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high dose amoxicillin/clavulanate
Amoxicillin inhibits bacterial cell wall synthesis by binding penicillin-binding proteins, while clavulanate inhibits beta-lactamase enzymes to prevent antibiotic degradation.
Amoxicillin inhibits bacterial cell wall synthesis by binding penicillin-binding proteins, while clavulanate inhibits beta-lactamase enzymes to prevent antibiotic degradation. Used for Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract, urinary tract, skin and soft tissue infections), Otitis media, Sinusitis.
At a glance
| Generic name | high dose amoxicillin/clavulanate |
|---|---|
| Sponsor | Albany Medical College |
| Drug class | Beta-lactam antibiotic with beta-lactamase inhibitor |
| Target | Penicillin-binding proteins (PBPs); beta-lactamase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Amoxicillin is a beta-lactam antibiotic that disrupts peptidoglycan cross-linking in bacterial cell walls, leading to cell lysis and death. Clavulanate is a beta-lactamase inhibitor that protects amoxicillin from enzymatic degradation by resistant bacteria, extending the spectrum of activity against beta-lactamase-producing organisms. High-dose formulations increase drug exposure to treat serious infections and overcome certain resistance mechanisms.
Approved indications
- Bacterial infections caused by beta-lactamase-producing organisms (respiratory tract, urinary tract, skin and soft tissue infections)
- Otitis media
- Sinusitis
- Community-acquired pneumonia
Common side effects
- Diarrhea
- Nausea
- Vomiting
- Rash
- Abdominal pain
- Allergic reaction
- Clostridium difficile-associated diarrhea
Key clinical trials
- Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
- A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis (PHASE3)
- Oral-only Antibiotics for Bone and Joint Infections in Children (PHASE4)
- Initial Oral Antibiotics for Bone and Joint Infections in Children
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection
- The Individualized M(X) Drug-resistant TB Treatment Strategy Study (PHASE4)
- Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis (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:
- high dose amoxicillin/clavulanate CI brief — competitive landscape report
- high dose amoxicillin/clavulanate updates RSS · CI watch RSS
- Albany Medical College portfolio CI