Prograf Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial dose for adults is tacrolimus 0.10~0.15mg/kg per dose 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.' Prevention of rejection in liver transplantation Usually, the initial dose for adults is tacrolimus 0.05~0.10mg/kg per dose 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, starting 1 day before transplantation, administer tacrolimus 0.06mg/kg per dose orally twice daily. During the initial post-transplant period, administer tacrolimus 0.06mg/kg per dose orally twice daily, followed by gradual dose reduction. In addition, when this medicine is initiated after the onset of graft-versus-host disease, the usual dose is tacrolimus 0.15mg/kg per dose orally twice daily. Adjust the dose as appropriate according to symptoms. Since absorption of this product 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 trough level to prevent adverse reactions when blood concentrations are high and rejection or graft-versus-host disease when blood concentrations are low. Measure blood concentrations frequently, especially immediately after transplantation or initiation of treatment. Also, use caution because adverse reactions are more likely to recur when the trough blood concentration remains above 20ng/mL for a prolonged period. Chronic rheumatoid arthritis The usual dose for adults 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, which may be increased to 3mg according to symptoms. Lupus nephritis The usual dose for adults is tacrolimus 3mg orally once daily after the evening meal. In clinical trials, if the effect was insufficient at 12 weeks after initiation of treatment and safety was considered acceptable, this medicine was administered at 4 mg/day for 4 weeks to confirm safety and then 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 an adequate effect on lupus nephritis was achieved, this medicine was reduced to the dose that maintained the effect. Myasthenia gravis For adults, administer tacrolimus 3mg orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation Usually, the initial dose for children is tacrolimus 0.15mg/kg per dose 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.' Prevention of rejection in liver transplantation Usually, the initial dose for children is tacrolimus 0.15mg/kg per dose 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.'

Since this medicine is an immunosuppressant, it may make you more susceptible to infections. It should only be used by physicians experienced with transplant patients or immunosuppressive treatments, and during administration, close observation by healthcare professionals is necessary. This drug may affect kidney function, so patients with renal impairment should frequently check their kidney status through blood tests, and dosage adjustments may be required if necessary. Also, taking this drug with other nephrotoxic agents can worsen kidney damage, so caution is advised. Blood potassium levels may increase, so it should not be taken with potassium-sparing diuretics, and frequent monitoring of serum potassium levels is required. It can affect the nervous system, leading to symptoms such as headache, tremors, and seizures, and in severe cases, there may be signs of encephalopathy, so any unusual symptoms should be reported to a doctor immediately. Long-term use of this drug may increase the risk of malignant tumors such as lymphoma or skin cancer, thus regular check-ups and caution are necessary. There is a risk of latent viral infections or other opportunistic infections due to suppressed immune function, so if symptoms of infection appear, prompt treatment is required. The dosing forms and dosages of this drug must be strictly adhered to, and any changes in formulations should be made under the supervision of an expert. There is a risk of developing diabetes, so blood sugar levels should be regularly monitored, and appropriate measures should be taken if diabetes symptoms appear. When administered to patients with rheumatoid arthritis or lupus nephritis, it should be done after sufficient explanation and with the care of a physician experienced in treating these conditions. This drug should not be used in patients with allergic reactions or in patients being co-administered specific drugs, nor in patients with hereditary lactose intolerance. Use during pregnancy may affect the fetus, so women of childbearing potential should have appropriate contraception, and pregnant women should carefully manage blood sugar and blood pressure. This drug can also be transmitted through breast milk, so breastfeeding should be avoided while taking this medication. Elderly patients or those with impaired liver or kidney function should have their dosage adjusted and their condition closely monitored. There are many interactions with other drugs, so blood concentrations and side effects should be carefully monitored when used together, especially with drugs affecting CYP3A4 enzymes. In cases of overdose, serious side effects may occur in organs such as the kidneys, pancreas, and heart, so the prescribed dosage must be strictly followed. During the use of this medication, regular blood tests and clinical evaluations should be conducted to check for adverse reactions, and if any unusual symptoms appear, immediate consultation with healthcare professionals is necessary. Furthermore, this drug may increase the risk of skin damage from sunlight, so using sunscreen and wearing protective clothing is advisable when going outside.

Increased susceptibility to infection, potential for lymphoma development, vasoconstriction effect, toxic tubulopathy, interstitial nephritis effects, acute renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, chronic kidney impairment, tremors, headaches, changes in motor function, changes in mental state, changes in sensory function, seizures, coma, delirium, posterior reversible encephalopathy syndrome (PRES), lymphoma, 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, and protozoal infections, Epstein-Barr virus-related lymphoproliferative disorders, generalized seizures, altered consciousness, confusion, speech disabilities, visual impairment, hemiplegia, cerebral infarction, intracerebral hemorrhage, pneumonitis, worsening of diabetes, pancreatitis, Stevens-Johnson syndrome (mucositis), shortness of breath, acute respiratory distress syndrome, myasthenic crisis, hypertension, edema, tachycardia, palpitations, hypotension, bradycardia, ataxia, hallucinations, sensory abnormalities, anxiety, delirium, insomnia, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, altered consciousness, localized sensory loss, nonsensical speech, depression, excitation, chest pain, abdominal bloating, gastrointestinal motility disorders, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, liver dysfunction (increased AST, ALT, ALP, LDH, 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 concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, taste disturbances, aplastic anemia, cerebral infarction, toxic epidermal necrolysis (Lyell syndrome), glaucoma, ketosis, nystagmus, mania, meningitis, erythrocytosis, thrombophlebitis, thrombosis, vasculitis, sensation of throat foreign body, pain, eye pain, erythema, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, diarrhea, hypertension, nausea, headaches, insomnia, sensory abnormalities, dizziness, indigestion, chest pain, urinary tract infection, frequent urination, hypophosphatemia, hyperlipidemia, edema, thrombocytopenia, shortness of breath, increased coughing, arthralgia, rash, pruritus, heartburn, epigastric discomfort, retinopathy, cold, herpes zoster, autoimmune reactions, soft tissue infections, thrombocytopenia, pneumonia, hyperglycemia, seizures, dizziness, hair loss, thrombocytopenia, cervical cancer, myocardial infarction, gastric ulcer, worsening of rheumatoid arthritis, cerebral infarction, abdominal pain, azotemia, pyelonephritis, hyperglycemia, diabetes, cytomegalovirus infection, uterine leiomyoma, cardiac arrest, dysphagia, low back pain, hoarseness, cold, dry skin, skeletal pain, gastroesophageal reflux, ulcerative stomatitis, biliary stricture, viral hepatitis, hepatic venous thrombosis, bile duct disorders, decreased high-density lipoprotein, increased low-density lipoprotein, hypocholesterolemia, hemorrhagic cystitis, pyelonephritis, leg pain, hyperpyrexia, liver failure due to reactivation of hepatitis B

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is also best to keep it at room temperature, avoiding excessively hot or cold places.

Appearance

Yellow hard capsules containing white powder

Package unit

50 capsules (10 capsules/PTP X 5) / box