POSACONAZOLE tablet, delayed release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Major Pharmaceuticals

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 (14.1)] 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 sirolimus increas

Product samenvatting:

Posaconazole delayed-release tablets are available as yellow-coated, capsule shaped tablets, debossed with "100P" on one side and plain on the other side. Available: Cartons of 20 tablets (10 tablets per blister pack x 2), NDC 0904-7149-10 Cartons of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7149-04 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].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
MAJOR PHARMACEUTICALS
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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
Warning and Precautions (5) 5/2021
INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows: (1)
•
DOSAGE AND ADMINISTRATION
•
•
TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTS AND PEDIATRIC PATIENTS
AGED 13 YEARS AND
OLDER
INDICATION
DOSE AND DURATION OF THERAPY
Prophylaxis of invasive _Aspergillus_ and _Candida_
infections
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
•
CONTRAINDICATIONS
•
•
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: (1.1)
•
POSACONAZOLE DELAYED-RELEASE TABLETS: adults and pediatric patients 13
years of age and
older
Posaconazole oral suspension is not substitutable with posaconazole
delayed-release tablets or
posaconazole 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, 2.8)
Administer P