Cellogla Capsule (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation The usual initial oral dosage for adults is 0.10~0.15mg/kg of tacrolimus per dose twice daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to the patient's symptoms, referring to the “recommended target trough blood concentration.” Prevention of rejection in liver transplantation The usual initial oral dosage is 0.05~0.10mg/kg of tacrolimus per dose for adults and 0.15mg/kg per dose for pediatric patients, twice daily, followed by gradual dose reduction. Adjust the maintenance dose as appropriate according to the patient's symptoms, referring to the “recommended target trough blood concentration.” Bone marrow transplantation: Prevention of graft rejection and graft-versus-host disease following bone marrow transplantation The usual dosage is 0.06mg/kg of tacrolimus per dose orally twice daily, starting 1 day before transplantation. During the initial period after transplantation, administer 0.06mg/kg of tacrolimus per dose orally twice daily, followed by gradual dose reduction. If treatment with this drug is initiated after the onset of graft-versus-host disease, the usual dosage is 0.15mg/kg of tacrolimus per dose orally twice daily. Adjust the dose as appropriate according to symptoms. Chronic rheumatoid arthritis The usual adult dosage is 3mg of tacrolimus orally once daily after the evening meal. Patients who develop adverse reactions require regular monitoring. The usual dosage for elderly patients is 1.5mg orally once daily after the evening meal; it may be increased to 3mg according to symptoms. Lupus nephritis The usual adult dosage is 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when the response was insufficient at 12 weeks after treatment initiation and there were no safety concerns, this drug was administered at 4 mg/day for 4 weeks to confirm safety and 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 consideration. When a sufficient effect on lupus nephritis was achieved, this drug was reduced to the dose that maintained the effect. Myasthenia gravis For adults, administer 3mg of tacrolimus orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: Pediatric patients should receive 0.15mg/kg per dose orally twice daily. Prevention of rejection in liver transplantation: Pediatric patients should receive 0.15mg/kg per dose orally twice daily.

This medication can suppress the immune system, thus increasing susceptibility to infections. Therefore, patients using this medication should be closely monitored for symptoms of infection. Additionally, this medication can affect kidney function, posing a risk of decreased kidney function, and regular kidney function testing is necessary. If kidney function worsens, dose adjustment or discontinuation may be needed. This medication can increase serum potassium levels, which may lead to hyperkalemia, so serum potassium concentrations should be monitored frequently, and concomitant use with potassium-sparing diuretics may be risky. It may affect the nervous system and cause symptoms such as headache, tremors, seizures, and changes in mental status; any occurrence of these symptoms should be reported to medical personnel immediately. In some patients, this medication may increase the risk of malignancies such as lymphoma or skin cancer, therefore regular check-ups are necessary during long-term use. During pregnancy, it may affect the fetus, hence women planning to become pregnant or who are pregnant should consult a doctor, and nursing mothers should cease breastfeeding while taking this medication. This medication should be administered with caution to patients with impaired liver and kidney function or to the elderly, with frequent monitoring of drug levels for appropriate dosage adjustments. Moreover, there are many drug interactions with this medication, so dosage adjustment or monitoring may be needed based on concomitant medications; therefore, patients should inform their healthcare provider of any other medications they are taking. In the event of overdose, renal and pancreatic dysfunction, nervous system abnormalities, heart problems, etc. may occur, so the prescribed dosage and administration should be strictly followed. During treatment, regular blood tests and clinical assessments should be performed to check for adverse reactions, and patients should report any abnormal symptoms to medical personnel immediately.

