Glevo Tablets 500 mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

LEVOFLOXACIN HEMIHYDRATE

Available from:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (International Name):

LEVOFLOXACIN HEMIHYDRATE

Units in package:

5Tablet Tablets

Manufactured by:

GLENMARK PHARMACEUTICALS LTD

Patient Information leaflet

GLEVO TABLETS
Levofloxacin Tablets (250mg, 500mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Glevo is used for
2.
How Glevo
_ _
works
3.
Before you use Glevo
4.
How to use Glevo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Glevo
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GLEVO_ _IS USED FOR
Glevo is used for the treatment of the
following infections:
-Acute sinusitis (inflammation of a nasal
sinus.)
-Acute exacerbation (increase in the
severity) of chronic bronchitis
-Community-acquired pneumonia
-Uncomplicated skin and soft tissue
infections
-Urinary tract infections including acute
pyelonephritis (inflammation of the
substance of the kidney)
-Chronic bacterial prostatitis
(inflammation of the prostate gland)
HOW GLEVO_ _WORKS
Bactericidal effects of Levofloxacin are
induced via inhibition of DCA gyrase
activity.
BEFORE YOU USE GLEVO_ _
-
_When you must not use it _
Do not use this product if you are
allergic to any excipients of this
product
_. _
_ _
_Pregnancy and lactation _
Do not take Glevo if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take Glevo if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_ _
-
_Before you start to use it _
-
Tell your healthcare providers if you
have been diagnosed with an
enlargement or “bulge” of a large
blood vessel (aortic aneurysm or
large vessel peripheral aneurysm).
_ _
- Tell your healthcare providers if you
_ _
have experienced a previous episode of
aortic dissection (a tear in the aorta
wall).
- Tell your healthcare providers if you
have a family history of aortic aneurysm
or aortic dissection or other risk factors
or predisposing conditions (e.g.
connective tissue disorders such as
Marfan syndrome, or vascular Ehlers-
Danlos syndrome, or vascular disorders
such as Takayasu arteritis, giant cell
arteritis, Behcet´s disease, high blood
pressure, or known atheroscleros

Summary of Product characteristics

SAME SIZE ARTWORK
LEAFLET SIZE : 264 mm x 186 mm
_For the use only of a Registered Medical Practitioner _
_or a Hospital or a Laboratory. _
Levofloxacin Tablets 250 mg / 500 mg
TABLETS
Glevo
250 / 500
25 mm
25 mm
24 mm
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE
PE37786
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
COMPOSITION :
GLEVO 250 TABLETS
Each film coated tablet contains:
Levofloxacin Hemihydrate
equivalent to Levofloxacin 250 mg
COLOURS: Red Oxide of Iron & Titanium Dioxide BP
DESCRIPTION:
Brick red round biconvex film coated tablets with break line on one
side.
GLEVO 500 TABLETS
Each film coated tablet contains:
Levofloxacin Hemihydrate
equivalent to Levofloxacin 500 mg
COLOURS: Red Oxide of Iron, Yellow Oxide of Iron & Titanium Dioxide BP
DESCRIPTION: Orange capsule shaped film coated tablets with break line
on one side.
THERAPEUTIC CLASS : S0610
PHARMACOLOGY
MECHANISM OF ACTION :
Like Ofloxacin and other fluoroquinolones, bactericidal effects of
Levofloxacin are induced via
inhibition of DNA gyrase activity. In comparison with racemic
Ofloxacin, the activity of Levofloxacin
may be more specific for bacterial DNA gyrase than mammalian
topoisomerase II.
Levofloxacin is reportedly 8 to 128 times more potent than
R(+)-ofloxacin (DR-3354), and twice as
potent as racemic Ofloxacin.
_SPECTRUM OF ANTIBACTERIAL ACTIVITY _
Levofloxacin has been shown to be active against most strains of the
following microorganisms
both in vitro and in clinical infections:
Aerobic
gram-positive
microorganisms:
Enterococcus
faecalis,
Staphylococcus
aureus
(methicillin-susceptible), Staphylococcus haemolyticus
(methicillin-susceptible), Staphylococcus
saprophyticus, Streptococcus pneumoniae (including
penicillin-resistant strains), Streptococcus
pyogenes, and Streptococci (Groups C and G).
Intermediate susceptibility: Staphylococcus haemolyticus
(methicillin-resistant).
Aerobic gram-negative microorganisms: Enterobacter cloacae,
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