Neuromis Capsule 0.5 mg (Tacrolimus Hydrate)

Adult dose

Suppression of rejection in kidney transplantation Usually, the initial dose for adults 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 appropriately according to symptoms, with reference to the “recommended target trough blood concentration.” Suppression of rejection in liver transplantation Usually, the initial dose for adults 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 appropriately according to symptoms, with reference to the “recommended target trough blood concentration.” General considerations for kidney and liver transplantation The initial doses given above are intended only as guidelines. Administration of this drug should be based primarily on clinical assessment of rejection and tolerability, together with measurement of blood concentrations in each patient (see “Recommended target trough blood concentrations” below). If clinical symptoms of rejection are evident, a change in the immunosuppressive treatment regimen should be considered. Recommended target trough blood concentrations in kidney and liver transplantation (whole blood trough level) Various immunoassays, including the semi-automated microparticle enzyme immunoassay (MEIA), are available for monitoring tacrolimus whole-blood concentrations (whole blood level) to optimize the dose. Comparisons between blood concentrations reported in the literature and those measured in clinical practice must be made with detailed knowledge of the assay used. In recent clinical practice, whole-blood concentrations are monitored using immunoassays. Tacrolimus trough blood concentrations should be monitored continuously. When this drug is administered orally, the tacrolimus trough blood concentration should be measured immediately before the next dose (approximately 12 hours after the previous dose). The frequency of blood concentration measurements should be determined according to clinical need. Because tacrolimus has low clearance, changes in blood drug concentrations may take several days to appear after adjustment of the dose. During the initial period after transplantation, monitoring should be performed approximately twice a week; during the maintenance period, monitoring should be performed regularly. Trough blood concentrations should be monitored when adjusting the dose, changing immunosuppressive therapy, or administering this drug concomitantly with drugs that may affect tacrolimus whole-blood concentrations (see “Interactions”). According to the results of clinical trial analyses, successful outcomes were achieved in most patients when tacrolimus trough blood concentrations were maintained below 20ng/mL. The patient's clinical condition should be taken into account when interpreting blood concentrations. Recommended target trough blood concentrations: In clinical practice, initial trough blood concentrations after transplantation were 5~20ng/mL in liver transplant patients and 10~20ng/mL in kidney transplant patients. Thereafter, during the maintenance period, trough blood concentrations were 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, 0.06mg/kg of tacrolimus per dose is administered orally twice daily. During the initial period after transplantation, 0.06mg/kg of tacrolimus per dose is administered orally twice daily, followed by gradual dose reduction. If administration of this drug is initiated after the onset of graft-versus-host disease, the usual dose is 0.15mg/kg of tacrolimus per dose, administered orally twice daily. The dose should also be adjusted appropriately according to symptoms. Since absorption of this preparation after oral administration is variable and differs between patients, blood concentrations should be measured according to the patient's condition, and the dose adjusted with reference to the trough level, in order to prevent adverse reactions when blood concentrations are high and rejection or graft-versus-host disease when blood concentrations are low. Blood concentrations should be measured frequently, particularly immediately after transplantation or initiation of treatment. Caution is also required because adverse reactions are likely to recur when the trough blood concentration remains above 20ng/mL for an extended period. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus administered 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 administered 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 administered orally once daily after the evening meal. In clinical trials, when the effect was insufficient at 12 weeks after treatment initiation and there were no safety concerns, 4 mg/day of this drug 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 in increments of 0.5 mg or 1 mg, taking the patient's condition into account. When a sufficient effect on lupus nephritis was achieved, the dose of this drug was reduced to the level that maintained the effect. Myasthenia gravis For adults, 3mg of tacrolimus is administered orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: In children, administer 0.15mg/kg per dose orally 2 times daily, then gradually reduce the dose. Adjust the maintenance dose as appropriate according to symptoms, referring to the ‘recommended target trough blood concentration.’ Prevention of rejection in liver transplantation: In children, administer 0.15mg/kg per dose orally 2 times daily, then gradually reduce the dose. Adjust the maintenance dose as appropriate according to symptoms, referring to the ‘recommended target trough blood concentration.’

