Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
POSACONAZOLE (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)
ATLANTIC BIOLOGICALS CORP.
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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 Belgenin tamamını okuyun