Amoxicillin / clavulanate

Class
Antibiotics
Subclass
Penicillin / β-lactamase inhibitor combination
Substance name
Amoxicillin / clavulanate, co-amoxiclav, amox-clav
Brand names
Augmentin®
Contains
Amoxicillin
Clavulanate
Common formulations
Film-coated tablet, Oral suspension
See also
Amoxicillin / clavulanate XR (Augmentin XR®)
Dosage and administration
Adults patients
Treatment
Acute bacterial rhinosinusitis
•
500/125 mg PO TID for 5-7 days
Alternative
•
875/125 mg PO BID for 5-7 days
Acute otitis media • Mild-to-moderate
•
500/125 mg PO BID for 5-7 days
Alternative
•
250/125 mg PO TID for 5-7 days
Acute otitis media • Severe
•
875/125 mg PO BID for 10 days
Alternative
•
500/125 mg PO TID for 10 days
Lower respiratory tract infections • Mild-to-moderate
•
500/125 mg PO BID
Alternative
•
250/125 mg PO TID
Lower respiratory tract infections • Severe
•
875/125 mg PO BID
Alternative
•
500/125 mg PO TID
SSTIs
•
875/125 mg PO BID for 5-7 days
UTIs • Pyelonephritis or complicated UTI
•
875/125 mg PO BID for 10 days
Alternative
•
500/125 mg PO TID for 10 days
UTIs • Uncomplicated cystitis
•
500/125 mg PO BID for 3-7 days
Alternative
•
250/125 mg PO TID for 3-7 days
Acute diverticulitis • Off-label
•
Start at: 1,200 mg IV QID for at least 48 hours
•
Maintenance: 500/125 mg PO TID for a total of 10 days
Aspiration pneumonia • Community-acquired • Off-label
•
875/125 mg PO TID for 5 days
Balanitis • Caused by anaerobic bacteria • Off-label
•
250/125 mg PO TID for 7 days
COPD • Acute exacerbation • Off-label
•
875/125 mg PO BID for 5 days
Alternative
•
500/125 mg PO TID for 5 days
Diabetic foot infection • Off-label
•
875/125 mg PO BID for 1-2 weeks, up to 3-4 weeks in severe cases
Febrile neutropenia • Empiric therapy, low-risk patients • Off-label
•
500/125 mg PO TID
Administered in combination with ciprofloxacin or levofloxacin.
Alternative
•
875/125 mg PO BID
Administered in combination with ciprofloxacin or levofloxacin.
GAS pharyngitis • Off-label
•
Maintenance: 40 mg/kg PO daily, in 3 divided doses, for 10 days
•
Maximum: 2,000 mg per day
Melioidosis • Off-label
•
20/5 mg PO TID for 3-6 months or longer
Odontogenic infection • Off-label
•
875/125 mg PO BID for 5-7 days
Prevention
Melioidosis • Post-exposure prophylaxis • Off-label
Weight ≥ 60 kg
•
1,500/375 mg PO TID for 21 days
Weight < 60 kg
•
1,000/250 mg PO TID for 21 days
SSTIs in patients with animal bites • Cat or dog • Off-label
•
875/125 mg PO BID for 3-7 days
Secondary prevention
Secondary prevention of prosthetic joint infection • Caused by oxacillin-susceptible staphylococci • Off-label
•
500/125 mg PO TID
Pediatric patients
No dosages available
Indications for use
Labeled indications
Adults
•
Treatment of acute bacterial rhinosinusitis
•
Treatment of acute otitis media (mild-to-moderate)
•
Treatment of acute otitis media (severe)
•
Treatment of lower respiratory tract infections (mild-to-moderate)
•
Treatment of lower respiratory tract infections (severe)
•
Treatment of SSTIs
•
Treatment of UTIs (pyelonephritis or complicated UTI)
•
Treatment of UTIs (uncomplicated cystitis)
Children
•
Treatment of lower respiratory tract infections (in patients > 3 months)
Off-label indications
Adults
•
Treatment of acute diverticulitis
•
Treatment of aspiration pneumonia (community-acquired)
•
Treatment of balanitis (caused by anaerobic bacteria)
•
Treatment of COPD (acute exacerbation)
•
Treatment of diabetic foot infection
•
Treatment of febrile neutropenia (empiric therapy, low-risk patients)
•
Treatment of GAS pharyngitis
•
Treatment of melioidosis
•
Treatment of odontogenic infection
•
Prevention of melioidosis (post-exposure prophylaxis)
•
Prevention of SSTIs in patients with animal bites (cat or dog)
•
Secondary prevention of prosthetic joint infection (caused by oxacillin-susceptible staphylococci)
Safety risks
Contraindications
Hypersensitivity to amoxicillin/clavulanate or its components or to other β-lactams
History of cholestatic jaundice or hepatic dysfunction associated with amoxicillin/clavulanate
Mononucleosis
•
Do not use amoxicillin/clavulanate in patients with mononucleosis because of the risk of amoxicillin-induced rash.
