Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
Posaconazole
KINGTOP INTERNATIONAL TRADING PTE LTD
J02AC04
TABLET, DELAYED RELEASE
Posaconazole 100 mg
ORAL
Prescription Only
HAIMEN PHARMA INC
ACTIVE
2022-04-13
FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 PROPHYLAXIS OF INVASIVE _ASPERGILLUS_ _ _ AND _CANDIDA_ _ _ INFECTIONS 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. 2 DOSAGE AND ADMINISTRATION 2.1 IMPORTANT ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE DELAYED-RELEASE TABLETS Posaconazole delayed-release tablets and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation _[see Dosage and Administration (2.3), (2.5)]._ • Swallow tablets whole. Do not divide, crush, or chew. • Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections when receiving posaconazole delayed-release tablets. 2.3 DOSAGE AND ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE DELAYED-RELEASE TABLETS DOSAGE: TABLE 1: DOSAGE FOR POSACONAZOLE DELAYED-RELEASE TABLETS 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. ADMINISTRATION INSTRUCTIONS FOR POSACONAZOLE DELAYED-RELEASE TABLETS: • Swallow tablets whole. Do not divide, crush, or chew. • Posaconazole delayed-release tablets can be taken without regard to food _[see Clinical Pharmacology _ _(12)]_ . _ _ • Posaconazole delayed-release tablets should be used only for the prophylaxis indication. • Posaconazol Прочетете целия документ