ROXITHROMYCIN AN roxithromycin 300mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin

Available from:

Sandoz Pty Ltd

INN (International Name):

Roxithromycin

Authorization status:

Registered

Patient Information leaflet

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_Roxithromycin AN tablets – Consumer Medicine Information _
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_Doc ID: 71.AN.M.1.0 _
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_Page 1 _
ROXITHROMYCIN AN FILM-COATED TABLETS
_ROXITHROMYCIN _
CONSUMER MEDICINE INFORMATION
WHAT IS THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Roxithromycin AN.
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 risk of you taking
this
medicine
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 ROXITHROMYCIN
AN IS USED FOR
This medicine is used to treat
various
infections
caused
by
bacteria such as:

acute
pharyngitis
(sore
throat and discomfort when
swallowing)

tonsillitis

sinusitis

acute bronchitis (infection of
the
bronchi
causing
coughing)

pneumonia
(lung
infection
characterised
by
fever,
malaise, headache)

skin
and
soft
tissue
infections

non gonococcal urethritis

impetigo (bacterial infection
causing sores on the skin).
It contains the active ingredient
roxithromycin.
Roxithromycin
belongs
to
a
group
of
medicines called macrolides.
It works by killing or stopping
the growth of the bacteria that
are causing the infection.
However,
Roxithromycin
AN
does
not
have
any
effect
on
viral infections such as the flu.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR
YOU.
Your
doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
ROXITHROMYCIN AN
_ _
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE THIS MEDICINE IF
YOU HAVE AN ALLERGY TO:

roxithromycin,
the
active
ingredient, or to any of the
other
ingredients
listed
at
the end of this leaflet under
Product Description.

any
other
macrolide
antibiotic
(such
as
azithromycin,
clarith

Summary of Product characteristics

_Roxithromycin AN tablets Product Information _
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167.AN.P.1.1
Page 1 of 9
ROXITHROMYCIN AN
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_(ROXITHROMYCIN TABLETS) _
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PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
Roxithromycin
CHEMICAL NAME_:_
Erythromycin-[O-[(2-methoxyethoxy)-methyl]oxime]
MOLECULAR FORMULA_: _
C
41
H
76
N
2
O
15
MOLECULAR WEIGHT_:_
837.1
CAS REGISTRY NUMBER
: [
_80214-83-1_
]
DESCRIPTION
It is a white crystalline powder.
Roxithromycin AN tablets also contain inactive ingredients:
microcrystalline cellulose, povidone,
croscarmellose sodium, silicon dioxide, lactose, hypromellose,
titanium dioxide, magnesium stearate,
macrogol 4000, poloxamer 188.
PHARMACOLOGY
Roxithromycin is a semisynthetic macrolide antibiotic.
Microbiology
At plasma concentrations achieved with the recommended therapeutic
doses, roxithromycin has been
demonstrated to have
_in vitro_
and clinical activity against the following microorganisms:
_Streptococcus _
_pneumoniae, _
_Strep. _
_pyogenes, _
_Mycoplasma _
_pneumoniae, _
_Moraxella _
_catarrhalis, _
_Ureaplasma urealyticum_
and Chlamydia sp.
_Roxithromycin AN tablets Product Information _
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167.AN.P.1.1
Page 2 of 9
Roxithromycin has been demonstrated to have clinical activity against
the following microorganisms
which are partially sensitive
_in vitro_
to roxithromycin:
_Haemophilus influenzae_
and
_Staphylococcus aureus_
, except methicillin resistant
_Staph. aureus_
(MRSA).
The following strains of microorganisms are resistant:
Multiresistant
_Staph. aureus_
, Enterobacteriaceae, Pseudomonas sp. and Acinetobacter sp.
DISC SUSCEPTIBILITY TESTING
_ _
Dilution or diffusion techniques – either quantitative (MIC) or
breakpoint, should be used following a
regularly updated, recognised and standardised method (eg. NCCLS).
Standardised susceptibility test
procedures require the use of laboratory control microorganisms to
control the technical aspects of the
laboratory procedures.
A report of “Susceptible” indicates that a pathogen is likely to
be inhibited if the antimicrobial
compound in the blood r