APO-Roxithromycin

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Roxithromycin

Tilgængelig fra:

Apotex Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

APO-ROXITHROMYCIN

_Contains the active ingredient roxithromycin_
CONSUMER MEDICINE INFORMATION

_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_

WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about Roxithromycin. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Roxithromycin. It contains the active
ingredient roxithromycin.
It is used to treat:
•
acute pharyngitis (sore throat and
discomfort when swallowing)
•
tonsillitis
•
sinusitis
•
acute bronchitis (infection of the
bronchi causing coughing)
•
worsening of chronic bronchitis
•
pneumonia (lung infection
characterised by fever, malaise,
headache)
•
skin and soft tissue infections
•
non gonoccocal urethritis
•
impetigo (bacterial infection
causing sores on the skin).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Roxithromycin is an antibiotic that
belongs to a group of medicines
called macrolides.
These antibiotics

Produktets egenskaber

Product Information – Australia 
APO-Roxithromycin tablets 
Page 1 
APO-ROXITHROMYCIN TABLETS 

NAME OF THE MEDICINE 

ACTIVE INGREDIENT:  Roxithromycin  

Chemical names:_ _  
(3_R_, 4_S_, 5_S_, 6_R_, 7_R_, 9_R_, 11_S_, 12_R_, 13_S_,
14_R_)-4-[(2,6-dideoxy-3-_C_-methyl-3-O-methyl-
α-
L
-_ribo_-
hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-10-[(_E_)-[(2-methoxyethoxy)-methoxy]imino]-
3,5,7,9,11,13,-hexamethyl-6-[(3,4,6-trideoxy-3-(dimethylamino)-
β-
D
-_xylo_-hexopyranosyl)oxy]-
oxacyclotetradecan-2-one. 

STRUCTURAL FORMULA:   
_ _

MOLECULAR FORMULA: C
41
H
76
N
2
O
15
. 

MOLECULAR WEIGHT:  837.07 

CAS REGISTRY NUMBER:  80214-83-1 
_ _

DESCRIPTION 

Roxithromycin is a
semi-synthetic macrolide antibiotic.  Each Roxithromycin
film-coated tablet 
contains either 150 mg or 300 mg of roxithromycin as the active
ingredient.  

GenRx ROXITHROMYCIN tablets also contain the following
inactive ingredients:  maize starch, 
hydroxypropylcellulose, silica –  colloidal anhydrous, sodium starch
glycollate, poloxamer, povidone, 
magnesium stearate, talc – purified, propylene
glycol, glucose, titanium dioxide and hypromellose. 

PHARMACOLOGY 
MICROBIOLOGY: 
Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. It binds 
to the 50S subunit of the
70S ribosome, thereby disrupting bacterial protein synthesis. 

A prolonged postantibiotic effect has been
observed with roxithromycin. Whilst the clinical significance 
Product Information – Australia 
APO-Roxithromycin tablets 
Page 2 
of this remains uncertain, it supports the rationale for once daily dosing. Although clinical data have 
demonstrated the efficacy and
safety of once daily dosing in adults, these have not been 
demonstrated in children. 

At plasma
concentrations achieved with the recommended therapeutic doses, roxithrom