Warnings and precautions
Antimicrobial resistance
•
Maintain a high level of suspicion, as the use of amoxicillin/clavulanate in the absence of a proven or strongly suspected bacterial infection increases the risk of developing drug-resistant bacteria.
C. difficile infection
•
Maintain a high level of suspicion, as nearly all antibiotics, including amoxicillin/clavulanate, are associated with an increased risk of C. difficile-associated diarrhea.
Enterocolitis
•
Use caution in all patients, especially in pediatric patients.
Exacerbation of phenylketonuria
•
Use caution in patients with phenylketonuria, as chewable tablets and powder for oral solution contain phenylalanine.
Hepatic dysfunction
•
Maintain a high level of suspicion, as amoxicillin/clavulanate has been associated with an increased risk of hepatic dysfunction, including hepatitis and cholestatic jaundice. Monitor liver function in patients with hepatic impairment.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 10-30 mL/min/1.73 m²
•
Maximal dose of 250-500/125 mg BID.
eGFR < 10 mL/min/1.73 m²
•
Maximal dose of 250-500/125 mg daily.
Renal replacement therapy
Continuous renal replacement
•
No guidance available.
Intermittent hemodialysis
•
Administer an additional dose both during and at the end of each session. Dose as in eGFR < 10 mL/min/1.73 m².
Peritoneal dialysis
•
Dose as in eGFR < 10 mL/min/1.73 m².
Hepatic impairment
Any severity
•
Use with caution. Monitor liver function tests.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if clearly needed. The 2020 ERS/TSANZ task force statement suggests that amoxicillin/clavulanate is compatible with pregnancy for the management of airway diseases. Do not use amoxicillin/clavulanate for preterm prelabor rupture of membranes due to the potential risk of necrotizing enterocolitis.
Breastfeeding
Use with caution during breastfeeding.
•
The 2020 ERS/TSANZ task force statement suggests that amoxicillin/clavulanate is compatible with breastfeeding for the management of airway diseases.
Unknown drug levels in breastfed infants.
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Common 1-10%
•
Diarrhea, nausea, skin rash, urticaria, vomiting, vaginitis
Uncommon < 1%
•
Abdominal discomfort, flatulence, headache, ↑ platelet count
Unknown frequency
•
Gastritis, glossitis, enterocolitis, mucocutaneous candidiasis, Clostridioides difficile infection, serum sickness-like reaction, erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, hypersensitivity vasculitis, hepatic dysfunction, hepatitis, cholestatic jaundice, interstitial nephritis, hemolytic anemia, dyspepsia, black hairy tongue, angioedema, pruritus, ↑ serum TBIL, ↑ serum transaminases, ↑ serum ALP, hematuria, crystalluria, anemia, ↓ platelet count, ↑ blood eosinophil count, purpura, ↓ WBC count, agranulocytosis, seizure, anxiety, confusion, dizziness, agitation, behavioral or personality changes, hyperactivity, insomnia, tooth discoloration
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource