Consumer medicine information

1. Why am I using Amikacin Medsurge?

Amikacin Medsurge contains the active ingredient amikacin sulfate equivalent to amikacin activity 500 mg (500,000 IU). Amikacin is used to treat serious bacterial infections.
For more information, see Section 1. Why am I using Amikacin Medsurge? in the full CMI.

2. What should I know before I use Amikacin Medsurge?

Do not use if you have ever had an allergic reaction to amikacin sulphate 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 Amikacin Medsurge? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Amikacin Medsurge 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 Amikacin Medsurge?

• Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight and kidney function.

5. What should I know while using Amikacin Medsurge?

6. Are there any side effects?

Tell your doctor or nurse if you notice any of the following and they worry you: Pain at the injection site, feeling sick, decreased appetite, headache, nausea and vomiting, fever. These side effects are usually mild.
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

Amikacin sulfate.

2 Qualitative and Quantitative Composition

Amikacin Medsurge injection is available in 500 mg/2 mL strength. Each 2 mL contains amikacin sulfate equivalent to amikacin activity 500 mg (500,000 IU).
Excipient with known effect. Sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Amikacin Medsurge injection is a sterile clear, colourless to pale yellow solution free from visible particulate matter.

4 Clinical Particulars

4.9 Overdose

Symptoms and signs. In case of overdosage there is a general risk for nephro-, oto- and neurotoxic (neuromuscular blockage) reactions.
Likely signs and symptoms include tinnitus, vertigo, reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, reduced renal function or renal failure.
Recommended treatment. Neuromuscular blockage with respiratory arrest needs appropriate treatment including application of ionic calcium (e.g. as gluconate or lactobionate in 10-20% solution) (see Section 4.4 Special Warnings and Precautions for Use).
In the event of overdosage or toxic reactions peritoneal dialysis or haemodialysis will aid in the removal of amikacin from the blood. Amikacin levels are also reduced during continuous arteriovenous hemofiltration. These procedures are of particular importance in patients with impaired renal function. In the newborn infant, exchange transfusion may also be considered.
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

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSAMISUL.gif Chemical name: as 6-O-(3-Amino-3-deoxy-α-D-glucopyranosyl)-4-O-(6-amino-6-deoxy-α-D-glucopyranosyl)-N¹-[(2S)-4-amino-2-hydroxybutyryl]-2-deoxystreptamine sulfate.
Molecular formula: C₂₂H₄₃N₅O₁₃.2H₂SO₄.
Molecular weight: 781.8.
Amikacin sulfate is a white crystalline powder. It is freely soluble in water and practically insoluble in alcohol and acetone.
CAS number. 39831-55-5.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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