TACROLIMUS capsule TACROLIMUS- tacrolimus capsules capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Belcher Pharmaceuticals,LLC

INN (Kansainvälinen yleisnimi):

TACROLIMUS

Koostumus:

TACROLIMUS ANHYDROUS 0.5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 [see Clinical Studies ( 14.1)] . Therapeutic drug monitoring is recommended for all patients receiving tacrolimus [see Dosage and Administration ( 2.6)]. 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 [see Clinical Studies ( 14.2)] . Therapeutic drug monitoring is recommended for all patients receiving tacrolimus [see Dosage and Administration ( 2.6)]. Tacrolimus Capsules is indicated for t

Tuoteyhteenveto:

Tacrolimus Capsules USP, 0.5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, yellow opaque cap and yellow opaque body imprinted “ 665” twice on the body and imprinted “0.5 mg” twice on the cap with red ink. Bottles of 100. NDC 62250-665-02 Tacrolimus Capsules USP, 1 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, white opaque cap and white opaque body imprinted “ 666” twice on the body and imprinted “1 mg” twice on the cap with red ink. Bottles of 100. NDC 62250-666-02 Tacrolimus Capsules USP, 5 mg are white to off white powder filled in hard gelatin capsule of size ‘4’, salmon opaque cap and salmon opaque body imprinted “ 667” on the body and imprinted “5 mg” twice on the cap with white ink. Bottles of 100. NDC 62250-667-02 Note: Tacrolimus capsules are not filled to maximum capsule capacity. Capsule contains labeled amount. Store and Dispense Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).[See USP Controlled Room Temperature.]

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

TACROLIMUS- TACROLIMUS CAPSULE
BELCHER PHARMACEUTICALS,LLC
----------
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 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 ( 5.1)
INDICATIONS AND USAGE
Tacrolimus 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
TACROLIMUS INITIAL ORAL
DOSAGE (TWO DIVIDED
DOSES EVERY 12 HOURS)
OBSERVED WHOLE BLOOD TROUGH
CONCENTRATIONS
Adult Kidney transplant patients
In combination with azathioprine
0.2 mg/kg/day
month 1-3: 7-20 ng/mL
month 4-12: 5-15 ng/mL
In combination with MMF/IL-2 receptor
antagonist
0.1 mg/kg/day
month 1-12: 4-11 ng/mL
Adult Liver transplant
0.10-0.15 mg/kg/day
month 1-12: 5-20 ng/mL
Pediatric L