TACROLIMUS–TEVA PROLONGED RELEASE HARD CAPSULE 1MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Tacrolimus monohydrate eqv tacrolimus

Available from:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

ATC code:

L04AD02

Pharmaceutical form:

CAPSULE, EXTENDED RELEASE

Composition:

Tacrolimus monohydrate eqv tacrolimus 1.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Teva Pharmaceutical Works Private Limited Company

Authorization status:

ACTIVE

Authorization date:

2021-04-21

Summary of Product characteristics

DESCRIPTION
0.5 MG: Size 5 hard gelatin capsules filled with white to off-white
powder. Body: light
orange with “0.5mg” radial black imprinting. Cap: light yellow
with “TR” radial black
imprinting.
1 MG: Size 4 hard gelatin capsules filled with white to off-white
powder. Body: light
orange with “1mg” radial black imprinting. Cap: White with
“TR” radial black imprinting.
5 MG: Size 0 hard gelatin capsules filled with white to off-white
powder. Body: light
orange with “5mg” radial black imprinting. Cap: greyish red with
“TR” radial black imprinting.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Prophylaxis of transplant rejection in adult kidney or liver allograft
recipients and
treatment of kidney or liver allograft rejection resistant to
treatment with other
immunosuppressive medicinal products in adult patients.
POSOLOGY AND METHOD OF ADMINISTRATION
Tacrolimus prolonged release (PR) capsule is a once-a-day oral
formulation. Tacrolimus
PR capsule therapy requires careful monitoring by adequately qualified
and equipped
personnel. This medicinal product should only be prescribed, and
changes in
immunosuppressive therapy initiated, by physicians experienced in
immunosuppressive
therapy and the management of transplant patients.
Inadvertent, unintentional or unsupervised switching of immediate- or
prolonged-release
formulations of tacrolimus is unsafe. This can lead to graft rejection
or increased incidence
of side effects, including under- or over-immunosuppression, due to
clinically
relevant differences in systemic exposure to tacrolimus. Patients
should be maintained
on a single formulation of tacrolimus with the corresponding daily
dosing regimen;
alterations in formulation or regimen should only take place under the
close supervision
of a transplant specialist (see Special warnings and precautions for
use and Undesirable
effects). Following conversion to any alternative formulation,
therapeutic drug monitoring
must be performed and dose adjustments made to ensure that systemic
exposure to