Amoxicillin and Clavulanic acid

Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis. • Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. • Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis. • Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. • Urinary Tract Infections -caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species, and Enterobacter species.

Amoxicillin and clavulanate potassium for oral suspension is an antibacterial drug.

• Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. • Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. • Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended.

• History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins). • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension.

• Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium for oral suspension if a reaction occurs. • Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. • Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of amoxicillin and clavulanate potassium for oral suspension. If this occurs, discontinue Amoxicillin and Clavulanate Potassium for Oral Suspension and institute appropriate therapy. • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. • Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs.

The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions • Severe Cutaneous Adverse Reactions • Drug-Induced Enterocolitis Syndrome (DIES) • Hepatic Dysfunction • Clostridioides difficile Associated Diarrhea (CDAD) The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%)

• Co-administration with probenecid is not recommended. • Concomitant use of amoxicillin and clavulanate potassium for oral suspension and oral anticoagulants may increase the prolongation of prothrombin time. • Coadministration with allopurinol increases the risk of rash. • Amoxicillin and clavulanate potassium for oral suspension may reduce efficacy of oral contraceptives.

Store dry powder at 20° to 25°C (68° to 77°F). Store reconstituted suspension under refrigeration.