Tarsin Capsule 0.5 Milligrams (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation The usual initial dose in adults is tacrolimus 0.10~0.15mg/kg orally twice daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, with reference to the 'recommended trough blood concentration.' Suppression of rejection in liver transplantation The usual initial dose in adults is tacrolimus 0.05~0.10mg/kg orally twice daily, followed by gradual dose reduction. Adjust the maintenance dose 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, administer tacrolimus 0.06mg/kg orally twice daily starting 1 day before transplantation. During the initial post-transplant period, administer tacrolimus 0.06mg/kg 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 tacrolimus 0.15mg/kg orally twice 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 in 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 tacrolimus 3mg orally once daily after the evening meal. In clinical trials, when the effect was insufficient at 12 weeks after initiation of treatment and there were no safety concerns, 4 mg/day of this medicine was administered for 4 weeks to confirm safety before increasing the dose 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, 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

Suppression of rejection in kidney transplantation: In children, administer 0.15mg/kg orally twice daily Suppression of rejection in liver transplantation: In children, administer 0.15mg/kg orally twice daily

This drug suppresses the immune system, which may increase the risk of infection. Therefore, patients using this medication should be under the care of a qualified physician and require regular blood tests and health status checks. This medication may put stress on the kidneys, and patients with kidney issues should be especially cautious. If kidney function worsens, dose adjustment or temporary cessation may be necessary. Since there is a risk of elevated potassium levels in the blood, potassium levels should be monitored frequently, and it should not be taken with potassium-sparing diuretics. It may affect the nervous system, causing symptoms such as tremors, headache, seizures, coma, or confusion, so if abnormal symptoms occur, immediate consultation with a physician is advised. Patients taking this medication may have an increased risk of lymphoma or other malignancies, so periodic evaluations are recommended. Due to immunosuppression, latent viral infections or other infections may worsen, so treatment should be sought immediately if infection symptoms arise. When administering, the same formulation with a consistent dose should be taken, and any changes in formulation must be done under the supervision of a professional. This drug may induce diabetes after transplantation; therefore, blood sugar levels should be monitored regularly. Specific patient groups, such as those with liver dysfunction, kidney dysfunction, the elderly, patients with infections, and pregnant women, require closer monitoring and management when taking this drug. It may impact heart function, so regular checks of the electrocardiogram and heart condition are necessary. This medication may interact with various drugs, so if other medications are being taken, it is crucial to inform a doctor or pharmacist, especially when combined with cyclosporine, potassium-sparing diuretics, certain antibiotics, and antifungal agents. Women who are pregnant or may become pregnant should consult a physician before taking this medication as it may affect the fetus, requiring careful administration. During breastfeeding, this drug may be excreted in breast milk, and it is advisable to discontinue breastfeeding. In case of overdose, symptoms such as kidney and pancreatic function abnormalities and nervous system disturbances may occur, so strict adherence to dosage is necessary, and careless consumption should be avoided. While taking this medication, regular clinical evaluations and blood concentration measurements are necessary for appropriate dose adjustments, and if abnormal symptoms occur, immediate consultation with healthcare professionals is required.

Infection, lymphoma, nephrotoxicity, elevated serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, proteinuria, tremor, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, confusion, posterior reversible encephalopathy syndrome (PRES), convulsions, visual impairment, hypertension, lymphoproliferative disorder (LPD), BK virus nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, reduced heart function, cardiac chamber enlargement, ventricular wall hypertrophy, 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, Epstein-Barr virus-related lymphoproliferative disorder, generalized seizures, alteration of consciousness, confusion, speech impairment, hemiplegia, cerebral infarction, cerebral hemorrhage, pneumonia, worsening of diabetes, pancreatitis, Stevens-Johnson syndrome, shortness of breath, acute respiratory distress syndrome, myasthenic crisis, elevated blood pressure, edema, tachycardia, palpitations, decreased blood pressure, bradycardia, ataxia, hallucinations, sensory disturbances, anxiety, delirium, insomnia, paresthesia, tremors, limb stiffness, paralysis, drowsiness, altered consciousness, localized sensory loss, nonsensical speech, depression, agitation, chest pain, abdominal distension, gastrointestinal motility disorder, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, elevated amylase, abnormal liver function (AST, ALT, ALP, LDH, increased 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 levels, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis (Lyell's syndrome), glaucoma, ketosis, nystagmus, mania, meningitis, hyperemia, thrombotic venous thrombosis, thrombosis, vasculitis, pharyngeal foreign body sensation, pain, ocular pain, redness, diaphoresis, thirst, temperature changes, optic nerve disease, febrile neutropenia, sleep disorders, agitation, worry, confusion, serendipity, euphoria, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, excessive tension, lack of coordination, muscular dystonia, neurological disorders, psychosis, inability to think, memory loss, dizziness, encephalopathy, hemorrhagic stroke, monoparesis, nerve compression, irritability, neuralgia, flaccid paralysis, partial limb paralysis, subacute disorder, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, dyspepsia, flatulence, gastrointestinal bleeding, increased γ-GTP, hepatitis, increased appetite, liver damage, oral moniliasis, dysphagia, esophagitis, gastritis, intestinal obstruction, abnormal liver function tests, rectal dysfunction, duodenitis, aerophagia, gastroesophageal reflux disease, granulomatous hepatitis, pancreatic pseudocyst, chest pain, abnormal ECG, hemorrhage, hypotension, angina, severe vascular venous thrombosis, orthostatic hypotension, peripheral vascular disease, arrhythmia, atrial fibrillation, bradycardia, heart tremors, cardiac failure, heart function loss, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic nephropathy, acute kidney failure, proteinuria, BK nephropathy, bladder spasm, decreased urine output, urgent urinary incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hyperglycemia, hypoglycemia, elevated lactate dehydrogenase, weight gain, increased BUN, edema, gout, hypercalcemia, hypercholesterolemia, peripheral edema, diabetes, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, generalized seizures, limb convulsions, 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, hirsutism, skin diseases, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin tumors, abdominal enlargement, pustules, chills, hernias, peritonitis, phototoxic reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, incidental injuries, back pain, soft tissue infections, falls, abnormal sensations, visual loss, visual changes, color vision changes, blurred vision, visual field defects

This medication is susceptible to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C, avoiding excessively hot or cold places.

Appearance

Hard capsule with a light yellow upper and lower part containing white powder

Package unit

100 capsules (10 capsules/PTP × 10)