Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about Marcain 0.5% and Marcain Spinal 0.5% Heavy. It does not contain all the information that is known about Marcain 0.5% and Marcain Spinal 0.5% Heavy.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Marcain 0.5% or Marcain Spinal 0.5% Heavy against the benefits they expect it will have for you.

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

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

What MARCAIN 0.5% and MARCAIN SPINAL 0.5% HEAVY are for

Marcain 0.5% and Marcain Spinal 0.5% Heavy are used to prevent or relieve pain, before surgery of the lower abdomen and lower limbs. They will not put you to sleep.

Marcain 0.5% and Marcain Spinal 0.5% Heavy can also be used to make childbirth less painful.

Marcain 0.5% and Marcain Spinal 0.5% Heavy belong to a group of medicines called spinal local anaesthetics. They are injected into the spinal fluid where they make the nerves unable to pass messages to the brain.

Depending on the amount used, Marcain 0.5% and Marcain Spinal 0.5% Heavy will either totally stop pain or will cause a partial loss of feeling.

Your doctor will have explained why you are being treated with Marcain 0.5% or Marcain Spinal 0.5% Heavy and told you what dose you will be given.

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

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Marcain 0.5% and Marcain Spinal 0.5% Heavy are not addictive.

Before you are given MARCAIN 0.5% or MARCAIN SPINAL 0.5% HEAVY

When you must not have it

Do not use Marcain 0.5% or Marcain Spinal 0.5% Heavy if you are pregnant or breastfeeding unless your doctor says so. Ask your doctor about the risks and benefits involved. We do not know if it is safe for you to be given it while you are pregnant. They may affect your baby if you take it early in pregnancy or in the last weeks before your baby is due. However, they can be used during childbirth.

Your baby can take in very small amounts of Marcain 0.5% or Marcain Spinal 0.5% Heavy from breast milk if breastfeeding.

Marcain 0.5% and Marcain Spinal 0.5% Heavy will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed. They may have no effect at all, or worse, an entirely unexpected effect if you are given them after the expiry date.

Before you are given it

You must tell your doctor if:

1. you have any allergies to

• any ingredients listed at the end of this leaflet
• other local anaesthetics eg. lignocaine
• any other substances

If you have an allergic reaction, you may get a skin rash, hay fever or difficulty breathing.

2. you have any of these medical conditions

• problems with your blood pressure or circulation
• blood poisoning
• problems with the clotting of your blood
• nerve or heart problems
• liver or kidney problems
• malignant hyperthermia
• diseases of the brain or spine
• some types of back problems

It may not be safe for you to be given Marcain 0.5% or Marcain Spinal 0.5% Heavy if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy at the chemist, supermarket or health food shop. These medicines may affect the way Marcain 0.5% or Marcain Spinal 0.5% Heavy work.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Marcain 0.5% or Marcain Spinal 0.5% Heavy.

How MARCAIN 0.5% and MARCAIN SPINAL 0.5% HEAVY are given

Marcain 0.5% or Marcain Spinal 0.5% Heavy will be injected by your doctor into the spinal canal, through a space between the bones in your lower back. This is called a SPINAL injection and it will result in a feeling of numbness in your lower body, in an area that may seem unrelated to the site of injection.

Marcain 0.5% and Marcain Spinal 0.5% Heavy should not be injected directly into the blood.

The dosage you will be given will depend on your body size, age and the type of pain relief required. Your doctor will have had a lot of experience injecting Marcain 0.5% and Marcain Spinal 0.5% Heavy or other local anaesthetics and will choose the best dose for you.

They will be willing to discuss this decision with you.

Overdose

The doctor giving you Marcain 0.5% or Marcain Spinal 0.5% Heavy will be experienced in the use of spinal local anaesthetics, so it is unlikely that you will be given an overdose.

However, if you are particularly sensitive to Marcain 0.5% or Marcain Spinal 0.5% Heavy, or the dose is accidently injected directly into your blood, you may develop problems for a short time with your sight or hearing. You may get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles.

Whenever you are given Marcain 0.5% or Marcain Spinal 0.5% Heavy, equipment will be available to care for you if an overdose happens.

While you are being given it

Things to be careful of

Be careful driving or operating machinery after you have been given Marcain 0.5% or Marcain Spinal 0.5% Heavy. You may be drowsy and your reflexes may be slow.

Do not drink alcohol while you are being given Marcain 0.5% or Marcain Spinal 0.5% Heavy. If you drink alcohol while you are being given Marcain 0.5% or Marcain Spinal 0.5% Heavy your blood pressure may drop, making you feel dizzy and faint.

Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Marcain 0.5% or Marcain Spinal 0.5% Heavy.

Marcain 0.5% and Marcain Spinal 0.5% Heavy will prevent or relieve pain in most people, but they may have unwanted side-effects. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

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

• nervousness
• dizziness
• blurred vision
• drowsiness
• ringing in the ears
• numbness
• feeling strange (disoriented)
• nausea
• vomiting

These are all mild side effects of Marcain 0.5% and Marcain Spinal 0.5% Heavy.

