Tacrolimus Capsule 0.5 Milligrams (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 appropriately according to symptoms, referring to the 'recommended minimum 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 appropriately according to symptoms, referring to the 'recommended minimum blood concentration'. Recommended minimum blood concentration (whole blood trough level) for kidney and liver transplantation In the early period after transplantation, the minimum blood concentration was 5~20ng/mL in liver transplant patients and 10~20ng/mL in kidney transplant patients. During the subsequent maintenance period, the minimum blood concentration was 5-15ng/mL in liver and kidney transplant patients. Bone marrow transplantation: Prevention of tissue 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. In the early period after transplantation, administer tacrolimus 0.06mg/kg per dose orally twice daily, followed by gradual dose reduction. If treatment with this medicine is initiated after the onset of graft-versus-host disease, tacrolimus 0.15mg/kg per dose is usually administered orally twice daily. Adjust the dose appropriately according to symptoms. Chronic rheumatoid arthritis The usual adult dose is tacrolimus 3mg orally once daily after the evening meal. The usual dose for elderly patients is 1.5mg orally once daily after the evening meal and may be increased to 3mg depending on symptoms. Lupus nephritis The usual adult dose is tacrolimus 3mg orally once daily after the evening meal. In clinical trials, if the effect was insufficient at 12 weeks after treatment initiation and safety concerns were not identified, this medicine was administered at 4 mg/day for 4 weeks to confirm safety, 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 account. When an adequate effect on lupus nephritis was achieved, this medicine was reduced to the dose that maintained the effect. Myasthenia gravis Administer tacrolimus 3mg orally once daily after a meal to adults.

Child dose

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

This drug is an immunosuppressant that suppresses the immune system, increasing the risk of infections, and may cause malignancies such as lymphoma in some patients. It should be used under the supervision of a physician experienced in immunosuppressive therapy, and patients must undergo regular laboratory testing and monitoring by healthcare professionals. It can affect kidney function; hence, dosage adjustment and continuous monitoring of renal function are necessary for patients with renal impairment. This drug may increase serum potassium levels, posing a risk of hyperkalemia, and should not be used with potassium-sparing diuretics. Neurological side effects may include headache, tremors, seizures, and changes in mental status, with severe cases potentially leading to symptoms of encephalopathy, necessitating caution. Patients taking this medication have an increased risk of infection; therefore, they should consult healthcare providers immediately if any signs of infection appear. During pregnancy, it may affect the fetus; hence, women of childbearing potential should employ appropriate contraceptive methods, and it should be used cautiously in pregnant women. This drug can interact with other medications, so individuals taking other drugs must inform their doctor or pharmacist. Overdose may lead to renal impairment, hypertension, and neurological disturbances, requiring immediate medical attention. This medication should be taken at the same times daily, and any changes to dosage or formulation must be done under expert supervision. Additionally, care must be taken to avoid direct contact with skin or mucous membranes, and it should be stored out of the reach of children.

Infection, lymphoma, nephrotoxicity, increased 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 disorders (LPD), BK virus-related nephropathy, JC virus-related progressive multifocal leukoencephalopathy (PML), CMV infection, transplant rejection, 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 (PRCA), agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, parasitic infection, chest pain, abdominal distension, impaired bowel motility, loss of appetite, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, abnormal liver function (increased AST, increased ALT, increased ALP, increased LDH, increased γ-GTP), jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphopenia, pruritus, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased phosphate concentration in blood, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, taste disturbance, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, cachexia, thrombotic venous inflammation, thrombosis, vasculitis, sensation of foreign body in the throat, pain, ocular pain, redness, excessive sweating, thirst, changes in body temperature, optic neuropathy, febrile neutropenia, headache, insomnia, sensory disturbances, anxiety, delirium, paresthesia, eye twitching, limb rigidity, paralysis, drowsiness, confusion, altered consciousness, localized sensory loss, incoherence, depression, agitation, sleep disturbances, emotional lability, confusion, excitation, ideas of reference, abnormal thoughts, loss of reflex, emotional instability, hallucinations, excessive tension, disharmony, dyskinesia, neurological disorders, psychosis, inability to think, amnesia, dizziness, encephalopathy, hemorrhagic stroke, unilateral limb paralysis, nerve compression, irritability, neuropathic pain, flaccid paralysis, incomplete limb paralysis, ataxia, 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, intestinal obstruction, abnormal liver function tests, rectal disorders, duodenitis, pneumoperitoneum, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, esophagitis ulcer, pancreatic pseudocyst, chest pain, abnormal ECG, hemorrhage, hypotension, tachycardia, angina pectoris, severe vascular inflammation, orthostatic hypotension, peripheral vascular disorders, arrhythmia, atrial fibrillation, bradycardia, heart palpitations, cardiopulmonary failure, heart function loss, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic nephropathy, acute renal function failure, proteinuria, BK nephropathy, bladder spasm, oliguria, urgency incontinence, polyuria, urinary incontinence, urinary retention, vaginitis, acidosis, increase in alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing wounds, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, increased lactate dehydrogenase, weight gain, edema, gout, hypercholesterolemia, peripheral edema, diabetes mellitus, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, systemic convulsions, segmental convulsions, myalgia, myasthenia, osteoporosis, joint disease, painful muscle cramps, reduced mobility, asthma, bronchitis, pulmonary disease, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, reduced lung function, hair loss, herpes simplex, hirsutism, skin disorders, sweating, acne, fungal dermatitis, skin discoloration, skin ulcer, exfoliative dermatitis, shingles, benign skin neoplasms, abdominal enlargement, abscess, chills, hernia, peritonitis, phototoxic reactions, allergic reactions, cellulitis, influenza-like syndrome, sepsis, accidental injury, back pain, soft tissue inflammation, falls, altered sensation, temperature intolerance, ulcers, 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. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to safely preserve its efficacy.

Appearance

Yellowish hard capsule containing white powder

Package unit

60 capsules/box (10 capsules/PTP packaging x 6), 120 capsules/box [(10 capsules/PTP packaging x 6) x 2]