Tacromin Capsule 1 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial dose for adults is 0.10~0.15mg/kg per dose of tacrolimus, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended trough blood concentration.” Prevention of rejection in liver transplantation Usually, the initial dose for adults is 0.05~0.10mg/kg per dose of tacrolimus, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended trough blood concentration.” Bone marrow transplantation: Prevention of graft rejection and graft-versus-host disease following bone marrow transplantation Usually, starting 1 day before transplantation, administer 0.06mg/kg per dose of tacrolimus orally twice daily. During the initial post-transplant period, administer 0.06mg/kg per dose of tacrolimus orally twice daily, followed by gradual dose reduction. If treatment with this medicine is initiated after the onset of graft-versus-host disease, the usual dose is 0.15mg/kg per dose of tacrolimus orally twice daily. The dose should also be adjusted as appropriate according to symptoms. Since absorption of this product after oral administration is variable and differs among patients, blood concentrations should be measured according to the patient's condition and the dose adjusted with reference to the trough level, in order to prevent adverse reactions when blood concentrations are high and rejection or graft-versus-host disease when blood concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or just after treatment is started. Caution is advised because adverse reactions are more likely to recur when the trough blood concentration remains above 20ng/mL for a prolonged period. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. Patients who develop adverse reactions require regular monitoring. The usual dose for elderly patients is 1.5mg orally once daily after the evening meal; it may be increased to 3mg according to symptoms. Lupus nephritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when the effect was insufficient 12 weeks after treatment initiation and there were no safety concerns, this medicine was administered at 4 mg/day for 4 weeks to confirm safety, then increased to a maximum of 5 mg/day. If adverse reactions occurred, the dose was appropriately reduced in 0.5 mg or 1 mg increments, taking the patient's condition into account. When sufficient efficacy for lupus nephritis was achieved, this medicine was reduced to the dose that maintained the effect. Myasthenia gravis In adults, administer 3mg of tacrolimus orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: In children, administer 0.15mg/kg per dose orally twice daily. Prevention of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally twice daily.

This medication suppresses the immune system, making it easier to get infections, and there is a rare risk of malignant tumors such as lymphoma occurring. It may put stress on the kidneys, so there is a risk of kidney function impairment; thus, kidney function should be regularly monitored, and dosages adjusted as necessary. Blood potassium levels may become elevated, so potassium concentrations should be frequently checked through blood tests and should not be taken with potassium-sparing diuretics. It may affect the nervous system, causing symptoms such as tremors, headaches, seizures, and changes in mental status, and if these symptoms occur, immediate consultation with a physician is necessary. There is an increased risk of infection while taking this medication, so if infection symptoms appear, healthcare personnel should be informed promptly. This medication should be used under the supervision of an experienced physician, particularly when used in conjunction with other immunosuppressants, as it may lead to excessive immunosuppression. Women who are pregnant or may become pregnant should consult with a physician before taking this medication and consider its potential effects on the fetus. This medication may increase blood pressure, so blood pressure should be monitored regularly, and appropriate treatment should be administered when necessary. Overdose may lead to decreased kidney function, hypertension, and neurological abnormalities, so the prescribed dosages must be strictly adhered to. While taking this medication, regular blood tests and physical examinations should be conducted to monitor for adverse reactions, and any unusual symptoms should be promptly reported to healthcare professionals. Additionally, consuming grapefruit juice should be avoided as it may increase the blood concentration of this medication and raise the risk of side effects. This medication may require caution during driving or operating machinery; therefore, activities requiring alertness should be approached with caution while taking it.

Infection, lymphoma, acute and chronic renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, proteinuria, tremors, headache, changes in motor function, changes in mental state, changes in sensory function, seizures, coma, confusion, reversible posterior leukoencephalopathy syndrome (PRES), convulsions, visual impairment, hypertension, lymphoproliferative disorders, BK virus-associated nephropathy, JC virus-associated PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, heart failure, ventricular and supraventricular arrhythmias, myocardial infarction, angina pectoris, pericardial effusion, QT prolongation, Torsades de pointes, acute renal failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial, viral, fungal, protozoal infections, Epstein-Barr virus-associated lymphoproliferative disorders, generalized seizures, altered consciousness, confusion, language disorder, hemiplegia, cerebral infarction, cerebral hemorrhage, pneumonitis, worsening diabetes, pancreatitis, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, elevated blood pressure, edema, tachycardia, palpitations, hypotension, bradycardia, ataxia, hallucinations, sensory abnormalities, anxiety, delirium, insomnia, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, delirium, localized sensory loss, nonsensical speech, depression, agitation, chest pain, abdominal distension, gastrointestinal motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, gastrointestinal perforation, increased amylase, hepatic dysfunction, jaundice, anemia, increase or decrease in platelet count, leukopenia, leukocytosis, lymphocytopenia, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate levels, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, vicious circle, thrombophlebitis, thrombosis, vasculitis, foreign body sensation in the throat, pain, ocular pain, erythema, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, tremors, diarrhea, hypertension, nausea, renal dysfunction, headache, insomnia, sensory abnormalities, dizziness, dyspepsia, chest pain, urinary tract infection, hypophosphatemia, hyperlipidemia, anemia, leukopenia, rash, pruritus, respiratory distress, increased cough, arthralgia, herpes zoster, autoimmune response, soft tissue infection, thrombocytopenia, chest pain, leg pain, back pain, hyperglycemia, diabetes, cytomegalovirus infection, cardiac arrest, dysphagia, epigastric discomfort, retinopathy, cold

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 degrees and 30 degrees Celsius.

Appearance

A white hard capsule containing white powder

Package unit

100 capsules/box [(10 capsules/PTP x 10)]