TACROLIMUS capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant [see Clinical Studies (14.1)] , liver transplant [see Clinical Studies (14.2)], heart transplant [see Clinical Studies (14.3)] or lung transplant [see Clinical Studies (14.4)] in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (t

Produktsammanfattning:

Tacrolimus Capsules, USP 1 mg (containing 1 mg tacrolimus) Shape/color: capsule/white, Branding on capsule cap/body: “TCR” on cap and “1” on body NDC: 70518-2124-00 NDC: 70518-2124-01 NDC: 70518-2124-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 16.4 Handling and Disposal Tacrolimus can cause fetal harm. Tacrolimus capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in tacrolimus capsules. If such contact occurs, wash the skin thoroughly with soap and water; if ocular contact occurs, rinse eyes with water. In case a spill occurs, wipe the surface with a wet paper towel. Follow applicable special handling and disposal procedures 1. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TACROLIMUS- TACROLIMUS CAPSULE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TACROLIMUS CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TACROLIMUS CAPSULES.
TACROLIMUS CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH
TACROLIMUS OR
OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR DEATH. (
5.1, 5.2)
RECENT MAJOR CHANGES
Indications and Usage ( 1.1)
7/2021
Dosage and Administration ( 2.2, 2.3)
7/2021
Warnings and Precautions ( 5.11)
12/2020
INDICATIONS AND USAGE
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for
the prophylaxis of organ rejection in
adult patients receiving allogeneic liver, kidney, heart, or lung
transplants, in combination with other
immunosuppressants. ( 1.1)
DOSAGE AND ADMINISTRATION
ADULT
Patient
Population
Initial Oral Dosage
(formulation)
Whole Blood Trough Concentration
Range
Kidney Transplant
With
azathioprine
0.2 mg/kg/day capsules, divided in two doses, every
12 hours
Month 1 to 3: 7 to 20 ng/mL
Month 4 to 12: 5 to 15 ng/mL
With MMF/IL-2
receptor
antagonist
0.1 mg/kg/day capsules, divided in two doses, every
12 hours
Month 1 to 12: 4 to 11 ng/mL
Liver Transplant
With
corticosteroids
only
0.1 to 0.15 mg/kg/day capsules, divided in two doses,
every 12 hours
Month 1 to 12: 5 to 20 ng/mL
Heart Transplant
With
0.075 mg/kg/day capsules, divided in two doses,
Month 1 to 3: 10 to 20 ng/mL
With
azathioprine
or
MMF
0.075 mg/kg/day capsules, divided in two doses,
every 12 hours
Month 1 to 3: 10 to 20 ng/mL
Month ≥ 4: 5 to 15 ng/mL
Lung Transplant
With
azathioprine
or
MMF
0.075 mg/kg/day
capsules, divided in two doses,
every 12 hours
Month 1 to 3: 10 to 15 ng/mL Month
4 to 12: 8 to 12 ng/mL
PEDIATRIC
Patient
Population
Initial Oral Dosage
(formulation)
Whole Blood Trough
Concentratio