Tacrolimus

1 mg

Product Details

Product Name:
Tacrolimus
Strength:
1 mg
Count:
100
NDC:
42291-753-01
Class:
Rx
Brand Name(s):
Astagraf XL, Envarsus XR, Prograf, Hecoria
Imprint Code:
1;mg;BP;666
Color(s):
WHITE (white opaque body and white opaque cap)
Shape:
CAPSULE
Score:
no score
Case Count:
Inactive Ingredients:
anhydrous lactose NF DT, hypromellose USP, croscarmellose sodium NF, and magnesium stearate NF. The 1 mg capsule shell contains gelatin and titanium dioxide.
Indications and Usage:

1.1 Prophylaxis of Organ Rejection in Kidney Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney transplants. It is recommended that tacrolimus be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus.

1.2 Prophylaxis of Organ Rejection in Liver Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that tacrolimus be used concomitantly with adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus.

1.3 Prophylaxis of Organ Rejection in Heart Transplant
Tacrolimus Capsules is indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (MMF) and adrenal corticosteroids. Therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules.

1.4 Limitations of Use
Tacrolimus Capsules should not be used simultaneously with cyclosporine.

Use with sirolimus is not recommended in liver and heart transplant. The safety and efficacy of tacrolimus with sirolimus has not been established in kidney transplant.

Intravenous use reserved for patients who cannot tolerate capsules orally.

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