SINOTRX POSACONAZOLE DELAYED RELEASE TABLET 100MG

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Posaconazole

Boleh didapati daripada:

KINGTOP INTERNATIONAL TRADING PTE LTD

Kod ATC:

J02AC04

Borang farmaseutikal:

TABLET, DELAYED RELEASE

Komposisi:

Posaconazole 100 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

HAIMEN PHARMA INC

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2022-04-13

Ciri produk

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