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(Approval lapsed) Amoxicillin and clavulanate potassium for oral suspension, USP 400mg/57mg per 5mL (Bionpharma)

Section 19A approved medicine
(Approval lapsed) Amoxicillin and clavulanate potassium for oral suspension, USP 400mg/57mg per 5mL (Bionpharma)
Section 19A approval holder
Pro Pharmaceuticals Group Pty Ltd ABN 20 605 457 430
Phone
1300 077 674
Approved until
Status
Expired
Medicines in short supply/unavailable
CURAM DUO 400/57 amoxicillin 400 mg/5mL (as trihydrate) / clavulanic acid 57 mg/5mL (as potassium clavulanate) powder for suspension bottle - ARTG 147109
Indication(s)

Amoxicillin and clavulanic acid is indicated for the short-term treatment of the following bacterial infections when caused by sensitive organisms

  • skin and skin structure infections;
  • urinary tract infections (complicated and uncomplicated);
  • upper respiratory tract infections including sinusitis and otitis media;
  • lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia.

Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid. 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 amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid should not require the addition of another antibiotic due to the amoxicillin content of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400mg/57mg per 5mL.

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