Amoxicillin / clavulanate XR

Class
Antibiotics
Subclass
Penicillin / β-lactamase inhibitor combination
Substance name
Amoxicillin / clavulanate, co-amoxiclav, amox-clav XR
Brand names
Augmentin XR®
Contains
Amoxicillin
Clavulanate
Common formulations
Film-coated tablet
See also
Amoxicillin / clavulanate (Augmentin®)
Dosage and administration
Adults patients
Acute bacterial rhinosinusitis
2,000/125 mg PO BID for 5-7 days
Community-acquired pneumonia
2,000/125 mg PO BID for 7-10 days
Acute diverticulitisUncomplicated, outpatient, symptoms persisting or worsening after 48-72 hoursOff-label
875/125 mg PO BID for 7-10 days
Indications for use
Labeled indications
Adults
Treatment of acute bacterial rhinosinusitis
Treatment of community-acquired pneumonia
Off-label indications
Adults
Treatment of acute diverticulitis (uncomplicated, outpatient, symptoms persisting or worsening after 48-72 hours)
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.
Exacerbation of phenylketonuria
Use caution in patients with phenylketonuria, as chewable tablets and powder for oral solution contain phenylalanine.
Hepatotoxicity
Use caution in patients with hepatic impairment.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
No guidance available.
eGFR < 30 mL/min/1.73 m²
Do not use.
Renal replacement therapy
Any modality
Do not use.
Hepatic impairment
Any severity
Use with caution. Monitor liver function tests.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
Generally acceptable for use. 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
Very common > 10%
Diarrhea
Common 1-10%
Nausea, vulvovaginal candidiasis
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, skin rash, vomiting, urticaria, abdominal discomfort, flatulence, ↑ platelet count, headache
Interactions
Drug(s)
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