Tacrolimus Capsule (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial adult dose is 0.10~0.15mg/kg of tacrolimus per dose, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended target trough blood concentration.” Prevention of rejection in liver transplantation Usually, the initial adult dose is 0.05~0.10mg/kg of tacrolimus per dose, administered orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted as appropriate according to symptoms, with reference to the “recommended target 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, 0.06mg/kg of tacrolimus per dose is administered orally twice daily. During the initial post-transplant period, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, followed by gradual dose reduction. If this drug is started after the onset of graft-versus-host disease, 0.15mg/kg of tacrolimus per dose is usually administered orally twice daily. The dose should also be adjusted as appropriate according to symptoms. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. The usual dose for older adults is 1.5mg orally once daily after the evening meal, and 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 at 12 weeks after starting treatment and there were no safety concerns, this drug was administered at 4 mg/day for 4 weeks to confirm safety, and then increased to a maximum of 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 on lupus nephritis was achieved, this drug was reduced to the dose that maintained that effect. Myasthenia gravis In adults, 3mg of tacrolimus is administered orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: In children, 0.15mg/kg per dose is administered orally twice daily. Prevention of rejection in liver transplantation: In children, 0.15mg/kg per dose is administered orally twice daily.

This drug suppresses immune function, thereby increasing susceptibility to infections and, rarely, the possibility of cancers such as lymphoma. Therefore, it should only be used by physicians experienced in immunosuppressive therapy, and patients must be observed under appropriate medical facilities and professionals. This medication may put a strain on the kidneys, potentially leading to acute or chronic kidney dysfunction, so patients with impaired kidney function should be especially cautious and frequently check their kidney condition through blood tests. If kidney function worsens, the dosage may need to be adjusted or stopped. While taking this drug, blood potassium levels may rise, so potassium levels should be monitored frequently, and potassium-sparing diuretics should not be taken concurrently. Neurological side effects may include tremors, headaches, seizures, and changes in mental state; if these symptoms appear, you should consult a doctor. Rarely, syndromes involving abnormalities of the brain have been reported, necessitating good blood pressure management and dosage reduction if needed. Due to immunosuppression raising the risk of infections, if symptoms of infection occur, the medical staff should be informed immediately, and caution is especially necessary when using this drug with other immunosuppressants. Especially, this drug may interact with certain specific medications, so if you are taking other drugs, be sure to inform your doctor or pharmacist. Grapefruit juice should also be avoided as it can increase the blood concentration of this drug. Women who are pregnant or may become pregnant should consult a doctor before taking this medication due to potential effects on the fetus and should use appropriate contraception. Additionally, this drug may also be transferred through breast milk, so it is recommended to stop taking it while breastfeeding. The safety of this drug in children, particularly in those under 12 years of age, has not been sufficiently confirmed, and the elderly may have decreased bodily functions, making careful usage imperative. While taking this medication, regular blood tests and other clinical tests should be performed, and any unusual symptoms should be discussed with the healthcare provider immediately. Finally, care should be taken on how to take this medication: capsules should always be taken with water on an empty stomach, and it is important to check the packaging state to minimize side effects during use.

Infection, lymphoma, renal dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, increased blood urea, proteinuria, tremors, headache, changes in motor function, changes in mental state, changes in sensory function, seizures, coma, delirium, occipital encephalopathy syndrome, convulsions, visual impairment, hypertension, lymphoproliferative disorders, BK virus nephropathy, JC virus-associated progressive multifocal leukoencephalopathy, CMV infection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, decreased heart function, cardiac chamber enlargement, ventricular wall hypertrophy, heart failure, ventricular arrhythmia, supraventricular arrhythmia, myocardial infarction, angina pectoris, 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, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, protozoal infection, lymphoma, malignant tumor, generalized convulsions, altered consciousness, confusion, speech disorders, hemiplegia, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening diabetes, pancreatitis, skin and mucous membrane syndrome, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, anemia, platelet count increase or decrease, leukopenia, leukocytosis, lymphopenia, itching, 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, taste disturbances, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, hyperglycemia, venous thrombosis, thrombosis, vasculitis, sensation of foreign body in throat, pain, eye pain, redness, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, diarrhea, constipation, loss of appetite, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, liver function abnormalities, jaundice, urinary tract infection, frequency of urination, decreased urine output, polyuria, post-void residual, glucosuria, hypomagnesemia, acidosis, hypercholesterolemia, hyperphosphatemia, hypophosphatemia, hypertriglyceridemia, hyperchloremia, hypercalcemia, hypocalcemia, hyponatremia, hypokalemia, elevated blood pressure, edema, tachycardia, palpitations, reduced blood pressure, bradycardia, ataxia, hallucinations, anxiety, delirium, insomnia, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, stupor, clouding of consciousness, loss of local sensation, delirium, depression, agitation, sleep disturbances, restlessness, worry, confusion, gloom, euphoric feeling, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, excessive tension, impaired coordination, neurotic syndrome of hypertrophic muscle cramps, neurological disorders, psychosis, inability to think, forgetfulness, dizziness, encephalopathy, hemorrhagic stroke, monoparesis, nerve compression, nervousness, neuralgia, flaccid paralysis, incomplete paralysis of limbs, tardive dyskinesia, aphasia, visual impairment, amblyopia, tinnitus, cataract, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, dyspepsia, flatulence, gastrointestinal bleeding, increased γ-GTP, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, duodenitis, pneumatosis intestinalis, gastroesophageal reflux, gastrointestinal disturbances, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, angina pectoris, severe vascular venulitis, orthostatic hypotension, peripheral vascular insufficiency, atrial fibrillation, bradycardia, cardiac tremors, cardiopulmonary failure, loss of cardiac function, increased heart rate, syncope, thrombosis, vasculitis, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, purulent urine, toxic kidney disease, acute kidney failure, proteinuria, BK nephropathy, bladder spasms, decreased urine output, urgency, incontinence, urine retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperuricemia, hypoalbuminemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hyperglycemia, hypoglycemia, increased lactate dehydrogenase, weight gain, increased BUN, edema, gout, hypercalcemia, hypercholesterolemia, peripheral edema, Cushing's syndrome, coagulopathy, petechial bleeding, hypopigmented anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, generalized convulsions, limb convulsions, myalgia, myasthenia, osteoporosis, joint diseases, painful muscle cramps, decreased mobility, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory disorders, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, reduced lung function, hair loss, herpes, hypertrichosis, skin diseases, sweating, acne, fungal dermatitis, skin discoloration, skin ulceration, exfoliative dermatitis, shingles, benign skin neoplasms, abdominal distension, abscess, chills, hernia, peritonitis, photosensitivity reaction, allergic reaction, cellulitis, influenza-like syndrome, sepsis, accidental injury, back pain, soft tissue infection, falling, abnormal sensations, intolerance to temperature, ulcers, heartburn, discomfort in the epigastrium, retinopathy, cardiac arrest, low back pain, hoarseness, cold

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. When storing, it is advisable to maintain a temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's effectiveness for a long time.

Appearance

A white hard capsule containing white powder

Package unit

100 capsules (10 capsules/PTP x 10)