Label: CEFADROXIL capsule

  • NDC Code(s): 0093-3196-01, 0093-3196-53
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2024

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  • SPL UNCLASSIFIED SECTION
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil capsules and other antibacterial drugs, cefadroxil capsules should be used only to treat or ...
  • DESCRIPTION
    Cefadroxil capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. Cefadroxil monohydrate is a white to yellowish-white crystalline powder. It is soluble in ...
  • CLINICAL PHARMACOLOGY
    Cefadroxil is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 mcg/mL, respectively ...
  • INDICATIONS AND USAGE
    Cefadroxil capsules are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused ...
  • CONTRAINDICATIONS
    Cefadroxil capsules are contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
  • WARNINGS
    BEFORE THERAPY WITH CEFADROXIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS ...
  • PRECAUTIONS
    General - Cefadroxil should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 m2). (See DOSAGE AND ADMINISTRATION. ...
  • ADVERSE REACTIONS
    Gastrointestinal - Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has ...
  • OVERDOSAGE
    A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general ...
  • DOSAGE AND ADMINISTRATION
    Cefadroxil capsules are acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints ...
  • HOW SUPPLIED
    Cefadroxil Capsules USP are available as: 500 mg: orange opaque cap and white opaque body imprinted with “93” and “3196” in bottles of 50 (NDC 0093-3196-53) and 100 (NDC 0093-3196-01). Store at ...
  • Package/Label Display Panel
    NDC 0093-3196-01 - Cefadroxil Capsules, USP - 500 mg - Rx only - 100 Capsules
  • INGREDIENTS AND APPEARANCE
    Product Information