Tacrolimus Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation Usually, initially, adults are given tacrolimus 0.10~0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted appropriately according to symptoms, with reference to the “recommended trough blood concentration.” Suppression of rejection in liver transplantation Usually, initially, adults are given tacrolimus 0.05~0.10mg/kg per dose orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted appropriately according to symptoms, with reference to the “recommended trough blood concentration.” Recommended trough blood concentrations for kidney and liver transplantation: Early after transplantation, trough blood concentrations were 5~20ng/mL in liver transplant recipients and 10~20ng/mL in kidney transplant recipients. During the subsequent maintenance period, trough blood concentrations were 5-15ng/mL in liver and kidney transplant recipients. Bone marrow transplantation: Usually, starting 1 day before transplantation, tacrolimus 0.06mg/kg per dose is administered orally twice daily. During the early post-transplant period, tacrolimus 0.06mg/kg per dose is administered orally twice daily, followed by gradual dose reduction. If treatment with this drug is initiated after the onset of graft-versus-host disease, tacrolimus 0.15mg/kg per dose is usually administered orally twice daily. The dose should also be adjusted appropriately according to symptoms. Blood concentrations should be measured frequently, particularly immediately after transplantation or immediately after starting treatment. Note that adverse reactions are more likely to recur when the trough blood concentration remains above 20ng/mL for a prolonged period. Chronic rheumatoid arthritis Usually, adults are given tacrolimus 3mg orally once daily after the evening meal. Elderly patients are usually given 1.5mg orally once daily after the evening meal; the dose may be increased to 3mg according to symptoms. Lupus nephritis Usually, adults are given tacrolimus 3mg orally once daily after the evening meal. In clinical trials, if the response was inadequate at 12 weeks after treatment initiation and the safety profile was considered acceptable, this drug was administered at 4 mg/day for 4 weeks to confirm safety and then increased to up to 5 mg/day. If adverse reactions occurred, the dose was appropriately reduced in increments of 0.5 mg or 1 mg, taking the patient's condition into account. When an adequate response in lupus nephritis was achieved, this drug was reduced to the dose that maintained the response. Myasthenia gravis Adults are given tacrolimus 3mg orally once daily after a meal.

Child dose

Suppression of rejection in kidney transplantation: Children are given 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted appropriately according to symptoms, with reference to the “recommended trough blood concentration.” Suppression of rejection in liver transplantation: Children are given 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted appropriately according to symptoms, with reference to the “recommended trough blood concentration.”

This medication suppresses the immune system, which may increase the risk of infections. Regular monitoring of kidney function is necessary, as it may affect kidney function and cause kidney damage. Blood potassium levels may increase; therefore, potassium levels should be frequently checked, and it should not be taken with potassium-sparing diuretics. This medication may affect the nervous system, leading to symptoms such as headaches, tremors, and seizures; if any unusual symptoms occur, consult a doctor immediately. There is a possibility of lymphomas or other malignant tumors due to immune suppression, necessitating regular check-ups and caution. Serious infection risks such as latent viral infections exist; inform healthcare personnel immediately if any infection symptoms appear. Caution is required when combined with other immunosuppressants, especially ciclosporin, as they should not be used together. Blood concentration must be frequently measured during treatment to adjust dosage appropriately. Women who are pregnant or may become pregnant should consult a doctor before use, and breastfeeding should be avoided. Elderly patients or those with impaired liver or kidney function should receive more cautious administration, and any adverse reactions should be reported to healthcare personnel immediately. During administration, regular checks of blood pressure, blood sugar, and liver and kidney function should be conducted to closely monitor the condition. Due to numerous drug interactions, it is essential to inform doctors or pharmacists about any other medications being taken, and the consumption of grapefruit juice should be avoided. During treatment, live vaccinations should be avoided; in necessary cases, inactivated vaccines can be used, but be aware that their effectiveness may be decreased. Should any unusual symptoms or discomfort occur while taking this medication, consult healthcare personnel immediately to receive appropriate measures.

Increased susceptibility to infections, possibility of lymphoma development, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, proteinuria, tremors, headache, changes in motor function, changes in mental status, changes in sensory function, convulsions, coma, confusion, reversible posterior leukoencephalopathy syndrome (PRES), seizures, visual impairment, hypertension, lymphoproliferative disease (LPD), BK virus-associated nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial impairment, decreased cardiac function, cardiac chamber enlargement, ventricular wall thickening, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina, pericardial effusion, QT prolongation, Torsades de pointes, acute renal failure, nephrotic syndrome, thrombotic microangiopathy, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, thrombocytopenic purpura, pure red cell aplasia (PRCA), agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, protozoal infection, fever, lymphadenopathy, generalized convulsions, altered consciousness, confusion, speech disorders, hemiplegia, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening of diabetes, pancreatitis, Stevens-Johnson syndrome (mucocutaneous syndrome), dyspnea, acute respiratory distress syndrome, myasthenic crisis, increased blood pressure, edema, tachycardia, palpitations, decreased blood pressure, bradycardia, ataxia, hallucinations, insomnia, paresthesia, eye tremors, limb rigidity, paralysis, drowsiness, confusion, regional sensory loss, delirium, depression, agitation, chest pain, abdominal distension, gastrointestinal motility disorder, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, elevated amylase, abnormal liver function (elevated AST, elevated ALT, elevated ALP, elevated LDH, elevated γ-GTP), jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate level, pleural effusion, ascites, asthma, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis (Lyell's syndrome), glaucoma, ketosis, nystagmus, mania, meningitis, macrocytosis, thrombophlebitis, thrombosis, vasculitis, foreign body sensation in the throat, pain, ocular pain, redness, hyperhidrosis, thirst, temperature changes, optic neuropathy, febrile neutropenia, tremors, diarrhea, hypertension, nausea, hyperkalemia, hypomagnesemia, hyperglycemia, insomnia, sensory disturbances, dizziness, dyspepsia, chest pain, urinary tract infection, edema, limb edema, pleural effusion, atelectasis, dyspnea, heartburn, epigastric discomfort, retinopathy, cardiac arrest, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, chest pain, leg pain, low back pain, hyperglycemia, diabetes, dysphagia, nasopharyngitis, lymphocytopenia, hypercholesterolemia, upper respiratory tract infection, dry mouth, constipation, palpitations, upper abdominal pain, fever, hair loss, paresthesia, dry mouth, dizziness, warts, autoantibody response, soft tissue infection, thrombocytopenia, abdominal pain, azotemia, herpes zoster, gastroenteritis, appendicitis, cystitis, albuminuria, pyelonephritis, pneumonia, seizures, herpes zoster, pneumonia, thrombocytopenia, pneumonia, abdominal pain, azotemia, albuminuria, hyperglycemia, infection, soft tissue infection, thrombocytopenia, pneumonia, autoantibody response, exacerbation of lupus erythematosus, eczema, cholecystitis, chickenpox, amenorrhea, appendicitis, hyperthermia, thymoma, vision loss, changes in vision, changes in color perception, blurred vision, visual field defects

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The optimal storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage ensures the medication's effectiveness.

Appearance

A light yellow hard capsule containing a white powder.

Package unit

100 capsules (10 capsules/PTP × 10)