LINEZOLID APOTEX linezolid 600 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-05-2019
Summary of Product characteristics
(SPC)
29-05-2019
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
linezolid
Available from:
Apotex Pty Ltd
INN (International Name):
Linezolid
Authorization status:
Registered
Patient Information leaflet
LINEZOLID APOTEX-
TABLETS
_Linezolid_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about linezolid. 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 this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Linezolid is an antibiotic used to treat
bacterial infections such as
pneumonia, skin infections or blood
infections. Depending on the type of
bacteria, you may need additional
medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
linezolid
•
any of the other ingredients listed
at the end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD THE FOLLOWING MEDICAL
CONDITIONS:
•
uncontrolled high blood pressure
•
pheochromocytoma (a type of
tumour of the adrenal gland)
•
thyrotoxicosis (an overactive
thyroid gland)
•
flushing or other symptoms
caused by a carcinoid tumour
TELL YOUR DOCTOR IF YOU ARE TAKING
THE FOLLOWING MEDICATIONS:
•
monoamine oxidase inhibitor
(currently taking or have taken in
the last two weeks)
•
pseudoephedrine
•
adrenaline
•
medicines that increase blood
pressure
•
serotonin
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
LINEZOLID APOTEX (LINEZOLID) TABLETS
1
NAME OF THE MEDICINE
Linezolid.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg linezolid as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
White coloured, oval shaped, biconvex, film-coated tablet with
engraved “APO” on one side
and “LIN600” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Linezolid APOTEX (intravenous or oral) is indicated for the treatment
of suspected or proven
infections due to Gram positive organisms resistant to multiple
classes of antibiotics, including
methicillin resistant _Staphylococcus_ species and vancomycin
resistant _Enterococcus_ species.
It is active against Gram-positive bacteria only and has no clinical
activity against Gram-
negative pathogens. Specific Gram-negative therapy is required if a
concomitant Gram-
negative pathogen is documented or suspected.
4.2
DOSE AND METHOD OF ADMINISTRATION
Linezolid APOTEX tablets are intended for oral administration.
This brand is only available as a 600 mg tablet and therefore only
appropriate for use in adults
and children who can tolerate tablets. For intravenous and oral
solution dosing requirements
another brand is available.
Patients who commence treatment on the parenteral formulation may be
switched to either
oral presentation when clinically indicated. In such circumstances, no
dose adjustment is
required as linezolid has an oral bioavailability of approximately
100%.
The injection should be administered over a period of 30 to 120
minutes. The film coated
tablets or oral suspension may be taken with or without food.
The maximum recommended duration of treatment is 28 days.
DOSAGE
ADULTS AND CHILDREN 12 YEARS OR OLDER
The recommended dosage should be administered intravenously (IV) or
orally twice daily as
shown in Table 1. Duration of treatment is variable. It is dependent
on the pathogen, the site
of
infection
and
its
severity,
and
on
the
pati
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