APO-AZITHROMYCIN azithromycin (as dihydrate) 500 mg tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

azithromycin dihydrate, Quantity: 524.05 mg (Equivalent: azithromycin, Qty 500 mg)

Boleh didapati daripada:

Arrotex Pharmaceuticals Pty Ltd

INN (Nama Antarabangsa):

azithromycin dihydrate

Borang farmaseutikal:

Tablet, film coated

Komposisi:

Excipient Ingredients: calcium hydrogen phosphate dihydrate; hyprolose; croscarmellose sodium; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin

Laluan pentadbiran:

Oral

Unit dalam pakej:

100

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

APO-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 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. ? APO-Azithromycin is also indicated for the treatment of Chlamydia trachomatis conjunctivitis and trachoma.

Ringkasan produk:

Visual Identification: White, oval, biconvex film coated tablets engraved "APO" on one side and "AZ500" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status kebenaran:

Registered

Tarikh kebenaran:

2012-12-12

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION
APO-AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)
TABLETS
1
NAME OF THE MEDICINE
Azithromycin dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Azithromycin (as dihydrate)
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White, oval, biconvex film coated tablets engraved “APO” on one
side and “AZ500” on the
other side.
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.
2
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