Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about TRACRIUM. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being given TRACRIUM against the benefits this medicine is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What TRACRIUM is used for

TRACRIUM will be given to you or your child during surgery. It is used together with anaesthetic medicines to relax the body’s muscles
TRACRIUM belongs to a group of medicines called “neuromuscular blockers”.
TRACRIUM works by blocking the effects of one of the body’s chemical messengers called acetylcholine. Acetylcholine is involved in muscle contraction.
Ask your doctor if you have any questions about why TRACRIUM has been prescribed for you.
Your doctor may have prescribed TRACRIUM for another reason.
There is no evidence that TRACRIUM is addictive.

Before you are given it

When you must not receive TRACRIUM

• You must not receive TRACRIUM if you have ever had an allergic reaction to atracurium besilate or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following:
  wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.

Before you receive it

• you have had any adverse reactions during an operation.

• you have had any type of allergic reaction to muscle relaxants, or to any medicines used during an operation.

• you are allergic to any other medicines or any other substance, such as foods, dyes or preservatives.

• if you or a relative have had previous difficulties with anaesthetics.

• you have or have ever had any of the following medical conditions:
  - asthma or any other breathing disorders
  - heart disease
  - kidney, liver disease or disease of the nervous system e.g. myaesthenia gravis

• you are pregnant, intend to become pregnant, are breast feeding or plan to breast feed.
  Your doctor will discuss the possible risks and benefits of being given TRACRIUM if you are pregnant or breast-feeding.

Taking other medicines

• antibiotics

• drugs for the heart

• blood pressure tablets

• magnesium

• lithium

• other muscle blockers (e.g. hexamethonium) and anaesthetics.

How TRACRIUM is given

TRACRIUM can be given into a vein in two ways:

• as an injection, or

• as a slow infusion.

While you are using it

Things to be careful of

Side effects

Check with your doctor as soon as possible if you have any problems after receiving TRACRIUM, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, TRACRIUM can cause some side effects.
The most commonly reported side effects are:

• skin flushing

• lowering of blood pressure

• changes in heart rate either increased or decreased

• tight breathing

• allergic reactions

• skin rash

• seizures (in certain patients)

• muscle weakness.

Storage

TRACRIUM should be stored by the hospital’s pharmacy between 2° and 8°C and protected from light. Do not freeze.
Once removed from the fridge, the ampoules may be stored below 25°C, protected from light for up to 1 week only, provided the product is used before the printed expiry date. Thereafter discard the ampoules.

Product description

What TRACRIUM looks like

Ingredients

Sponsor

1 Name of Medicine

Atracurium besilate.

2 Qualitative and Quantitative Composition

Tracrium injection, 10 mg atracurium besilate in each mL.
Each 2.5 mL glass ampoule contains 25 mg of atracurium besilate and each 5 mL glass ampoule contains 50 mg of atracurium besilate. The pH is adjusted to 3.2-3.7 with benzenesulfonic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tracrium injection is a sterile solution in water. It is a clear slightly yellow solution; practically free from particles.

4 Clinical Particulars

4.9 Overdose

There has been limited experience with Tracrium overdosage. The possibility of iatrogenic overdosage can be minimised by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of Tracrium can be expected to produce enhanced pharmacological effects. Overdosage may increase the risk of histamine release and cardiovascular effects, especially hypotension. If cardiovascular support is necessary, this should include proper positioning, fluid administration, and the use of vasopressor agents if necessary. The patient's airway should be maintained, with manual or mechanical ventilation as necessary. A longer duration of neuromuscular blockade may result from overdosage and a peripheral nerve stimulator should be used to monitor recovery. Full sedation will be required since consciousness is not impaired. Recovery may be facilitated by administration of an anticholinesterase reversing agent such as neostigmine, edrophonium or pyridostigmine, in conjunction with an anticholinergic agent such as atropine.
Further information. Haemofiltration and haemodiafiltration have a minimal effect on plasma levels of atracurium and its metabolites, including laudanosine. The effects of haemodialysis and haemoperfusion on plasma levels of atracurium and its metabolites are unknown.
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. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tracrium is chemically unique, and is designated as 2,2'-(3,11-dioxo-4,10 -dioxatridecamethylene) -bis-(2-methyl-1, 2,3,4 -tetrahydropapaverinium benzenesulfonate). It has a molecular weight of 1243.49, and its empirical formula is C₅₃H₇₂N₂O₁₂.2C₆H₅O₃S.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSATRABE.gif CAS number. 64228-81-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TRACINST.gif