Tarimus Capsule 1 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation The usual 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 minimum whole blood concentration.” Prevention of rejection in liver transplantation The usual 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 minimum whole blood concentration.” Bone marrow transplantation: Prevention of graft rejection and graft-versus-host disease following bone marrow transplantation The usual regimen is to administer 0.06mg/kg of tacrolimus per dose orally twice daily, starting 1 day before transplantation. During the initial post-transplant period, administer 0.06mg/kg of tacrolimus 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, the usual dose is 0.15mg/kg of tacrolimus per dose orally twice daily. Adjust the dose appropriately according to symptoms. Chronic rheumatoid arthritis The usual adult dose is 3mg of tacrolimus orally once daily after the evening meal. Regular monitoring is required in patients who develop adverse reactions. The usual dose in elderly patients is 1.5mg orally once daily after the evening meal; the dose may be increased to 3mg depending on symptoms. Lupus nephritis The usual adult dose is 3mg of tacrolimus 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, 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 account. When an adequate effect on lupus nephritis was achieved, this medicine was reduced to the dose that maintained that effect. Myasthenia gravis Administer 3mg of tacrolimus orally to adults once daily after a meal.

Child dose

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

This medication can suppress the immune system, potentially increasing the risk of infections. Patients using this medication should be under the care of an experienced physician, with regular testing and monitoring required. It may affect kidney function, thus, dosage adjustment is necessary for patients with renal impairment, and immediate consultation with a physician is advised in the event of worsening kidney function. It can increase serum potassium levels, so it should not be used with potassium-sparing diuretics, and regular monitoring of serum potassium levels is required. Nervous system side effects such as tremors, headaches, seizures, and changes in mental state may occur; therefore, it is crucial to notify a healthcare provider immediately if these symptoms arise. This medication may increase the risk of cancer, particularly lymphomas and skin cancers; hence periodic examinations are required during long-term use. The risk of viral infections is increased, so patients should notify healthcare providers immediately if symptoms of infections occur. Caution is needed when using this medication with other immunosuppressants and especially never with cyclosporine simultaneously. During pregnancy, it could potentially affect the fetus, so women of childbearing age should use appropriate contraception, and strict medical supervision is necessary during pregnancy. For breastfeeding mothers, it is recommended to discontinue breastfeeding as this medication can be transmitted through breast milk. It should be prescribed cautiously to children and the elderly, particularly since safety and efficacy in children have not been fully established. In case of overdose, symptoms such as renal impairment, neurological abnormalities, hypertension, and others may occur, and immediate medical attention is necessary. Regular monitoring of drug concentrations in the blood is essential to maintain appropriate dosage while taking this medication. It is advisable to take the medication on an empty stomach, either one hour before meals or two to three hours after meals with water. Numerous medications may interact with this drug, and it is imperative to inform healthcare providers about any other medications being taken. Consumption of grapefruit juice should be avoided as it may elevate the serum concentration of this drug, increasing the risk of side effects. During treatment with this medication, reduce sun exposure and use sunscreen to protect the skin. Existing conditions such as heart dysfunction, hypertension, diabetes, etc. require more careful management. Gastrointestinal perforation, interstitial pneumonia, and thrombotic microangiopathy have been reported as side effects of this medication; any unusual symptoms should be reported to a healthcare provider immediately.

