Tacrolimus Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation The usual initial oral dose for adults is tacrolimus 0.10~0.15mg/kg per dose 2 times daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring to the “recommended trough blood concentration.” Prevention of rejection in liver transplantation The usual initial oral dose for adults is tacrolimus 0.05~0.10mg/kg per dose 2 times daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring 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 tacrolimus 0.06mg/kg per dose orally 2 times daily. During the early post-transplant period, administer tacrolimus 0.06mg/kg per dose orally 2 times 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 tacrolimus 0.15mg/kg per dose orally 2 times daily. Adjust the dose as appropriate according to symptoms. Chronic rheumatoid arthritis The usual adult dose is tacrolimus 3mg orally once daily after the evening meal. Regular monitoring is required in patients who develop adverse reactions. The usual dose for elderly patients is 1.5mg orally once daily after the evening meal, and may be increased to 3mg according to symptoms. Lupus nephritis The usual adult dose is tacrolimus 3mg orally once daily after the evening meal. In clinical trials, when the effect was insufficient at 12 weeks after treatment initiation and there were no safety concerns, 4 mg/day of this medicine was administered for 4 weeks to confirm safety, after which the dose was increased to up to 5 mg/day. If adverse reactions occurred, the dose was appropriately reduced by 0.5 mg or 1 mg, taking the patient's condition into consideration. When an adequate effect on lupus nephritis was achieved, the dose of this medicine was reduced to the dose that maintained the effect. Myasthenia gravis In adults, administer tacrolimus 3mg orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: For children, administer 0.15mg/kg per dose orally 2 times daily, followed by gradual dose reduction. Prevention of rejection in liver transplantation: For children, administer 0.15mg/kg per dose orally 2 times daily, followed by gradual dose reduction.

This medication is an immunosuppressant, and its use may increase the risk of infection. It may affect kidney function, so patients with impaired kidney function should be closely monitored. Blood potassium levels should be checked frequently, and it should not be taken with potassium-sparing diuretics. Neurological side effects such as tremors, headaches, and changes in mental state may occur, and if unusual symptoms are present, they should be reported immediately. This medication may increase the risk of certain cancers, particularly lymphoma, necessitating regular examinations. Due to immunosuppression, there may be an increased risk of viral infections, so patients should be cautious of infection symptoms. During administration, it should only be taken in the same formulation and dosage, and any changes in formulation should be followed as directed by a specialist. This drug may increase the risk of diabetes, so patients must be cautious in blood sugar management. Patients with rheumatoid arthritis and lupus nephritis should use this under the supervision of a physician experienced in the treatment of related diseases. It should be administered cautiously to those with impaired liver or kidney function, the elderly, and pregnant women, with regular monitoring required. Serious side effects such as cardiovascular issues, blood disorders, or central nervous system abnormalities may occur, and patients should consult healthcare professionals immediately in case of abnormal symptoms. This medication has many drug interactions, so inform healthcare professionals about any other medications being taken. Women who are pregnant or may become pregnant should consult a specialist before taking this medication and should use appropriate contraception during treatment. Breastfeeding is not recommended while taking this drug. Safety in children and adolescents has not been sufficiently established, and caution is warranted. Overdose can affect kidney and pancreatic function, so strict adherence to prescribed dosages is necessary. While taking this medication, regular monitoring of blood concentration and clinical tests is needed for dosage adjustment and side effect monitoring. This drug should be avoided when consumed with grapefruit juice, as it may increase blood concentration. Patients should avoid exposure to sunlight and take care of skin protection. Changes in vision may occur as a side effect, so immediate testing is required if vision abnormalities arise.

Increased sensitivity to infections, potential for lymphoma development, nephrotoxicity, acute kidney injury, elevated serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, chronic kidney disease, tremors, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, mental confusion, posterior reversible encephalopathy syndrome (PRES), seizures, visual impairment, hypertension, lymphoproliferative disorders, BK virus-related nephropathy, JC virus-related progressive multifocal leukoencephalopathy (PML), CMV infection, transplant rejection, insulin-dependent post-transplant diabetes mellitus (PTDM), hyperglycemia, cardiac dysfunction, decreased cardiac function, enlarged heart chambers, 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, parasitic infection, systemic infection, localized infection, chest pain, abdominal distension, gastrointestinal motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, black stools, rectal bleeding, gastrointestinal perforation, elevated amylase, liver function abnormalities (elevated AST, ALT, ALP, LDH, γ-GTP), jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphopenia, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, taste disturbances, aplastic anemia, cerebral infarction, toxic epidermal necrolysis (Lyell's syndrome), glaucoma, ketosis, nystagmus, mania, meningitis, critical illness, thrombophlebitis, thrombosis, vasculitis, sensation of a foreign body in the throat, pain, ocular pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, insomnia, sensory disturbances, anxiety, delirium, eye twitching, limb rigidity, paralysis, drowsiness, confusion, altered consciousness, localized sensory loss, hallucinations, depression, agitation, ataxia, hallucinations, palpitations, hypertension, edema, tachycardia, hypotension, bradycardia, dizziness, indigestion, cholangitis, cholestatic jaundice, gastrointestinal bleeding, gastroesophageal reflux, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, eosophageal ulcer, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, angina, severe vascular thrombophlebitis, orthostatic hypotension, peripheral vascular disease, arrhythmias, atrial fibrillation, slow pulse, heart tremor, cardiac arrest, cardiac dysfunction, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, pyuria, toxic kidney disease, acute renal failure, proteinuria, BK nephropathy, bladder spasms, oliguria, urgency incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing ulcers, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, elevated AST, elevated ALT, decreased bicarbonate, dehydration, hypoglycemia, lactic dehydrogenase elevation, weight gain, edema, gout, hypercholesterolemia, peripheral edema, diabetes, Cushing's syndrome, coagulopathy, petechiae, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, hemoglobin abnormalities, leukocytosis, generalized seizures, limb spasms, myalgia, myasthenia gravis, osteoporosis, joint disease, painful muscle spasms, decreased mobility, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, reduced lung function, hair loss, herpes simplex, hypertrichosis, skin disorders, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin tumors, abdominal distension, abscesses, chills, hernias, peritonitis, photosensitivity reactions, allergic reactions, cell inflammation, influenza-like illness, sepsis, accidental injuries, back pain, soft tissue infections, falls, altered sensation, temperature intolerance, ulcers, heartburn, epigastric discomfort, retinopathy, common cold, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, dysphagia, low back pain, hoarseness, cold

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and the temperature should be kept between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain the drug's effectiveness and prevents degradation.

Appearance

Hard capsule with pale yellow upper and lower parts containing white powder

Package unit

100 capsules/PTP [(10 capsules/PTP × 10)]