After a spinal injection you may develop a headache or backache which is not always related to the medicine used. These can, on rare occasions, last for some months after the injection is given.

If Marcain 0.5% or Marcain Spinal 0.5% Heavy is given wrongly, or you are very sensitive to it, it sometimes causes

• fits
• unconsciousness
• breathing problems
• low blood pressure
• slow heart beat
• collapse

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

Some people may get other side effects while being given Marcain 0.5% or Marcain Spinal 0.5% Heavy.

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

After using it

Storage

Marcain 0.5% or Marcain Spinal 0.5% Heavy will be stored by your doctor or pharmacist under the recommended conditions.

It should be kept in a cool dry place where the temperature stays below 25 °C.

Disposal

Any Marcain 0.5% or Marcain Spinal 0.5% Heavy which is not used, will be disposed of in a safe manner by your doctor or pharmacist.

Product description

Each Marcain 0.5% Injection contains bupivacaine hydrochloride 0.5% (5mg/mL) as the active ingredient,

plus

• Sodium chloride
• Hydrochloric acid or sodium hydroxide for pH adjustment
• Water for Injections

Each Marcain Spinal 0.5% Heavy Injection contains bupivacaine hydrochloride 0.5% w/v (5mg/ml) as the active ingredient,

plus

• Glucose 8% w/v (80mg/mL)
• Hydrochloric acid or sodium hydroxide for pH adjustment
• Water for Injections

The inclusion of glucose in Marcain Spinal 0.5% Heavy means that it will move along your spinal canal with gravity, depending on which way your body is tilted.

Marcain 0.5% and Marcain Spinal 0.5% Heavy are available as 4mL glass ampoules in Sterile AstraZeneca Theatre Pack™ in packs of 5.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

Australian Registration Number

MARCAIN 0.5% (SPINAL)
glass ampoules 21016

MARCAIN SPINAL 0.5% HEAVY
glass ampoules 11941

This leaflet was revised in May 2017

Marcain and Sterile AstraZeneca Theatre Pack are trade marks of the AstraZeneca group of companies

Published by MIMS September 2017

Boxed Warnings

Not for intravenous administration under any circumstances.

1 Name of Medicine

Bupivacaine hydrochloride.

2 Qualitative and Quantitative Composition

Marcain Spinal 0.5% Heavy contains bupivacaine hydrochloride 0.5% w/v (5 mg/mL) with glucose monohydrate 8% w/v (80 mg/mL).
Marcain Spinal 0.5% Heavy solution for injection is a sterile, hyperbaric, isotonic aqueous solution of bupivacaine hydrochloride in Water for Injections BP. It has a specific gravity of 1.026 at 20°C. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.0 during the approved shelf-life.
Marcain Spinal 0.5% contains bupivacaine hydrochloride 0.5% (5 mg/mL).
Marcain Spinal 0.5% solution for injection is a sterile, isobaric, isotonic aqueous solution bupivacaine hydrochloride and sodium chloride in Water for Injections BP. The pH of the solution is adjusted with sodium hydroxide or hydrochloric acid to remain between 4.0 - 6.5 during the approved shelf-life.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Clear, colourless solution for injection.

4 Clinical Particulars

4.9 Overdose

Acute emergencies associated with the use of local anaesthetics are generally related to high plasma levels (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.4 Special Warnings and Precautions for Use). Since the dose required for spinal anaesthesia is so small (20% or less than that required for epidural anaesthesia), acute systemic toxicity is extremely unlikely and has not been reported.
With accidental intravascular injections of local anaesthetics, the toxic effects will be obvious within 1-3 minutes. With overdosage, peak plasma concentrations may not be reached for 20-30 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.
Cardiovascular toxicity indicates a more severe situation. Hypotension, bradycardia, arrhythmia and even 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 ultra-short 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.
To counteract the pressor effects of adrenaline, use rapidly acting vasodilators, for instance nitrates or α-blocking agents.
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. There is no evidence from human data that bupivacaine may be mutagenic.
Carcinogenicity. Long-term studies in animals of most local anaesthetics, including bupivacaine, to evaluate the carcinogenic potential have not been conducted. There is no evidence from human data that bupivacaine may be carcinogenic.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical name for bupivacaine hydrochloride is (2RS)-1-butyl-N-(2,6-dimethylphenyl) piperidine-2-carboxamide hydrochloride monohydrate.
Bupivacaine has a pKa of 8.1 and is more lipid soluble than lignocaine. The Australian Approved Name is bupivacaine hydrochloride monohydrate.
The chemical structure of bupivacaine hydrochloride monohydrate is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBUPIVH.gif CAS number. The CAS number for bupivacaine hydrochloride, monohydrate is 73360-54-0.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

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