LINEZOLID AMNEAL linezolid 600 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 600 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Linezolid

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; titanium dioxide; hypromellose; ethylcellulose; silicon dioxide; povidone; microcrystalline cellulose; diethyl phthalate; purified talc

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

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. It 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, oval shaped, film coated tablets, debossed with AI006 on one side and plain on the 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:

Licence status A

Authorization date:

2016-06-01

Patient Information leaflet

_Linezolid AMNEAL tablets – Consumer Medicine Information _
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_Linezolid AMNEAL CMI v 0.1 _
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_Page 1 _
LINEZOLID AMNEAL
_Linezolid _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Linezolid AMNEAL tablets. 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
Linezolid AMNEAL tablets
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 LINEZOLID
AMNEAL IS USED FOR
Linezolid AMNEAL contains the
active ingredient, linezolid.
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 may have
prescribed it for another reason.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is not addictive.
BEFORE YOU TAKE
LINEZOLID AMNEAL
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE LINEZOLID AMNEAL
IF YOU ARE ALLERGIC TO LINEZOLID
OR 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
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching or hives on the
skin.
DO NOT TAKE LINEZOLID AMNEAL
IF YOU:

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 that is a
monoamine oxidase
inhibitor (e.g.,
moclobemide, ph

Summary of Product characteristics

Linezolid AMNEAL PI v1.0
Page 1 of 23
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_Linezolid AMNEAL tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
LINEZOLID AMNEAL
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_(LINEZOLID TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
Non-proprietary name:
Linezolid
Chemical name:
(_S_)-_N_-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-
oxazolidinyl]methyl]-acetamide
The empirical formula of linezolid is C
16
H
20
FN
3
O
4
and its chemical structure is represented
below:
O
O
N
N
O
F
O
C
N
CH
3
H
CAS Number: CAS-165800-03-3
DESCRIPTION
Linezolid AMNEAL tablets contain 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.
Linezolid AMNEAL 600 mg tablets for oral administration are white to
off white, oval shaped,
film-coated tablets debossed on one side “AI006” and plain on the
other side. In addition to
linezolid, the tablets contain, in the core, microcrystalline
cellulose, croscarmellose sodium,
povidone, silicon dioxide, magnesium stearate and, in the film
coating, hypromellose, diethyl
phthalate, purified talc, ethylcellulose and titanium dioxide.
Linezolid AMNEAL PI v1.0
Page 2 of 23
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_Linezolid AMNEAL tablets Product Information _
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_ Amneal Pharma Australia Pty Ltd _
PHARMACOLOGY
PHARMACODYNAMICS
_GENERAL PROPERTIES_
Linezolid
is
a
synthetic,
antibacterial
agent
belonging
to
a
new
class
of
antibiotics,
the
oxazolidinones,
with
_in _
_vitro _ activity against
Gram positive aerobic bacteria, some Gram
positive anaerobic bacteria and certain Gram negative bacteria. It
selectively inhibits bacterial
protein synthesis via a mechanism of action different from that of
other antibacterial agents.
Linezolid binds to the 23S ribosomal RNA of the 50S subunit of the
bacterial ribosome and
prevents the formation of a functional 70S initiation complex which is
an essential component