Tacrolimus Tablets 2 mg (Tacrolimus Hydrate)

Adult dose

Prevention of rejection in kidney transplantation Usually, the initial dose for adults is 0.10~0.15mg/kg of tacrolimus per dose, orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted according to symptoms, referring to the 'recommended minimum blood concentration.' Prevention of rejection in liver transplantation Usually, the initial dose for adults is 0.05~0.10mg/kg of tacrolimus per dose, orally twice daily, followed by gradual dose reduction. The maintenance dose should be adjusted according to symptoms, referring to the 'recommended minimum blood concentration.' Bone marrow transplantation: Graft rejection and graft-versus-host disease following bone marrow transplantation Usually, starting 1 day before transplantation, administer 0.06mg/kg of tacrolimus per dose orally twice daily. During the early post-transplant period, administer 0.06mg/kg of tacrolimus per dose orally twice daily, followed by gradual dose reduction. If administration of 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. The dose should also be adjusted appropriately according to symptoms. Because absorption of this preparation after oral administration is variable and differs among patients, measure blood concentrations according to the patient's condition and adjust the dose with reference to the trough level to prevent adverse effects 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. Also, use caution because adverse effects are likely to recur when the period during which the trough level exceeds 20ng/mL is prolonged. Chronic rheumatoid arthritis The usual dose for adults is 3mg of tacrolimus orally once daily after the evening meal. Patients who develop adverse reactions require regular monitoring. For elderly patients, the usual dose is 1.5mg orally once daily after the evening meal, which may be increased to 3mg according to symptoms. Lupus nephritis The usual dose for adults is 3mg of tacrolimus orally once daily after the evening meal. In clinical trials, when efficacy was considered insufficient and there were no safety concerns at 12 weeks after treatment initiation, this medicine was administered at 4 mg/day for 4 weeks to confirm safety and then increased to 5 mg/day. If adverse reactions were observed, the dose was appropriately reduced by 0.5 mg or 1 mg, taking the patient's condition into consideration. If an adequate effect on lupus nephritis was achieved, this medicine was reduced to the dose that maintained that effect. Myasthenia gravis For adults, administer 3mg of tacrolimus orally once daily after a meal.

Child dose

Prevention of rejection in kidney transplantation: For children, administer 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction. Prevention of rejection in liver transplantation: For children, administer 0.15mg/kg per dose orally twice daily, followed by gradual dose reduction.

This drug suppresses immune function, making patients more susceptible to infections, and increases the risk of malignant tumors such as lymphoma. Therefore, it should only be used by physicians experienced in immunosuppressive therapy, and patients must be under thorough observation by qualified health professionals. This drug can cause damage to the kidneys and nerves, especially when used in high doses. Patients with weakened kidney function should undergo frequent testing to adjust the drug dose, and may need to temporarily reduce or suspend the dose when necessary. During treatment, blood potassium levels may rise, so they should be monitored frequently and this drug should not be taken with potassium-sparing diuretics. It may also cause neurological side effects such as headache, tremors, changes in mental state, and sensory abnormalities; in severe cases, seizures or coma may occur, requiring caution. Patients taking this drug may have an increased risk of malignant tumor occurrences, such as lymphoma or skin cancer, and regular check-ups are necessary. Increased susceptibility to latent viral infections or other infectious diseases occurs due to weakened immunity, potentially leading to serious complications. Any dosage forms or adjustments of this drug should be made under strict supervision by a transplant specialist, and drug dosage and blood concentrations must be carefully managed. This drug may induce diabetes post-transplant, so blood glucose levels should be monitored periodically, and patients should consult a doctor immediately if diabetic symptoms appear. When administered to rheumatoid arthritis or lupus nephritis patients, it should be employed only with careful consideration by physicians experienced in treating those conditions. During treatment, attention should be paid to interactions with other medications, especially those that cause nephrotoxicity or affect CYP3A4 enzymes; blood concentration and kidney function should be monitored frequently in such cases. Women who are pregnant or may become pregnant should consult a physician before taking this drug. Pregnant women should use it cautiously as it may affect the fetus. This drug can excrete into breast milk, so it is advisable to avoid taking it while breastfeeding. Elderly individuals may have reduced kidney and liver function; therefore, their conditions should be carefully monitored and usage should be cautious. In the event of overdose, serious side effects may occur in the kidneys, pancreas, heart, etc.; hence, the dosing regimen must be strictly adhered to. When taking this medication, it is beneficial to take it one hour before meals or on an empty stomach 2 to 3 hours after meals with plenty of water to aid absorption. Care should be taken to avoid the powder of this drug coming into contact with skin or mucous membranes; if contact occurs, it should be washed off immediately. If any unusual symptoms or side effects occur during treatment, immediate consultation with healthcare professionals is necessary, and regular clinical tests should be conducted to consistently monitor kidney function, blood sugar, blood pressure, etc.

• Myocardial dysfunction
• decreased cardiac function
• heart chamber enlargement
• ventricular wall thickening
• heart failure
• ventricular arrhythmia
• supraventricular arrhythmia
• myocardial infarction
• angina
• pericardial effusion

Store this drug in an airtight container to protect it from air and moisture. Additionally, it is advisable to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness.

Appearance

Orange rectangular film-coated tablets

Package unit

50 tablets (10 tablets/PTP × 5)