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U.S. Department of Health and Human Services

Safety

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Augmentin XR (amoxicillin/clavulanate potassium) extended release tablet

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010

Summary View

PRECAUTIONS

Drug Interactions
  • Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Pediatric Use
  • A pharmacokinetic study in pediatric patients (7 to 15 years of age and weighing ≥ 40 kg) was conducted.