Cyclosporin Soft Capsules 25 mg

Adult dosage

1. Organ transplantation 1) Initial dose: Administer 10 ∼ 15 mg/kg of body weight per day in 2 divided doses, starting 12 hours before surgery. 2) Maintenance dose: For 1 ∼ 2 weeks after surgery, use the same dose as the initial dose, then gradually reduce the dose according to blood levels until it reaches 2 ∼ 6 mg/kg of body weight per day in 2 divided doses. The total daily dose of this medicine must always be administered in 2 divided doses. 3) Concomitant therapy: When treated with concomitant corticosteroids or triple or quadruple immunosuppressive therapy, a lower dose may be used (e.g., initial oral dose: 3 ∼ 6 mg/kg of body weight in 2 divided doses). 2. Bone marrow transplantation 1) The first dose should be administered one day before surgery, preferably by intravenous injection (see Dosage and Administration for the injection formulation). 2) Administer 12.5 ∼ 15 mg/kg of body weight per day in 2 divided doses on the day before surgery. Administer a maintenance dose of approximately 12.5 mg/kg of body weight per day for 3 ∼ 6 months (preferably 6 months) after transplantation, before reducing the dose to 0 (zero) by 1 year after transplantation. 3) Patients with malabsorptive gastrointestinal disorders may require higher oral doses or intravenous injection. The total daily dose of this medicine must be administered in 2 divided doses. 4) GVHD may occur after discontinuation of this medicine, but generally responds well to re-administration. Use a low dose to treat chronic mild GVHD. 3. Psoriasis 1) The initial dose is 2.5 mg/kg of body weight per day in 2 divided doses. If there is no improvement after 4 weeks, the dose may be increased by 0.5 ~ 1 mg/kg of body weight per day each month, up to 5 mg/kg of body weight per day. 2) Discontinue treatment if there is no improvement in the lesions after 4 weeks of use at 5 mg/kg of body weight per day, or if the effective dose does not comply with the information in the following safety information. 3) For patients who require rapid improvement of symptoms, the initial dose is 5 mg/kg of body weight per day. The maintenance dose should be adjusted individually to the minimum effective dose, not exceeding 5 mg/kg of body weight per day. 4) If improvement in symptoms is maintained for 6 months, gradually reduce the dose of this medicine, even though the risk of relapse after discontinuation is very high. 4. Nephrotic syndrome 1) To induce remission, a dose of 5 mg/kg per day in adults, administered in 2 divided doses, is recommended. However, for patients with renal function below the limit, the initial dose should not exceed 2.5 mg/kg per day (maximum serum creatinine level: adults >200 μmol/L). 2) Patients who do not respond adequately to this medicine (primarily steroid-resistant patients) should receive it in combination with low-dose oral steroids. Discontinue this medicine if no improvement is seen after 3 months. 3) Adjust the dose individually according to safety (primarily serum creatinine) and efficacy (proteinuria). 4) However, do not exceed 5mg/kg/ day in adults, and gradually reduce the dose to the minimum effective dose for maintenance. 5. Rheumatoid arthritis 1) The recommended dose during the first 6 weeks of treatment is 3 mg/kg of body weight per day, administered orally in 2 divided doses. After 6 weeks, if symptom improvement is insufficient, the dose may be increased to 5 mg/kg of body weight per day only in patients whose serum creatinine has not increased by 30 % or more; treatment may continue for up to 12 weeks. 2) Discontinue treatment if symptoms have not improved after use at the maximum daily dose for 12 weeks, or if the patient does not meet the criteria in ‘*Safety Information’. The maintenance dose should be adjusted individually to the minimum effective dose, without exceeding the maximum dose. 6. Aplastic anemia Usually, administer 6 mg/kg of body weight per day in 2 divided doses, and measure the trough blood concentration. If it is 200 ng/mL(serum) or higher, reduce the dose to 4 mg/kg of body weight per day. 7. Switching from conventional oral cyclosporine to the microemulsion formulation 1) Exposure may increase when switching from conventional oral cyclosporine to this medicine; therefore, observe the following: Initially, administer this medicine at the same dose as the conventional formulation. Monitor total blood cyclosporine trough levels for the first 4 ~ 7 days after switching, and clinical safety parameters such as serum creatinine and blood pressure for the first 2 months after switching. Adjust the dose accordingly if the blood level is outside the therapeutic range or if any of the safety parameters are abnormal. 2) Switching from conventional oral cyclosporine to another oral cyclosporine formulation should be done under the supervision of a physician and requires caution. Monitor after switching to the new formulation to ensure that the previous cyclosporine blood level is achieved. 8. Precautions for administration 1) The total daily dose of this medicine must always be administered in 2 divided doses. 2) A distinctive odor when opening the blister packaging is normal and does not indicate any problem. Swallow the capsules whole.

Children's dosage

4. Nephrotic syndrome 1) To induce remission, administration of 6 mg/kg per day in children, divided into 2 doses daily, is recommended. However, in patients with renal function below the threshold, the initial dose should not exceed 2.5 mg/kg per day (maximum serum creatinine: children >140 μmol/L). 4) However, do not exceed 6mg/kg/day in children; gradually reduce the dose to the minimum effective maintenance dose.

