AKM LINEZOLID linezolid 600 mg film-coated tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 600 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: pregelatinised maize starch; copovidone; mannitol; silicon dioxide; sodium stearylfumarate; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

20, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

AKM 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.,AKM LINEZOLID is active against Gram-positive bacteria only. AKM 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.

Product summary:

Visual Identification: White to off white capsule shape film-coated tablet debossed with "LIN 600" on one side, plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2018-10-15

Patient Information leaflet

AKM LINEZOLID
_TABLETS_
_ _
_linezolid _ CONSUMER MEDICINE INFORMATION
AKM LINEZOLID CMI (V-03)
Page
1
of
5
WHAT IS IN THIS LEAFLET
Please
read
this
leaflet
carefully
before
taking
AKM
LINEZOLID.
This leaflet answers some common
questions about AKM LINEZOLID.
It does not contain all the available
information. It does not take the place
of
talking
to
your
or
your
child's
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed
the risks of you or your child taking
AKM
LINEZOLID
against
the
expected benefits it will have.
ASK
THE
DOCTOR
IF
YOU
HAVE
ANY
CONCERNS ABOUT YOU OR YOUR CHILD
TAKING THIS MEDICINE.
KEEP THIS LEAFLET EVEN AFTER YOUR
TREATMENT WITH AKM LINEZOLID
IS FINISHED.
You may need to read it again.
WHAT AKM
LINEZOLID IS USED FOR
AKM
LINEZOLID
contains
the
active ingredient, linezolid.
AKM LINEZOLID is an antibiotic
(an
agent
used
to
destroy
certain
types of bacteria). It is used in the
treatment of bacterial infections such
as
pneumonia,
skin
infections
or
blood infections.
Depending on the type of bacteria,
you
may
be
given
additional
medicines.
Your doctor, however, may prescribe
AKM
LINEZOLID
for
another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS
ABOUT
WHY
AKM
LINEZOLID HAS BEEN PRESCRIBED
FOR YOU OR YOUR CHILD.
This medicine is not addictive.
BEFORE TREATMENT WITH
AKM LINEZOLID
_WHEN AKM LINEZOLID _
_MUST NOT BE USED _
AKM
LINEZOLID
MUST
NOT
BE
GIVEN IF YOU OR YOUR CHILD:

are allergic to linezolid or 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.

have
uncontrolled
high
blood
pressure

have pheochromocytoma (a type
of tumour of the adrenal gland)

have thyrotoxicosis (an overactive
thyroid gland)

have flushing or other symptoms
caused by a carcinoid tumour

are taking or have taken in the last
two weeks any medicine th

Summary of Product characteristics

AKM LINEZOLID PI (V-03)
Page
1
of
27
AUSTRALIAN PRODUCT INFORMATION – AKM LINEZOLID (LINEZOLID)
1.
NAME OF THE MEDICINE
Linezolid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of Linezolid
List of excipients with known effect
'For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.'
3.
PHARMACEUTICAL FORM
Film coated tablets
AKM LINEZOLID 600 mg tablets
Linezolid 600 mg Film-coated tablets are white to off white capsule
shape film coated tablet
debossed with "LIN 600" on one side, plain on other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AKM 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.
AKM LINEZOLID is active against Gram-positive bacteria only. AKM
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
DOSAGE
_Linezolid solution for injection and granules for oral suspension are
unavailable in the AKM _
_LINEZOLID brand. For intravenous and oral suspension dosing
requirements other brands are _
_available. Information obtained using linezolid solution for
injection and granules for oral _
_suspension formulations have been retained throughout the PI, where
appropriate, for continuity _
_and prescriber information. _
AKM LINEZOLID PI (V-03)
Page
2
of
27
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 tablets has an oral bioavailability of approximately 100%.
The film coated tablets may be taken with or without food.
The maximum recommended duration of treatment is 28 days. Serious
adverse effects have been
associated with treatment prolonged be