Amoxicillin And Clavulanate Potassium Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
Amoxicillin and Clavulanate Potassium is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Amoxicillin and Clavulanate Potassium Extended Release Tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia oracute bacterial sinusitis due to confirmed, or suspected beta-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. pneumoniae, or methicillin-susceptible S. aureus) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs equal to 2 mcg/mL). Limitations of Use Amoxicillin and Clavulanate Potassium Extended Release Tablets is not indicated for the treatment of infections due to S.
What should I know before taking it?
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AUGMENTIN or to other beta‑lactams (e.g., penicillins or cephalosporins). (4.1) History of cholestatic jaundice/hepatic dysfunction associated with AUGMENTIN. (4.2) In patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients. (4.3) 4.1 Serious Hypersensitivity Reactions Amoxicillin and Clavulanate Potassium Extended Release Tablets is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam.
What important warnings are listed?
5 WARNINGS AND PRECAUTIONS Serious (including fatal) hypersensitivity reactions: Discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Amoxicillin and Clavulanate Potassium Extended Release Tablets. If this occurs, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets and institute appropriate therapy. (5.3) Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of.
How is this medication usually taken?
Amoxicillin and Clavulanate Potassium Extended Release Tablets; 1,000 mg/62.5 mg: Each white, oval film-coated bilayer scored tablet, debossed with "AUGMENTIN XR", contains 1,000 mg of amoxicillin (as amoxicillin sodium and amoxicillin trihydrate) and 62.5 mg clavulanic acid as the potassium salt.
What side effects are listed?
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [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 [see Warnings and Precautions (5.6)]
What interactions are listed?
7 DRUG INTERACTIONS Co-administration with probenecid is not recommended. (7.1) Concomitant use Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Extended Release Tablets may reduce efficacy of oral contraceptives. (7.4) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxicillin and Clavulanate Potassium Extended Release Tablets may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=45c60b69-1b65-01ed-e063-6294a90a57be
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.