Summary for ARTG Entry:
AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid
(as potassium) 125mg film-coated tablet blister pack
ARTG entry for
Southern Cross Pharma Pty Ltd
PO Box 2037,MALUA BAY, NSW, 2536
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as
potassium) 125mg film-coated tablet blister pack
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Amoxycillin and clavulanic acid tablets are indicated for short-term treatment of bacterial infections at the following sites when caused by sensitive
organisms (Microbiology): - Urinary tract infections (uncomplicated and complicated). - Lower respiratory tract infections, including community acquired
pneumonia and acute exacerbations of chronic bronchitis. - Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis. -
Skin and skin structure infections. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine
its (their) susceptibility to AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 and AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 875/125 tablets.
However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, therapy may be
instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if
appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to
AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 and AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 875/125 tablets should not require the addition of
another antibiotic due to the amoxycillin content of these products.
Additional Product information
Store below 25
Protect from Moisture
Pack Size/Poison information
(S4) Prescription Only Medicine
1. AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxycillin (as trihydrate) 500mg and clavulanic acid (as potassium) 125mg
film-coated tablet blister pack
Tablet, film coated
Route of Administration
White convex capsule shaped film coated tablet
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 28.11.2017 at 01:20:38 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information