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Amoxicillin and Clavulanic Acid
Amoxicillin inhibits bacterial cell wall synthesis while clavulanic acid protects amoxicillin from degradation by bacterial beta-lactamases.
Amoxicillin inhibits bacterial cell wall synthesis while clavulanic acid protects amoxicillin from degradation by bacterial beta-lactamases. Used for Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media), Sinusitis, Pneumonia.
At a glance
| Generic name | Amoxicillin and Clavulanic Acid |
|---|---|
| Also known as | AMOXICILLINE / acide clavulonique SANDOZ, Antibiotics vs no antibiotics, Augmentine 500-125 mg 24 pills |
| Sponsor | Maggiore Bellaria Hospital, Bologna |
| Drug class | Beta-lactam antibiotic with beta-lactamase inhibitor |
| Target | Penicillin-binding proteins (PBPs); bacterial beta-lactamases |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Amoxicillin is a beta-lactam antibiotic that binds to penicillin-binding proteins and disrupts peptidoglycan cross-linking in bacterial cell walls, leading to cell lysis. Clavulanic acid is a beta-lactamase inhibitor that irreversibly binds to and inactivates bacterial beta-lactamases, preventing enzymatic degradation of amoxicillin and restoring its efficacy against beta-lactamase-producing organisms.
Approved indications
- Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract infections, urinary tract infections, skin and soft tissue infections, otitis media)
- Sinusitis
- Pneumonia
- Acute bacterial exacerbation of chronic bronchitis
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Rash
- Abdominal pain
- Allergic reactions
Key clinical trials
- Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients. (PHASE3)
- Amoxicillin/Clavulanic Acid Susceptibility in Acute Community-acquired Pneumonia Requiring Intensive Care Management
- Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children (PHASE2)
- Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis (PHASE4)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- A Platform Trial for Gram Negative Bloodstream Infections (NA)
- Collaborative Urological Prosthetics Investigation Directive Research Group (EARLY_PHASE1)
- 'Propolis Versus Chlorhexidine Gluconate on Wound Healing After Third Molar Surgery: a Randomized Controlled Trial' (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Amoxicillin and Clavulanic Acid CI brief — competitive landscape report
- Amoxicillin and Clavulanic Acid updates RSS · CI watch RSS
- Maggiore Bellaria Hospital, Bologna portfolio CI