FLUCLOXACILLIN KABI flucloxacillin 1000 mg (as sodium) powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

flucloxacillin sodium monohydrate, Quantity: 1088.1 mg (Equivalent: flucloxacillin, Qty 1000 mg)

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients:

Administration route:

Intramuscular, Intravenous, Intrapleural, Intraarticular

Units in package:

10 vials, 5 vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections. Indications include pneumonia, osteomyelitis, skin and skin structure and wound infections, infected burns and cellulitis.

Product summary:

Visual Identification: white or almost white powder; Container Type: Vial; Container Material: Glass Type II Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-06-07

Patient Information leaflet

FLUCLOXACILLIN KABI
1
FLUCLOXACILLIN KABI
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FLUCLOXACILLIN KABI?
Flucloxacillin Kabi contains the active ingredient flucloxacillin
sodium monohydrate. Flucloxacillin Kabi, belongs to a group of
medicines called penicillins. These antibiotics work by killing the
bacteria causing your infection.
For more information, see Section 1. Why am I using Flucloxacillin? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLUCLOXACILLIN KABI?
Do not use if you have ever had an allergic reaction to flucloxacillin
or other penicillin’s 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
Flucloxacillin Kabi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Flucloxacillin Kabi 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 FLUCLOXACILLIN KABI?
Flucloxacillin Kabi will be given to you by a doctor or nurse. Your
doctor will decide what dose and how long you will
receive Flucloxacillin Kabi for. This depends on your infection and
other factors, such as your weight. For most infections,
Flucloxacillin Kabi is usually given in divided doses throughout the
day.
More instructions can be found in Section 4. How do I use
Flucloxacillin Kabi? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLUCLOXACILLIN KABI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Flucloxacillin Kabi.
•
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 diffic

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – FLUCLOXACILLIN KABI
(FLUCLOXACILLIN AS SODIUM MONOHYDRATE)
1
NAME OF THE MEDICINE
Flucloxacillin (as sodium monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg or 1000 mg of flucloxacillin (as sodium
monohydrate).
Each gram of flucloxacillin sodium monohydrate contains approximately
2.2 mmol (51 mg)
sodium.
This product contains no excipients.
3
PHARMACEUTICAL FORM
Flucloxacillin sodium is white or almost white, hygroscopic,
crystalline powder. The
substance is freely soluble in water and in methanol and soluble in
ethanol (96 %).
Flucloxacillin Kabi is provided as a powder for Injection, for
Intraarticular, Intramuscular,
Intrapleural or Intravenous use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of confirmed or suspected staphylococcal infections
and other Gram-
positive coccal infections. Indications include pneumonia,
osteomyelitis, skin and skin
structure and wound infections, infected burns and cellulitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
_USUAL ADULT DOSAGE: _
_Intramuscular: _250 mg 6 hourly.
_IV injection/infusion: _250 mg to 1000 mg 6 hourly.
_Intrapleural: _250 mg once daily.
_Intra-articular: _250 to 500 mg once daily.
NOTE: Systemic doses may be doubled where necessary in severe
infections.
_ _
_CHILDREN'S DOSAGE: _
2 to 10 years: half adult dose.
Under 2 years: quarter adult dose.
NOTE: In severe infections dosage may be increased.
_ _
_DOSAGE IN PATIENTS WITH IMPAIRED LIVER FUNCTION: _Adjustment of
dosage may not be
necessary as flucloxacillin is not metabolised in the liver to any
appreciable extent. However,
during prolonged treatment it is advisable to check periodically for
hepatic dysfunction.
_ _
_DOSAGE IN PATIENTS WITH IMPAIRED RENAL FUNCTION: _As flucloxacillin
is excreted to a large
extent by the kidney, the dose or dose interval may need modification
in patients with renal
failure, as the half life in patients with renal failure is increased.
However, dosage
recommendations for various plasma