TACROLIMUS capsule, gelatin coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Kremers Urban Pharmaceuticals Inc.

INN (الاسم الدولي):

TACROLIMUS

تركيب:

TACROLIMUS ANHYDROUS 0.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Tacrolimus Capsules USP are 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 [see Clinical Studies (14.1)] . Therapeutic drug monitoring is recommended for all patients receiving Tacrolimus Capsules USP [see Dosage and Administration (2.6)] . Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver transplants. It is recommended that Tacrolimus be used concomitantly with adrenal corticosteroids [see Clinical Studies (14.2)] . Therapeutic drug monitoring is recommended for all patients receiving Tacrolimus Capsules USP [see Dosage and Administration (2.6)] . Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. It is recommended that Tacrolimus Capsules USP be used concomitantly with azathioprine

ملخص المنتج:

Tacrolimus Capsules USP, 0.5 mg: Light yellow color, oblong shape, size “5” hard gelatin capsules printed with “PBT” and “0.5” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 62175-380 -37               Bottle of 100 Tacrolimus Capsules USP, 1 mg: White color, oblong shape, size “5” hard gelatin capsules printed with “PBT” and “1.0” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 62175-381 -37               Bottle of 100 Tacrolimus Capsules USP, 5 mg: Pink color, oblong shape, size “4” hard gelatin capsules printed with “PBT” and “5.0” in red ink on cap and body respectively. Capsules are supplied as follows: NDC 62175-382 -37               Bottle of 100 Storage: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F)

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

TACROLIMUS- TACROLIMUS CAPSULE, GELATIN COATED
KREMERS URBAN PHARMACEUTICALS INC.
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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 BOXED 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)
INDICATIONS AND USAGE
Tacrolimus Capsules USP is a calcineurin-inhibitor immunosuppressant
indicated for
Prophylaxis of organ rejection in patients receiving allogeneic liver,
kidney or heart transplants (1.1, 1.2, 1.3)
Use concomitantly with adrenal corticosteroids; in kidney and heart
transplant, use in conjunction with azathioprine or
mycophenolate mofetil (MMF) (1.1, 1.2, 1.3)
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 and heart transplant;
use with sirolimus in kidney transplant has not
been established.
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
HO URS)
OBSERVED WHOLE BLOOD
TROUGH CONCENTRATIONS
Adult Kidney
transplant
In combination with
azathioprine
In combination with
MMF/IL-2 receptor
antagonist
0.2 mg/kg/day
0.1 mg/kg/day
month 1-3: 7-20 ng/mL
month 4-12: 5-15 ng/mL
month 1-12: 4-11 ng/mL
Adult Liver transplant
Pediatric Liver
trans