AZITHROMYCIN AN azithromycin (as monohydrate) 500mg film-coated tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

azithromycin

Dostopno od:

Medis Pharma Pty Ltd

INN (mednarodno ime):

Azithromycin

Status dovoljenje:

Registered

Navodilo za uporabo

Azithromycin AN CMI_v1
1
AZITHROMYCIN AN Tablets
_contains the active ingredient azithromycin (as monohydrate) _
_ _
_ _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about AZITHROMYCIN AN.
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 AZITHROMYCIN
AN 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 AZITHROMYCIN AN is
used for
AZITHROMYCIN AN is used to treat
bacterial infection including the
following:
•
respiratory infections such as
sinusitis, sore throat, tonsillitis,
bronchitis and pneumonia
•
skin and underlying tissue
infections
•
genital infections such as
Chlamydia
•
an uncommon eye infection
(Chlamydia trachomatis
conjunctivitis and trachoma).
AZITHROMYCIN AN may also be
used to prevent infections by
bacterium called Mycobacterium
avium-intracellulare Complex.
AZITHROMYCIN AN is an antibiotic
which belongs to a group of
medicines called azalides, a
subclass of the macolide
antibiotics. It works by killing or
stopping the growth of bacteria
causing your infection.
AZITHROMYCIN AN does not work
against viral infections such as
colds or flu.
Your doctor may have prescribed
AZITHROMYCIN AN for another
reason. Ask your doctor if you have
any questions about why
AZITHROMYCIN AN has been
prescribed for you.
AZITHROMYCIN AN is available only
with a doctor's prescription.
Before you take
AZITHROMYCIN AN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE AZITHROMYCIN AN IF
YOU ARE ALLERGIC TO:
•
AZITHROMYCIN
•
ANY OTHER MACROLIDE ANTIBIOTICS
SUCH AS CLARITHROMYCIN,
ERYTHROMYCIN AND
ROXITHROMYCIN
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include skin
rash, itchiness or hiv

Lastnosti izdelka

Azithromycin AN 500mg PI V1.2
Azithromycin AN
PRODUCT INFORMATION
NAME OF THE MEDICINE
Azithromycin (as monohydrate). The chemical name for azithromycin
monohydrate is 9-deoxo-9a-
aza-9a-methyl-9a-homoerythromycin A monohydrate.
The structural formula of azithromycin monohydrate is:
.H
2
O
C
38
H
72
N
2
O
12
.H
2
O
Molecular weight: 767.01
Cas No.: 121470-24-4
DESCRIPTION
Azithromycin monohydrate is a white or almost-white powder.
Azithromycin AN tablets contain 500 mg of azithromycin (as
monohydrate). The tablets also
contain the following excipients: calcium hydrogen phosphate ,
pregelatinised maize starch,
croscarmellose sodium, sodium lauryl sulfate, magnesium stearate and
Opadry AMB Complete film
coating system OY-B-28920 White (Proprietary Ingredient ID: 4271). The
tablets are gluten free.
PHARMACOLOGY
MECHANISM OF ACTION
Azithromycin acts by binding to the 50S ribosomal subunit of
susceptible organisms, thus
interfering with microbial protein synthesis. Nucleic acid synthesis
is not affected.
AZITHROMYCIN AN – Product information
2
Azithromycin AN 500mg PI V1.2
MICROBIOLOGY
AZITHROMYCIN DEMONSTRATES ACTIVITY _IN VITRO_ AGAINST A WIDE RANGE OF
BACTERIA INCLUDING:
•
GRAM-POSITIVE AEROBIC BACTERIA. _Staphylococcus aureus_,
_Streptococcus pyogenes_ (group A
beta-haemolytic Streptococci), _Streptococcus pneumoniae_,
alpha-haemolytic Streptococci
(viridans group) and other Streptococci, and _Corynebacterium
diphtheriae_. Azithromycin
demonstrates cross resistance with erythromycin resistant
gram-positive strains, including
_Streptococcus _
_faecalis _
(enterococcus)
and
most
strains
of
methicillin
resistant
Staphylococci.
•
GRAM-NEGATIVE
AEROBIC
BACTERIA.
_Haemophilus _
_influenzae _
(including
beta-lactamase
producing _ Haemophilus influenzae_), _ Haemophilus parainfluenzae_, _
Moraxella catarrhalis_,
Acinetobacter species, Yersinia species, _ Legionella pneumophila_, _
Bordetella pertussis_,
_Bordetella parapertussis_, Shigella species, Pasteurella species,
_Vibrio cholerae_ and _Vibrio _
_parahaemolytic