Increased susceptibility to infections, possibility of lymphoma development, vasoconstriction effect, toxic tubular nephropathy, interstitial nephritis effect, acute and chronic 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 status, changes in sensory function, seizures, coma, confusion, occipital encephalopathy syndrome, hypertension, lymphoma, malignant tumors, lymphoproliferative disorders, BK virus nephropathy, JC virus associated PML, CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial disorder, decreased cardiac function, cardiomegaly, ventricular wall hypertrophy, heart failure, ventricular arrhythmia, supraventricular arrhythmia, myocardial infarction, angina, 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 infection, viral infection, fungal infection, protozoal infection, fever, lymphadenopathy, generalized seizures, altered consciousness, confusion, speech impairment, visual impairment, hemiplegia, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening of diabetes, pancreatitis, Stevens-Johnson syndrome, respiratory distress, acute respiratory distress syndrome, myasthenic crisis, increased blood pressure, edema, tachycardia, palpitations, decreased blood pressure, bradycardia, ataxia, hallucinations, sensory disturbances, anxiety, delirium, insomnia, paresthesia, eye twitching, limb stiffness, paralysis, drowsiness, consciousness disturbance, localized sensory loss, hallucinations, depression, agitation, chest pain, abdominal distension, gastrointestinal motility disorder, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, black stool, bleeding, gastrointestinal perforation, increased amylase, liver dysfunction, jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, itching, hair loss, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, weight loss, flushing, generalized malaise, menorrhagia, myalgia, arthralgia, taste disturbances, aplastic anemia, cerebral infarction, toxic epidermal necrolysis, glaucoma, ketosis, nystagmus, mania, meningitis, cholecystitis, thrombophlebitis, thrombosis, vasculitis, sensation of foreign body in throat, pain, eye pain, redness, excessive sweating, thirst, temperature changes, optic nerve dysfunction, febrile neutropenia, tremors, diarrhea, hypertension, nausea, renal dysfunction, increased creatinine, increased blood urea nitrogen, urinary tract infection, increased urinary frequency, hyperkalemia, hypokalemia, hyperglycemia, hypomagnesemia, anemia, leukocytosis, thrombocytopenia, abdominal pain, pain, fever, weakness, low back pain, ascites, limb edema, pleural effusion, atelectasis, respiratory distress, itching, rash, sleep disturbances, agitation, worry, confusion, depression, hyperthymia, dream, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hypervigilance, disharmony, myotonic contractions, neurological disorders, psychosis, inability to think, amnesia, dizziness, encephalopathy, hemorrhagic stroke, unilateral lower limb paralysis, nerve compression, irritability, neuralgia, flaccid paralysis, incomplete limb paralysis, obstructive sleep apnea, aphasia, visual impairment, amblyopia, tinnitus, cataract, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestasis jaundice, dyspepsia, flatulence, gastrointestinal bleeding, hepatitis, increased appetite, liver damage, oral moniliasis, dysphagia, esophagitis, gastritis, intestinal obstruction, abnormal liver function tests, rectal disorders, duodenitis, air retention in stomach and intestines, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, bleeding, hypotension, angina, severe vascular venous inflammation, orthostatic hypotension, peripheral vascular disorders, arrhythmia, atrial fibrillation, slow pulse, cardiac tremors, cardiopulmonary failure, cardiac function loss, increased heart rate, syncope, thrombosis, vasodilation, hematuria, renal failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic kidney disease, acute renal function loss, proteinuria, BK virus nephropathy, bladder spasms, decreased urine output, urgency urinary incontinence, increased urinary frequency, 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, edema, gout, hypercalcemia, hypercholesterolemia, peripheral edema, diabetes mellitus, Cushing's syndrome, coagulopathy, petechial hemorrhage, hypochromic anemia, leukopenia, decreased platelet count, increased erythrocytes, decreased prothrombin, decreased plasma iron, increased hematocrit, abnormal hemoglobin, leukocytosis, arthralgia, generalized seizures, limb spasms, myalgia, myasthenia, osteoporosis, joint disorders, painful muscle spasms, decreased movement, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory disability, 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 skin neoplasms, abdominal enlargement, abscess, chills, hernia, peritonitis, photosensitivity reaction, allergic reaction, cell inflammation, influenza-like syndrome, sepsis, accidental trauma, back pain, soft tissue infection, falling, altered sensations, heat intolerance, ulcer, heartburn, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, shingles, warts, eczema, cholecystitis, chickenpox, pyelonephritis, amenorrhea, appendicitis, hyperthermia, autoimmune antibody response, exacerbation of lupus erythematosus, uterine leiomyoma, cardiac arrest, cytomegalovirus infection, cytomegalovirus gastrointestinal infection, secondary malignancy, liver 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. It is recommended to maintain a storage temperature between 1°C and 30°C at room temperature. Storing it this way will help preserve its effectiveness over time.

Appearance

Opaque white hard capsules containing white powder

Package unit

100 capsules/box [10 capsules/PTP × 5 × 2 packs]