ZITHRO azithromycin (as dihydrate) 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

azithromycin dihydrate, Quantity: 524 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

azithromycin dihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; hypromellose; triacetin; calcium hydrogen phosphate; titanium dioxide; pregelatinised maize starch; crospovidone; sodium lauryl sulfate; magnesium stearate

Administration route:

Oral

Units in package:

15, 2, 3

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Azithromycin is indicated for use in adults for the treatment of the following infections of mild to moderate severity:,1. Lower respiratory tract infections:,Acute bacterial bronchitis due to Streptococcus pneumoniae, Haemophilus influenza or Moraxella catarrhalis.,Community acquired pneumonia due to Streptococcus pneumoniae or Haemophilus influenzae in patients suitable for outpatient oral treatment.,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.,2. Upper respiratory tract infections:,Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.,Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. Azithromycin appears to be almost as effective in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,3. Uncomplicated skin and skin structure infections:,Uncomplicated infections due to Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae. Abscesses usually require surgical drainage.,4. Sexually transmitted diseases: Uncomplicated urethritis and cervicitis due to Chlamydia trachomatis.,Note: At the recommended dose azithromycin cannot be relied upon to treat gonorrhoea or syphilis. As with other drugs for the treatment of non-gonococcal infections, it may mask or delay the symptoms of incubating gonorrhoea or syphilis. Appropriate tests should be performed for the detection of gonorrhoea or syphilis and treatment should be instituted as required.,Azithromycin is also indicated for the treatment of Chlamydia trachomatis conjunctivitis and trachoma.,Azithromycin is also indicated for the prevention of infection due to Mycobacterium avium-intracellulare Complex (MAC) disease, when used as the sole agent or in combination with rifabutin at its approved dose, in adults and children aged more than 12 years with HIV infection and CD4 cell count less than or equal to 75 cells/?L (see Precautions). Disseminated infection due to Mycobacterium avium-intracellulare complex should be excluded by a negative blood culture prior to commencement of therapy.,Azithromycin is indicated for use in children for the treatment of the following infections:,1. Acute streptococcal pharyngitis/tonsillitis:,Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. The 20 mg/kg azithromycin dose appears to be as effective as penicillin in the treatment of streptococcal pharyngitis. However, substantial data establishing the efficacy of azithromycin in the subsequent prevention of rheumatic fever are not available at present.,2. Chlamydia trachomatis conjunctivitis and trachoma in children 12 months or older.

Product summary:

Visual Identification: White, oblong, biconvex, film-coated tablet, scored on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-05-30

Patient Information leaflet

ZITHRO
_Azithromycin dihydrate (a-zithro-my-sin)_
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zithro. 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 taking Zithro 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 YOUR
MEDICINE.
You may need to read it again.
WHAT ZITHRO IS USED FOR
Zithro
is
used
to
treat
infections
in
different parts of the body caused by
bacteria.
It is commonly used to treat
Chlamydia. Zithro is also used to
prevent infections by a bacterium
called Mycobacterium Avium-
intracellulare Complex (MAC) in some
people.
Zithro 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.
Zithro works by killing or stopping the
growth of bacteria causing your
infection.
Zithro will not work against viral
infections such as colds or flu.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY ZITHRO HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
Zithro is only available 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 TAKE ZITHRO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ZITHRO IF YOU ARE
ALLERGIC TO:
•
azithromycin
•
any other macrolide or ketolide
antibiotics (e.g., clarithromycin,
erythromycin, roxithromycin,
telithromycin)
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction may
include shortness of breath, wheezing
or difficulty breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives on the
skin.
DO NOT TAKE THIS MEDICINE IF THE
EXPIRY DATE (EXP) PRINTED ON THE

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZITHRO (AZITHROMYCIN
DIHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Azithromycin dihydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZITHRO tablets contain azithromycin dihydrate equivalent to 500 mg of
azithromycin.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ZITHRO tablets are white, oblong, biconvex, film coated tablets,
scored on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Azithromycin is indicated for use in ADULTS for the treatment of the
following infections of mild
to moderate severity:
1.
Lower respiratory tract infections:
Acute
bacterial
bronchitis
due
to _Streptococcus _
_pneumoniae, _
_Haemophilus _
_influenza _or
_Moraxella catarrhalis._
Community
acquired
pneumonia
due
to
_Streptococcus _
_pneumoniae _
or
_Haemophilus _
_influenzae _in patients suitable for outpatient oral treatment.
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_.
2.
Upper respiratory tract infections:
Acute sinusitis due to _Streptococcus pneumoniae _or _Haemophilus
influenzae_.
Acute streptococcal pharyngitis. Note: Penicillin is the usual drug of
choice in the treatment
of
Streptococcus
pyogenes
pharyngitis,
including
the
prophylaxis
of
rheumatic
fever.
Azithromycin appears to be almost as effective in the treatment of
streptococcal pharyngitis.
2
However,
substantial
data
establishing
the
efficacy of azithromycin in
the
subsequent
prevention of rheumatic fever are not available at present.
3.
Uncomplicated skin and skin structure infections:
Uncomplicated
infections
due
to
_Staphylococcus _
_aureus, _
_Streptococcus _
_pyogenes _
or
_Streptococcus agalactiae_. Abscess