Consumer medicine information

Flubiclox 500 mg Powder for injection

Flucloxacillin

BRAND INFORMATION

Brand name

Flubiclox

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Flubiclox 500 mg Powder for injection.

1. Why am I being given FLUBICLOX?


FLUBICLOX contains the active ingredient flucloxacillin sodium monohydrate. FLUBICLOX is an antibiotic used to treat some infections in different parts of the body caused by bacteria.
For more information, see Section 1. Why am I being given FLUBICLOX? in the full CMI.

2. What should I know before I am given FLUBICLOX?


Do not use if you have ever had an allergic reaction to FLUBICLOX, other penicillins 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 am given FLUBICLOX? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with FLUBICLOX 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 am I given FLUBICLOX?


FLUBICLOX will be given to you by a doctor or nurse. Your doctor will decide what the dose is and how long you will receive FLUBICLOX. This depends on your infection and other factors, such as your weight. For most infections, FLUBICLOX is usually given in divided doses throughout the day.
More instructions can be found in Section 4. How am I given FLUBICLOX? in the full CMI.

5. What should I know after receiving FLUBICLOX?

Things you should do
  • If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
  • If you develop itching with swelling or skin rash or difficulty breathing after you have been given FLUBICLOX, contact your doctor immediately.
  • If you develop yellow eyes and/or skin (jaundice) while, or soon after receiving FLUBICLOX, contact your doctor immediately.
  • If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs up to several weeks after FLUBICLOX has been stopped.
  • If you get a sore white mouth or tongue after you have been given FLUBICLOX, tell your doctor. Also tell your doctor if you get a vaginal itching or discharge.
  • If you become pregnant while you are receiving FLUBICLOX, tell your doctor.
  • If you have to have any tests tell your doctor you have been given FLUBICLOX.
  • Remind any doctor, dentist or pharmacist you visit that you are being treated with FLUBICLOX.
Things you should not do
  • Do not take any diarrhoea medicine without first checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how FLUBICLOX affects you.

For more information, see Section 5. What should I know after receiving FLUBICLOX? in the full CMI.

6. Are there any side effects?


Side effects include pain or redness at the site of injection, mild rash, oral thrush, vaginal thrush, nausea, stomach upsets, mild diarrhoea, constipation, dizziness or headaches.
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

Flubiclox

Active ingredient

Flucloxacillin

Schedule

S4

 

Boxed Warnings

Liver toxicity. Flucloxacillin sodium can cause severe hepatitis and cholestatic jaundice, which may be protracted. This reaction is more frequent in older patients and those who take the drug for prolonged periods (see Section 4.8 Adverse Effects (Undesirable Effects)).

1 Name of Medicine

Flucloxacillin (as flucloxacillin sodium).

2 Qualitative and Quantitative Composition

Flucloxacillin 500 mg powder for injection.
Flucloxacillin 1 gram powder for injection.
Flucloxacillin 2 gram powder for injection.
Each vial contains 95-105% of the stated amount of flucloxacillin.
Each gram of flucloxacillin sodium monohydrate contains approximately 2 mmol of sodium.
Each 2 g product vial contains 2 g flucloxacillin (as flucloxacillin sodium monohydrate) and approximately 4.52 mmol (104 mg) sodium.
This product contains no excipients.

3 Pharmaceutical Form

Flubiclox is a white to off-white powder contained in a clear glass vial.

4 Clinical Particulars

4.9 Overdose

Symptoms. No information is available, but it could be anticipated that overdosage with flucloxacillin would cause gastrointestinal and CNS symptoms (see Section 4.8 Adverse Effects (Undesirable Effects)). As the blood brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels of flucloxacillin in patients with meningitis.
Flucloxacillin is not significantly removed from the circulation by haemodialysis. General supportive measures should be instituted.
Treatment. The drug should be withdrawn and general supportive measures of symptomatic treatment instituted.
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/CSFLUCSO.gif Chemical name: (2S, 5R, 6R)-6- [[[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4- yl]carbonyl]amino] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.
CAS number. [1847-24-1].
Molecular formula: C19H16ClFN3NaO5S.H2O.
Molecular weight: 493.9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes

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