Label: AMOXICILLIN AND CLAVULANATE POTASSIUM suspension

  • NDC Code(s): 0143-9853-16, 0143-9853-24, 0143-9853-75
  • Packager: Hikma Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 24, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP, 600 mg/42.9 mg per 5 mL safely and effectively. See full prescribing ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with - Recurrent or persistent acute otitis media due to S ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL should ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: orange-flavored powder for oral suspension (each 5 mL of reconstituted suspension contains 600 mg ...
  • 4 CONTRAINDICATIONS
    4.1 Serious Hypersensitivity Reactions - Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is contraindicated in patients with a history of serious ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Serious Allergic Reactions, Including Anaphylaxis - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam ...
  • 6 ADVERSE REACTIONS
    The following are discussed in more detail in other sections of the labeling [see Warnings and Precautions (5)]: Anaphylactic reactions [see Warnings and Precautions (5.1)] Severe Cutaneous ...
  • 7 DRUG INTERACTIONS
    7.1 Probenecid - Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL may ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - There are no adequate and well-controlled studies of amoxicillin and clavulanate potassium in pregnant women. Because animal reproduction studies are not always predictive of ...
  • 10 OVERDOSAGE
    Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been ...
  • 11 DESCRIPTION
    Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is an oral antibacterial combination consisting of the semisynthetic antibacterial amoxicillin and the ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL is an antibacterial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - The ...
  • 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 (4:1 ...
  • 14 CLINICAL STUDIES
    Two clinical studies were conducted in pediatric patients with acute otitis media. A noncomparative, open-label study assessed the bacteriologic and clinical efficacy of amoxicillin and ...
  • 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
    How Supplied -  Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin ...
  • 17 PATIENT COUNSELING INFORMATION
    Administration Instructions - Inform patients to take amoxicillin and clavulanate potassium for oral suspension 600 mg/42.9 mg per 5 mL every 12 hours with a meal or snack to reduce the ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0143-9853-75 - Amoxicillin and Clavulanate Potassium - for Oral Suspension, USP - 600 mg/42.9 mg* per 5 mL - 75 mL (when reconstituted) Rx only
  • PRINCIPAL DISPLAY PANEL
    NDC 0143-9853-16 - Amoxicillin and Clavulanate Potassium - for Oral Suspension, USP - 600 mg/42.9 mg* per 5 mL - 125 mL (when reconstituted) Rx only
  • PRINCIPAL DISPLAY PANEL
    NDC 0143-9853-24 - Amoxicillin and Clavulanate Potassium - for Oral Suspension, USP - 600 mg/42.9 mg* per 5 mL - 200 mL (when reconstituted) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information