AZITHROMYCIN MYLAN azithromycin (as dihydrate) 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Sandoz Pty Ltd

INN (International Name):

azithromycin dihydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type A; magnesium stearate; maize starch; sodium lauryl sulfate; lactose monohydrate; hypromellose; titanium dioxide; macrogol 4000

Administration route:

Oral

Units in package:

3 tablets, 2 tablets

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 influenzae 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 medicines 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-intracellular 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/microliter (see Precautions). Disseminated infection due to Mycobacterium avium-intracellular complex should be excluded by a negative blood culture prior to commencement of therapy.

Product summary:

Visual Identification: white to off-white, oval film-coated tablets, plain on one side with a breaking notch and 'A500' embossed on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-04-29

Patient Information leaflet

AZITHROMYCIN
MYLAN
_azithromycin (as dihydrate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AZITHROMYCIN
MYLAN.
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 MYLAN against
the benefits expected 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
MYLAN IS USED FOR
This medicine is used to treat
infections in different parts of the
body caused by bacteria.
It is commonly used to treat
Chlamydia.
This medicine is also used to prevent
infections by a bacterium called
Mycobacterium Avium-intracellulare
Complex (MAC) in some people.
It contains the active ingredient
azithromycin.
AZITHROMYCIN MYLAN belongs
to a group of medicines called
azalides.
The azalides are a sub-class of a
group of antibiotics called
macrolides.
It works by killing or stopping the
growth of bacteria causing your
infection.
AZITHROMYCIN MYLAN will not
work against viral infections such as
colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
AZITHROMYCIN MYLAN 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
AZITHROMYCIN
MYLAN
_WHEN YOU MUST NOT TAKE IT_
YOU MUST NOT TAKE
AZITHROMYCIN MYLAN IF YOU
HAVE AN ALLERGY TO:
•
Any medicine containing
Azithromycin
•
Any other ketolide or macrolide
antibiotics (e.g. roxithromycin,
erythromycin, clarithromycin,
telithromycin)
•
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 inc

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AZITHROMYCIN MYLAN
_Azithromycin dihydrate tablets _
1
NAME OF THE MEDICINE
Azithromycin dihydrate
2
&
3.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
&
PHARMACEUTICAL FORM
.
AZITHROMYCIN MYLAN is supplied as a white to off-white, film-coated,
oval shaped, plain on one side,
with a breaking notch and ‘A500’ embossed on the other side. Each
film-coated tablet contains 500 mg of
azithromycin (as azithromycin dihydrate) as the active ingredient.
Excipients with known effect: lactose and sulfites
For the full list of excipients, see Section 6.1 List of excipients.
4
CLINICAL PARTICULARS
4.1
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 influenzae_
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 d