Fixed-dose combination: aminopenicillin plus beta-lactamase inhibitor
ATC code: J01CR02 (Amoxicillin and clavulanic acid)
Amoxicillin binds penicillin-binding proteins in the bacterial wall and disrupts peptidoglycan synthesis. Clavulanic acid binds bacterial beta-lactamases and protects amoxicillin from hydrolysis, extending coverage to beta-lactamase-producing H. influenzae, M. catarrhalis, S. aureus (methicillin-sensitive), and B. fragilis. Does not cover MRSA, Pseudomonas, or enterococci other than E. faecalis.
First line
Acute bacterial sinusitis with suspected bacterial cause (symptoms >10 days without improvement, severe fever >39 °C, or worsening after initial improvement). Per 2012, SEORL 2023, 2013 (children) – first-line for suspected resistant strains. Adult dose: 875/125 mg every 12 h for 5-7 days; in severe cases 2000/125 mg every 12 h. Children: 45-90 mg/kg/day amoxicillin component in two divided doses.
First line
Acute otitis media in children when antibiotics are indicated (bilateral otitis in children <2 years, severe pain, fever >39 °C, otorrhea with perforation). Per 2013 and SEORL 2023 – first-line when resistant pneumococci or beta-lactamase-producing H. influenzae are suspected. Dose: 80-90 mg/kg/day amoxicillin component in two divided doses for 5-10 days (5 days in children ≥2 years; 10 days in children <2 years or with perforation).
First line
Mild-to-moderate community-acquired pneumonia in outpatients and inpatients outside the ICU. Per ATS/ 2019 and SEPAR 2024 – first-line regimen (often combined with azithromycin when atypical pathogens are suspected). Adult dose: 875/125 mg every 8 h for 5-7 days or 2000/125 mg every 12 h. Reassess at 48-72 h; if no response, reconsider diagnosis and escalate.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Acute viral upper respiratory infections – common cold, pharyngitis without confirmed streptococcus, bronchitis in patients without COPD. Per 2012, ATS/IDSA 2019, CDC "Be Antibiotics Aware" (2023), and SEMERGEN 2023, antibiotics do not work for viral URTI – they neither shorten duration nor prevent bacterial complications. Prescribing amoxicillin-clavulanate "just in case" raises the risk of antibiotic-associated diarrhea (including C. difficile), candidiasis, and resistance selection. If it was prescribed for a runny nose, common cold, or mild cough <7 days without other findings, consider getting a second opinion.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
Compatible. Use as indicated in any trimester. Extensive clinical data – no teratogenic effects reported.
Fully compatible. Hale L1. RID about 1%. Transient infant diarrhea or candidiasis possible – monitor and continue breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Amoxicillin + Clavulanic Acid is evaluated for the following indications with varying evidence strength: Acute bacterial rhinosinusitis (evidence tier A), Community-acquired pneumonia (evidence tier A), Acute otitis media in children (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Amoxicillin + Clavulanic Acid (≥ 1 in 100): Diarrhea (10-25%), Nausea, vomiting, Rash, Vaginal candidiasis, Transaminase elevation. See the Safety section for uncommon and serious reactions.
FDA category B. Compatible. Use as indicated in any trimester. Extensive clinical data – no teratogenic effects reported.
Fully compatible. Hale L1. RID about 1%. Transient infant diarrhea or candidiasis possible – monitor and continue breastfeeding.
Amoxicillin + Clavulanic Acid is contraindicated in: Hypersensitivity to penicillins or other beta-lactams; History of cholestatic jaundice or hepatitis after prior amoxicillin/clavulanate; History of severe cutaneous reactions (SJS, DRESS) to beta-lactams; Infectious mononucleosis (rash risk). Full list in the Safety section.