Sandimmun Injection (Cyclosporine)

Adult dosage

1. Organ transplantation 1) Initial dose: 3 ∼ 5 mg/kg of body weight per day, within 12 hours before surgery 2) Maintenance dose: Same as the initial dose for 1 ∼ 2 weeks after surgery, then gradually reduce according to blood concentration until reaching 0.7 ∼ 2 mg/kg of body weight per day in 2 divided doses 3) Concomitant dose: When treated with concomitant corticosteroid therapy or triple or quadruple immunosuppressive therapy, use an initial dose of 1 ∼ 2 mg/kg in 2 divided doses 2. Bone marrow transplantation (1) Prevention of graft rejection: Begin administration one day before surgery; administer 3 ∼ 5 mg/kg of body weight per day (2) Graft-versus-host disease (GVHD): Inject 3 ∼ 5 mg/kg of body weight once daily for 50 days, then reduce the dose by 5 % at weekly intervals to maintain 0.65 mg/kg of body weight per day When gastrointestinal disorders may impair absorption of the oral formulation or oral administration is not feasible, the injection may be administered by intravenous drip at 1/3 of the oral dose. For administration, dilute 20 ∼ 100-fold with saline injection or 5% dextrose injection and slowly infuse intravenously over 2 ∼ 6 hours or administer by continuous drip infusion. - In patients with renal impairment, monitor serum creatinine levels. - Regular evaluation of blood pressure and liver function tests is recommended. - Periodic measurement of creatinine levels is required for 6 months after treatment ends.

Children's dosage

The standard dose may be given to children 1 year of age and older, but there is very little experience with use in infants. Some pediatric studies have found that children require higher doses than adults and tolerate higher doses per kg of body weight. Do not administer to children with serum creatinine of 140 μmol/L or higher. - Monitoring of renal and liver function is essential. - Caution regarding safety and adverse reactions is necessary.

When using this drug in injection form, be cautious when cutting glass ampules. If glass shards mix in, serious adverse reactions may occur, so particular care should be taken when using it on children and the elderly. This drug should not be administered to certain patients. For example, it should not be given to patients with allergies to this drug or its components, those with kidney diseases, uncontrolled infections, malignant tumors, patients under 18 years with rheumatoid arthritis, pregnant or nursing women, and patients taking certain medications (aliskiren, bosentan, dabigatran). Care should be taken when using this drug in the elderly or infants under 24 months. This drug can cause various side effects such as kidney dysfunction, hypertension, gastrointestinal issues, neurological abnormalities, skin changes, etc. Side effects generally vary by dosage, and symptoms can be alleviated by adjusting the dosage. Due to its immunosuppressive action, the risk of infections may increase, so if symptoms of infection appear, immediate consultation with medical staff is required. Moreover, this drug may increase the risk of malignant tumors, so patients using it for a prolonged period should undergo regular examinations. It is important to periodically check blood concentration levels to maintain the appropriate dosage. Blood pressure, kidney function, liver function, and electrolyte levels should also be monitored regularly. This drug may interact with other medications, so if you are taking any other drugs, you must inform your healthcare provider. Care should be taken particularly in combination with drugs that may affect the kidneys, immunosuppressants, certain antibiotics, calcium channel blockers, and statins. Pregnant or nursing women should not use this drug and should decide in consultation with their doctor if necessary. This drug may require caution while driving or operating machinery, so if any abnormal symptoms occur, activities should be refrained from. In case of overdose, kidney dysfunction may occur, so it is crucial to adhere strictly to the prescribed dosage, and immediate medical intervention is required in case of overdose. This drug should be stored out of reach of children and should not be transferred to another container for safety reasons. In the case of injections, it should be used within 24 hours after dilution and avoid using PVC containers or polyurethane infusion sets.

Kidney dysfunction, tremors, hirsutism, hypertension, diarrhea, loss of appetite, nausea, vomiting, similar anaphylaxis reactions, infections, leukopenia, anemia, thrombocytopenia, tubular dysplasia hemolytic anemia, hemolytic uremic syndrome, hyperlipidemia, hyperglycemia, hyperuricemia, hyperkalemia, hypomagnesemia, migraine, headache, recurrent seizures, sensory abnormalities, convulsions, confusion, orientation disturbances, decreased responsiveness, anxiety, insomnia, visual impairment, visual cortex loss, coma, incomplete paralysis, cerebellar ataxia, multifocal neuropathy, papilledema, disc edema, flushing, upper abdominal 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, epistaxis, lymphadenopathy, coagulopathy, gingivitis, toothache, gastritis, hiccups, gastric ulcer, distension, rectal bleeding, stomatitis, gum bleeding, glossitis, salivary gland enlargement, dry mouth, dysphagia, esophagitis, gastrointestinal inflammation, abdominal distention, upper gastrointestinal bleeding, constipation, colitis, cholestasis, hepatitis, liver failure, elevated AST, ALT, ALP, LDH, total bilirubin, jaundice, elevated serum creatinine, elevated serum BUN, pyelonephritis, dysuria, increased urination, polyuria, hematuria, elevated NPN, urethritis, acute pancreatitis, allergic rash, hair loss, skin ulcer, abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorders, urticaria, hair breakage, keratosis, itching, paresthesia, generalized convulsions, confusion, drowsiness, somnolence, dizziness, paresthesia, anxiety, depression, decreased libido, increased libido, concentration difficulties, nervous hyperreactivity, brain disorders, visual and motor function abnormalities, decreased perception ability, loss of sense of direction, motor paralysis, cerebellar ataxia, insomnia, polyneuropathy, headache, ataxia, emotional incontinence, extrapyramidal symptoms, consciousness disturbances, fluid cell enlargement, fever, thrombotic microangiopathy, thrombotic thrombocytopenic purpura, visual impairment, hearing loss, tinnitus, cataract, conjunctivitis, eye pain, taste disturbances, vestibular disorders, sinusitis, bronchitis, cough, dyspnea, pharyngitis, pneumonia, rhinitis, upper respiratory tract infections, bronchospasm, arthralgia, rigidity, fractures, bursitis, leg pain, muscle disorders, fatigue, weakness, flushing, influenza-like syndrome, increased sweating, facial flushing, anxiety, burning sensation in hands and feet, vaginal discharge, uterine bleeding, mastalgia, diabetes, hypoglycemia, increased triglycerides, increased cholesterol, fluid retention, gout, dysmenorrhea, amenorrhea, mild anemia, muscle cramps, bleeding, melena, albuminuria, vaginal bleeding, pancytopenia, granulocytopenia, agranulocytosis, disseminated intravascular coagulation (DIC), anaphylactic reaction, flushing of the face and upper chest, acute respiratory distress, wheezing, blood pressure changes, tachycardia, non-cardiogenic pulmonary edema, vomiting, dizziness, headache, tachycardia, reversible renal dysfunction, myocardial infarction, chest pain, heart failure, peripheral ischemia, myopathy, neuropathy, rhabdomyolysis

This drug should be stored at room temperature between 1°C and 30°C, and it is important to store it in a transparent sealed container to protect it from air and light exposure.

Appearance

Yellow-brown viscous injection

Package unit

50mL (5mL * 10 ampules)