Label: FLUCONAZOLE powder, for suspension

  • NDC Code(s): 16714-695-01, 16714-696-01
  • Packager: NorthStar Rx LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 22, 2024

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  • DESCRIPTION
    Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as a powder for oral suspension. Fluconazole is designated chemically as ...
  • CLINICAL PHARMACOLOGY
    Pharmacokinetics and Metabolism - The pharmacokinetic properties (PK) of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the ...
  • INDICATIONS AND USAGE
    Fluconazole for oral suspension is indicated for the treatment of: Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole ...
  • CLINICAL STUDIES
    Cryptococcal meningitis: In a multicenter study comparing fluconazole (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a ...
  • CONTRAINDICATIONS
    Fluconazole for oral suspension is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding ...
  • WARNINGS
    (1) Hepatic injury: Fluconazole should be administered with caution to patients with liver dysfunction. Fluconazole has been associated with rare cases of serious hepatic toxicity, including ...
  • PRECAUTIONS
    General - Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. Fluconazole causes QT prolongation via the inhibition of ...
  • ADVERSE REACTIONS
    Fluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results ...
  • OVERDOSAGE
    There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.  In the event of overdose, symptomatic treatment (with supportive measures and gastric ...
  • DOSAGE AND ADMINISTRATION
    Dosage and Administration in Adults: SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF FLUCONAZOLE IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ...
  • HOW SUPPLIED
    Fluconazole for Oral Suspension USP, 10 mg/mL is supplied as an orange flavored white to off-white powder to provide 35 mL per bottle as follows:                      35 mL Bottle ...
  • REFERENCES
    Maalox® is a registered trademark of Novartis Consumer Health, Inc. XELJANZ® is a registered trademark of Pfizer Inc. LYNPARZA®  is a registered trademark of AstraZeneca group of ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg/mL (35 mL Bottle)
    Rx only - NDC 16714-695-01 - Fluconazole for Oral - Suspension USP  - 10 mg/mL - when reconstituted - 35 mL when reconstituted - NORTHSTAR®
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg/mL Carton Label
    Rx only - NDC 16714-695-01 - Fluconazole for Oral - Suspension USP  - 10 mg/mL - when reconstituted - ORANGE FLAVORED - 35 mL - when reconstituted  - NORTHSTAR®
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg/mL (35 mL Bottle)
    Rx only - NDC 16714-696-01 - Fluconazole for Oral - Suspension USP  - 40 mg/mL - when reconstituted - 35 mL when reconstituted - NORTHSTAR®
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 40 mg/mL Carton Label
    Rx only - NDC 16714-696-01 - Fluconazole for Oral - Suspension USP  - 40 mg/mL - when reconstituted - ORANGE FLAVORED - 35 mL - when reconstituted - NORTHSTAR®
  • INGREDIENTS AND APPEARANCE
    Product Information