Consumer medicine information

1. Why am I using Atracurium besilate Medsurge?

Atracurium besilate Medsurge contains the active ingredient atracurium besilate. Atracurium besilate is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation, and to facilitate mechanical ventilation in Intensive Care Unit (ICU) patients.
For more information, see Section 1. Why am I using Atracurium besilate Medsurge? in the full CMI.

2. What should I know before I use Atracurium besilate Medsurge?

Do not use if you have ever had an allergic reaction to atracurium besilate or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Atracurium besilate Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with atracurium besilate and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Atracurium besilate Medsurge?

More instructions can be found in Section 4. How do I use Atracurium besilate Medsurge? in the full CMI.
Atracurium besilate Medsurge will be given into your vein as an injection or by a 'drip' (infusion). This will be done by an anaesthetist or a doctor with special training.

5. What should I know while using Atracurium besilate Medsurge?

6. Are there any 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.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Notes

Distributed by Medsurge Healthcare

1 Name of Medicine

Atracurium besilate.

2 Qualitative and Quantitative Composition

Atracurium Besilate Medsurge solution for injection, 10 mg atracurium besilate in each mL.
Each 2.5 mL glass ampoule contains 25 mg of atracurium besilate.
Each 5 mL glass ampoule contains 50 mg of atracurium besilate.
The pH is adjusted to 3.4-3.6 with benzenesulfonic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Atracurium Besilate Medsurge solution for injection is a sterile solution in water. It is clear, colourless or yellowish solution, free from visible particles.

4 Clinical Particulars

4.9 Overdose

There has been limited experience with atracurium besilate overdosage. The possibility of iatrogenic overdosage can be minimised by carefully monitoring muscle twitch response to peripheral nerve stimulation. Excessive doses of atracurium besilate 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 anti-cholinesterase 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

Atracurium besilate is white or yellowish-white, slightly hygroscopic powder. Soluble in water, very soluble in acetonitrile, in ethanol (96 per cent) and in methylene chloride and is designated as 5-[3-[1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-3,4-dihydro-1-Hisoquinolin-2-ium-2-yl]propanoyloxy]pentyl3-[1-[(3,4-dimethoxyphenyl)methyl]-6,7-dimethoxy-2-methyl-3,4-dihydro-1H-isoquinolin-2-ium-2-yl]propanoate 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)

Prescription only medicine - Schedule 4.

Summary Table of Changes

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