AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as potassium) 125mg film-coate

Main information

  • Trade name:
  • AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as potassium) 125mg film-coate
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as potassium) 125mg film-coate
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 196894
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

196894

AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid

(as potassium) 125mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Southern Cross Pharma Pty Ltd

Postal Address

PO Box 2037,MALUA BAY, NSW, 2536

Australia

ARTG Start Date

26/11/2012

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. AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxicillin (as trihydrate) 500mg and clavulanic acid (as

potassium) 125mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective date

26/11/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

2 Years

Store below 25

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

10 tablets

(S4) Prescription Only Medicine

Components

1. AMOXYCILLIN/CLAVULANIC ACID-SPIRIT 500/125 amoxycillin (as trihydrate) 500mg and clavulanic acid (as potassium) 125mg

film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White convex capsule shaped film coated tablet

Active Ingredients

amoxicillin trihydrate

574 mg

potassium clavulanate

148.9 mg

© 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.

Public Summary

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