Label: CEFDINIR powder, for suspension

  • NDC Code(s): 67877-547-88, 67877-547-98, 67877-548-88, 67877-548-98
  • Packager: Ascend Laboratories, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 29, 2022

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  • SPL UNCLASSIFIED SECTION
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are ...
  • DESCRIPTION
    Cefdinir for Oral Suspension USP contains the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α, 7 ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics and Drug Metabolism  - Absorption  - Oral Bioavailability  - Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration ...
  • INDICATIONS & USAGE
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir and other antibacterial drugs, cefdinir should be used only to treat or prevent infections that are ...
  • CONTRAINDICATIONS
    Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.
  • WARNINGS
    BEFORE THERAPY WITH CEFDINIR IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFDINIR, OTHER CEPHALOSPORINS ...
  • PRECAUTIONS
    GENERAL - Prescribing cefdinir in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the ...
  • ADVERSE EVENTS
    Clinical Trials-Cefdinir for Oral Suspension (Pediatric Patients) In clinical trials, 2289 pediatric patients (1783 U.S. and 506 non-U.S.) were treated with the recommended dose of cefdinir ...
  • OVERDOSAGE
    Information on cefdinir overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600- mg/kg dose produced no adverse effects. Toxic signs and symptoms following ...
  • DOSAGE & ADMINISTRATION
    (see INDICATIONS AND USAGEfor Indicated Pathogens) Powder for Oral Suspension - The recommended dosage and duration of treatment for infections in pediatric patients are described in the ...
  • HOW SUPPLIED
    Cefdinir for Oral Suspension USP is a off white to yellow free flowing powder filled in HDPE bottle that, when reconstituted as directed, contains 125 mg cefdinir/5 mL or 250 mg cefdinir/5 ...
  • CLINICAL STUDIES
    Community-Acquired Bacterial Pneumonia - In a controlled, double-blind study in adults and adolescents conducted in the US, cefdinir BID was compared with cefaclor 500 mg TID. Using strict ...
  • REFERENCES
    Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41.  Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    60 mL bottle (Container); NDC 67877-547-98  -  Cefdinir for Oral Suspension USP 125 mg/5 mL - Rx Only  - 60 mL bottle -    60 mL bottle (Container); NDC 67877-548-98  - Cefdinir for Oral Suspension USP 250 ...
  • INGREDIENTS AND APPEARANCE
    Product Information