Tacrobel Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation: Usually, initially, tacrolimus is administered orally to adults at 0.10~0.15mg/kg per dose twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted according to symptoms, with reference to the “recommended trough blood concentration.” Suppression of rejection in liver transplantation: Usually, initially, tacrolimus is administered orally to adults at 0.05~0.10mg/kg per dose twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted according to symptoms, with reference to the “recommended trough blood concentration.” Bone marrow transplantation: Usually, starting 1 day before transplantation, tacrolimus is administered orally at 0.06mg/kg per dose twice daily. In the early post-transplant period, tacrolimus is administered orally at 0.06mg/kg per dose twice daily, followed by gradual dose reduction. In addition, when administration of this drug is initiated after the onset of graft-versus-host disease, tacrolimus is usually administered orally at 0.15mg/kg per dose twice daily. The dose should also be adjusted as appropriate according to symptoms. Chronic rheumatoid arthritis: Adults are usually administered tacrolimus 3mg orally once daily after the evening meal. Elderly patients are usually administered 1.5mg orally once daily after the evening meal; the dose may be increased to 3mg according to symptoms. Lupus nephritis: Adults are usually administered tacrolimus 3mg orally once daily after the evening meal. In clinical trials, when the response was insufficient at 12 weeks after initiation of treatment and there were no safety concerns, this drug was administered at 4 mg/day 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 consideration. When a sufficient response in lupus nephritis was achieved, this drug was reduced to the dose that maintained the response. Myasthenia gravis: Adults are administered tacrolimus 3mg orally once daily after a meal.

Child dose

Suppression of rejection in kidney transplantation: Children are administered 0.15mg/kg per dose orally twice daily. Suppression of rejection in liver transplantation: Children are administered 0.15mg/kg per dose orally twice daily.

This medication suppresses immune function, which may increase susceptibility to infections and the risk of certain cancers, such as lymphoma. Therefore, it should only be used by physicians experienced in immunosuppressive therapy, and patients receiving this medication need appropriate testing and monitoring. It may burden the kidneys, and kidney function may deteriorate rapidly, so kidney function tests should be conducted frequently, adjusting the dose or discontinuing treatment if abnormalities are found. Additionally, caution is required as use with other nephrotoxic medications may worsen kidney damage. There is a risk of elevated potassium levels in the blood, so potassium levels should be frequently monitored, and it should not be used in combination with potassium-sparing diuretics. It can affect the nervous system, leading to tremors, headaches, seizures, and changes in mental status, with severe cases potentially resulting in symptoms of encephalopathy; if these occur, immediate consultation with a doctor is necessary. There may also be an increased risk of malignancies such as lymphoma or skin cancer while taking this medication, necessitating regular check-ups and caution. Immunodeficiency may lead to vulnerability to latent viruses or other infections, so any symptoms of infection should be reported immediately to medical personnel. Strict medical supervision is required when changing formulations or dosage alterations, and it should not be mixed with other formulations. Special care is needed for patients with kidney dysfunction, liver dysfunction, elderly patients, those with infections, pregnant women, or women of childbearing potential. During pregnancy, it should be administered only after consulting a physician as it may affect the fetus, and breastfeeding should be avoided. Regular monitoring of blood pressure, blood glucose, kidney function, liver function, and electrolyte levels should be performed while on this medication, and immediate action should be taken if abnormalities are found. There are numerous drug interactions, especially with certain antifungals, antibiotics, calcium channel blockers, antivirals, etc., which may alter blood concentrations and increase the risk of side effects; thus, all medications being taken should be disclosed to medical personnel. Serious adverse effects on the kidneys, pancreas, heart, etc., may occur in the event of overdose, so prescribed dosages and methods must be strictly followed. This medication may increase the risk of skin cancer when exposed to sunlight or UV rays, so sunscreen should be used and protective clothing worn when going outdoors. Attention is required during driving or operating machinery, and any changes in vision or neurological symptoms should be reported to a doctor immediately.

Increased susceptibility to infections, possibility of lymphoma, vasoconstriction effect, toxic tubular nephropathy, interstitial nephritis effects, acute and chronic renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal impairment, increased blood urea, proteinuria, tremor, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, confusion, posterior reversible encephalopathy syndrome (PRES), seizures, visual impairment, hypertension, lymphoproliferative disorders, malignant tumors, 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, systemic, localized infections, reversible posterior encephalopathy syndrome, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening diabetes, pancreatitis, Stevens-Johnson syndrome, dyspnea, acute respiratory distress syndrome, myasthenic crisis, hypertension, edema, tachycardia, palpitations, ECG abnormalities, hypotension, bradycardia, ataxia, hallucinations, sensory disturbances, anxiety, delirium, insomnia, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, clouding of consciousness, localized sensory loss, nonsense, depression, agitation, chest pain, abdominal bloating, gastrointestinal motility disorder, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hemorrhage, gastrointestinal perforation, increased amylase, abnormal liver function, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphopenia, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized weakness, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, convulsions, venous thrombosis, thrombosis, vasculitis, sensation of foreign body in the throat, pain, ocular pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, tremor, diarrhea, hypertension, nausea, renal dysfunction, hyperkalemia, hypomagnesemia, hyperglycemia, anemia, leukocytosis, thrombocytopenia, abdominal pain, pain, fever, weakness, low back pain, ascites, limb edema, pleural effusion, atelectasis, dyspnea, pruritus, rash, tremor, headache, insomnia, sensory disturbances, dizziness, dyspepsia, chest pain, hematuria, cystitis, dysuria, hydronephrosis, purulent urination, toxic kidney disease, acute kidney failure, proteinuria, BK nephropathy, bladder spasms, decreased urination, urgent urinary incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoalbuminemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, weight gain, edema, gout, hypercholesterolemia, peripheral edema, Cushing's syndrome, coagulation disorders, petechial hemorrhage, hypopigmented anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, systemic convulsions, limb convulsions, myalgia, myasthenia gravis, osteoporosis, joint diseases, painful muscle cramps, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, decreased lung function, hair loss, herpes simplex, hypertrichosis, skin diseases, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign skin neoplasms, abdominal distension, abscesses, chills, hernia, peritonitis, phototoxic reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, incidental injuries, back pain, soft tissue infection, falls, sensation abnormalities, temperature intolerance, ulcers, nasopharyngitis, glycosuria, lymphopenia, cervical cancer, myocardial infarction, gastric ulcer, exacerbation of rheumatoid arthritis, cerebral infarction, chest pain, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, dysphagia, heartburn, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, dry skin, skeletal pain, gastroesophageal reflux, ulcerative stomatitis, bile duct stricture, viral hepatitis, hepatic vein thrombosis, biliary disorders, decreased high-density lipoprotein, increased low-density lipoprotein, hypocholesterolemia, hemorrhagic cystitis, pyelonephritis, leg pain, hyperpyrexia, gastrointestinal infection due to cytomegalovirus, secondary malignancy, liver failure due to reactivation of hepatitis B

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally in an ambient temperature between 1 to 30 degrees Celsius. Proper storage maintains the efficacy of the medication and allows for safe use.

Appearance

A light yellow hard capsule containing white or off-white powder.

Package unit

50 capsules (10 capsules/PTP×5)