Roximycin

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Roxithromycin

Доступно од:

Alphapharm Pty Ltd

Класа:

Medicine Registered

Информативни летак

ROXIMYCIN
1
ROXIMYCIN
_contains the active ingredient roxithromycin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Roximycin.
It does not contain all the available
information.  It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks.  Your doctor has weighed the
risks of you taking Roximycin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT ROXIMYCIN IS
USED FOR
Roximycin 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)
*
pneumonia (lung infection
characterised by fever, malaise,
headache)
*
skin and soft tissue infections
*
non gonococcal urethritis
*
impetigo (bacterial infection
causing sores on the skin)
Roximycin 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.
Roximycin, like other antibiotics,
does not work against viral
infections such as the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ROXIMYCIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Roximycin for another reason.
This medicine is available only with
a doctor's prescription.
Roximycin is not addictive.
BEFORE YOU TAKE
ROXIMYCIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ROXIMYCIN IF:
1. YOU HAVE AN ALLERGY TO:
*
roxithromycin or any other
macrolide antibiotic eg.
azithromycin (Zithromax),
clarithromycin (eg. Klacid,
Kalixocin) or erythromycin (eg.
EES, E-Mycin)
*
any of the ingredients listed at the
end of this leaflet (see Product
desc

Карактеристике производа

ROXIMYCIN 
_Roxithromycin _

PRODUCT INFORMATION 

NAME OF THE MEDICINE 
Active ingredient: 

Roxithromycin 
Chemical name: 
 (3R, 4S, 5S, 6R, 7R, 9R, 11S, 12R, 13S, 14R)-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 
no.: 
80214-83-1 

DESCRIPTION 
Roxithromycin is a semi-synthetic macrolide antibiotic. Each
Roximycin film-coated tablet contains either 
150 mg or 300 mg of roxithromycin as the active ingredient.
 Roximycin film-coated tablets also contain 
the following inactive excipients: povidone, hydroxypropylcellulose,
starch – maize, poloxamer 188, silica 
– colloidal anhydrous, talc – purified, magnesium stearate,
glucose anhydrous and OPADRY complete 
film coating system OY-S-58918 White. 

ROXIMYCIN – Product Information 
2
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 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