CLARITHROMYCIN AN clarithromycin 250mg film-coated tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

clarithromycin

Saadav alates:

Amneal Pharma Australia Pty Ltd

INN (Rahvusvaheline Nimetus):

Clarithromycin

Volitamisolek:

Registered

Infovoldik

_Clarithromycin AN tablets – Consumer Medicine Information _
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_Doc ID: 51.AN.M.1.0 _
_ _
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_Page 1 _
CLARITHROMYCIN AN TABLETS
_Clarithromycin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Clarithromycin AN tablets.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
CLARITHROMYCIN AN 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
CLARITHROMYCIN
AN IS USED FOR
CLARITHROMYCIN AN IS USED
TO
TREAT
CERTAIN
BACTERIAL
INFECTIONS,
INCLUDING
THE
FOLLOWING:

RESPIRATORY TRACT INFECTIONS

SKIN INFECTIONS

PEPTIC ULCER
CLARITHROMYCIN AN is also
used
to
prevent
a
specific
bacterial
infection
associated
with HIV infection.
Your doctor, however, may have
prescribed
CLARITHROMYCIN
AN
for
another
purpose.
Ask
your
doctor
if
you
have
any
questions
about
why
CLARITHROMYCIN
AN
has
been prescribed for you.
CLARITHROMYCIN
AN
IS
AN
ANTIBIOTIC THAT BELONGS TO THE
GROUP
OF
MEDICINES
CALLED
MACROLIDES.
THESE
MEDICINES
WORK
BY
KILLING OR STOPPING THE GROWTH
OF
BACTERIA
WHICH
CAUSE
INFECTIONS.
CLARITHROMYCIN AN WILL NOT
WORK
AGAINST
INFECTIONS
CAUSED
BY
VIRUSES,
SUCH
AS
COLDS OR FLU.
CLARITHROMYCIN
AN
IS
AVAILABLE ONLY WITH A DOCTOR’S
PRESCRIPTION.
CLARITHROMYCIN AN TO TREAT
PEPTIC ULCER
Peptic ulcers are associated with
an infection in the intestine and
stomach
by
a
bacteria
called
_Helicobacter _
_pylori_
(_H. _
_pylori_).
Nearly
all
patients
with
peptic
ulcers
are
infected
with
this
bacteria.
The _ H. pylori_ infection can be
treated
with
a
combination
of
CLARITHROMYCIN
AN
(clarithromycin),
another
antibiotic
(amoxycillin)
and
another
medicine
called
omeprazole (used to control the
acidity of the stomach).
However, the best combination
of
tablet

Toote omadused

_Clarithromycin AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Clarithromycin AN PI v.3.0
Page 1
CLARITHROMYCIN AN
_ _
_(CLARITHROMYCIN TABLETS) _
_ _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
The name of the medicine is clarithromycin.
CHEMICAL NAME:
(3
_R_
,4
_S_
,5
_S_
,6
_R_
,7
_R_
,9
_R_
,11
_R_
,12
_R_
,13
_S_
,14
_R_
)-4-[(2,6-Dideoxy-3-
_C_
- methyl-3-
_O_
-
methyl-α-
L
-
_ribo_
-hexopyranosyl)oxy]-14-ethyl-12,13-dihydroxy-7-methoxy-3,5,7,9,11,13-
hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-
_xylo_
-
hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (6-
_O_
-methylerythromycin A)
MOLECULAR FORMULA:
C
38
H
69
NO
13
MOLECULAR WEIGHT:
747.97
CAS REGISTRY NUMBER:
_[81103-11-9] _
DESCRIPTION
Clarithromycin is a semi-synthetic macrolide antibiotic.
Clarithromycin is a white to off-
white crystalline powder. It is soluble in acetone, slightly soluble
in methanol, ethanol and
acetonitrile, and practically insoluble in water.
Other
ingredients
in
Clarithromycin AN 250
mg
Tablets
are
microcrystalline
cellulose,
pregelatinised
maize
starch,
croscarmellose
sodium,
povidone,
stearic
acid,
magnesium
stearate, colloidal
anhydrous silica, quinoline yellow, Opadry White Y-1-7000 (containing
hypromellose,
titanium
dioxide
and
Macrogol
400),
Quinoline
yellow
aluminium
lake,
hypromellose and vanillin.
PHARMACOLOGY
Hepatotoxicity,
atrophy of lymphatic
tissues (lymph,
thymus)
and
adverse
reproductive
toxicity were seen in several species at exposures less than those
which might be expected
clinically at the proposed doses. The clinical significance of these
observations is not known.
_Clarithromycin AN tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Clarithromycin AN PI v.3.0
Page 2
There are no data from long term animal carcinogenicity studies.
_Clinical Pharmacokinetics: _
Clarithromycin is absorbed from the gastrointestinal tract after
oral administration. The absolute bioavailability of 250 mg tablets is
approximately 50%.
Food
intake
half
an
hour
before
tablet
dos