Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)
Belcher Pharmaceuticals,LLC
TACROLIMUS
TACROLIMUS ANHYDROUS 0.5 mg
ORAL
PRESCRIPTION DRUG
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
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.]
Abbreviated New Drug Application
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 Belgenin tamamını okuyun