Overview
Clavulanic acid is a beta-lactamase inhibitor that is frequently combined with Amoxicillin or Ticarcillin to fight antibiotic resistance by preventing their degradation by beta-lactamase enzymes, broadening their spectrum of susceptible bacterial infections. Clavulanic acid is derived from the organism Streptomyces clavuligerus.When it is combined with amoxicillin, clavulanic acid is frequently known as Augmentin, Co-Amoxiclav, or Clavulin.
Indication
Clavulanic acid combined with other antibiotics is indicated to prevent the development of drug-resistant strains of bacteria and promotes their therapeutic antibacterial effects. The following conditions, when they produced beta-lactamases, have been treated with a combination of amoxicillin and clavulanic acid or ticarcillin and clavulanic acid: Acute otitis media caused by H. influenzae and M. catarrhalis Sinusitis due to H. influenzae and M. catarrhalis Lower respiratory tract infections due to Haemophilus influenzae, S.aureus, Klebsiella species, and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus, Escherichia coli, and Klebsiella species Urinary Tract Infections due to E. coli, Klebsiella species of bacteria, and Enterobacter species of bacteria, S.marcescens, or S.aureus Gynecologic infections due to a variety of bacteria, including P.melaninogenicus, Enterobacter species, E.Coli species, Klebsiella species, S. aureus, S.epidermidis Septicemia due to a variety of bacteria, including Klebsiella species, E.Coli species, S.aureus, or Pseudomonas species Bone and joint infections due to S.aureus Intraabdominal infections due to E.Coli, K.pnemoniae, or B.fragilis group A note on susceptibility It should be noted that it is only to be administered in infections that are confirmed or highly likely to be caused by susceptible bacteria. Culture and susceptibility tests should be performed if possible and used in selecting whether this antibiotic is prescribed. When beta-lactamase enzyme production is not detected during microbiological testing, clavulanic acid should not be used. When these tests are not available patterns of local infection and susceptibility may be used to determine the appropriateness of using clavulanic acid. Ticarcillin with clavulanate has shown particular efficacy in mixed infections in addition to empiric therapy before determining the susceptibility of causative organisms. The ticarcillin-clavulanic acid combination may prove to be an effective single-agent antibiotic therapy to treat infections where a regimen of several drugs may normally be used.
Associated Conditions
- Infection Due to Escherichia Coli
- Skin and skin structure infections
- Acute Uncomplicated Pyelonephritis
- Bronchitis
- Haemophilus Influenzae
- Lower Respiratory Infection
- Otitis Media (OM)
- Moraxella catarrhalis
- Upper Respiratory Tract Infection
- Acute Cystitis
- Cysto-Urethritis
- Bone and Joint Infections
- Sinusitis
- Intraabdominal Infections
- Tonsillitis
- Proteus mirabilis
- Lower Respiratory Tract Infection (LRTI)
- Neisseria Gonorrhoeae Infection
- Susceptible Bacterial Infections
- Pharyngitis
- Bacterial infection due to streptococcus, group A
- Urinary Tract Infection
- Septicemia
- Bacterial Infections
- Bacterial Pneumonia
- Streptococcus Pneumoniae
- Gynecological Infection
Research Report
A Comprehensive Pharmacological Review of Clavulanic Acid
1. Introduction to Clavulanic Acid
- 1.1. Overview and Clinical Significance Clavulanic acid is a potent β-lactamase inhibitor that has fundamentally altered the approach to treating bacterial infections, particularly those caused by β-lactamase-producing resistant organisms.1 While possessing only weak intrinsic antibacterial activity itself, its primary clinical utility lies in its ability to protect co-administered β-lactam antibiotics from enzymatic degradation, thereby restoring or expanding their spectrum of efficacy.3 This mechanism has made clavulanic acid a cornerstone in combating a significant form of antibiotic resistance. It is most frequently combined with amoxicillin (forming co-amoxiclav) or