ROXITHROMYCIN GH roxithromycin 300 mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Roxithromycin

Authorization status:

Registered

Patient Information leaflet

ROXITHROMYCIN GH
130703 V 2.0
1
ROXITHROMYCIN
GH
_Roxithromycin _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Roxithromycin GH.
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 or pharmacist
has weighed the risks 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
GH IS USED FOR
Roxithromycin GH is used to treat
infections in different parts of the
body caused by bacteria. For
example:
•
acute pharyngitis (sore throat and
discomfort when swallowing)
•
tonsillitis
•
sinusitis
•
acute bronchitis (infection of the
bronchi causing coughing)
•
exacerbation of chronic bronchitis
•
pneumonia (lung infection
characterised by fever, malaise,
headache)
•
skin and soft tissue infections
•
non gonococcal urethritis
•
impetigo (bacterial infection
causing sores on the skin).
Roxithromycin GH is an antibiotic
that belongs to a group of medicines
called macrolides.
These antibiotics work by killing or
stopping the growth of the bacteria
that are causing your infection.
Roxithromycin GH, like other
antibiotics, does not work against
viral infections such as the flu.
Your doctor, however, may prescribe
Roxithromycin GH for another
purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ROXITHROMYCIN GH IF
YOU HAVE SEVERE LIVER PROBLEMS.
DO NOT TAKE ROXITHROMYCIN GH IF
YOU HAVE AN ALLERGY TO:
•
roxithromycin or any other
macrolide antibiotic eg
azithromycin, clarithromycin or
erythromycin
•
any of the ingredients listed at the

Summary of Product characteristics

roxithromycin-ccdsv7-piv5-26sep17
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_Page 1_
PRODUCT INFORMATION
ROXITHROMYCIN GH
NAME OF THE MEDICINE
Roxithromycin GH Tablets
NON-PROPRIETARY NAME
Roxithromycin
CHEMICAL STRUCTURE
Roxithromycin has the following structural formula:
The empirical formula for roxithromycin is C
41
H
76
N
2
O
15
. Its molecular weight is 837.07.
CAS NUMBER
Chemical Abstracts Number: [80214–83-1]
DESCRIPTION
Roxithromycin
is
a
semi-synthetic
macrolide
antibiotic.
It
is
a
white
crystalline
powder.
Roxithromycin is very slightly soluble in water, freely soluble in
acetone, in alcohol and in
methylene chloride. It is slightly soluble in dilute hydrochloric
acid.
roxithromycin-ccdsv7-piv5-26sep17
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_Page 2_
Roxithromycin GH tablets contain 150 mg or 300 mg of roxithromycin.
Roxithromycin GH tablets also contain hyprolose, poloxamer, povidone,
colloidal anhydrous silica,
magnesium stearate (470), purified talc (553), maize starch,
hypromellose, glucose, titanium
dioxide (171) and propylene glycol (1520).
PHARMACOLOGY
PHARMACOKINETICS
Absorption
Roxithromycin
is
absorbed
after
oral
administration
with
an
absolute
bioavailability
of
approximately 50%. Peak plasma concentrations following administration
of 150 mg and 300 mg
film-coated tablets are achieved in young and elderly adult patients
approximately 1 to 2 hours
post-dose.
As food intake decreases absorption, Roxithromycin GH should be
administered at least 15
minutes before food or, alternatively, on an empty stomach (_i.e._
more than 3 hours after a meal).
Absorption is not linear; with increasing doses in the range 150 mg to
300 mg, peak plasma levels
and AUC do not increase in proportion to the dose.
After repeated administration of 2.5 mg/kg every 12 hours to children,
the average peak plasma
concentration at steady state was 9 mg/L and the AUC was 61 mg.h/L.
Following administration of a single oral dose of Roxithromycin GH 150
mg to healthy young
adults, the mean peak plasma concentration was 6.6 mg/L and the AUC
was 69 mg.h/L. At steady
state following d