Siclin Soft Capsule 50 mg (Cyclosporine)

Adult dosage

1. Organ transplantation 1) Initial dose: 10 ∼ 15 mg/kg body weight per day, in 2 divided 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 concentrations until the dose is 2 ∼ 6 mg/kg body weight per day, administered in 2 divided doses. The total daily dose of this drug 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 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 Injection). 2) Administer 12.5 ∼ 15 mg/kg body weight per day in 2 divided doses on the day before surgery. Administer a maintenance dose of approximately 12.5 mg/kg body weight per day for 3 ∼ 6 months (preferably 6 months) after transplantation before tapering to a dose of 0 (zero) by 1 year after transplantation. 3) Patients with malabsorption or gastrointestinal disorders may require higher oral doses or intravenous administration. 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 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 body weight per day each month, up to 5 mg/kg body weight per day. 2) Discontinue treatment if there is no improvement in the affected areas after 4 weeks of treatment at 5 mg/kg body weight per day, or if the effective dose does not comply with the information in the following Safety Information section. 3) For patients requiring rapid improvement of symptoms, the initial dose is 5 mg/kg body weight per day. Adjust the maintenance dose individually to the minimum effective dose, not exceeding 5 mg/kg body weight per day. 4) If symptom improvement is maintained for 6 months, gradually reduce the dose of this drug, 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, in patients with renal function below the threshold, the initial dose should not exceed 2.5 mg/kg per day (maximum serum creatinine: adults >200 μmol/L). 2) In patients who do not respond adequately to this drug (primarily those with steroid resistance), use it in combination with low-dose oral steroids. If no improvement is seen after 3 months, discontinue this drug. 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 body weight per day, administered orally in 2 divided doses. If symptom improvement is insufficient after 6 weeks, the dose may be increased to 5 mg/kg 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 do not improve after 12 weeks at the maximum daily dose, or if the treatment does not comply with the information in ‘*Safety Information’. Adjust the maintenance dose individually to the minimum effective dose, not exceeding the maximum dose. 6. Aplastic anemia Usually, administer 6 mg/kg body weight per day in 2 divided doses. Measure the trough blood concentration and reduce the dose to 4 mg/kg body weight per day if it is 200 ng/mL (in serum) or higher. 7. Switching from conventional oral cyclosporine to the microemulsion formulation 1) Exposure may increase when switching from conventional oral cyclosporine to this drug; therefore, observe the following: Initially, administer this drug at the same dose as the previous formulation. Monitor total blood 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 one conventional oral cyclosporine product to another oral cyclosporine product should be done under a physician’s supervision and with caution. After switching to the new formulation, monitor to ensure that the previous cyclosporine blood concentration is achieved. 8. Precautions for administration 1) The total daily dose of this drug must always be administered in 2 divided doses. 2) A characteristic odor upon opening the blister package is normal and does not indicate a problem. Swallow the capsules whole.

Children's dosage

For children, administration of 6 mg/kg in 2 divided doses daily is recommended. 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). 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, patients allergic to this medication or its components, those with severe kidney disease or uncontrolled infections, and patients with malignancies should not take this medication. Furthermore, this medication should not be used in patients under 18 years of age with rheumatoid arthritis, pregnant women or those who may become pregnant, and breastfeeding women. Elderly patients and infants under 24 months should be particularly cautious when using this medication. This medication can affect kidney function, so caution is required in patients with reduced kidney function. Additionally, it may increase the risk of infection, so patients with symptoms of infection or at high risk for infections should be especially careful. Regular monitoring is necessary while taking this medication, including blood pressure, blood tests, and liver function tests. This medication can interact with various other medications, so it is important to inform the doctor or pharmacist of any other medications being taken. Pregnant or breastfeeding women should avoid using this medication due to potential risks to the fetus or newborn, and it should only be used if the risk to the fetus is determined to be greater than the benefit. Side effects such as nausea, vomiting, hypertension, kidney dysfunction, skin rash, and muscle pain may occur, and it is essential to consult a healthcare professional immediately if any unusual symptoms arise. Overdose may cause kidney dysfunction, so it is crucial to adhere strictly to the prescribed dosage, and immediate emergency treatment should be sought in case of an overdose suspicion. When storing this medication, keep it out of reach of children and do not transfer it to other containers. Caution is required when driving or operating machinery due to decreased alertness from potential side effects of this medication. Lastly, regular check-ups and monitoring according to the doctor's instructions are important to maintain the therapeutic efficacy and safety of this medication.

Kidney damage, tremors, hirsutism, hypertension, diarrhea, loss of appetite, nausea, vomiting, similar anaphylactic reactions, infections, leukopenia, anemia, thrombocytopenia, tubular atypical hemolytic anemia, hemolytic uremic syndrome, hyperlipidemia, hyperglycemia, hyperuricemia, hyperkalemia, hypomagnesemia, migraine, headache, recurrent seizures, sensory disturbances, convulsions, confusion, disorientation, diminished responsiveness, anxiety, insomnia, visual impairment, cortical visual loss, coma, incomplete paralysis, cerebellar ataxia, multifocal neuropathy, papilledema, disc edema, flushing, epigastric discomfort, gingival hyperplasia, abdominal pain, peptic ulcer, pancreatitis, hepatotoxicity, abnormal liver function, 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, distension, rectal bleeding, stomatitis, gum bleeding, glossitis, salivary gland enlargement, dry mouth, dysphagia, esophagitis, gastroenteritis, abdominal bloating, 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, hair loss, skin ulcers, abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorders, urticaria, hair breakage, keratosis, pruritus, paresthesia, generalized seizures, confusion, drowsiness, hypersomnolence, dizziness, paresthesia, anxiety, depression, decreased libido, increased libido, difficulty concentrating, neurogenic hypersensitivity, brain disease, visual and motor disturbances, partial loss of consciousness, reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, loss of sense of direction, motor paralysis, insomnia, polyneuropathy, headache, ataxia, affective incontinence, extrapyramidal symptoms, consciousness disturbance, hyperplastic lymphocytic infiltrate, fever, pneumonia, sepsis, abscess, soft tissue infection, folliculitis, cytomegalovirus infection, wound and skin infection, renal abscess, moniliasis, tonsillitis, urinary tract infection, herpes simplex, herpes zoster, thrombotic microangiopathy, thrombotic thrombocytopenic purpura, visual impairment, hearing loss, tinnitus, cataract, conjunctivitis, ocular pain, taste disorder, vestibular disease, sinusitis, bronchitis, cough, dyspnea, pharyngitis, bronchospasm, arthralgia, rigidity, fracture, bursitis, leg pain, myopathy, malaise, weakness, nocturnal hyperhidrosis, influenza-like syndrome, increased sweating, facial flushing, agitation, paresthesia of hands and feet, vaginal discharge, uterine bleeding, breast pain, diabetes mellitus, 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

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to store it at a cool room temperature, specifically between 1 degree and 30 degrees Celsius, to maintain its effectiveness.

Appearance

A pale yellow to pale yellowish-brown microemulsion liquid contained in a sky blue oval soft capsule with an oily or alcohol odor.

Package unit

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