Flucloxacillin Oral Solution (AFT)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Flucloxacillin sodium monohydrate 54.4 mg/mL equivalent to Flucloxacillin 50 mg/mL;  ; Flucloxacillin sodium monohydrate 57.26 mg/mL equivalent to Flucloxacillin 50 mg/mL

Available from:

AFT Pharmaceuticals Ltd

INN (International Name):

Flucloxacillin sodium monohydrate 54.4 mg/mL (=Flucloxacillin 50 mg/mL)

Dosage:

250 mg/5mL

Pharmaceutical form:

Powder for syrup

Composition:

Active: Flucloxacillin sodium monohydrate 54.4 mg/mL equivalent to Flucloxacillin 50 mg/mL   Excipient: Ammonium glycyrrhizinate Disodium edetate dihydrate Erythrosine Menthol flavour 17410157 Pineapple flavour 17410011 Saccharin sodium Sodium benzoate Sodium citrate dihydrate Sucrose Active: Flucloxacillin sodium monohydrate 57.26 mg/mL equivalent to Flucloxacillin 50 mg/mL Excipient: Citric acid monohydrate Colloidal silicon dioxide Disodium edetate dihydrate Lemon flavour 17.41.0212 Menthol flavour 17410157 Saccharin sodium Sodium benzoate Sodium citrate Sorbitol Strawberry flavour 17.43.2172 Xanthan gum

Units in package:

Bottle, plastic, HDPE with child-resistant PP or HDPE cap (sugar free), 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fresenius Kabi Anti-Infectives S.r.l.

Therapeutic indications:

The treatment of infections due to Gram-positive organisms, including infections caused by ?-lactamase producing staphylococci

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with child-resistant PP or HDPE cap (sugar free) - 100 mL - 18 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2001-08-24

Patient Information leaflet

1
New Zealand Consumer Medicine Information
FLUCLOXACILLIN
_FLUCLOXACILLIN (AS THE SODIUM SALT) 250 MG AND 500 MG CAPSULES _
_FLUCLOXACILLIN (AS THE SODIUM SALT) 125 MG/5 ML AND 250 MG/5 ML _
_POWDER FOR ORAL SOLUTION_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
FLUCLOXACILLIN.
This leaflet answers some common questions about FLUCLOXACILLIN. It
does not
contain all the available information. It does not take the place of
talking to your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
FLUCLOXACILLIN against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT FLUCLOXACILLIN IS USED FOR
FLUCLOXACILLIN contains the active ingredient flucloxacillin.
Flucloxacillin is an
antibiotic that belongs to a group of medicines called penicillins.
These medicines work
by killing the bacteria that are causing infection.
FLUCLOXACILLIN is used to treat infections caused by bacteria.
Examples of some
of the infections that may be caused by bacteria include respiratory
tract infections
and skin or fleshy tissue skin infections.
FLUCLOXACILLIN will not work against infections caused by viruses,
such as colds
or the flu.
Your doctor may have prescribed FLUCLOXACILLIN for another reason.
Ask your doctor if you have any questions about why FLUCLOXACILLIN has
been
prescribed for you.
There is no evidence that FLUCLOXACILLIN is addictive.
2
FLUCLOXACILLIN is available only with a doctor's prescription.
BEFORE YOU TAKE FLUCLOXACILLIN
_ _
WARNING: FLUCLOXACILLIN CAN CAUSE SEVERE LIVER DAMAGE, PARTICULARLY IN
OLDER
PATIENTS AND THOSE WHO TAKE IT FOR MORE THAN 14 DAYS.
_ _
_WHEN YOU MUST NOT TAKE IT _
Do not take FLUCLOXACILLIN if you are allergic to:
•
medicines containing flucloxacillin or any other penicillin;
•
cephalosporin antibiotics;
•
beta-lactam antibiotics;
•
any of the ingredien

Summary of Product characteristics

Page 1 of 11
NEW ZEALAND DATA SHEET
1.
FLUCLOXACILLIN
Flucloxacillin 250 mg capsules.
Flucloxacillin 500 mg capsules.
Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution.
Flucloxacillin Oral Solution 250 mg/5 mL powder for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Flucloxacillin 250 mg capsules: Each capsule contains 250 mg
flucloxacillin (as sodium).
Flucloxacillin 500 mg capsules: Each capsule contains 500 mg
flucloxacillin (as sodium).
Flucloxacillin Oral Solution 125 mg/5 mL powder for oral solution:
Following reconstitution, each
5 mL of solution contains 125 mg flucloxacillin (as sodium).
Flucloxacillin Oral Solution 250 mg/5 mL powder for oral solution:
Following reconstitution, each
5 mL of solution contains 250 mg flucloxacillin (as sodium).
Excipients with known effect:
Sodium
Sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules:
250 mg: Size ‘2’ hard gelatine capsule having an opaque caramel
body fitted with opaque grey cap.
Both printed 'FXN 250' in black.
500 mg: Size ‘0E’ hard gelatine capsule having an opaque caramel
body fitted with opaque grey cap.
Both printed 'FXN 500' in black.
Powder for oral solution:
Free-flowing white granular powder with a slight lemon odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Flucloxacillin is indicated for the treatment of infections due to
Gram-positive organisms, including
infections caused by β-lactamase producing staphylococci.
Page 2 of 11
Typical indications include:
•
Skin and soft tissue infections: boils, abscesses, carbuncles,
furunculosis, cellulitis, infected wounds,
infected burns, protection of skin grafts, and impetigo.
•
Infected skin conditions: ulcer, eczema and acne.
•
Respiratory tract infections: Pneumonia, lung abscess, empyema,
sinusitis, pharyngitis, tonsillitis,
quinsy, otitis media and externa.
•
Other infections caused by flucloxacillin-sensitive organisms such as
osteomyelitis, enteritis,
endocarditis, urinary tract infection, meningitis, se