Consumer medicine information

1. Why am I using ROCURONIUM BAXTER?

ROCURONIUM BAXTER contains the active ingredient rocuronium bromide. ROCURONIUM BAXTER is one of a group of medicines called muscle relaxants. ROCURONIUM BAXTER is used during an operation as part of the general anaesthetic. When you have an operation, your muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation.
For more information, see Section 1. Why am I using ROCURONIUM BAXTER? in the full CMI.

2. What should I know before I use ROCURONIUM BAXTER?

Do not use if you have ever had an allergic reaction to ROCURONIUM BAXTER 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 ROCURONIUM BAXTER? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ROCURONIUM BAXTER 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 ROCURONIUM BAXTER is given?

• ROCURONIUM BAXTER will be given by a doctor. It will not be given to you until you are asleep from the anaesthetic.

• It will be injected into a vein before and/or during an operation. It will be given as a single injection or continuous infusion.

5. What should I know after having ROCURONIUM BAXTER?

6. Are there any side effects?

Like all medicines, ROCURONIUM BAXTER can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of using ROCURONIUM BAXTER. When you get ROCURONIUM BAXTER, you can have some serious side effects.
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.

1 Name of Medicine

Rocuronium bromide.

2 Qualitative and Quantitative Composition

Rocuronium Baxter 50 mg/5 mL. 5 mL of solution contains 50 mg rocuronium bromide.
Rocuronium Baxter 100 mg/10 mL. 10 mL of solution contains 100 mg rocuronium bromide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rocuronium Baxter is a clear, colourless to yellow or orange solution.

4 Clinical Particulars

4.9 Overdose

Symptoms. The symptoms of overdosage with a non-depolarising muscle relaxant are those of prolonged paralysis, apnoea, low tidal volume, respiratory depression and/or persistent muscle weakness. In animal studies, severe depression of cardiovascular function ultimately leading to cardiac collapse did not occur until a cumulative dose of 750 times the ED₉₀ (rocuronium bromide 135 mg.kg^-1) was administered.
Treatment. In the event of overdosage and prolonged neuromuscular block, the patient should continue to receive ventilatory support and sedation. In this situation there are two options for the reversal of neuromuscular block: (1) Sugammadex can be used for reversal of intense (profound) and deep block. The dose of sugammadex to be administered depends on the level of neuromuscular block. An acetylcholinesterase inhibitor (e.g. neostigmine, edrophonium, pyridostigmine), with appropriate vagolytic (e.g. atropine) can be used at reappearance of T₂ or at the first signs of clinical recovery and should be administered in adequate doses. If administration of an acetylcholinesterase inhibiting agent fails to reverse the effects of rocuronium, ventilation must be continued until spontaneous breathing is restored.
Use of a reversal agent should not begin until definite signs of spontaneous recovery are present. Overdosage of an acetylcholinesterase inhibitor can be dangerous.
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. Rocuronium bromide showed no genotoxic potential in standard assays of gene mutation and chromosomal damage.
Carcinogenicity. Carcinogenicity studies with rocuronium bromide have not been conducted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Rocuronium bromide is an almost white to pale yellow amorphous powder which is freely soluble in water (> 200 mg/mL). A 1% w/v solution in water has a pH of 8.9 to 9.5. In aqueous solution rocuronium bromide is more stable at acidic pH. Rocuronium Baxter has a pH of 3.8 to 4.2. The partition coefficient of Rocuronium bromide in n-octanol/water is 0.5 at 20°C.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSROCURO.gif Molecular formula. C₃₂H₅₃BrN₂O₄.
Molecular weight. 609.7 g/mol.
CAS number. 119302-91-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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