This medication is an immunosuppressant and may suppress the immune system, increasing the risk of infections. Therefore, it should only be used by healthcare professionals experienced in immunosuppressive therapy and treatment of transplant patients. During treatment, continuous monitoring of the patient's condition is necessary within appropriate medical facilities. This medication can affect kidney function, potentially leading to acute and chronic renal dysfunction. Particularly, patients with compromised renal function must be monitored frequently through blood tests, and dosage adjustments or discontinuation may be necessary if needed. Serum potassium levels may increase; hence, potassium levels should be regularly checked, and it should not be combined with potassium-sparing diuretics. Neurological effects may lead to symptoms such as headaches, tremors, convulsions, coma, and confusion. If these symptoms occur, consultation with a physician is essential, and it may necessitate dose reduction or discontinuation. Patients using this medication are at an increased risk of developing malignancies such as lymphomas, thus regular check-ups and vigilance are required. Immunosuppression may increase the risk of latent viral infections or opportunistic infections, and any signs of infection should be promptly reported to healthcare providers. Interactions may occur when used concurrently with other immunosuppressants or specific medications, so it is crucial to consult a physician or pharmacist before taking. Women who are pregnant or may become pregnant must consult a physician before using this medication, and caution is warranted during pregnancy as it may pose risks to the fetus. This medication can also be transmitted through breast milk, so it is recommended to discontinue breastfeeding during treatment. Elderly patients or those with compromised liver or kidney function should be cautiously dosed and monitored. While taking this medication, regular tests for blood pressure, blood sugar, kidney function, liver function, and serum drug levels should be conducted, and any abnormal symptoms should be immediately discussed with healthcare providers. This medication is best taken on an empty stomach, one hour before or two to three hours after meals to aid absorption. In case of overdose, renal and pancreatic dysfunction, neurological abnormalities, and heart diseases may occur, so strict adherence to dosage is necessary. It is advisable to avoid grapefruit juice during the use of this medication and to refrain from receiving live vaccinations. When administered, it is important to educate the patient about the risks and side effects of the medication.

Infection, lymphoma, vasoconstriction, toxic tubulopathy, interstitial nephritis effects, acute kidney injury, increased serum creatinine, hyperkalemia, decreased urea elimination, hyperuricemia, chronic kidney disease, proteinuria, tremors, headache, changes in motor function, alterations in mental status, changes in sensory function, seizures, coma, confusion, posterior reversible encephalopathy syndrome (PRES), convulsions, visual impairment, hypertension, lymphoproliferative disease (LPD), BK virus nephropathy, JC virus-related PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, decreased cardiac function, cardiac chamber dilation, left ventricular hypertrophy, heart failure, ventricular arrhythmias, supraventricular arrhythmias, myocardial infarction, angina, 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, protozoan infection, lymphoma, malignant tumors, generalized convulsions, altered consciousness, disorientation, speech impairment, hemiplegia, cerebral infarction, cerebral hemorrhage, epilepsy pneumonia, diabetes mellitus, pancreatitis, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, pleural effusion, ascites, asthma, fever, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, gastroparesis, thrombophlebitis, thrombosis, vasculitis, sensation of a foreign body in the throat, pain, ocular pain, erythema, excessive sweating, thirst, temperature changes, optic neuropathy, fever-induced neutropenia, diarrhea, nausea, vomiting, melena, hemorrhage, gastrointestinal perforation, increased amylase, liver dysfunction, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, chest pain, abdominal distention, bowel motility disorders, anorexia, gastric ulcer, duodenal ulcer, colitis, stomatitis, cholangitis, cholestasis jaundice, gastrointestinal bleeding, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, bowel obstruction, abnormalities in liver function tests, rectal dysfunction, duodenitis, intestinal air obstruction, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, hemorrhage, hypotension, tachycardia, angina, severe vascular thrombosis, orthostatic hypotension, peripheral vascular disease, arrhythmia, atrial fibrillation, bradycardia, cardiac tremors, cardiac failure, cardiac dysfunction, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic nephropathy, acute kidney function loss, proteinuria, BK virus nephropathy, bladder spasms, decreased urine output, urge incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, hyperbilirubinemia, non-healing, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, increased AST, increased ALT, decreased bicarbonate, dehydration, hyperglycemia, hypoglycemia, increased lactate dehydrogenase, weight gain, increased BUN, edema, gout, hypercalcemia, hypercholesterolemia, hypophosphatemia, peripheral edema, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, reduced plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, sleep disorders, agitation, anxiety, confusion, depression, fortune-seeking, fortune, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hallucinations, hypertonia, disharmony, dilated cardiomyopathy, neuropathy, psychosis, inability to think, amnesia, dizziness, encephalopathy, hemorrhagic stroke, monoparesis, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete quadriplegia, dystonia, aphasia, visual impairment, amblyopia, tinnitus, cataract, photophobia, hearing loss, ear pain, otitis media, heartburn, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, shingles, autoimmune response, soft tissue infection, thrombocytopenia, pneumonia, warts, eczema, cholecystitis, chickenpox, pyelonephritis, amenorrhea, appendicitis, hyperpyrexia, uterine leiomyoma, cardiac arrest, cytomegalovirus infection, cytomegalovirus gastrointestinal infection, secondary malignancy, hepatic failure due to reactivation of hepatitis B

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should ideally be maintained at room temperature between 1°C and 30°C. This helps in preserving the medication's efficacy.

Appearance

Hard capsule in light yellow color containing white powder

Package unit

100 capsules/PTP [10 capsules/PTP X 10]