AUGMENTIN '125'

Mean amoxicillin and clavulanate potassium pharmacokinetic parameters in normal adults following administration of Amoxicillin and Clavulanate Potassium Tablets are shown in Table 6 and following administration of Amoxicillin and Clavulanate Potassium for Oral Suspension and Chewable Tablets are shown in Table 7.

Table 6Mean (±S.D.) Amoxicillin and Clavulanate Potassium Pharmacokinetic Parameters a,b with Amoxicillin and Clavulanate Potassium Tablets a Mean (± standard deviation) values of 14 ...

14.1 Lower Respiratory Tract and Complicated Urinary Tract Infections Data from 2 pivotal trials in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium every 12 hours to 500 mg/125 mg tablets of Amoxicillin and Clavulanate Potassium dosed every 8 hours (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the every 12 hours and every 8 hours dosing regimens. There was no significant difference in the percentage of adverse eve...

The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Hepatic Dysfunction [see Warnings and Precautions (5.3) ] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) an...

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin and Clavulanate Potassium or to other beta‑lactams (e.g., penicillins or cephalosporins). ( 4.1 ) History of cholestatic jaundice/hepatic dysfunction associated with Amoxicillin and Clavulanate Potassium. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium ...

Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium if a reaction occurs. ( 5.1 ) Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2 ) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ( 5.3 ) Clostridioides difficile -associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5....

7 DRUG INTERACTIONS Co‑administration with probenecid is not recommended. ( 7.1 ) Concomitant use of Amoxicillin and Clavulanate Potassium and oral anticoagulants may increase the prolongation of prothrombin time.( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin and Clavulanate Potassium may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Pro...