POSACONAZOLE tablet, delayed release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

ATLANTIC BIOLOGICALS CORP.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. Posaconazole delayed-release tablets 100 mg are indicated in patients 13 years of age and older. 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 increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)] . Posaconazole is contraindicated with CYP3A4 substrates that prolong the QT interval. Concomitant administration of posacona

Resumen del producto:

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].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
ATLANTIC BIOLOGICALS CORP.
----------
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 delayed-release tablets is an azole antifungal agent
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 HSCT
recipients with GVHD or
those with hematologic malignancies with prolonged neutropenia from
chemotherapy. (1.1)
DOSAGE AND ADMINISTRATION
Posaconazole delayed-release tablets and oral suspension are not
interchangeable due to the differences
in the dosing of each formulation.
INDICATION
DOSE AND DURATION OF THERAPY
Prophylaxis of
invasive
_Aspergillus_
and _Candida_
Infections
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. (2.3)
† Posaconazole delayed-release tablets should be taken with food.
(2)
DOSAGE FORMS AND STRENGTHS
Posaconazole delayed-release tablet 100 mg (3)
CONTRAINDICATIONS
Do not administer to persons with known hypersensitivity to
posaconazole or other azole antifungal
agents. (4.1)
Do not coadminister posaconazole with the following drugs;
posaconazole increases concentrations of:
Sirolimus: can result in sirolimus toxicity (4.2, 7.1)
CYP3A4 substrates (pimozide, quinidine): can result in QTc interval
prolongation and cases of TdP
(4.3, 7.2)
HMG-CoA Reductase Inhibitors Primarily Metabolized Through CYP3A4: can
lead to rhabdomyolysis
(4.4, 7.3)
Ergot alkaloids: can result in ergotism (4.5, 7.4