TACROLIMUS capsule gelatin coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Bryant Ranch Prepack

INN (국제 이름):

TACROLIMUS

구성:

TACROLIMUS ANHYDROUS 1 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

TACROLIMUS- TACROLIMUS CAPSULE, GELATIN COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TACROLIMUS CAPSULES USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TACROLIMUS CAPSULES
USP.
TACROLIMUS CAPSULES USP
INITIAL U.S. APPROVAL 1994
RX ONLY
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOX WARNING_
INCREASED RISK OF DEVELOPMENT OF LYMPHOMA AND OTHER MALIGNANCIES,
PARTICULARLY OF THE SKIN, DUE TO
IMMUNOSUPPRESSION (5.2)
INCREASED SUSCEPTIBILITY TO BACTERIAL, VIRAL, FUNGAL, AND PROTOZOAL
INFECTIONS, INCLUDING OPPORTUNISTIC
INFECTIONS (5.3, 5.4, 5.5)
ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND
MANAGEMENT OF ORGAN TRANSPLANT
PATIENTS SHOULD PRESCRIBE TACROLIMUS CAPSULES USP (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions, Use with CYP3A4 Inhibitors and Inducers
(5.13) 08/2013
Warnings and Precautions, QT Prolongation (5.14) 08/2013
Warnings and Precautions, Gastrointestinal Perforation (5.18) 08/2013
INDICATIONS AND USAGE
Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant
indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver
and kidney transplants (1.1, 1.2)
Use concomitantly with adrenal corticosteroids; in kidney transplant,
use in conjunction with azathioprine or
mycophenolate mofetil (MMF) (1.1, 1.2)
Limitations of Use (1.4):
Do not use simultaneously with cyclosporine.
Intravenous use reserved for patients who can not tolerate capsules
orally.
Use with sirolimus is not recommended in liver transplant; use with
sirolimus in kidney transplant has not been
e stablishe d.
DOSAGE AND ADMINISTRATION
Summary of Initial Oral Dosage Recommendation and Observed Whole Blood
Trough Concentrations (2.1, 2.2).
PATIENT POPULATION
RECOMMENDED INITIAL ORAL DOSAGE (TWO
DIVIDED DOSES EVERY 12 HOURS)
OBSERVED WHOLE BLOOD
TROUGH CONCENTRATIONS
Adult Kidney transplant
In combination with
azathioprine
0.2 mg/kg/d