POSACONAZOLE- posaconazole delayed-release tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chartwell RX, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 62135-429-60). 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POSACONAZOLE- POSACONAZOLE DELAYED-RELEASE TABLET
CHARTWELL RX, 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)
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
graftversushost 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
( 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)
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)
DOSAGE FORMS AND STRENGTHS
Posaconazole delayed-re