Increased susceptibility to infections, possibility of lymphoma development, vasoconstrictive effect, toxic tubulopathy, interstitial nephritis effect, acute kidney dysfunction, increased serum creatinine, hyperkalemia, decreased urea excretion, hyperuricemia, chronic kidney failure, tremors, headache, changes in motor function, alterations in mental state, sensory changes, seizures, coma, delirium, posterior reversible encephalopathy syndrome (PRES), hypertension, lymphoproliferative diseases, possibility of malignant tumor formation, BK virus-related nephropathy, JC virus-related progressive multifocal leukoencephalopathy (PML), CMV infection, transplant rejection, insulin-dependent post-transplant diabetes, hyperglycemia, myocardial dysfunction, decreased cardiac function, enlargement of cardiac chambers, 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, pancytopenia, thrombocytopenic purpura, pure red cell aplasia (PRCA), agranulocytosis, hemolytic anemia, bowel obstruction, bacterial infections, viral infections, fungal infections, protozoan infections, systemic infections, local infections, reversible posterior encephalopathy syndrome, generalized seizures, consciousness disturbances, confusion, speech disorders, visual impairment, hemiplegia, cerebral infarction, cerebral hemorrhage, aspiration pneumonia, worsening of diabetes, pancreatitis, Steven-Johnson syndrome (mucocutaneous syndrome), dyspnea, 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 rigidity, paralysis, drowsiness, stupor, altered consciousness, local sensory loss, nonsensical talk, depression, agitation, chest pain, abdominal distension, bowel motility disorders, anorexia, diarrhea, abdominal pain, gastric ulcer, duodenal ulcer, colitis, stomatitis, nausea, vomiting, melena, hematochezia, gastrointestinal perforation, increased amylase, liver function abnormalities (AST increase, ALT increase, ALP increase, LDH increase, γ-GTP increase), jaundice, anemia, increased or decreased platelet count, leukopenia, leukocytosis, lymphocytopenia, pruritus, alopecia, erythema, rash, tubular necrosis, hypertrophic cardiomyopathy, gynecomastia, vasodilation, decreased serum phosphate concentration, pleural effusion, ascites, asthma, fever, weight loss, flushing, systemic malaise, menorrhagia, myalgia, arthralgia, dysgeusia, aplastic anemia, cerebral infarction, colitis, toxic epidermal necrolysis (Lyell's syndrome), glaucoma, ketosis, nystagmus, mania, meningitis, cholecystitis, thrombophlebitis, thrombosis, vasculitis, throat foreign body sensation, pain, ocular pain, redness, hyperhidrosis, thirst, temperature changes, optic neuropathy, febrile neutropenia, tremors, diarrhea, hypertension, nausea, kidney dysfunction, headache, insomnia, sensory disturbances, dizziness, dyspepsia, chest pain, urinary tract infection, frequent urination, hypophosphatemia, hyperlipidemia, edema, infection, limb edema, weakness, abdominal pain, pain, fever, dyspnea, increased cough, arthralgia, rash, pruritus, sleep disturbances, agitation, worry, confusion, depression, euphoria, dreams, abnormal thoughts, drowsiness, loss of reflexes, emotional instability, hyperarousal, disharmony, dystonic muscle spasms, neurological disorders, psychosis, impaired thought, forgetfulness, encephalopathy, hemorrhagic stroke, mono paresis, nerve compression, irritability, neuralgia, flaccid paralysis, partial limb paralysis, inferior limb dysfunction, aphasia, visual impairment, amblyopia, tinnitus, cataracts, photophobia, hearing loss, ear pain, otitis media, cholangitis, cholestatic jaundice, gastrointestinal bleeding, gastrointestinal perforation, hepatitis, increased appetite, liver damage, oral candidiasis, dysphagia, esophagitis, gastritis, bowel obstruction, abnormal liver function tests, rectal dysfunction, duodenitis, air retention in the gastrointestinal tract, gastroesophageal reflux, gastrointestinal disorders, granulomatous hepatitis, ulcerative esophagitis, pancreatic pseudocyst, chest pain, abnormal ECG, hypotension, angina, severe vascular venous inflammation, orthostatic hypotension, peripheral vascular disorder, atrial fibrillation, bradycardia, cardiac trembling, cardiac and respiratory failure, congestive heart failure, deep vein thrombosis, abnormal echocardiogram, abnormal QRS complex on ECG, abnormal ST complex on ECG, heart failure, increased heart rate, syncope, thrombosis, vasculitis, hematuria, kidney failure, cystitis, dysuria, hydronephrosis, renal tubular necrosis, nocturia, pyuria, toxic nephropathy, acute renal failure, proteinuria, BK nephropathy, bladder spasm, decreased urine output, urinary urgency incontinence, frequent urination, urinary incontinence, urinary retention, vaginitis, acidosis, increased alkaline phosphatase, alkalosis, bilirubinemia, refractory wounds, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypocalcemia, hyponatremia, hypoproteinemia, AST increase, ALT increase, decreased bicarbonate, dehydration, hyperglycemia, hypoglycemia, increased lactate dehydrogenase, weight gain, increased BUN, edema, gout, hypercalcemia, hypercholesterolemia, hyperkalemia, hypophosphatemia, peripheral edema, diabetes mellitus, Cushing's syndrome, coagulopathy, petechial bleeding, hypochromic anemia, leukopenia, thrombocytopenia, erythrocytosis, decreased prothrombin, decreased plasma iron, increased hematocrit, hemoglobin abnormalities, leukocytosis, generalized seizures, limb seizures, myalgia, myasthenia, osteoporosis, joint disease, painful muscle spasms, asthma, bronchitis, lung disease, pulmonary edema, pharyngitis, pneumonia, respiratory distress, rhinitis, sinusitis, voice changes, pneumothorax, hiccups, reduced lung function, alopecia, herpes simplex, hypertrichosis, skin diseases, sweating, acne, fungal skin disease, skin discoloration, skin ulcers, exfoliative dermatitis, herpes zoster, benign skin tumors, abdominal enlargement, abscess, chills, hernia, peritonitis, photosensitivity reaction, allergic reaction, cellulitis, influenza-like syndrome, sepsis, accidental injury, back pain, soft tissue infections, falls, altered sensation, temperature intolerance, ulcers, heartburn, epigastric discomfort, retinopathy, cardiac arrest, low back pain, hoarseness, cold, herpes zoster, autoimmune responses, thrombocytopenia, pneumonia

Store this medication in a tightly sealed container to prevent exposure to air or light, ideally at room temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevent degradation.

Appearance

A white hard capsule containing white powder.

Package unit

100 capsules (10 capsules/PTP × 10)