Unirol Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial dose of tacrolimus for adults is 0.10~0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring to the “recommended trough blood concentration.” Prevention of rejection in liver transplantation Usually, the initial dose of tacrolimus for adults is 0.05~0.10mg/kg per dose orally twice daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to symptoms, referring 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, then gradually reduce the dose. If administration of 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. 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 for elderly patients 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 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, after which the dose was 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 In adults, administer tacrolimus 3mg orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: In children, administer 0.15mg/kg per dose orally twice daily, then gradually reduce the dose. Prevention of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally twice daily, then gradually reduce the dose.

This drug suppresses immune function, which may increase the risk of infections. During treatment with this drug, patients must be closely monitored for infection symptoms, and if an infection occurs, they should inform healthcare professionals immediately. Renal function can be affected, necessitating regular renal function tests. If renal function worsens, dose adjustments or discontinuation may be required. Potassium levels in the blood may increase, so potassium concentrations should be checked frequently, and it should not be used with potassium-sparing diuretics. As it may affect the central nervous system, symptoms such as headaches, tremors, and seizures may occur; if these symptoms arise, consultation with a healthcare professional is necessary. This drug may elevate blood pressure; therefore, monitoring and managing blood pressure regularly is essential. While taking this drug, there may be an increased risk of malignancies, particularly lymphoma and skin cancer, necessitating regular check-ups. Women who are pregnant or may become pregnant should consult a doctor before taking this drug, and pregnant women should use it with caution due to risks to the fetus. Dose adjustments may be necessary for patients with impaired liver and kidney function, and elderly patients should be treated cautiously. Due to many potential drug interactions, patients should inform healthcare professionals about any other medications they are taking, particularly to avoid concomitant use with cyclosporine, potassium-sparing diuretics, certain antibiotics, antifungals, and grapefruit juice. It is crucial to frequently measure the blood concentration to maintain adequate dosing. It is advisable to take the drug on an empty stomach with water, one hour before or two to three hours after meals. Caution is needed when driving or operating machinery during treatment; if there are changes in vision or neurological symptoms, patients should consult healthcare professionals immediately. During treatment, it is recommended to use sunscreen and avoid sun exposure. In case of an overdose, seek appropriate treatment immediately from a medical institution. The safety of this drug has not been established in children, especially those under 12 years old, so it should be used cautiously.

Increased susceptibility to infection, lymphoma, nephrotoxicity, elevated serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, progressive renal dysfunction, proteinuria, tremors, headache, changes in motor function, changes in mental status, changes in sensory function, seizures, coma, delirium, occipital encephalopathy syndrome, lymphoproliferative disorders, 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, pericardial effusion, QT prolongation, Torsades de pointes, acute kidney failure, nephrotic syndrome, thrombotic microangiopathy, pancytopenia, thrombocytopenic purpura, pure red cell aplasia, agranulocytosis, hemolytic anemia, intestinal obstruction, bacterial infection, viral infection, fungal infection, protozoal infection, fever, lymphoma, reversible occipital encephalopathy syndrome, generalized seizures, consciousness disturbances, confusion, language disorders, visual impairments, hemiplegia, cerebral infarction, cerebral hemorrhage, pneumonia, worsening diabetes, pancreatitis, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, anemia, fluctuations in platelet count, leukopenia, leukocytosis, pruritus, hair loss, erythema, rash, renal tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate levels, pleural effusion, ascites, asthma, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, colitis, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, cardiomyopathy, thrombophlebitis, thrombosis, vasculitis, foreign body sensation in the throat, pain, ocular pain, erythema, excessive sweating, thirst, temperature changes, optic neuropathy, febrile neutropenia, headache, diarrhea, hypertension, nausea, constipation, loss of appetite, vomiting, melena, hematochezia, gastrointestinal perforation, elevated amylase, liver function abnormalities, jaundice, nocturia, urinary tract infection, glucosuria, hypomagnesemia, hypercholesterolemia, hyperphosphatemia, hypophosphatemia, hypertriglyceridemia, hyperchloremia, hypercalcemia, hypocalcemia, hyponatremia, hypokalemia, diabetes, elevated blood pressure, edema, tachycardia, palpitations, hypotension, bradycardia, ataxia, hallucinations, anxiety, delirium, insomnia, paresthesia, tremors, limb rigidity, paralysis, drowsiness, clouding of consciousness, localized sensory loss, nonsensical speech, depression, agitation, sleep disturbances, restlessness, worry, confusion, relief, dreams, abnormal thoughts, loss of reflexes, emotional instability, hypertonicity, ataxic spasms, neurological disorders, psychosis, inability to think, amnesia, encephalopathy, hemorrhagic stroke, partial paralysis, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete limb paralysis, dysarthria, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, dyspepsia, flatulence, gastrointestinal bleeding, elevated γ-GTP, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, duodenitis, pneumoperitoneum, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, hemorrhage, hypotension, angina, severe vasculo-venous inflammation, orthostatic hypotension, peripheral vascular disorders, arrhythmia, atrial fibrillation, bradycardia, heart flutter, cardiac arrest, congestive heart failure, deep venous thrombosis, abnormal echocardiogram, abnormal QRS complex on ECG, abnormal ST segment on ECG, cardiac dysfunction, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturnal enuresis, pyuria, toxic nephropathy, acute renal failure, proteinuria, BK nephropathy, bladder spasm, oliguria, urge incontinence, frequent urination, urinary incontinence, urinary accumulation, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperphosphatemia, hyperuricemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hypoglycemia, increased lactate dehydrogenase, weight gain, increased BUN, edema, gout, peripheral edema, diabetes mellitus, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, decreased plasma iron, increased hematocrit, abnormal hemoglobin, increased leukocytes, systemic seizures, limb spasms, myasthenia gravis, osteoporosis, joint disease, painful muscle cramps, reduced movement, 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 disorders, sweating, acne, fungal dermatitis, skin discoloration, skin ulcers, exfoliative dermatitis, shingles, benign cutaneous tumors, abdominal distension, abscess, chills, hernia, peritonitis, photosensitivity reaction, allergic reaction, cell inflammation, influenza-like syndrome, sepsis, accidental injury, back pain, soft tissue infection, falls, dysesthesia, heat intolerance, ulceration, heartburn, epigastric discomfort, retinopathy, cardiac arrest, lumbago, hoarseness, cold, shingles, autoimmune response, exacerbation of lupus erythematosus, warts, eczema, cholecystitis, chickenpox, pyelonephritis, amenorrhea, appendicitis, hyperthermia

This medicine should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best stored at room temperature between 1°C and 30°C. Storing in this manner will help preserve the effectiveness of the drug for a longer period.

Appearance

A hard capsule with a pale yellow upper and lower part containing white powder

Package unit

100 capsules/box [(10 capsules/PTP x 10)]