Cyclosporine Injection (Cyclosporin)

Adult dosage

1. Organ transplantation 1) Initial dose: 3 ∼ 5 mg per kg of body weight per day, within 12 hours before surgery 2) Maintenance dose: Use the same dose as the initial dose for 1 ∼ 2 weeks after surgery, then gradually reduce according to blood concentration until reaching 0.7 ∼ 2 mg per kg of body weight per day in 2 divided doses 3) Concomitant therapy: A lower dose (e.g., initial dose: 1 ∼ 2 mg/kg in 2 divided doses) may be used when treatment is combined with corticosteroids or as triple or quadruple immunosuppressive therapy. Method of use: Dilute 20 ∼ 100-fold with normal saline injection or 5% glucose injection and infuse slowly intravenously over approximately 2 ∼ 6 hours. 2. Bone marrow transplantation 1) Prevention of graft rejection: The first dose is administered one day before surgery; intravenous infusion is preferably given for 2 weeks after surgery. The recommended dose is 3 ∼ 5 mg per kg of body weight per day. Method of injection: Dilute 20 ∼ 100-fold with normal saline injection or 5% glucose injection and administer by slow intravenous infusion over approximately 2 ∼ 6 hours. Continuous infusion over 24 hours is also possible. For patients with gastrointestinal disorders that may impair absorption of oral preparations, the injection may be administered by intravenous infusion at 1/3 of the oral dose. 2) Graft-versus-host disease (GVHD): Inject 3 ∼ 5 mg per kg of body weight once daily for 50 days. Reduce the dose by 5 % at 1-week intervals, maintaining a dose of 0.65 mg per kg of body weight per day; treatment may be discontinued. When oral administration is not feasible, the injection may be used at 1/3 of the oral dose.

Children's dosage

- No problems have been reported in children 1 year of age or older receiving the standard dose, and some pediatric studies indicate that they tolerate higher doses better than adults. - Do not administer this medicine to children with a serum creatinine level > 140 μmol/L. - Children 1 year of age or older may be treated according to the adult dose, but there is very little experience with use in infants. - For prevention of graft rejection in bone marrow transplantation, the recommended dose is the same as for adults: 3 ∼ 5 mg per kg of body weight per day.

Care must be taken when using this injection, as glass fragments may be introduced when breaking the ampoule. Special caution is needed for use in children and the elderly. This medication should not be administered to patients with hypersensitivity, renal disease, psoriasis, atopic dermatitis, multiple rheumatic arthritis, uveitis, or aplastic anemia. Additionally, it should not be used in patients with renal function reduced by more than 50%, patients with hyperuricemia or hyperkalemia, rheumatoid arthritis patients under 18 years old, pregnant or nursing women, and those taking specific medications. Care should be taken when administering this medication to the elderly or infants under 24 months. This medication may cause side effects such as impaired kidney function, tremors, hirsutism, hypertension, diarrhea, loss of appetite, nausea, and vomiting, with the incidence typically depending on the dosage. Due to its immunosuppressive action, there is an increased risk of infections, as well as an increased risk of malignancies or skin cancers. Regular blood tests, liver function tests, and kidney function tests should be conducted, and if kidney function worsens, dosage adjustments or cessation of treatment may be necessary. This medication may interact with various other drugs, so patients must inform their physician or pharmacist if they are taking other medications. Caution is needed as co-administration with certain drugs may result in renal toxicity or changes in blood concentration. Pregnant or nursing women are advised against using this medication, and during pregnancy, it should be used with caution considering potential risks to the fetus. This medication may cause neurological side effects that require caution while driving or operating machinery. Overdosage may result in kidney dysfunction, so precise dosing as directed by the physician is essential, and in cases of overdose, immediate medical attention should be sought. This medication should be stored out of reach of children, and precautions regarding storage and use must be strictly observed.

Kidney impairment, tremor, hirsutism, hypertension, diarrhea, loss of appetite, nausea, vomiting, similar anaphylactic reactions, infection, leukopenia, anemia, thrombocytopenia, tubular dysfunction hemolytic anemia, hemolytic uremic syndrome, hyperlipidemia, hyperglycemia, hyperuricemia, hyperkalemia, hypomagnesemia, migraine, headache, recurrent seizures, paresthesia, convulsion, confusion, disorientation, decreased responsiveness, anxiety, insomnia, visual impairment, cortical visual loss, coma, incomplete paralysis, cerebellar ataxia, multifocal neuropathy, papilledema, optic disc edema, flushing, upper abdominal 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, nasal bleeding, lymphadenopathy, coagulopathy, 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, elevated ALT, elevated ALP, elevated LDH, increased total bilirubin, jaundice, elevated serum creatinine, elevated serum BUN, pyelonephritis, dysuria, frequency of urination, polyuria, hematuria, elevated NPN, urethral infection, acute pancreatitis, hair loss, skin ulcer, abnormal pigmentation, angioedema, dermatitis, dry skin, eczema, nail disorders, urticaria, hair breakage, keratosis, itching, tactile sensation, generalized convulsions, confusion, drowsiness, hypersomnia, dizziness, paresthesia, anxiety, depression, decreased libido, increased libido, difficulty concentrating, neural irritability, brain disorders, visual and motor function abnormalities, decreased perception ability, loss of sense of direction, motor paralysis, visual impairment, insomnia, polyneuropathy, headache, ataxia, affective incontinence, extrapyramidal symptoms, altered consciousness, fluid cell enlargement, 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 microangiopathy, thrombotic thrombocytopenic purpura, visual impairment, hearing loss, tinnitus, cataract, conjunctivitis, eye pain, dysgeusia, vestibular disorders, sinusitis, bronchitis, cough, dyspnea, pharyngitis, bronchospasm, arthralgia, rigidity, fracture, bursitis, lower limb pain, muscle disorders, fatigue, weakness, flushing, influenza-like syndrome, increased sweating, facial flushing, nausea, burning sensation in hands and feet, vaginal discharge, uterine bleeding, mastalgia, diabetes, hypoglycemia, elevated triglycerides, elevated 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 function impairment, rhabdomyolysis, and elevated creatine kinase.

This medication should be stored in a sealed container to protect it from air and light exposure. Avoid direct sunlight and store in a cool room temperature, ideally between 1 to 30 degrees Celsius.

Appearance

A viscous brownish-yellow liquid in a brown glass ampoule.

Package unit

5 milliliters × 10 ampoules