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U.S. Department of Health and Human Services


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Augmentin (amoxicillin/clavulanate potassium) Tablets, Powder for Oral Suspension, Chewable Tablets, and Oral Suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

Augmentin (amoxicillin/clavulanate potassium) Tablets, 250 mg/125mg and 500 mg/125 mg
Augmentin (amoxicillin/clavulanate potassium) Powder for Oral Suspension
Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets
Augmentin (amoxicillin/clavulanate potassium) Tablets, 875mg/125 mg
Augmentin (amoxicillin/clavulanate potassium) Oral Suspension
Augmentin (amoxicillin/clavulanate potassium) Chewable Tablets


January 2013

Summary View


7.2 Oral Anticoagulants
  • Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be .....