Tacrolimus Tablets 0.5 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial adult dose of tacrolimus is 0.10~0.15mg/kg per dose, administered orally twice daily, followed by gradual dose reduction. Refer to the ‘recommended minimum blood drug concentration’ for the maintenance dose, and adjust as appropriate according to symptoms. Prevention of rejection in liver transplantation Usually, the initial adult dose of tacrolimus is 0.05~0.10mg/kg per dose, administered orally twice daily, followed by gradual dose reduction. Refer to the ‘recommended minimum blood drug concentration’ for the maintenance dose, and adjust as appropriate according to symptoms. Bone marrow transplantation: Graft rejection and graft-versus-host disease following bone marrow transplantation Usually, starting 1 day before transplantation, administer tacrolimus at a dose of 0.06mg/kg per dose orally twice daily. In the early period after transplantation, administer tacrolimus at a dose of 0.06mg/kg per dose orally twice daily, followed by gradual dose reduction. When treatment with this drug is initiated after the onset of graft-versus-host disease, the usual dose of tacrolimus is 0.15mg/kg per dose orally twice daily. Adjust the dose as appropriate according to symptoms. Since absorption of this formulation after oral administration is variable and differs among patients, measure blood concentrations according to the patient's condition and adjust the dose with reference to the minimum blood drug concentration (trough level) in order to prevent adverse reactions when blood concentrations are high and rejection or onset of graft-versus-host disease when blood concentrations are low. Measure blood concentrations frequently, particularly immediately after transplantation or immediately after starting treatment. Also, use caution because adverse reactions are likely to recur when the minimum blood drug 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. 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, which 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 starting treatment and safety was considered acceptable, 4 mg/day of this drug 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 account. When a sufficient effect on lupus nephritis was achieved, this drug was reduced to a 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.

Since this medication is an immunosuppressive drug, it may increase susceptibility to infections, and there is a rare risk of malignant tumors such as lymphoma. Therefore, this medication should only be used by physicians experienced in immunosuppressive therapy, and close observation by appropriate medical facilities and specialists is needed during administration. This medication can cause damage to the kidneys and nerves when administered in high doses, so patients with poor renal function should be monitored particularly carefully, and dosage adjustments or temporary discontinuation may be necessary. Serum potassium levels may increase, so it should not be taken with potassium-sparing diuretics, and regular monitoring of serum potassium concentrations is necessary. Neurological side effects may include headache, tremor, changes in mental status, and seizures; if any symptoms occur, immediate consultation with a physician is required. Blood pressure and blood sugar may rise during treatment, so regular monitoring of blood pressure and blood sugar is necessary, and the risk of diabetes may increase. Caution should be exercised as this medication, when combined with other immunosuppressants, can lead to excessive immunosuppression, particularly it should not be used in conjunction with cyclosporine. It may pose risks to the fetus when taken during pregnancy, so women of childbearing potential should ensure appropriate contraception prior to treatment, and pregnant women require strict medical supervision when using this medication. If breastfeeding, it is recommended to discontinue breastfeeding as this drug may pass into breast milk. Caution should be exercised when using this medication in children and the elderly, with adequate monitoring of renal and hepatic function. Adhere to the prescribed dosage and formulation without arbitrary changes or mixing with other formulations. In case of overdose, immediate medical attention is necessary due to potential renal and pancreatic dysfunction, neurological anomalies, and cardiac diseases. Furthermore, if symptoms of infection, hypertension, diabetes, or neurological abnormalities occur during treatment, immediate consultation with a physician is essential. This medication should be avoided with grapefruit juice as it may increase blood concentration, thus increasing the risk of side effects. Finally, regular blood tests and renal and hepatic function tests are crucial during usage to identify and manage adverse reactions early.

Myocardial dysfunction, decreased cardiac function, dilation of the heart chambers, ventricular hypertrophy, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina pectoris, pericardial effusion, QT prolongation, Torsade de Pointes, acute renal failure, nephrotic syndrome, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, seizures, intestinal obstruction, bacterial infections, viral infections, fungal infections, protozoan infections, BK virus nephropathy, JC virus-related PML, CMV infection, lymphoproliferative disorders, lymphoma, posterior reversible encephalopathy syndrome, generalized seizures, altered consciousness, confusion, language disorders, visual impairment, hemiplegia, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, diabetes mellitus, worsening diabetes, hyperglycemia, pancreatitis, skin and mucous membrane syndrome, Stevens-Johnson syndrome, dyspnea, acute respiratory distress syndrome, myasthenic crisis, renal impairment, decreased urine output, polyuria, urinary frequency, post-void residual, glucosuria, hyperkalemia, hyperuricemia, hypomagnesemia, acidosis, hypercholesterolemia, hyperphosphatemia, hypophosphatemia, hypertriglyceridemia, hyperchloremia, hypercalcemia, hypocalcemia, hyponatremia, hypokalemia, diabetes, increased blood pressure, edema, tachycardia, palpitations, electrocardiogram abnormalities, decreased blood pressure, bradycardia, ataxia, hallucinations, tremors, headache, sensory disturbances, anxiety, delirium, insomnia, numbness, eyelid twitching, limb rigidity, paralysis, drowsiness, clouding of consciousness, localized sensory loss, nonsensical speech, depression, excitement, chest pain, abdominal distension, gastrointestinal motility disorders, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, elevated amylase, hepatic dysfunction, jaundice, anemia, increased platelet count, decreased platelets, leukopenia, leukocytosis, lymphocytopenia, pruritus, 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, glaucoma, ketosis, nystagmus, mania, meningitis, hyperreflexia, thrombophlebitis, thrombosis, vasculitis, throat foreign body sensation, pain, ocular pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, tremors, hypertension, nausea, diarrhea, headache, insomnia, sensory disturbances, renal function impairment, increased creatinine, elevated blood urea nitrogen, urinary tract infection, urinary frequency, hyperkalemia, hyperglycemia, hypomagnesemia, anemia, leukocytosis, thrombocytopenia, abdominal pain, pain, fever, weakness, low back pain, ascites, limb swelling, pleural effusion, atelectasis, dyspnea, pruritus, rash, tremors, dizziness, dry mouth, constipation, palpitations, epigastric pain, dyspepsia, edema, hair loss, increased SGPT, increased SGOT, increased C-reactive protein, dry mouth, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, shingles, autoimmune response, soft tissue inflammation, thrombocytopenia, pneumonia, warts, hair loss, thrombocytopenia, pneumonia, abdominal pain, azotemia, albuminuria, hyperglycemia, worsening diabetes, increased alkaline phosphatase, pharyngitis, nausea, diarrhea, dyspepsia, vomiting, pyelonephritis, hematuria, fever, pneumonia, seizures, dizziness, infections, warts, autoimmune response, thrombocytopenia, pneumonia, abdominal pain, azotemia, shingles, infections, soft tissue inflammation, thrombocytopenia, pneumonia, chest pain, leg pain, low back pain, hyperglycemia, diabetes, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, dysphagia, heartburn, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold

This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it is best to store the medication at room temperature, which should not be too hot or too cold, ideally between 1 degree and 30 degrees.

Appearance

Pale yellow round film-coated tablets

Package unit

50 tablets (10 tablets/PTP × 5)