PBS arrangements during shortage of amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL oral suspension effective 1 November 2023
Page last updated: 1 November 2023
Due to the shortage of Curam Duo (amoxicillin 400 mg/5 mL + clavulanic acid 57 mg/5 mL powder for oral liquid, 60 mL), the Department will be temporarily listing on the PBS an alternative medicine, Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400 mg/57 mg per 5 mL (Aurobindo) from 1 November 2023.
The Therapeutic Goods Administration has temporarily approved the listing of the Aurobindo medicine as a Section 19A product. Section 19A of the Therapeutic Goods Act 1989 allows medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply. The Aurobindo brand is an overseas registered medicine.
The Aurobindo brand will be ‘a’-flagged to the Curam Duo 400/57. However, the Aurobindo brand is available in a pack size of 50 mL bottle compared to 60 mL of Curam Duo.
Changes to PBS Listing effective 1 November 2023:
|
Item in shortage |
PBS listing from 1 November 2023 |
PBS listing substitution notes |
|---|---|---|
|
Amoxicillin with clavulanic acid, powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL, Curam Duo |
Amoxicillin with clavulanic acid, powder for oral suspension containing 400 mg amoxicillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 50 mL (S19A), Amoxicillin and clavulanate potassium for oral suspension, USP 400 mg/57 mg per 5 mL (Aurobindo). |
The 50 mL Aurobindo brand is ‘a’-flagged to the 60 mL Curam Duo 400/57 brand. |
Advice for dispensing from 1 November 2023:
- Prescriptions written from 1 November 2023 can be filled with either brand, provided brand substitution is allowed on the prescription and pharmacies have stock.
- The dosing amount and duration of antibiotics are at the discretion of the prescriber, based on their clinical judgement.
- If the prescription is written for a course duration requiring more than 50 mL, pharmacists should consult with the prescriber on whether a prescription with a repeat is required. There are also established provisions in place for authority approvals for increased quantities, minimising the need for additional doctor visits.
- Pharmacists should communicate any changes or substitutions to patients at the time of dispensing, ensuring that patients are fully informed and can make decisions about their medication in consultation with their prescriber.
- For dental prescriptions, requests for increased quantities are not permitted within a single PBS prescription. However, if a quantity exceeding 50 mL is required, dentists have the discretion to issue an additional non-PBS prescription on the same day.
Please visit the Therapeutic Goods Administration’s s19A webpage for more information regarding amoxicillin and clavulanate potassium for oral suspension, USP, 400 mg/57 mg per 5 mL, 50 mL (Aurobindo) and the shortage of amoxicillin brands.
For information pertaining to PBS listings, including medical and product information for amoxicillin, please visit the relevant PBS webpage.
