Staphlex

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Flucloxacillin sodium monohydrate 545mg (Quantity variable: based on the assay of Flucloxacillin sodium)

Disponible des:

Viatris Limited

Designació comuna internacional (DCI):

Flucloxacillin sodium monohydrate 545 mg (Quantity variable: based on the assay of Flucloxacillin sodium)

Dosis:

500 mg

formulario farmacéutico:

Capsule

Composición:

Active: Flucloxacillin sodium monohydrate 545mg (Quantity variable: based on the assay of Flucloxacillin sodium) Excipient: Capsugel black 01.911 Capsugel yellow 42.957 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Sodium starch glycolate

Unidades en paquete:

Bottle, plastic, 50 capsules, 50 capsules

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

DSM Sinochem Pharmaceuticals India Private Limited

indicaciones terapéuticas:

The treatment of infections due to sensitive Gram-positive organisms, including beta-lactamase producing staphylococci and streptococci.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, plastic, - 50 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 250 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 500 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 500 capsules - 18 months from date of manufacture stored at or below 25°C

Data d'autorització:

1986-02-20

Informació per a l'usuari

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
STAPHLEX
_FLUCLOXACILLIN (AS THE SODIUM SALT) 250 MG AND 500 MG CAPSULES _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about STAPHLEX.
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 taking STAPHLEX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT STAPHLEX IS
USED FOR
STAPHLEX contains the active
ingredient flucloxacillin. STAPHLEX
is an antibiotic that belongs to a
group of medicines called
penicillins. These medicines work
by killing the bacteria that are
causing your infection.
STAPHLEX is used to treat
infections in different parts of the
body 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.
STAPHLEX can also be used to
treat other types of infections such
as:

Bone infection

Inflammation of small
intestine

Heart infection

Urinary tract infection

Brain and spinal cord
infection

Blood infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
STAPHLEX will not work against
infections caused by viruses, such
as colds or the flu.
STAPHLEX is available only with a
doctor’s prescription.
There is no evidence that
STAPHLEX is addictive.
BEFORE YOU TAKE
STAPHLEX
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE STAPHLEX IF YOU
HAVE AN ALLERGY TO:

medicines containing
flucloxacillin or any other
penicillin

beta-lactam antibiotics
including cephalosporin
antibiotics

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shor

Fitxa tècnica

Page 1 of 8
NEW ZEALAND DATA SHEET
STAPHLEX
1. PRODUCT NAME
STAPHLEX, 250 mg and 500 mg capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg or 500 mg flucloxacillin (as the sodium
salt).
Excipient with known effect: contains sulfites.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
STAPHLEX 250 mg capsule: Yellow_ _body, Black Cap, Size 2, contains a
white powder.
STAPHLEX 500 mg capsule:_ _Yellow body, Black Cap, Size 0, contains a
white powder.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Flucloxacillin is indicated for the treatment of infections due to
sensitive Gram-positive organisms,
including

-lactamase producing staphylococci and streptococci.
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, septicaemia.
Page 2 of 8
Oral preparations of the

-lactamase-resistant penicillins (or flucloxacillin) should not be
used as
initial therapy in serious, life threatening infections. Oral therapy
with flucloxacillin may be used to
follow-up the previous use of parenteral flucloxacillin as soon as the
clinical condition warrants.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
ADULTS (INCLUDING ELDERLY PATIENTS):
Oral – 250 mg four times a day.
Oral doses should be administered 1 hour before meals.
Osteomyelitis, endocarditis – Up to 8 g daily, in divided doses six
to eight hourly.
SPECIAL POPULATIONS
_ABNORMAL RENAL FUNCTION _
In common with other penicillins, flucloxacillin usage in patients
with renal impairment does not
usually require dosage reduction. However, in the presenc