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Amoxicillin + Clavulanic Acid

Penicillin · Antibiotic

Also known as Augmentin, Moxikind-CV, Amoxyclav, Clavam, Novamox CV

PenicillinAntibioticATC J01CR02
CDSCO approvedSchedule HATC J01CR02
Pharmacokineticsplasma · t hours
1hONSET1.8hPEAK1h8hDURATION
ONSET
1h · Rapid, typically within 1 hour.
PEAK
1.8h · Approximately 1 to 2.5 hours after oral administration.
1h · Amoxicillin: Approximately 1 hour. Clavulanic acid: Approximately 1 hour.
DURATION
8h · Approximately 8 hours.
EXCRETION
not curated
INTERACTIONS
none in our sources
PREGNANCY
B
FDA category + note

Mechanism

Amoxicillin is a broad-spectrum beta-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds to and inactivates a wide range of bacterial beta-lactamase enzymes, thereby protecting amoxicillin from hydrolysis and extending its antibacterial spectrum against many resistant strains. Combination rationale: Amoxicillin is a potent broad-spectrum penicillin, but its effectiveness can be compromised by bacterial resistance mediated by beta-lactamase enzymes. Clavulanic acid acts as a beta-lactamase inhibitor, safeguarding amoxicillin from enzymatic degradation. This combination synergistically expands the antibacterial spectrum of amoxicillin to include many beta-lactamase producing strains, enhancing its clinical utility against a wider range of bacterial infections.

Indications

Acute bacterial sinusitisAcute otitis mediaAcute exacerbations of chronic bronchitisCommunity-acquired pneumoniaCystitisPyelonephritisSkin and soft tissue infections (e.g., cellulitis, animal bites, severe dental abscess with spreading cellulitis)Bone and joint infections (e.g., osteomyelitis)

Dosing

Adult
Standard oral dose: 250mg amoxicillin/125mg clavulanic acid (375mg total) three times daily, or 500mg amoxicillin/125mg clavulanic acid (625mg total) two or three times daily, or 875mg amoxicillin/125mg clavulanic acid (1000mg total) twice daily, depending on severity and site of infection. Available as tablets, dispersible tablets, and suspension.
Pediatric
Dosing is based on the amoxicillin component, typically 20-45 mg/kg/day in divided doses (e.g., every 8-12 hours). For severe infections, up to 90 mg/kg/day of amoxicillin may be used. Clavulanic acid component remains at 10 mg/kg/day. Available as oral suspension (e.g., 125mg/31.25mg per 5ml, 200mg/28.5mg per 5ml, 400mg/57mg per 5ml).
Renal adjustment
Creatinine Clearance (CrCl) >30 mL/min: No adjustment. CrCl 10-30 mL/min: 250mg/125mg or 500mg/125mg every 12 hours. CrCl <10 mL/min: 250mg/125mg or 500mg/125mg every 24 hours. Hemodialysis: 250mg/125mg or 500mg/125mg every 24 hours, with an additional dose during and at the end of dialysis.
Hepatic adjustment
Use with caution; regular monitoring of hepatic function is recommended. If hepatic impairment is severe, dose reduction or discontinuation may be necessary. Contraindicated in patients with a history of amoxicillin/clavulanic acid-associated jaundice/hepatic dysfunction.
Geriatric
No specific dose adjustment is required unless there is evidence of impaired renal function. Monitor renal function in elderly patients.
Max dose
Maximum daily dose is typically 6g amoxicillin and 600mg clavulanic acid for IV administration, and for oral administration, it varies depending on formulation, but generally not exceeding 3000mg amoxicillin and 375mg clavulanic acid per day (e.g., three 875mg/125mg tablets).

Pharmacokinetics

Onset
Rapid, typically within 1 hour.
Peak effect
Approximately 1 to 2.5 hours after oral administration.
Duration
Approximately 8 hours.
Half-life
Amoxicillin: Approximately 1 hour. Clavulanic acid: Approximately 1 hour.
Bioavailability
Amoxicillin: 70-90% orally. Clavulanic acid: 60-70% orally.
Protein binding
Amoxicillin: 17-20%. Clavulanic acid: 22-30%.
Metabolism
Amoxicillin is minimally metabolized, with about 10-25% converted to inactive penicilloic acid. Clavulanic acid is extensively metabolized (50-70%) in the liver to inactive metabolites before renal and fecal excretion.
Excretion
Mainly renal. Amoxicillin is excreted predominantly unchanged in urine (60-80%). Clavulanic acid is also largely excreted unchanged in urine (30-50%), with some metabolism prior to excretion.

Contraindications

  • Hypersensitivity to amoxicillin, clavulanic acid, or any other penicillin
  • History of severe immediate hypersensitivity reaction (e.g., anaphylaxis) to any other beta-lactam agent (e.g., cephalosporin, carbapenem)
  • History of jaundice/hepatic dysfunction associated with amoxicillin/clavulanic acid
  • Patients with infectious mononucleosis (due to risk of maculopapular rash)

Side effects

Common
DiarrheaNauseaVomitingSkin rash (maculopapular)Vaginal candidiasisDizzinessHeadacheAbdominal discomfort
Serious
  • Anaphylaxis and severe allergic reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Cholestatic jaundice/hepatitis (can be severe and prolonged)
  • Clostridium difficile-associated diarrhea (CDAD)
  • Angioedema
  • Interstitial nephritis
  • Seizures (especially in patients with impaired renal function or high doses)
  • Thrombocytopenia, leukopenia, hemolytic anemia

Pregnancy & lactation

Pregnancy

B

Lactation

Both amoxicillin and clavulanic acid are excreted in small amounts in human milk. Generally considered safe, but monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis, or allergic sensitization.

Related guidelines

Other Penicillin drugs

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