ROXITHROMYCIN SCP roxithromycin 300 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 300 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Roxithromycin

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hyprolose; povidone; propylene glycol; purified talc; sodium starch glycollate type A; hypromellose; sodium starch glycollate type B; maize starch; magnesium stearate; colloidal anhydrous silica; poloxamer; glucose; titanium dioxide

Administration route:

Oral

Units in package:

5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults: Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections caused by or likely to be caused by susceptible microorganisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbations of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Appropriate culture and sensitivity tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Product summary:

Visual Identification: White to off-white, round, convex film coated tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-04-10

Patient Information leaflet

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:

roxithromycin or any other
macrolide antibiotic eg.,
azithromycin, clarithromycin
or erythromycin.

any of the ingredients listed
at the end of this leaflet (see
Product description)
Some of the symptoms of an
allergic reaction may include
shortness of breath, whe

Summary of Product characteristics

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 microorganisms: _Streptococcus pneumoniae, Strep. pyogenes,
_
_Mycoplasma pneumoniae, Moraxella catarrhalis, Ureaplasma urealyticum
_and_ _
_Chlamydia_ sp. Roxithromycin has been demo