Label: AMOXICILLIN AND CLAVULANATE POTASSIUM tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 30, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Amoxicillin and Clavulanate Potassium Tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Amoxicillin and Clavulanate Potassium Tablets, USP - 875 mg/125 mg Tablets: Each scored white capsule-shaped tablet, debossed with WW949 on the upper side and scored on the other side, contains ...
  • 4 CONTRAINDICATIONS
    4.1 Serious Hypersensitivity Reactions - Amoxicillin and Clavulanate Potassium Tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hypersensitivity Reactions - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 7 DRUG INTERACTIONS
    7.1 Probenecid - Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with Amoxicillin and Clavulanate Potassium ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects: Reproduction studies performed in pregnant rats and mice given Amoxicillin and Clavulanate Potassium Tablets (2:1 ratio formulation of ...
  • 10 OVERDOSAGE
    In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center ...
  • 11 DESCRIPTION
    Amoxicillin and Clavulanate Potassium Tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Amoxicillin and Clavulanate Potassium Tablets are an antibacterial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Mean amoxicillin and clavulanate potassium ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin and Clavulanate Potassium ...
  • 14 CLINICAL STUDIES
    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 ...
  • 15 REFERENCES
    1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7415 - NDC: 50090-7415-0 14 TABLET in a BOTTLE
  • 17 PATIENT COUNSELING INFORMATION
    Administration Instructions - Inform patients that Amoxicillin and Clavulanate Potassium Tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should ...
  • Amoxicillin and Clavulanate Potassium
    Label Image
  • INGREDIENTS AND APPEARANCE
    Product Information