Amoxicillin and clavulanate potassium tablets for bacterial infections in adults and older children

Amoxicillin and clavulanate potassium tablets combine a penicillin-class antibiotic with a beta-lactamase inhibitor to treat infections caused by bacteria resistant to amoxicillin alone. This oral formulation is intended for adults and pediatric patients weighing 40 kg or more who can swallow tablets. It targets specific bacterial infections involving the respiratory tract, sinuses, ears, skin, and urinary tract.

Amoxicillin and clavulanate potassium tablets are used to treat infections caused by beta-lactamase-producing bacteria, in patients weighing at least 40 kg who can swallow tablets. The approved infections include:

• Lower respiratory tract infections due to Haemophilus influenzae and Moraxella catarrhalis
• Acute bacterial sinusitis caused by Haemophilus influenzae and Moraxella catarrhalis
• Acute bacterial otitis media with suspected beta-lactamase-producing pathogens
• Skin and skin structure infections caused by Staphylococcus aureus, Escherichia coli, and Klebsiella species
• Urinary tract infections involving E. coli, Klebsiella species, and Enterobacter species

Therapy may start before bacteriological results are available when beta-lactamase-producing bacteria are suspected; if testing later shows susceptibility to amoxicillin alone, this combination should not be continued. Use is intended only in infections confirmed or strongly suspected to be caused by susceptible bacteria to reduce drug resistance development.

Amoxicillin; Clavulanate potassium

This combination contains amoxicillin, a penicillin antibiotic that kills bacteria by interfering with their cell wall synthesis, and clavulanate potassium, which inhibits beta-lactamase enzymes produced by some bacteria that would otherwise degrade amoxicillin. By protecting amoxicillin from degradation, clavulanate extends the antibiotic's spectrum against resistant bacteria.

Adults and pediatric patients weighing 40 kg or more who can swallow tablets:

Take tablets at the start of a meal to improve absorption of clavulanate and reduce gastrointestinal side effects. For patients with severe renal impairment (glomerular filtration rate [GFR] below 30 mL/min), reduced dosing is required, and the 875 mg/125 mg dose should be avoided. Specific dosage adjustments depend on the degree of renal impairment and dialysis status.

Important administration notes: This product is for patients weighing 40 kg or more who can swallow tablets whole. It should not be used in pediatric patients under 40 kg due to differing amoxicillin-to-clavulanate ratios. Switching between formulations should preserve the amoxicillin-to-clavulanate ratio to ensure proper dosing.

• History of serious hypersensitivity (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate potassium, or other beta-lactam antibiotics including penicillins and cephalosporins.
• History of cholestatic jaundice or hepatic dysfunction associated with prior use of amoxicillin/clavulanate potassium.

• Serious hypersensitivity reactions: Discontinue immediately if signs of an allergic reaction occur, such as anaphylaxis or Stevens-Johnson syndrome, and provide appropriate treatment.
• Severe cutaneous adverse reactions (SCAR): Monitor for skin rash; discontinue if lesions progress.
• Drug-induced enterocolitis syndrome (DIES): Non-IgE mediated hypersensitivity presenting as prolonged vomiting after ingestion; discontinue drug if this occurs.
• Hepatic dysfunction and cholestatic jaundice: Cases of reversible and fatal liver dysfunction have been reported; discontinue if symptoms of hepatitis appear. Contraindicated in patients with prior amoxicillin-clavulanate associated hepatic dysfunction.
• Clostridioides difficile-associated diarrhea (CDAD): Evaluate patients who develop diarrhea during or after treatment; may be severe or fatal.
• Mononucleosis: Avoid use in patients with infectious mononucleosis due to increased risk of rash.

• Common gastrointestinal effects include diarrhea, nausea, and vomiting.
• Skin rash may occur, particularly in patients with mononucleosis.
• Rare but serious reactions include severe hypersensitivity reactions (anaphylaxis, Stevens-Johnson syndrome), liver dysfunction, and drug-induced enterocolitis syndrome.