LINEVOX linezolid 600mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 600 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Linezolid

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; purified talc; poloxamer; colloidal anhydrous silica; sodium starch glycollate type A; propylene glycol; brilliant blue FCF; ethanol; purified water; Shellac; strong ammonia solution; titanium dioxide; hypromellose; macrogol 400

Administration route:

Oral

Units in package:

10

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. 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 oval biconvex tablets, printed with '600' on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/PE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-03-21

Patient Information leaflet

LINEVOX
FILM COATED TABLETS
linezolid
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before taking Linevox. This leaflet
answers some common questions
about Linevox.
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
Linevox 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 LINEVOX IS FINISHED.
You may need to read it again.
WHAT LINEVOX IS USED
FOR
Linevox contains the active
ingredient, linezolid.
Linevox 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 Linevox for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LINEVOX HAS
BEEN PRESCRIBED FOR YOU OR YOUR
CHILD.
This medicine is not addictive.
BEFORE TAKING LINEVOX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LINEVOX OR GIVE
LINEVOX TO YOUR CHILD BEFORE YOU
TALK TO YOUR DOCTOR OR PHARMACIST 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 that
is a monoamine oxidase inhibitor
(e.g., moclobemide, ph

Summary of Product characteristics

1
AUSTRALIAN PI – LINEVOX (LINEZOLID)
1
NAME OF THE MEDICINE
Linezolid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LINEVOX tablets contain 600mg of linezolid.
PHYSICAL AND CHEMICAL CHARACTERISTICS:
Linezolid 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.
EXCIPIENTS WITH KNOWN EFFECT:
LINEVOX tablets contain lactose monohydrate. For the full list of
excipients, see SECTION 6.1 LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
LINEVOX film-coated tablets are white oval biconvex tablets, printed
with ‘600’on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
Patients who commence treatment on the parenteral
#
formulation may be switched to either tablet
or suspension
#
oral presentations when clinically indicated. In such circumstances,
no dose
adjustment is required as linezolid has an oral bioavailability of
approximately 100%.
2
The film coated tablets may be taken with or without food.
The maximum recommended duration of treatment is 28 days.
#
Linezolid injection and oral suspension are unavailable in Linevox
brand however are available in
other brands. Where correct dosing requires injection or oral
suspension formulations in paediatric
or adult patients, the injection or oral suspension formulations from
other suppliers should be used.
ADULTS AND CHILDRE