Consumer medicine information

Flucloxacillin Baxter 1 g Powder for injection

Flucloxacillin

BRAND INFORMATION

Brand name

Flucloxacillin Baxter

Active ingredient

Flucloxacillin

Schedule

S4

1. Why am I being given FLUCLOXACILLIN BAXTER?


FLUCLOXACILLIN BAXTER contains the active ingredient flucloxacillin sodium monohydrate. FLUCLOXACILLIN BAXTER 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 Flucloxacillin? in the full CMI.

2. What should I know before I am given FLUCLOXACILLIN BAXTER?


Do not take if you have ever had an allergic reaction to flucloxacillin, 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 FLUCLOXACILLIN BAXTER? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with FLUCLOXACILLIN 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 am I given FLUCLOXACILLIN BAXTER?


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

5. What should I know after receiving FLUCLOXACILLIN BAXTER?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are being treated with FLUCLOXACILLIN BAXTER.
  • If 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 while you are receiving FLUCLOXACILLIN BAXTER, do not have any more and tell your doctor immediately.
  • If you develop yellow eyes and/or skin (jaundice) while, or soon after receiving FLUCLOXACILLIN BAXTER, contact your doctor immediately.
  • If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after FLUCLOXACILLIN BAXTER has been stopped.
  • If you get a sore white mouth or tongue while being treated with or soon after stopping FLUCLOXACILLIN BAXTER, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
  • If you become pregnant while you are taking FLUCLOXACILLIN BAXTER, tell your doctor.
  • If you have to have any tests, tell your doctor you are taking FLUCLOXACILLIN BAXTER.
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 FLUCLOXACILLIN BAXTER affects you

For more information, see Section 5. What should I know after receiving FLUCLOXACILLIN BAXTER? 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

Flucloxacillin Baxter

Active ingredient

Flucloxacillin

Schedule

S4

Boxed Warnings

Hepatic toxicity. Flucloxacillin 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 Baxter powder for injection 1 g vials contain flucloxacillin sodium equivalent to 1 g of flucloxacillin.
Each vial contains 95.0 to 105.0% of the stated amount of flucloxacillin. Each one gram of monograph substance represents 2 mmol of sodium.

3 Pharmaceutical Form

Flucloxacillin Baxter powder for injection is a fine white to off-white homogeneous powder, soluble in water. The injection is prepared by the addition of the appropriate volume of water for injections to give the desired concentration of flucloxacillin.

4 Clinical Particulars

4.9 Overdose

No information is available, but it could be anticipated that overdosage with Flucloxacillin Baxter 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.
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. Flucloxacillin Baxter (flucloxacillin sodium) is the sodium salt of (2S, 5R, 6R)-6-[3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid. It is a member of the beta-lactamase-stable group of penicillins derived from the penicillin nucleus, 6-amino-penicillanic acid. Flucloxacillin sodium has the following structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFLUSOD.gif C19H16CIFN3NaO5S.H20.
Flucloxacillin sodium has a molecular weight of 493.9.
CAS number. 1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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