POSACONAZOLE tablet, delayed release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Westminster Pharmaceuticals, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Posaconazole delayed-release tablets are indicated for 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 posaconaz

Podsumowanie produktu:

Posaconazole delayed-release tablets are available as yellow, coated, oblong, debossed with "100" on one side containing 100 mg of posaconazole. Bottles with child-resistant closures of 60 (NDC 69367-248-06) 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].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
WESTMINSTER PHARMACEUTICALS, 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
INDICATIONS AND USAGE
Posaconazole is an azole antifungal agent indicated as follows:
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 as follows: (1.2)
Posaconazole delayed-release tablets: adults and pediatric patients 13
years of age and older.
DOSAGE AND ADMINISTRATION
NOXAFIL ORAL SUSPENSION is not substitutable with POSACONAZOLE
DELAYED-RELEASE TABLETS or
NOXAFIL POWDERMIX FOR DELAYED-RELEASE ORAL SUSPENSION due to the differences
in the dosing
of each formulation. (2.1, 2.2, 2.3)
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.
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)
DOSAGE FORMS AND STRENGTHS
Posaconazole delayed-release tablet 100 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to posaconazole or other azole antifungal
agents. (4.1)
Coadministration of posac