Amoxicillin And Clavulanate Potassium Amoxicillin 500 Mg Clavulanate Potassium 125 Mg 8 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?
This medication 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 tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli,and Klebsiellaspecies .
What should I know before taking it?
Teratogenic Effects: Pregnancy Category B. Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in.
What important warnings are listed?
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) Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets. If this occurs, discontinue amoxicillin and clavulanate potassium and institute appropriate therapy. (5.3)Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. (5.4) Clostridioides difficile-associated diarrhea.
How is this medication usually taken?
250 mg/125 mg :White to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side, contains 250 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 500 mg/125 mg:White to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side, contains 500 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic acid as the potassium salt. 875 mg/125 mg:White to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side, contains 875 mg of amoxicillin USP as the trihydrate and 125 mg of clavulanic.
What side effects are listed?
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) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3)] Hepatic Dysfunction [see Warnings and Precautions (5.4)] Clostridioides difficileAssociated Diarrhea (CDAD) [see Warnings and Precautions (5.5)]
What interactions are listed?
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)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fabeca32-3f26-4b65-b8b6-5f0e23765ab0
⚠️ 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.