Label: POSACONAZOLE tablet, delayed release

  • NDC Code(s): 59651-596-60
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 14, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use POSACONAZOLE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for POSACONAZOLE DELAYED-RELEASE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.2 Prophylaxis of Invasive Aspergillus and Candida Infections - Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Non-substitutable - Noxafil® oral suspension is not substitutable with posaconazole delayed-release tablets due to the differences in the dosing of ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Posaconazole Delayed-Release Tablets - Posaconazole delayed-release tablets are available as yellow colored, matt finished, film-coated, oblong shaped tablets, debossed with "P" on one side and ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Posaconazole delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. 4.2 Use with ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Calcineurin-Inhibitor Toxicity - Concomitant administration of posaconazole with cyclosporine or tacrolimus increases the whole blood trough concentrations of these calcineurin-inhibitors ...
  • 6 ADVERSE REACTIONS
    The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [see Contraindications (4.1)] Arrhythmias and QT ...
  • 7 DRUG INTERACTIONS
    Posaconazole is primarily metabolized via UDP glucuronosyltransferase and is a substrate of p-glycoprotein (P-gp) efflux. Therefore, inhibitors or inducers of these clearance pathways may affect ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal data, posaconazole may cause fetal harm when administered to pregnant women. Available data for use of posaconazole in pregnant ...
  • 10 OVERDOSAGE
    There is no experience with overdosage of posaconazole delayed-release tablets. During the clinical trials, some patients received Noxafil® oral suspension up to 1600 mg/day with no adverse ...
  • 11 DESCRIPTION
    Posaconazole is an azole antifungal agent available as delayed-release tablet for oral administration. Posaconazole is designated chemically as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4)]. 12.2 Pharmacodynamics - Exposure Response Relationship Prophylaxis: In clinical studies ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - No drug-related neoplasms were recorded in rats or mice treated with posaconazole for 2 years at doses higher than ...
  • 14 CLINICAL STUDIES
    14.2 Prophylaxis of Aspergillus and Candida Infections with Noxafil® Oral Suspension - Two randomized, controlled studies were conducted using posaconazole as prophylaxis for the prevention of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - Posaconazole Delayed-Release Tablets - Posaconazole Delayed-Release Tablets 100 mg are available as yellow colored, matt finished, film-coated, oblong shaped tablets ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions - Posaconazole Delayed-Release Tablets - Advise patients that ...
  • PATIENT PACKAGE INSERT
    Patient Information - Posaconazole (poe″ sa kon′ a zole) Delayed-Release Tablets  - What are posaconazole delayed-release tablets? Posaconazole delayed-release tablets are ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (60 Tablets Bottle)
    NDC 59651-596-60 - Posaconazole - Delayed-Release Tablets - 100 mg - Attention: Noxafil® oral suspension and - posaconazole delayed-release tablets are - NOT interchangeable due to differences ...
  • INGREDIENTS AND APPEARANCE
    Product Information