LINEZOLID APO linezolid 600 mg/300 mL injection solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid

Available from:

Apotex Pty Ltd

INN (International Name):

Linezolid

Authorization status:

Registered

Patient Information leaflet

LINEZOLID APO INJECTION
_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 receiving linezolid
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOU.
You may need 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 be given additional
medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LINEZOLID HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU USE THIS
MEDICINE
_WHEN LINEZOLID MUST NOT BE_
_GIVEN_
DO NOT RECEIVE LINEZOLID 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.
DO NOT RECEIVE LINEZOLID IF YOU HAVE
OR HAVE HAD ANY OF 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
DO NOT RECEIVE LINEZOLID IF YOU ARE
TAKING THE FOLLOWING MEDICINES:
•
are taking or have taken in the
last two weeks a monoamine
oxidase inhibitor (e.g.
moclobemide, phenelzine or
tranylcypromine, selegiline)
•
pseudoephedrine
•
adrenaline
•
medicines that increases blood
pressure (e.g. no

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LINEZOLID APO
(LINEZOLID) INJECTION
1
NAME OF THE MEDICINE
Linezolid
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
LINEZOLID APO injection contains linezolid, which is a synthetic
antibacterial agent of the
oxazolidinone class with a molecular weight of 337.35. Linezolid is
biologically active and is
metabolised to form inactive derivatives. The aqueous solubility of
linezolid is approximately 3
mg/mL, independent of pH between pH 3 to 9.
Each 1 mL of LINEZOLID APO injection contains 2 mg of linezolid in an
isotonic, clear,
colourless to yellow solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Linezolid 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.
Linezolid is active against Gram-positive bacteria only. Linezolid 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
The injection should be administered over a period of 30 to 120
minutes.
The maximum recommended duration of treatment is 28 days. Serious
adverse effects have
been associated with treatment prolonged beyond 28 days. See section
4.4 Special warnings
and precautions for use, Myelosuppression and Peripheral neuropathy
and optic neuropathy.
ADULTS AND CHILDREN 12 YEARS OR OLDER
The recommended dosage should be administered intravenously (IV) 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 patient’s clinical response. The
maximum recommended duration
of treatment is 28 days. No increase in the recommended dosage or
duration of treatment is
required for infections associated with concurrent bacteraemia.
2
TABLE 1. DOSAGE GUIDELINES