ticarcillin, rendering these antibiotics effective against a wider array of bacterial pathogens.2 The profound impact of this agent is underscored by the inclusion of the amoxicillin-clavulanic acid combination on the World Health Organization's Model List of Essential Medicines.1 The discovery and introduction of clavulanic acid marked a strategic evolution in antimicrobial therapy. Historically, the emergence of bacterial resistance, often mediated by β-lactamase enzymes that hydrolyze the critical β-lactam ring of penicillins and cephalosporins, necessitated a continuous search for entirely new antibiotic compounds. Clavulanic acid, however, represented a shift towards developing "enhancer" molecules. Instead of directly killing bacteria, it disarms a key bacterial defense mechanism, effectively rejuvenating older, well-characterized antibiotics like amoxicillin. This inhibitor strategy has proven to be a more sustainable approach in certain respects, prolonging the clinical lifespan of valuable antimicrobial agents in the face of ongoing bacterial adaptation. Its development, patented in 1974, has been crucial in managing infections that would otherwise be untreatable with standard penic
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/05 | N/A | Not yet recruiting | |||
2023/06/29 | Phase 4 | Not yet recruiting | Biruni University | ||
2023/04/07 | Not Applicable | Completed | |||
2022/04/22 | Phase 2 | Withdrawn | |||
2021/10/29 | Early Phase 1 | Active, not recruiting | |||
2020/10/23 | Phase 4 | Completed | |||
2020/06/02 | Phase 1 | Completed | |||
2019/06/14 | Phase 1 | Completed | |||
2018/10/19 | Phase 2 | Recruiting | |||
2018/10/11 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 68788-7958 | ORAL | 125 mg in 1 1 | 2/8/2024 | |
| Pharmasource Meds, LLC | 82982-069 | ORAL | 125 mg in 1 1 | 5/26/2023 | |
| Northwind Pharmaceuticals. LLC | 51655-160 | ORAL | 125 mg in 1 1 | 7/31/2014 | |
| A-S Medication Solutions | 50090-1857 | ORAL | 42.9 mg in 5 mL | 2/4/2023 | |
| medsource pharmaceuticals | 45865-928 | ORAL | 42.9 mg in 5 mL | 12/29/2019 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-077 | ORAL | 125 mg in 1 1 | 7/17/2023 | |
| A-S Medication Solutions | 50090-3309 | ORAL | 57 mg in 5 mL | 12/27/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-7890 | ORAL | 125 mg in 1 1 | 3/28/2023 | |
| Dr. Reddy's Laboratories Inc | 43598-213 | ORAL | 28.5 mg in 5 mL | 9/12/2016 | |
| NuCare Pharmaceuticals,Inc. | 68071-2916 | ORAL | 57 mg in 5 mL | 1/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AUGMEX TABLET 375 mg | SIN11639P | TABLET, FILM COATED | 125 mg | 8/20/2001 | |
| CURAM FILM-COATED TABLET 625 mg | SIN10599P | TABLET, FILM COATED | 125 mg | 12/31/1998 | |
| SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL | SIN15043P | INJECTION, POWDER, FOR SOLUTION | 200 mg | 7/4/2016 | |
| AUGMEX TABLET 625 mg | SIN11780P | TABLET, FILM COATED | 125 mg | 1/18/2002 | |
| AMOCLA TABLETS 625 mg | SIN11219P | TABLET, FILM COATED | 125 mg | 11/9/1999 | |
| AUGMENTIN ES POWDER FOR ORAL SUSPENSION | SIN13201P | POWDER, FOR SUSPENSION | 42.9 mg/5 ml | 4/20/2006 | |
| Koact 625 Film-coated Tablet 500 mg/125 mg | SIN14317P | TABLET, FILM COATED | 125 mg | 2/22/2013 | |
| ENHANCIN TABLETS 625 mg | SIN11027P | TABLET, FILM COATED | 125.00 mg | 7/19/1999 | |
| AUGMENTIN TABLET 1 g | SIN08956P | TABLET, FILM COATED | 125 mg | 10/7/1996 | |
| KOACT 1000 FILM-COATED TABLETS 875MG/125MG | SIN16676P | TABLET, FILM COATED | 125mg | 1/11/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Augmentin Forte Syrup powder for oral liquid bottle | 11142 | Medicine | A | 8/14/1991 | |
| AUGMENTIN DUO amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium clavulanate) | 142692 | Medicine | A | 10/18/2007 | |
| AUGMENTIN DUO amoxicillin 500mg (as trihydrate) & clavulanic acid 125mg (as potassium clavulanate) | 406956 | Medicine | A | 5/15/2023 | |
| AUGMENTIN DUO 400 powder for oral liquid bottle | 67352 | Medicine | A | 2/12/1999 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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