Consumer medicine information

Flucil 500 mg Powder for injection

Flucloxacillin

BRAND INFORMATION

Brand name

Flucil

Active ingredient

Flucloxacillin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

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

1. Why am I being given FLUCIL?


FLUCIL contains the active ingredient flucloxacillin sodium monohydrate. FLUCIL 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 FLUCIL? in the full CMI.

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


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

3. What if I am taking other medicines?


Some medicines may interfere with FLUCIL 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 FLUCIL?


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

5. What should I know after receiving FLUCIL?

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 FLUCIL, contact your doctor immediately.
  • If you develop yellow eyes and/or skin (jaundice) while, or soon after receiving FLUCIL, 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 FLUCIL has been stopped.
  • If you get a sore white mouth or tongue after you have been given FLUCIL, tell your doctor. Also tell your doctor if you get a vaginal itching or discharge.
  • If you become pregnant while you are receiving FLUCIL, tell your doctor.
  • If you have to have any tests tell your doctor you have been given FLUCIL.
  • Remind any doctor, dentist or pharmacist you visit that you are being treated FLUCIL.
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 FLUCIL affects you.

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

Flucil

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

Flucil powder for injection 500 mg vials contain flucloxacillin sodium equivalent to 500 mg of flucloxacillin.
Flucil 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

Flucil 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 Flucil 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. Flucil (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 C19H16ClFN3NaO5S.H2O.
Flucloxacillin sodium has a molecular weight of 493.9.
CAS number. 1847-24-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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