacaine.

However, if you are given too much bupivacaine, you may experience some of the effects listed under "Side Effects" below. Some side effects such as unconsciousness, low blood pressure and collapse will be monitored and detected by your doctor or nurse if it occurs.

Whenever you are given Bupivacaine Injection BP, equipment is available to treat you if you experience severe side effects.

If you think you have been given too much Bupivacaine Injection BP or if you experience severe side effects, tell your doctor or nurse immediately.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with bupivacaine. Like other medicines, bupivacaine can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

Ask your doctor or nurse to answer any questions that you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse if you notice any of the following:

• nervousness, agitation
• dizziness
• ringing in the ears
• blurred vision
• numbness
• disorientation (feeling strange)
• nausea
• vomiting
• difficulty swallowing, slurred speech
• shakes (tremor), tingling sensation (pins and needles).

These are usually mild side effects and should only last a short time.

After an epidural injection of bupivacaine you may develop a headache or backache which is not always related to the medicine used. This may last for some months after the injection was given, although this is rare.

Tell your doctor or nurse immediately if notice any of the following:

• fits
• difficulty breathing
• severe dizziness with slow or irregular heart beat
• joint pain, stiffness or loss of motion.

If Bupivacaine Injection BP is given wrongly, or you have a known sensitivity to it, it may cause the above side effects.

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above, may occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be detected by your doctor.

Tell your doctor if you notice anything else that is making you feel unwell.

After being given Bupivacaine Injection BP

Be careful driving or operating machinery after you have been given Bupivacaine Injection BP. You may be drowsy and feel light headed. Your reflexes may be made slower and you may feel nauseous.

Be careful when drinking alcohol following injection with bupivacaine. It may cause your blood pressure to drop and cause you to feel dizzy and faint.

Disposal

Any Bupivacaine Injection BP which is not used will be disposed of in a safe manner by your doctor or pharmacist.

Bupivacaine Injection BP is for single use only.

Product description

What it looks like

Bupivacaine Injection BP is a clear, colourless solution in either a 20 mL glass theatre vial or a plastic 10 mL Steriamp® or Steriluer® ampoule.

Ingredients

Bupivacaine Injection BP contains Bupivacaine Hydrochloride (as monohydrate) (0.25% or 0.5%).

It also contains:

• Sodium Chloride
• Hydrochloric acid
• Sodium hydroxide
• Water for Injections.

This medicine does not contain a preservative.

Supplier

Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free number: 1800 675 229
www.pfizer.com.au

Australian registration numbers

Bupivacaine Injection BP 0.25% (sterile) 50 mg in 20 mL Theatre Vial: AUST R 11314

Bupivacaine Injection BP 0.5% (sterile) 100 mg in 20 mL Theatre Vial: AUST R 12725

Bupivacaine Injection BP 0.5% (sterile) 50 mg in 10 mL Steriluer® or Steriamp® Ampoule: AUST R 11312

Date of preparation

This leaflet was prepared in June 2022.

®= Registered Trademark

Published by MIMS July 2022

Boxed Warnings

Not for intravenous administration under any circumstances.

1 Name of Medicine

Bupivacaine hydrochloride monohydrate.

2 Qualitative and Quantitative Composition

Each vial of Bupivacaine Injection BP contains bupivacaine hydrochloride (as monohydrate) 50 mg or 100 mg.
Each ampoule of Bupivacaine Injection BP contains bupivacaine hydrochloride (as monohydrate) 50 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Bupivacaine Injection BP is a sterile, isotonic, preservative-free solution.

4 Clinical Particulars

4.9 Overdose

Acute emergencies associated with the use of local anaesthetics are generally related to high plasma levels, or to unintended subarachnoid injection of the local anaesthetic solution (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.4 Special Warnings and Precautions for Use).
With accidental intravascular injections of local anaesthetics, the toxic effects will be obvious within 1 to 3 minutes. With overdosage, peak plasma concentrations may not be reached for 20 to 30 minutes, depending on the site of injection, and toxic signs will be delayed. Toxic reactions mainly involve the central nervous and cardiovascular systems.
Symptoms of acute toxicity. Central nervous system toxicity is a graded response with symptoms and signs of escalating severity. The first symptoms are circumoral paraesthesia, numbness of the tongue, lightheadedness, hyperacusis and tinnitus. Visual disturbances and muscular tremors are more serious and precede the onset of generalised convulsions. These signs must not be mistaken for neurotic behaviour.
Unconsciousness and grand mal convulsions may follow. These may last from a few seconds to several minutes. Hypoxia and hypercapnia occur rapidly following convulsions due to increased muscular activity, together with the interference with normal respiration and loss of the airway. In severe cases, apnoea may occur. Acidosis, hyperkalaemia, hypocalcaemia and hypoxia increase and extend the toxic effects of local anaesthetics.
Recovery is due to redistribution of the local anaesthetic drug from the central nervous system and metabolism. Recovery may be rapid unless large amounts of the drug have been injected.
Signs of cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, decreased cardiac output, heart block, arrhythmia and even ventricular arrhythmias, ventricular fibrillation and cardiac arrest may occur as a result of high systemic concentrations of local anaesthetics.
Cardiovascular toxic effects are generally preceded by signs of toxicity in the central nervous system, unless the patient is receiving a general anaesthetic or is heavily sedated with drugs such as benzodiazepines or barbiturates.
Treatment of overdosage. If signs of acute systemic toxicity appear, injection of the local anaesthetic should be immediately stopped.
If convulsions occur then immediate attention is required for the maintenance of patent airway and assisted or controlled ventilation with oxygen, via a positive airway pressure delivery system mask. Adequacy of the circulation should then be evaluated, bearing in mind that drugs used to treat convulsions depress the circulation when administered intravenously.
Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, appropriate anticonvulsant medication such as an ultrashort acting barbiturate (e.g. thiopentone) or a benzodiazepine (e.g. diazepam) may be administered IV. The clinician should be familiar with these anticonvulsant drugs prior to use of local anaesthetics.
Suxamethonium will stop the muscle convulsions rapidly but will require tracheal intubation and controlled ventilation, and should only be used by those familiar with these procedures.
If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, inotropic agents and/or lipid emulsion should be considered. Children should be given doses commensurate with age and weight.
If ventricular fibrillation or cardiac arrest occurs, effective cardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary. Optimal oxygenation and ventilation, and circulatory support as well as treatment of acidosis are of vital importance.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mutagenic potential has not been determined.
Carcinogenicity. Long term studies in animals of most local anaesthetics, including bupivacaine, to evaluate the carcinogenic potential, have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. It appears as a white, crystalline powder or colourless crystals. It is soluble in water, freely soluble in ethanol (96%), slightly soluble in chloroform and in ether. Bupivacaine has a pKa of 8.1 and is more lipid soluble than lignocaine.
The structural formula of bupivacaine hydrochloride monohydrate is represented below.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUPIVA.gif Chemical name: (2RS)-1-butyl-N-(2,6-dimethylphenyl) piperidine-2-carboxamide hydrochloride monohydrate.
Molecular Formula: C₁₈H₂₉ClN₂O.H₂O.
Molecular Weight: 342.9.
CAS number. 73360-54-0 (bupivacaine hydrochloride monohydrate).

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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