Consumer medicine information

Colistin Link 150 mg Powder for injection

Colistin

BRAND INFORMATION

Brand name

Colistin Link

Active ingredient

Colistin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Colistin Link 150 mg Powder for injection.

1. Why am I using COLISTIN LINK?


COLISTIN LINK contains the active ingredient colistimethate sodium. COLISTIN LINK is used to treat certain types of bacterial infections.
For more information, see Section 1. Why am I using COLISTIN LINK? in the full CMI.

2. What should I know before I use COLISTIN LINK?


Do not use if you have ever had an allergic reaction to COLISTIN LINK or any of the ingredients listed at the end of the CMI. COLISTIN LINK should not be used if you have myasthenia gravis.
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 COLISTIN LINK? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with COLISTIN LINK 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 COLISTIN LINK?

  • COLISTIN LINK is given as an injection by a doctor or other healthcare professional into a vein or muscle. You may receive doses of this medicine as injections, or infusions (via drip).

More instructions can be found in Section 4. How do I use COLISTIN LINK? in the full CMI.

5. What should I know while using COLISTIN LINK?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using COLISTIN LINK.
  • Tell your doctor if symptoms of your infection do not improve within a few days, or they become worse.
Driving or using machines
  • Be careful driving or operating machinery until you know how this medicine affects you.
  • This medicine may cause temporary numbness, tingling in the fingers and toes, and dizziness. If you have any of these symptoms, do not drive, or operate machinery.
Drinking alcohol
  • Be careful when drinking alcohol whilst being given this medicine.
Looking after your medicine
  • COLISTIN LINK vials should be kept in a cool dry place below 25°C.
  • Once the vial is opened, the prepared solution should be stored in the refrigerator between 2°C-8°C for a maximum of 24 hours.

For more information, see Section 5. What should I know while using COLISTIN LINK? in the full CMI.

6. Are there any side effects?


Side effects that require urgent medical attention include: difficulty breathing; decreased urine output or difficulty passing urine. Other possible side effects include dizziness, tingling or numbness of the mouth or tongue, itching, upset tummy, slurred speech, fever.
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.

BRAND INFORMATION

Brand name

Colistin Link

Active ingredient

Colistin

Schedule

S4

 

1 Name of Medicine

Colistin (as colistimethate sodium).

2 Qualitative and Quantitative Composition

Colistin Link contains the sodium salt of colistimethate, a polypeptide antibiotic. Each dose contains colistimethate sodium equivalent to colistin 150 mg. When reconstituted each dose provides 150 mg of colistin in 2 mL equivalent to 4,500,000 IU antibiotic activity.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
White to slightly yellow lyophilised powder cake.

4 Clinical Particulars

4.9 Overdose

Overdose can result in renal insufficiency, muscle weakness and apnoea. As in any case of overdose, colistimethate sodium therapy should be discontinued and general supportive measures should be utilised.
In albino rabbits and beagle dogs, IV doses of 5, 10 and 20 mg/kg/day for 28 days resulted in elevated blood urea nitrogen in the dog (10 mg/kg/day dose group) and in both 20 mg/kg dose groups.
For information on the management of overdose, contact the Poison Information Centre on 131 126 (Australia) or 0800 764 766 (New Zealand).

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/CSCOLSOD.gif Molecular formula: C56H106N16Na6O26S6. Molecular weight: 1750.
CAS number. 8068-28-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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