Clavulanic acid

Generic Name
Clavulanic acid
Brand Names
Clavulin, Augmentin
Drug Type
Small Molecule
Chemical Formula
C8H9NO5
CAS Number
58001-44-8
Unique Ingredient Identifier
23521W1S24
Background

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 amoxi...

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:
...

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
Associated Therapies
-
Clinical Trials
Related News
biospace.com
·

Iterum Wins FDA Approval For Oral UTI Antibiotic, Seeks 'Strategic Transaction' for Asset

FDA approves Iterum Therapeutics' Orlynvah, an oral antibiotic for treating uncomplicated urinary tract infections in adult women, targeting Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Orlynvah is the first oral penem approved in the U.S., offering a solution to antimicrobial resistance. Iterum plans to maximize value for stakeholders through strategic transactions.
ng.investing.com
·

FDA approves new oral antibiotic ORLYNVAH for uUTIs

Iterum Therapeutics plc announced FDA approval of ORLYNVAH™, the first oral penem antibiotic for treating uncomplicated uUTIs in adult women caused by E. coli, K. pneumoniae, or P. mirabilis. The approval is based on Phase 3 trials showing ORLYNVAH™'s safety and efficacy, with common adverse reactions including diarrhea, nausea, and headache. Iterum's CEO emphasized the importance of this approval for patients with limited treatment options and plans to seek strategic transactions. uUTIs are prevalent, affecting up to 60% of women, with 1% caused by pathogens resistant to all commonly available oral antibiotics.
pharmaceutical-technology.com
·

Iterum's oral sulopenem acceptance hinges on antibiotic stewardship efforts

Iterum Therapeutics' oral sulopenem faces FDA approval for uUTIs, with concerns over antibiotic resistance. The drug, a thiopenem antibiotic, previously faced rejection due to insufficient evidence. A Phase III trial showed efficacy in 61.7% of patients, leading to an NDA resubmission. The FDA's PDUFA date is October 25. The approval hinges on responsible use to prevent resistance.

Related Clinical Trials:

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
contemporaryobgyn.net
·

Advisory committee meeting for oral sulopenem occurring September 9, 2024

Advisory committee meeting on September 9, 2024, to discuss the NDA for oral sulopenem tablets, developed by Iterum Therapeutics to treat UTIs in women. The REASSURE trial demonstrated non-inferiority of sulopenem compared to Augmentin, with a similar safety profile and no new safety signals except those linked to β-lactams. The FDA accepted the resubmitted NDA with a PDUFA action date of October 25, 2024.

Related Clinical Trials:

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
drugs.com
·

Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem

Iterum Therapeutics resubmits NDA to FDA for oral sulopenem to treat uncomplicated urinary tract infections in adult women, with data from phase 3 clinical trials demonstrating its efficacy and safety.
© Copyright 2024. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy