Cyclosporin Soft Capsules 100 mg

Adult dosage

1. Organ transplantation 1) Initial dose: 10 ∼ 15 mg/kg of body weight per day, divided into 2 doses, starting 12 hours before surgery. 2) Maintenance dose: The same as the initial dose for 1 ∼ 2 weeks after surgery, then gradually reduce according to blood concentration until reaching 2 ∼ 6 mg/kg of body weight per day, divided into 2 doses. The total daily dose of this drug should 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, divided into 2 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 Injection). 2) Administer 12.5 ∼ 15 mg/kg of body weight per day in 2 divided doses on the day before surgery. As a maintenance dose, administer 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 drug must be administered in 2 divided doses. 4) GVHD may occur after discontinuation of this drug, 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 lesions after 4 weeks of treatment at 5 mg/kg of body weight per day, or if the effective dose does not meet the safety information below. 3) For patients requiring rapid symptom improvement, the initial dose is 5 mg/kg of body weight per day. Adjust the maintenance dose individually to the minimum effective dose, not exceeding 5 mg/kg of body weight per day. 4) If symptom improvement is maintained for 6 months, gradually reduce the dose of this drug, although 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, divided into 2 doses, is recommended. However, in patients with renal function below the threshold, the initial dose should not exceed 2.5 mg/kg per day (peak serum creatinine: adults >200 μmol/L). 2) Patients who do not respond adequately to this drug (primarily those with steroid resistance) should receive it in combination with low-dose oral steroids. Discontinue this drug if no improvement is observed 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; gradually reduce the dose and use the minimum effective dose as the maintenance dose. 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 there is no symptom improvement after 12 weeks at the maximum daily dose, or if the patient does not meet the criteria in ‘*Safety Information’. Adjust the maintenance dose 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. Measure the trough blood concentration; if it is 200 ng/mL (in 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) Because exposure may increase when switching from conventional oral cyclosporine to this drug, observe the following: Initially, administer this drug at the same dose as the previous formulation. Monitor total blood cyclosporine trough concentrations 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 concentration 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 performed under a physician's supervision and requires caution. After switching to the new formulation, monitor to ensure that blood cyclosporine concentrations reach the previous levels. 8. Precautions for administration 1) The total daily dose of this drug should always be administered in 2 divided doses. 2) The distinctive odor upon opening the blister package is normal and does not indicate a problem. Swallow the capsules whole.

Children's dosage

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

This drug should not be used in patients with certain diseases. For instance, it should not be administered to patients with allergies to this drug or its components, renal disease, psoriasis, atopic dermatitis, certain conditions of rheumatoid arthritis, uveitis, or aplastic anemia. Additionally, it should be avoided in patients with renal function reduced by more than 50%, those with hyperuricemia or hyperkalemia, patients younger than 18 with rheumatoid arthritis, pregnant or potentially pregnant women, nursing mothers, and patients taking certain medications. Caution should be exercised when administering to the elderly or infants under 24 months, as this drug can cause various side effects such as reduced kidney function, hypertension, gastrointestinal symptoms, and skin changes. Particularly, there is a heightened risk of infection due to immunosuppressive effects, and there may also be an increased risk of malignant tumors. During use of this drug, blood pressure, renal function, liver function, and blood tests should be conducted regularly to detect and manage adverse reactions early. Additionally, measuring serum concentration is important for appropriate drug concentration adjustment, and attention should be paid to interactions with other drugs. Pregnant or nursing women should not use this drug, and care should be taken when driving or operating machinery during its use. Overdosage can lead to renal dysfunction, so if any symptoms appear, immediate consultation with healthcare personnel is necessary. This drug must be stored out of reach of children, and transferring to other containers should be avoided. Patients taking this drug should avoid excessive ultraviolet exposure and regularly check for the occurrence of malignant tumors, such as skin cancer.

Kidney damage, tremors, hirsutism, hypertension, diarrhea, anorexia, nausea, vomiting, similar anaphylaxis reaction, infection, leukopenia, anemia, thrombocytopenia, tubular atypical hemolytic anemia, hemolytic uremic syndrome, hyperlipidemia, hyperglycemia, hyperuricemia, hyperkalemia, hypomagnesemia, migraine, headache, recurrent spasms, sensory disturbances, convulsions, confusion, disorientation, reduced reactivity, anxiety, insomnia, visual impairment, cortical visual loss, coma, partial paralysis, cerebellar ataxia, multifocal neuropathy, optic disc swelling, optic nerve head edema, flushing, gastric discomfort, gingival hyperplasia, abdominal pain, peptic ulcer, pancreatitis, hepatotoxicity, liver dysfunction, hirsutism, acne, rash, allergic rash, muscle cramps, myalgia, muscle weakness, myopathy, menstrual disorders, gynecomastia, fatigue, fever, edema, weight gain, lymphoma, nasal bleeding, lymphadenopathy, coagulopathy, gingivitis, toothache, gastritis, hiccups, gastric ulcer, bloating, rectal bleeding, stomatitis, gum bleeding, glossitis, salivary gland enlargement, dry mouth, dysphagia, esophagitis, gastroenteritis, abdominal distension, upper gastrointestinal bleeding, constipation, colitis, cholestasis, hepatitis, liver failure, elevations of AST, ALT, ALP, LDH, total bilirubin, jaundice, skin ulcers, abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorders, urticaria, hair breakage, keratosis, itching, paresthesia, generalized convulsions, confusion, drowsiness, hypersomnia, dizziness, paresthesia, anxiety, depression, decreased libido, increased libido, concentration difficulties, nervousness, brain disease, visual and motor disorders, partial loss of consciousness, reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, loss of directional sense, consciousness disorder, motor paralysis, polyneuropathy, headache, ataxia, emotional incontinence, extrapyramidal symptoms, consciousness disorder, fluid cellular enlargement, fever, pneumonia, sepsis, abscess, soft tissue infection, folliculitis, cytomegalovirus infection, wound and skin infection, renal abscess, candidiasis, tonsillitis, urinary tract infection, herpes simplex, herpes zoster, thrombotic thrombocytopenic purpura, thrombotic microangiopathy, visual impairment, hearing loss, tinnitus, cataract, conjunctivitis, ocular pain, taste distortion, vestibular disorders, sinusitis, bronchitis, cough, difficulty breathing, pharyngitis, bronchospasm, arthralgia, stiffness, fracture, bursitis, limb pain, muscle disorders, malaise, weakness, flushing, influenza-like syndrome, increased sweating, facial flushing, hyperesthesia, vaginal discharge, uterine bleeding, mastalgia, diabetes, hypoglycemia, increased triglycerides and cholesterol, fluid retention, gout, dysmenorrhea, amenorrhea, mild anemia, muscle cramps, bleeding, malignant tumors, lymphoproliferative diseases, brain diseases, visual and motor function abnormalities, decreased perceptual ability, rhabdomyolysis, myalgia, weakness, elevation of creatine kinase, elevated serum and urinary myoglobin, cholestasis, jaundice, hepatitis, liver failure, liver damage, hepatotoxicity, black stools, albuminuria, vaginal bleeding, pancytopenia, agranulocytosis, neutropenia, disseminated intravascular coagulation

This drug should be stored in a sealed container to avoid exposure to air and moisture, maintaining a storage temperature between 1°C and 30°C. This will help maintain the effectiveness of the drug and allow for safe use.

Appearance

Light yellow to light brown microemulsion liquid with an oily or alcoholic smell contained in a blue-gray oblong soft capsule.

Package unit

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