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Augmentin 250 (CLAVULANIC ACID)
Augmentin 250 (Clavulanate) is a beta-lactamase inhibitor developed by Dr. Reddy's Labs Inc. It is a small molecule modality that works by inhibiting bacterial beta-lactamase enzymes, thereby enhancing the effectiveness of penicillin-class antibiotics. Augmentin 250 is approved to treat various bacterial infections, including sinusitis, pneumonia, and urinary tract infections. It has been FDA-approved since 1984 and is currently owned by Dr. Reddy's Labs Inc. Key safety considerations include its short half-life of 0.9 hours and moderate bioavailability of 75%.
At a glance
| Generic name | CLAVULANIC ACID |
|---|---|
| Sponsor | Dr Reddys Labs Inc |
| Drug class | beta Lactamase Inhibitor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1984 |
Approved indications
- Acute bacterial sinusitis
- Bacterial infection due to Klebsiella pneumoniae
- Bacterial pneumonia
- Bacterial septicemia
- Bacterial urinary infection
- Bacteroides Endometritis
- Bacteroides Peritonitis
- Citrobacter Urinary Tract Infection
- E. Coli Endometritis
- E. Coli Peritonitis
- Enterobacter Endometritis
- Escherichia coli urinary tract infection
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Parainfluenzae Pneumonia
- Haemophilus influenzae pneumonia
- Infection due to Escherichia coli
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
- Infective otitis media
- Klebsiella Endometritis
Common side effects
Key clinical trials
- APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) (PHASE2)
- Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics (PHASE4)
- 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)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |