Kanada - englanti - Health Canada

apotex inc - tacrolimus - capsule (immediate release) - 0.5mg - tacrolimus 0.5mg - immunosuppressive agents

Kanada - englanti - Health Canada

apotex inc - tacrolimus - capsule (immediate release) - 1mg - tacrolimus 1mg - immunosuppressive agents

Kanada - englanti - Health Canada

apotex inc - tacrolimus - capsule (immediate release) - 5mg - tacrolimus 5mg - immunosuppressive agents

Yhdysvallat - englanti - NLM (National Library of Medicine)

cardinal health - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus 1 mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

kaiser foundation hospitals - tacrolimus (unii: wm0haq4wnm) (anhydrous tacrolimus - unii:y5l2157c4j) - tacrolimus 1 mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

watson laboratories, inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus anhydrous 5 mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

remedyrepack inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - 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 the prophylaxis of organ rejection in patients receiving allogeneic heart transplants. it is recommended that tacrolimus capsules be used concomitantly with azathioprine or mycophenolate mofetil (mmf) and adrenal corticosteroids [ see clinical studies ( 14.3)]. therapeutic drug monitoring is recommended for all patients receiving tacrolimus capsules [ see dosage and administration ( 2.6)]. tacrolimus capsules should not be used simultaneously with cyclosporine [ see dosage and administration ( 2.5)]. use with sirolimus is not recommended in liver and heart transplant. the safety and efficacy of tacrolimus with sirolimus has not been established in kidney transplant [ see warnings and precautions ( 5.12)]. intravenous use reserved for patients who cannot tolerate capsules orally. tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. tacrolimus injection is contraindicated in patients with a hypersensitivity to hco-60 (polyoxyl 60 hydrogenated castor oil). hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions (6)]. pregnancy category c - there are no adequate and well-controlled studies in pregnant women. tacrolimus is transferred across the placenta. the use of tacrolimus during pregnancy in humans has been associated with neonatal hyperkalemia and renal dysfunction. tacrolimus given orally to pregnant rabbits at 0.5 to 4.3 times the clinical dose and pregnant rats at 0.8 to 6.9 times the clinical dose was associated with an increased incidence of fetal death in utero, fetal malformations (cardiovascular, skeletal, omphalocele, and gallbladder agenesis) and maternal toxicity. tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. in pregnant rabbits, tacrolimus at oral doses of 0.32 and 1.0 mg/kg, 0.5 to 4.3 times the clinical dose range (0.075 – 0.2 mg/kg) based on body surface area, was associated with maternal toxicity as well as an increased incidence of abortions. at the 1 mg/kg dose, fetal rabbits showed an increased incidence of malformations (ventricular hypoplasia, interventricular septal defect, bulbous aortic arch, stenosis of ductus arteriosus, interrupted ossification of vertebral arch, vertebral and rib malformations, omphalocele, and gallbladder agenesis) and developmental variations. in pregnant rats, tacrolimus at oral doses of 3.2 mg/kg, 2.6 to 6.9 times the clinical dose range was associated with maternal toxicity, an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability. tacrolimus, given orally to pregnant rats after organogenesis and during lactation at 1.0 and 3.2 mg/kg, 0.8 to 6.9 times the recommended clinical dose range was associated with reduced pup weights and pup viability (3.2 mg/kg only); among the high dose pups that died early, an increased incidence of kidney hydronephrosis was observed. tacrolimus is excreted in human milk. as the effect of chronic exposure to tacrolimus in healthy infants is not established, patients maintained on tacrolimus should discontinue nursing taking into consideration importance of drug to the mother. the safety and efficacy of tacrolimus in pediatric kidney and heart transplant patients have not been established. successful liver transplants have been performed in pediatric patients (ages up to 16 years) using tacrolimus. two randomized active-controlled trials of tacrolimus in primary liver transplantation included 56 pediatric patients. thirty-one patients were randomized to tacrolimus-based and 25 to cyclosporine-based therapies. additionally, a minimum of 122 pediatric patients were studied in an uncontrolled trial of tacrolimus in living related donor liver transplantation. pediatric patients generally required higher doses of tacrolimus to maintain blood trough concentrations of tacrolimus similar to adult patients [ see dosage and administration ( 2.2)]. clinical trials of tacrolimus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. the pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy volunteers with normal renal function. however, consideration should be given to dosing tacrolimus at the lower end of the therapeutic dosing range in patients who have received a liver or heart transplant and have pre-existing renal impairment. further reductions in dose below the targeted range may be required [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)]. the mean clearance of tacrolimus was substantially lower in patients with severe hepatic impairment (mean child-pugh score: >10) compared to healthy volunteers with normal hepatic function. close monitoring of tacrolimus trough concentrations is warranted in patients with hepatic impairment [ see clinical pharmacology ( 12.3)]. the use of tacrolimus in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole-blood trough concentrations of tacrolimus. these patients should be monitored closely and dosage adjustments should be considered. some evidence suggests that lower doses should be used in these patients [ see dosage and administration ( 2.3) and clinical pharmacology ( 12.3)].

Yhdysvallat - englanti - NLM (National Library of Medicine)

remedyrepack inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

remedyrepack inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see clinical studies ( 14.1)] , liver transplants [see clinical studies ( 14.2)] and heart transplant [see clinical studies ( 14.3)] , in combination with other immunosuppressants. tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions ( 6) ] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that

Yhdysvallat - englanti - NLM (National Library of Medicine)

civica, inc. - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric 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 . tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions (6)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. healthcare