Tacrobel Capsule 1 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation: Initially, administer tacrolimus orally to adults at 0.10~0.15mg/kg per dose twice daily, then gradually reduce the dose. Adjust the maintenance dose appropriately according to symptoms, referring to the “recommended trough blood concentrations.” Prevention of rejection in liver transplantation: Initially, administer tacrolimus orally to adults at 0.05~0.10mg/kg per dose twice daily, then gradually reduce the dose. Adjust the maintenance dose appropriately according to symptoms, referring to the “recommended trough blood concentrations.” Recommended trough blood concentrations in kidney and liver transplantation (whole blood trough level): 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, beginning 1 day before transplantation, administer tacrolimus 0.06mg/kg per dose orally twice daily. During the early post-transplant period, administer tacrolimus 0.06mg/kg per dose orally twice daily, then gradually reduce the dose. If administration of this medicine is initiated after the onset of graft-versus-host disease, usually administer tacrolimus 0.15mg/kg per dose orally twice daily. Adjust the dose appropriately according to symptoms. Chronic rheumatoid arthritis: Usually, administer tacrolimus 3mg orally once daily after the evening meal to adults. For older adults, usually administer 1.5mg orally once daily after the evening meal; the dose may be increased to 3mg according to symptoms. Lupus nephritis: Usually, administer tacrolimus 3mg orally once daily after the evening meal to adults. 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, then the dose was increased 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 a sufficient effect was achieved for lupus nephritis, this medicine was reduced to the dose that maintained the effect. Myasthenia gravis: Administer tacrolimus 3mg orally to adults once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: Administer 0.15mg/kg per dose orally to children twice daily. Prevention of rejection in liver transplantation: Administer 0.15mg/kg per dose orally to children twice daily.

This drug suppresses immune function, which may lead to an increased susceptibility to infections and a higher risk of cancers such as lymphoma. It may affect kidney and vascular function and can lead to rapid deterioration of kidney function; therefore, kidney function should be checked frequently and monitored carefully. There is a risk of elevated blood potassium levels, so potassium levels should be checked regularly, and this medication should not be taken with potassium-sparing diuretics. This drug may affect the nervous system, leading to symptoms such as tremors, headaches, changes in mental status, and seizures; if any abnormal symptoms occur, consult a doctor immediately. Immune function is suppressed, making patients vulnerable to viral infections or other opportunistic infections, necessitating prompt treatment if symptoms of infection appear. This medication should be used cautiously in patients with poor liver or kidney function, the elderly, those with infections, and women who are pregnant or may become pregnant. When taking this drug with certain medications or supplements, drug concentrations may change; therefore, it is essential to consult a physician or pharmacist. It should not be used during pregnancy unless absolutely necessary, as it may affect the fetus, and breastfeeding should be discontinued when taking this medication. Blood pressure and blood sugar levels may increase while using this drug, so regular monitoring is necessary, and appropriate treatment should be received as needed. The dosage and blood concentration of this medication should be regularly monitored and adjusted, and any adverse effects or abnormal symptoms should be reported to healthcare professionals immediately. Caution may be required when driving or operating machinery; activities should be adjusted based on symptoms. There may be an increased risk of skin damage from sunlight while using this drug, so it is advised to use sunscreen and protect the skin when going outside. When taking the medication, it must be ensured that the exact dosage and administration are followed according to the physician's instructions, and it should not be stopped or changed arbitrarily.

Infection, lymphoma, nephrotoxicity, increased serum creatinine, hyperkalemia, reduced urea excretion, hyperuricemia, progressive renal dysfunction, proteinuria, tremors, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, delirium, posterior reversible encephalopathy syndrome (PRES), convulsions, visual disturbances, hypertension, lymphoproliferative disorders, BK virus nephropathy, JC virus-associated PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, cardiac dysfunction, decreased cardiac function, cardiac chamber enlargement, ventricular wall hypertrophy, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina, pericardial effusion, QT prolongation, Torsades de pointes, acute kidney injury, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, bowel obstruction, bacterial infection, viral infection, fungal infection, protozoal infection, fever, lymphadenopathy, generalized convulsions, altered consciousness, confusion, speech disturbances, hemiplegia, cerebral infarction, cerebral hemorrhage, pneumonia, worsening of diabetes, pancreatitis, skin and mucous membrane syndrome, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, edema, tachycardia, palpitations, hypotension, bradycardia, ataxia, hallucinations, sensory abnormalities, anxiety, delirium, insomnia, paresthesia, eye tremors, rigidity of limbs, paralysis, drowsiness, clouding of consciousness, localized sensory loss, incoherence, depression, agitation, chest pain, abdominal distension, bowel motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, abnormal liver function, jaundice, anemia, increase or decrease in platelet count, leukopenia, leukocytosis, lymphocytopenia, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, weight loss, flushing, generalized fatigue, heavy menstrual bleeding, myalgia, arthralgia, taste abnormalities, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, myopathy, thrombophlebitis, thrombosis, vasculitis, sensation of foreign body in throat, pain, ocular pain, erythema, excessive sweating, thirst, changes in body temperature, optic neuropathy, febrile neutropenia, tremors, diarrhea, hypertension, nausea, renal dysfunction, insomnia, sensory abnormalities, dizziness, dyspepsia, chest pain, urinary tract infection, frequent urination, hypophosphatemia, hyperlipidemia, anemia, leukopenia, fever, low back pain, limb swelling, pleural effusion, atelectasis, respiratory distress, chest tightness, epigastric discomfort, retinopathy, uterine leiomyoma, cardiac arrest, cold, herpes zoster, autoimmune response, soft tissue infection, thrombocytopenia, pneumonia, warts, dry mouth, paresthesia, sputum, fatigue, sprain, surgical intervention, worsening condition, weakness, spinal fusion surgery, anti-adenosine deaminase positive, cervical cancer, myocardial infarction, gastric ulcer, flare-up of rheumatoid arthritis, cerebral infarction, pharyngitis, pyelonephritis, hematuria, pneumonia, seizures, infection, hair loss, thrombocytopenia, abdominal pain, azotemia, albuminuria, hyperglycemia, worsening of diabetes, increase in alkaline phosphatase, dysphagia, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, low back pain, hoarseness, cold, dry skin, skeletal pain, gastroesophageal reflux, ulcerative stomatitis, biliary stricture, viral hepatitis, hepatic venous thrombosis, biliary tract disorder, decrease in high-density lipoprotein, increase in low-density lipoprotein, hypocholesterolemia, hemorrhagic cystitis, pyelonephritis, leg pain, hyperpyrexia, cytomegalovirus gastrointestinal infection, secondary malignancy, hepatic failure due to reactivation of hepatitis B.

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to keep the storage temperature between 1 and 30 degrees Celsius. Proper storage will maintain the efficacy of the medication for a longer period.

Appearance

White hard capsule filled with white or off-white powder

Package unit

For domestic use - 100 capsules (10 capsules/PTP×10) For export - 50 capsules (10 capsules/PTP×5)