Country: United States
Language: English
Source: NLM (National Library of Medicine)
POSACONAZOLE (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)
Lannett Company Inc.
ORAL
PRESCRIPTION DRUG
Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. [see Clinical Studies (14.2)] as follows: • Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole) delayed-release tablets. However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole is contraindicated with sirolimus. Concomitant administration of posaconazole with si
Posaconazole delayed-release tablets are available as yellow, coated, oblong tablets, debossed with “100” on one side containing 100 mg of posaconazole. Bottles with child-resistant closures of 60 delayed-release tablets (NDC 0527-2133-35). Bottles with screw cap closures of 1,000 delayed-release tablets (NDC 0527-2133-43). Cartons of 24 delayed-release tablets (12 units/blister, 2 blisters/carton) (NDC 0527-2133-30). Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE LANNETT COMPANY INC. ---------- 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 TABLETS. POSACONAZOLE DELAYED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2006 RECENT MAJOR CHANGES Indications and Usage (1) 6/2021 Dosage and Administration (2) 6/2021 Contraindications (4) 1/2022 Warnings and Precautions (5) 1/2022 INDICATIONS AND USAGE Posaconazole delayed-release tablets is an azole antifungal agent indicated as follows: (1) POSACONAZOLE DELAYED-RELEASE TABLETS are indicated for the prophylaxis of invasive _Aspergillus_ and _Candida_ infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graftversus- host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) o POSACONAZOLE DELAYED-RELEASE TABLETS: adults and pediatric patients 13 years of age and older (1) DOSAGE AND ADMINISTRATION POSACONAZOLE ORAL SUSPENSION is not substitutable with POSACONAZOLE DELAYED-RELEASE TABLETS due to the differences in the dosing of each formulation. (2.1) Administer POSACONAZOLE DELAYED-RELEASE TABLETS with or without food. (2.1) TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 13 YEARS AND OLDER INDICATION DOSAGE FORM, DOSE AND DURATION OF THERAPY Prophylaxis of invasive Aspergillus and Candida infections POSACONAZOLE DELAYED-RELEASE TABLETS: Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day. (2) (2) Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression. (2.2, 2.3) (2) (2) DOSAGE FORMS AND STRENGTHS Posaconazole delaye Read the complete document