amoxicillin-clavulanate

Brand: Augmentin, Augmentin ES, Augmentin XR

Prototype: penicillin-g
Drug Class: antibiotic
Drug Family: antibiotic
Subclass: aminopenicillin + beta-lactamase inhibitor
Organ Systems: infectious-disease

Mechanism of Action

Amoxicillin inhibits PBPs; clavulanate is a suicide inhibitor of bacterial beta-lactamases (especially class A enzymes such as TEM-1, SHV-1), protecting amoxicillin from hydrolytic inactivation and extending spectrum to beta-lactamase-producing organisms.

penicillin-binding proteins (PBPs)beta-lactamase enzymes

Indications

  • community-acquired pneumonia (mild-moderate)
  • sinusitis (moderate-severe)
  • otitis media (treatment failure)
  • skin and soft tissue infections
  • diabetic foot infections (mild-moderate)
  • bite wounds (animal/human)

Contraindications

  • penicillin allergy
  • cholestatic jaundice/hepatic dysfunction from prior amoxicillin-clavulanate use

Adverse Effects

Common

  • diarrhea (more common than amoxicillin alone due to clavulanate)
  • nausea
  • vomiting
  • rash

Serious

  • cholestatic hepatitis (clavulanate-associated; occurs more commonly in older adults and male patients)
  • anaphylaxis
  • C. difficile colitis

Pharmacokinetics (ADME)

Absorption Amoxicillin: ~80%; clavulanate: ~75%; take with food to improve tolerance and clavulanate absorption
Distribution Both components widely distributed; similar Vd to amoxicillin
Metabolism Both partially metabolized; clavulanate to inactive products
Excretion Renal
Half-life Amoxicillin: 1–1.5 hours; clavulanate: ~1 hour
Onset 1–2 hours
Peak 1–2.5 hours
Duration 8–12 hours
Protein Binding ~20%
Vd ~0.3 L/kg

Drug Interactions

Drug / Agent Mechanism Severity
warfarin may increase INR via gut flora alteration moderate
allopurinol increased rash risk moderate

Nursing Considerations

  1. Administer with food to reduce GI side effects (nausea, diarrhea) from clavulanate — the most common reason for intolerance
  2. Note that Augmentin 250 mg and Augmentin 500 mg tabs contain the same amount of clavulanate (125 mg) — do NOT double up on 250 mg tablets to make an 'equivalent' of 500 mg; use the appropriate tablet size
  3. Monitor for jaundice or RUQ pain, especially in elderly male patients — hepatotoxicity can occur up to 6 weeks after completing the course
  4. Augmentin ES (600 mg/5 mL) is for resistant otitis media in children; Augmentin XR (2000/125 mg) is for community-acquired pneumonia — verify formulation and dose by indication

Clinical Pearls

  • Clavulanate inhibits class A beta-lactamases but NOT AmpC (class C) or class B metallo-beta-lactamases — organisms like Pseudomonas and MRSA remain intrinsically resistant
  • The diarrhea associated with Augmentin is partly due to clavulanate's prokinetic effects on gut motility, not just antibiotic-associated dysbiosis; can be partially mitigated by dosing with food

Safety Profile

Pregnancy generally-safe
Lactation safe
Renal Adjustment Required
Hepatic Adjustment Required
TDM Not required