Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
POSACONAZOLE (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)
SpecGx LLC
ORAL
PRESCRIPTION DRUG
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 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 delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole delayed-release tablets are contraindicated w
Posaconazole delayed-release tablets are yellow, modified, oval, convex tablets debossed with a logo "M" inside a square on one side and "100" on the opposite side containing 100 mg of posaconazole. Bottles of 60 . . . . . . . . . . . . . . NDC 0406-7711-60 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]. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure.
Abbreviated New Drug Application
POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE SPECGX LLC ---------- 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) 06/2021 Dosage and Administration (2)06/2021 Contraindications (4) 01/2022 Warnings and Precautions (5) 01/2022 INDICATIONS AND USAGE Posaconazole delayed-release tablets are an azole antifungal indicated as follows: 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 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 POSACONAZOLE DELAYED-RELEASE TABLETS are not substitutable with NOXAFIL® ORAL SUSPENSION or NOXAFIL® 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) Administer POSACONAZOLE DELAYED-RELEASE TABLETS with or without food. (2.1) TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTS 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 immunosuppre Đọc toàn bộ tài liệu