AUGMENTIN ES-600

The pharmacokinetics of amoxicillin and clavulanate were determined in a study of 19 pediatric patients, 8 months to 11 years, given AUGMENTIN ES-600 at an amoxicillin dose of 45 mg/kg q12h with a snack or meal. The mean plasma amoxicillin and clavulanate pharmacokinetic parameter values are listed in the Table 3. Table 3. Mean (±SD) Plasma Amoxicillin and Clavulanate Pharmacokinetic Parameter Values Following Administration of 45 mg/kg of AUGMENTIN ES-600 Every 12 Hours to Pediatric Patients * ...

Two clinical studies were conducted in pediatric patients with acute otitis media. A non-comparative, open-label study assessed the bacteriologic and clinical efficacy of AUGMENTIN ES-600 (90/6.4 mg/kg/day, divided every 12 hours) for 10 days in 521 pediatric patients (3 to 50 months) with acute otitis media. The primary objective was to assess bacteriological response in children with acute otitis media due to S. pneumoniae with amoxicillin/clavulanic acid MICs of 4 mcg/mL. The study sought the enrollment of patients with the following risk factors: Failure of antibacterial therapy for acute ...

The following clinically significant adverse reactions are described elsewhere in labeling: Anaphylactic reactions [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions (SCAR) [see Warnings and Precautions (5.2)] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3)] Hepatic Dysfunction [see Warnings and Precautions (5.4)] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.5)] Skin Rash in Patients with Mononucleosis [...

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN ES-600 or any other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN ES-600. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions AUGMENTIN ES-600 is contraindicated in patients with a history of serious hyper...

Serious (including fatal) hypersensitivity reactions: Discontinue AUGMENTIN ES-600 if a reaction occurs and institute appropriate therapy. ( 5.1 ) Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of AUGMENTIN ES-600. If this occurs, discontinue AUGMENTIN ES-600 and institute appropriate therapy. ( 5.3 ) Hepatic dysfunction and cholestatic jaundice: ...

7 DRUG INTERACTIONS Co-administration with probenecid is not recommended. ( 7.1 ) Concomitant use of AUGMENTIN ES-600 with oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) AUGMENTIN ES-600 may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secr...