Aeroclav-DS

Composition: Amoxicillin 200mg + Potassium Clavulanate 28.5mg (oral suspension). It combines Amoxicillin (aminopenicillin antibiotic) and Potassium Clavulanate (beta-lactamase inhibitor). The beta-lactamase inhibitor is included so that the partner beta-lactam remains active against organisms that produce susceptible beta-lactamase enzymes.

Amoxicillin is an aminopenicillin that inhibits bacterial cell-wall synthesis. Clavulanic acid inhibits many bacterial beta-lactamases, helping protect the partner beta-lactam antibiotic from enzymatic breakdown.

AEROCLAV-DS is a prescription medicine from Aerochem Neutron's pediatric range, for use on the prescription of a registered medical practitioner.

·       Contains Amoxicillin 200mg + Potassium Clavulanate 28.5mg

·       Amoxicillin — aminopenicillin that inhibits bacterial cell-wall synthesis

·       Clavulanic acid inhibits many bacterial beta-lactamases, helping protect the partner beta-lactam antibiotic from enzymatic breakdown

·       Presented as oral suspension

Prescription-only medicine

·       Otitis media and sinusitis in children

·       Upper and lower respiratory tract infections

·       Urinary tract infections

·       Skin and soft-tissue infections

·       Other indications as per the approved prescribing information

·       Note: indications reflect established uses of the individual molecules; confirm against the CDSCO-approved label for this fixed-dose combination

Safety

·       Contraindicated in patients with known hypersensitivity to any component.

·       Contraindicated in patients with hypersensitivity to beta-lactam antibiotics (penicillins, cephalosporins or carbapenems); Clostridioides difficile-associated diarrhoea can occur. Amoxicillin-clavulanate has been associated with cholestatic hepatitis; use caution in hepatic impairment.

·       Store in a cool and dry place below 25°C. Protect from moisture..

Clinical Rationale: The mechanisms and labelled uses of amoxicillin, amoxicillin and clavulanate potassium described here follow the US prescribing information (DailyMed); antibiotic choice should follow local resistance data and the WHO AWaRe antibiotic book. Use of the combination should follow the CDSCO-approved label for this fixed-dose combination.

References (Verified)

·       DailyMed (US NLM) prescribing information – amoxicillin: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=AMOXICILLIN

·       DailyMed (US NLM) prescribing information – amoxicillin and clavulanate potassium: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=AMOXICILLIN%20AND%20CLAVULANATE%20POTASSIUM

·       WHO AWaRe (Access, Watch, Reserve) antibiotic book (2022): https://www.who.int/publications/i/item/9789240062382