Label: POSACONAZOLE tablet, delayed release

  • NDC Code(s): 70748-258-07
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 10, 2025

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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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Non-substitutable - Noxafil® oral suspension is not substitutable with posaconazole delayed-release tablets or Noxafil® powdermix for ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Posaconazole delayed-release tablets are available as yellow-coated, capsule shaped tablets, debossed with "100P" on one side and plain on the other side, containing 100 mg of posaconazole.
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. 4.2 Use with Sirolimus - Posaconazole is ...
  • 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 women ...
  • 10 OVERDOSAGE
    There is no experience with overdosage of posaconazole delayed-release tablets. During the clinical trials, some patients received posaconazole oral suspension up to 1600 mg/day with no adverse ...
  • 11 DESCRIPTION
    Posaconazole is an azole antifungal agent. Posaconazole is available as delayed-release tablet intended for oral administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3R,5R)-5 ...
  • 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 ...
  • 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 the ...
  • 14 CLINICAL STUDIES
    14.2 Prophylaxis of Aspergillus and Candida Infections with NoxafilOral 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 are available as yellow-coated, capsule shaped tablets, debossed with "100P" on one side and plain on the other side. Bottles with ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions - Advise patients that posaconazole delayed-release tablets must be ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: AET Laboratories Private Limited - Telangana state, 502319, India - Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 - United States - December 2024 - The trademarks ...
  • PATIENT PACKAGE INSERT
    Patient Information - Posaconazole (poe sa kon a zole) delayed-release tablets - What is posaconazole delayed-release tablets? Posaconazole delayed-release tablets are ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Posaconazole Delayed-Release Tablets - 100 mg - NDC: 70748-258-07 - 60s Bottle Pack
  • INGREDIENTS AND APPEARANCE
    Product Information