This medication should not be used in certain patients. For instance, do not administer it to those who have allergies or hypersensitive reactions to this medication or its components. Patients with kidney diseases, uncontrolled infections, or malignancies should also avoid using this medication. Individuals with psoriasis, atopic dermatitis, polyarthritis, or uveitis should not take this medication if they have poor kidney function, uncontrolled hypertension, infections, or malignancies. Patients with significantly reduced kidney function, high uric acid levels or high potassium levels, rheumatoid arthritis patients under 18, pregnant or potentially pregnant women, and nursing mothers should not use this medication. Care must be taken when administering this medication to the elderly or infants under 24 months. Adverse reactions may include impaired kidney function, tremors, hirsutism, hypertension, gastrointestinal symptoms, etc. Generally, reducing the dosage of this medication can alleviate adverse reactions. Patients receiving this medication may have an increased risk of infection, so they should carefully monitor for symptoms of infection, and there is an increased risk of malignancy, necessitating regular check-ups for long-term users. This medication can affect kidney and liver functions, so regular blood tests and kidney and liver function tests should be conducted during treatment. Notably, symptoms such as hypertension, hyperlipidemia, and high blood sugar may occur, requiring periodic monitoring of blood pressure, blood sugar, and lipid levels. This medication interacts with many drugs, and the concentration or risk of adverse effects may change when taken with specific medications, so it is essential to consult with a doctor or pharmacist. Pregnant or nursing women should not take this medication, and those planning a pregnancy or who might become pregnant must consult a specialist before use. Also, caution is needed when driving or operating machinery while taking this medication, as hyperkalemia may occur, requiring regulation of potassium-containing foods or medications. In the case of overdose, renal impairment may occur, and immediate medical attention is essential, as this drug is not removed through dialysis. Lastly, this medication should be kept out of reach of children and should not be transferred to another container.

Kidney impairment, tremors, hirsutism, hypertension, diarrhea, loss of appetite, nausea, vomiting, similar anaphylaxis reactions, infection, leukopenia, anemia, thrombocytopenia, tubular dysgenesis hemolytic anemia, hemolytic uremic syndrome, hyperlipidemia, hyperglycemia, hyperuricemia, hyperkalemia, hypomagnesemia, migraine, headache, recurrent seizures, sensory disturbances, convulsions, confusion, disorientation, reduced responsiveness, anxiety, insomnia, visual disturbances, visual cortex loss, coma, incomplete paralysis, cerebellar ataxia, multifocal neuropathy, optic papilledema, flushing, gastric discomfort, gingival hyperplasia, abdominal pain, peptic ulcer, pancreatitis, hepatotoxicity, abnormal liver function, hirsutism, acne, rash, allergic rash, muscle cramps, myalgia, muscle weakness, myopathy, menstrual disorders, gynecomastia, fatigue, fever, edema, weight gain, lymphoma, epistaxis, lymphadenopathy, blood coagulation disorders, gingivitis, toothache, gastritis, hiccups, gastric ulcer, bloating, rectal bleeding, stomatitis, gum bleeding, glossitis, salivary gland enlargement, dry mouth, dysphagia, esophagitis, gastrointestinal inflammation, abdominal distension, upper gastrointestinal bleeding, constipation, colitis, cholestasis, hepatitis, liver failure, elevated AST, ALT, ALP, LDH, and total bilirubin, jaundice, elevated serum creatinine, elevated serum BUN, pyelonephritis, dysuria, frequent urination, polyuria, hematuria, elevated NPN, urethritis, acute pancreatitis, allergic rash, hair loss, skin ulcers, abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorders, urticaria, hair breakage, keratosis, itching, paraesthesia, generalized seizures, confusion, drowsiness, hypersomnia, dizziness, paresthesia, anxiety, depression, decreased libido, increased libido, difficulty concentrating, nervous hyperreactivity, brain disease, visual and motor disturbances, partial loss of consciousness, reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, polyneuropathy, headache, ataxia, emotional incontinence, extrapyramidal symptoms, consciousness disturbance, increased fluid cell volume, fever, pneumonia, sepsis, abscess, soft tissue infection, folliculitis, cytomegalovirus infection, wound and skin infection, renal abscess, moniliasis, tonsillitis, urinary tract infection, herpes simplex, shingles, thrombotic uremic syndrome, thrombotic thrombocytopenic purpura, visual impairment, hearing loss, tinnitus, cataract, conjunctivitis, ocular pain, dysgeusia, vestibular disorders, sinusitis, bronchitis, cough, dyspnea, pharyngitis, rhinitis, upper respiratory tract infection, bronchospasm, arthralgia, stiffness, fracture, bursitis, leg pain, neuromuscular disorders, fatigue, weakness, flushing, influenza-like syndrome, increased sweating, facial flushing, heat sensation in hands and feet, vaginal discharge, uterine bleeding, breast pain, diabetes, hypoglycemia, increased triglycerides and cholesterol, fluid retention, gout, dysmenorrhea, amenorrhea, mild anemia, muscle cramps, bleeding, black stools, albuminuria, vaginal bleeding, pancytopenia, neutropenia, agranulocytosis, disseminated intravascular coagulation

Store this medication in a tightly closed container to avoid exposure to air or moisture. It is essential to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

Grayish-blue oval soft capsule containing a pale yellow to pale brown microemulsion liquid with the smell of oil or alcohol.

Package unit

50 capsules/box [(5 capsules/Alu-Alu x 10)]