CDSCO Panel grants GSK's Updated Prescribing Information for Antibiotic FDC of Amoxicillin, Clavulanic acid

New Delhi: The drug major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to update the prescribing information of the fixed-dose combination (FDC) Amoxicillin Trihydrate 759.04mg eq. to Amoxicillin free acid 652.78mg plus Potassium Clavulanate 61.48mg eq. to Clavulanic acid 50.41mg per 5ml powder for reconstitution into suspension.

This came after the drug maker GlaxoSmithKline Pharmaceuticals presented the proposal for updating prescribing information for the FDC changes based on the Global Data Sheet (GDS) v25 (dated 10th Feb 2022) and GDS v26 (dated 23rd Feb 2023).

Amoxicillin trihydrate is a hydrate that is the trihydrate form of amoxicillin; a semisynthetic antibiotic used either alone or in combination with potassium clavulanate (under the trade name Augmentin) for the treatment of a variety of bacterial infections.

Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin-binding proteins. Penicillin-binding proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin-binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.

Clavulanate potassium (the potassium salt of clavulanic acid) is a β-lactamase inhibitor that is added to amoxicillin to prevent inactivation by bacterial enzymes. β-Lactamase inhibitors (clavulanate, sulbactam, tazobactam) irreversibly bind to β-lactamase.

At the recent SEC meeting Antimicrobial and Antiviral held on 22nd February 2024, the expert panel reviewed the proposal for updated prescribing information for the FDC changes based on the Global Data Sheet (GDS) v25 (dated 10th Feb 2022) and GDS v26 (dated 23rd Feb 2023).

After detailed deliberation, the committee recommended the grant of approval for the proposed update in prescribing information as presented by the firm.

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