STAPHYLEX 250 capsule

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

flucloxacillin sodium monohydrate, Quantity: 272.5 mg (Equivalent: flucloxacillin, Qty 250 mg)

Verfügbar ab:

Alphapharm Pty Ltd

Darreichungsform:

Capsule, hard

Zusammensetzung:

Excipient Ingredients: povidone; brilliant blue FCF; magnesium stearate; sodium starch glycollate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; microcrystalline cellulose; Gelatin

Verabreichungsweg:

Oral

Einheiten im Paket:

24, 30

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Approval granted as specified in the letter of 1 May 1992 from Dr H. Arora. Indicated for the treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis.

Produktbesonderheiten:

Visual Identification: Size 2 capsule with yellow body and black cap.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1991-09-20

Gebrauchsinformation

STAPHYLEX
_flucloxacillin (as sodium monohydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Staphylex. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Staphylex against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT STAPHYLEX IS
USED FOR
Staphylex contains the active
ingredient flucloxacillin.
It is used to treat infections in
different parts of the body caused by
bacteria.
It is an antibiotic that belongs to a
group of medicines called penicillins.
These medicines work by killing the
bacteria that are causing your
infection.
Staphylex will not work against
infections caused by viruses, such as
colds.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Staphylex for another reason.
This medicine is not addictive.
It is available only with a doctor's
prescription.
BEFORE YOU TAKE
STAPHYLEX
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 STAPHYLEX IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
flucloxacillin
•
any other penicillin medicines or
cephalosporins
•
beta-lactam antibiotics including
imipenem and aztreonam
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face, lips, tongue
or any other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE STAPHYLEX IF YOU HAVE
HAD A REACTION AFFECTING YOUR LIVER
WHILE YOU WERE TAKING A MEDICINE
CONTAINING FLUCLOXACILLIN.

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
STAPHYLEX
_Flucloxacillin (as sodium monohydrate) capsule_
_ _
1
NAME OF THE MEDICINE
Flucloxacillin sodium monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Staphylex 250 mg and 500 mg capsule contains 250 mg or 500 mg of
Flucloxacillin (as sodium
monohydrate) as the active ingredient.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of confirmed or suspected staphylococcal and other
Gram-positive coccal infections including
pneumonia, osteomyelitis, skin and soft tissue and wound infections,
infected burns, cellulitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
USUAL ADULT DO
se: 250 mg, 6 hourly.
CHILDREN
: 2 to 10 years: half adult dose.
NOTE:
In severe infections the dosage may be increased.
METHOD OF ADMINISTRATION
The oral dose should be administered half to one hour before meals.
DOSAGE ADJUSTMENT IN:
RENAL IMPAIRMENT
As flucloxacillin sodium monohydrate 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 these patients
is increased. Dosage recommendations for various plasma creatinine
levels for patients with
impaired renal function are not available. Flucloxacillin sodium
monohydrate is not significantly
removed by haemodialysis.
HEPATIC IMPAIRMENT
Adjustment of dosage may not be necessary as flucloxacillin sodium
monohydrate is not
metabolised in the liver to any appreciable extent. However, during
prolonged treatment, it is
Staphylex
250 mg capsule:
Each 250 mg capsule contain Flucloxacillin (as sodium monohydrate) as
the
active ingredient, presented as a yellow body with black cap.
Staphylex
500 mg capsule:
Each 500 mg capsule contains Flucloxacillin (as sodium monohydrate) as
the
active ingredient, presented as a yellow body with black cap.
STAPHYLEX – PRODUCT INFORMATION
2
advisable to check periodically for hepatic dysfunction (
_SEE SECTION