Roxithromycin SCP
Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
Lietošanas instrukcija
(PIL)
25-05-2024
Produkta apraksts
(SPC)
25-05-2024
Aktīvā sastāvdaļa:
Roxithromycin
Pieejams no:
Southern Cross Pharma Pty Ltd
Klase:
Medicine Registered
Lietošanas instrukcija
C:Products/Roxi/CMI 17feb12 scp
17/2/12
Page 1 of 4
ROXITHROMYCIN SCP
ROXITHROMYCIN
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about this
medicine.
It does not contain all the
available information. It does not
take the place of talking to your
doctor and pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
roxithromycin 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 IS
USED FOR
Roxithromycin 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 gonoccocal urethritis
impetigo (bacterial infection
causing sores on the skin)
Roxithromycin 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, like other
antibiotics, does not work
against viral infections such as
the flu.
YOUR DOCTOR MAY HAVE
PRESCRIBED ROXITHROMYCIN FOR
ANOTHER REASON. ASK YOUR
DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
Roxithromycin is not addictive.
BEFORE YOU TAKE
ROXITHROMYCIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ROXITHROMYCIN IF:
1. you have an allergy to:
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Produkta apraksts
C:Products/Roxi/PI 17feb12 scp
17/2/12
Page 1 of 9
PRODUCT INFORMATION
ROXITHROMYCIN SCP
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.
ROXITHROMYCIN SCP 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.
C:Products/Roxi/PI 17feb12 scp
17/2/12
Page 2 of 9
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 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,
roxithromycin has been demonstrated to have _in vitro_ and clinical
activity against the
following mi
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