LINEZOLID CA linezolid 600 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

linezolid, Quantity: 600 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Linezolid

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; hyprolose; microcrystalline cellulose; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000

Administration route:

Oral

Units in package:

10, 30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LINEZOLID CA 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 CA is active against Gram-positive bacteria only. ,LINEZOLID CA 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, biconvex, film-coated tablets, debossed on one side "CL".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-01-24

Patient Information leaflet

LINEZOLID CA*
1
LINEZOLID CA*
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LINEZOLID CA?
LINEZOLID CA contains the active ingredient linezolid. LINEZOLID CA is
used to treat bacterial infections such as pneumonia,
skin infections or blood infections.
For more information, see Section 1. Why am I using LINEZOLID CA? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LINEZOLID CA?
Do not use if you have ever had an allergic reaction to linezolid or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LINEZOLID CA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LINEZOLID CA and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE LINEZOLID CA?
•
The recommended dose for adults and adolescents 12 years and older is
one 600 mg tablet twice daily (every 12 hours).
More instructions can be found in Section 4. How do I use LINEZOLID
CA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LINEZOLID CA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist that you are taking LINEZOLID
CA.
•
It is important to tell the doctor if you develop diarrhea, sore white
mouth or tongue during or after
treatment with LINEZOLID CA.
•
Tell the doctor if you or your child get vaginal itching or discharge.
THINGS YOU
SHOULD NOT DO
•
Do not start taking any other medicines, prescription or not, without
first telling your doctor or
pharmacist.
•
Do not give your child any other medicines, prescription or purchased
from a health food shop,
pharmacy or supermarket without first telling your doctor or
pharmacist.
DRIVING OR USING
MACHI

Summary of Product characteristics

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PRODUCT INFORMATION
LINEZOLID CA
600MG FILM-COATED TABLETS
NAME OF THE MEDICINE
Non-proprietary name:
Linezolid
Chemical name:
(5
_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:
CAS Number:
CAS-165800-03-3
DESCRIPTION
LINEZOLID CA 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 and is sparingly soluble
in methanol and soluble
in chloroform. The partition coefficient (Log P) is 0.61 and pKa is
1.8. LINEZOLID CA
exhibits polymorphism (form II).
LINEZOLID CA 600 mg tablets for oral administration are white to
off-white, oval shaped,
biconvex, film-coated tablets, debossed on one side “CL”. In
addition to linezolid, the
tablets contain, in the core, cellulose-microcrystalline,
starch-pregelatinised maize, sodium
starch glycollate type A, hyprolose, magnesium stearate and, in the
film coating, Opadry II
complete film coating system 85F28751 White (Proprietary Ingredient #
10277).
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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
of the bacterial transla