Public Summary

Summary for ARTG Entry: 236898 COMOX 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets strip
pack

ARTG entry for Medicine Registered

Sponsor Micro Labs Pty Ltd

Postal Address 15 Melliodora Crescent, GREENSBOROUGH, VIC, 3088
Australia
ARTG Start Date 7/04/2016
Product Category Medicine
Status Active
Approval Area Drug Safety Evaluation Branch

Conditions

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.

Products

1 . COMOX 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets strip

Public Summary
pack
Product Type Single Medicine Product Effective Date 7/04/2016

Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

COMOX 875/125 tablets are indicated for short-term treatment of bacterial infections at the following sites when caused by sensitive organisms (refer to
Microbiology):,Urinary Tract Infections (complicated and uncomplicated),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
Infection.,Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to
amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms
listed above, 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 amoxicillin susceptible organisms and beta-lactamase producing organisms
susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these
products.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions

Strip Pack Al/Al 24 Months Store below 25 Neither child resistant Protect from Moisture
degrees Celsius closure nor restricted
flow insert

Pack Size/Poison information

Pack Size Poison Schedule

Alu/Alu strip packs of 10 tablets packed in monocarton (S4) Prescription Only Medicine

Components
1 . COMOX 875/125, amoxicillin (as trihydrate) 875 mg and clavulanic acid (as potassium) 125 mg tablets strip pack

Dosage Form Tablet, film coated

Page 1 of 2 Produced at 03.10.2020 at 04:03:42 AEST

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
 Route of Administration Oral
Visual Identification White colored capsule shaped film coated tablet debossed with 'I 07' on one side and plain on other side.

Active Ingredients

amoxicillin trihydrate 1004.31 mg

potassium clavulanate 151.917 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

dichloromethane
hypromellose
isopropyl alcohol
macrogol 400
magnesium stearate
microcrystalline cellulose
sodium starch glycollate
titanium dioxide

Public Summary
© 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 2 of 2 Produced at 03.10.2020 at 04:03:42 AEST

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