POSACONAZOLE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POSACONAZOLE (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)

Available from:

SpecGx LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole delayed-release tablets are contraindicated w

Product summary:

Posaconazole delayed-release tablets are yellow, modified, oval, convex tablets debossed with a logo "M" inside a square on one side and "100" on the opposite side containing 100 mg of posaconazole. Bottles of 60 . . . . . . . . . . . . . . NDC 0406-7711-60 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]. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
SPECGX LLC
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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 TABLETS.
POSACONAZOLE DELAYED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Indications and Usage (1)
06/2021
Dosage and Administration (2)06/2021
Contraindications (4)
01/2022
Warnings and Precautions (5)
01/2022
INDICATIONS AND USAGE
Posaconazole delayed-release tablets are an azole antifungal indicated
as follows:
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 graft-versus-
host disease (GVHD) or those with hematologic malignancies with
prolonged neutropenia from
chemotherapy as follows: (1.2)
POSACONAZOLE DELAYED-RELEASE TABLETS: adults and pediatric patients 13
years of age and older
DOSAGE AND ADMINISTRATION
POSACONAZOLE DELAYED-RELEASE TABLETS are not substitutable with
NOXAFIL® ORAL SUSPENSION or
NOXAFIL® POWDERMIX FOR DELAYED-RELEASE ORAL SUSPENSION due to the
differences in the dosing
of each formulation. Therefore, follow the specific dosage
recommendations for each of the
formulations. (2.1, 2.2, 2.3)
Administer POSACONAZOLE DELAYED-RELEASE TABLETS with or without food.
(2.1) TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTS 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.
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 immunosuppre