ZITHROMAX IV azithromycin (as dihydrate) 500mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azithromycin dihydrate, Quantity: 524.1 mg (Equivalent: azithromycin, Qty 500 mg)

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: citric acid; sodium hydroxide

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Community acquired pneumonia caused by susceptible organisms in patients who require initial intravenous therapy. In clinical studies efficacy has been demonstrated against Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophilia, Moraxella catarrhalis, Mycoplasma pneumoniae, Staphylococcus aureus and Streptococcus pneumoniae.

Product summary:

Visual Identification: WHITE TO OFF-WHITE CAKE POWDER; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-11-19

Patient Information leaflet

ZITHROMAX
® IV
_Azithromycin (a-zithro-my-sin)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zithromax IV. It
does not contain all 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 being given
Zithromax IV 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 YOU.
You may need to read it again.
WHAT ZITHROMAX IV IS
USED FOR
Zithromax IV is used to treat
pneumonia, a lung infection caused
by certain bacteria including
Legionella pneumophila.
Zithromax is an antibiotic which
belongs to a group of medicines
called azalides.
The azalides are a sub-class of a
group of antibiotics called
macrolides.
Zithromax works by killing or
stopping the growth of bacteria
causing your infection.
Zithromax IV will not work against
viral infections such as colds or flu.
Your doctor may have prescribed
Zithromax IV for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZITHROMAX IV
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU ARE GIVEN
ZITHROMAX IV
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN ZITHROMAX
IV IF YOU HAVE AN ALLERGY TO:
Azithromycin or any other ketolide
or macrolide antibiotic (e.g.,
roxithromycin, erythromycin,
clarithromycin, telithromycin) or any
of the ingredients listed at the end of
this leaflet
IF YOU ARE NOT SURE IF YOU ARE
ALLERGIC TO ANY OF THE ABOVE, ASK
YOUR DOCTOR.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
to other parts of the body; skin rash,
itching or hives.
Zithromax IV must not be given if
the expiry date (EXP) or use

Summary of Product characteristics

Version: pfpzithv10619
Supersedes: pfpzithv10617
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION -
ZITHROMAX
® IV (AZITHROMYCIN
DIHYDRATE)
1. NAME OF THE MEDICINE
Azithromycin dihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial containing 500 mg of
azithromycin,
providing 100 mg/mL solution following
reconstitution.
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Community acquired pneumonia caused by susceptible organisms in
patients who require
initial intravenous therapy. In clinical studies efficacy has been
demonstrated against
_Chlamydia _
_pneumoniae_
,
_Haemophilus _
_influenzae_
,
_Legionella _
_pneumophilia_
,
_Moraxella _
_catarrhalis_
,
_Mycoplasma pneumoniae_
,
_Staphylococcus aureu_
s and
_Streptococcus pneumoniae._
4.2 DOSE AND METHOD OF ADMINISTRATION
The dose of ZITHROMAX IV for the treatment of adult patients with
community acquired
pneumonia is:
500 mg as a single daily IV dose for at least two days. IV therapy
should be followed by oral
therapy of 500 mg azithromycin administered as a single daily dose to
complete a 7 to 10 day
course of therapy. The timing of the conversion to oral azithromycin
therapy should be done at
the discretion of the physician and in accordance with clinical
response.
After
re-constitution
and
dilution,
the
recommended
route
of
administration
for
IV
azithromycin is by IV infusion only.
DO NOT ADMINISTER AS AN IV BOLUS OR INTRAMUSCULAR
INJECTION.
USE IN ELDERLY
No dose adjustment is necessary in elderly patients requiring
azithromycin therapy.
Version: pfpzithv10619
Supersedes: pfpzithv10617
Page 2 of 17
USE IN PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment is needed in patients with mild or moderate renal
impairment. After oral
administration of a single dose of azithromycin 1 g in subjects with
severe renal impairment
(GFR <10 mL/min), mean AUC
0-120h
and mean C
max
were increased by approximately 30%
and 60%, respectively when