藥品名稱
drug name
Methylprednisolone 500mg/vial (Solu-Medrol)舒汝美卓佑注射劑
藥檔狀態使用中
成  份
Ingredient
Methylprednisolone
單位含量500mg/vial
Dosage Forms50mg/vial
顏  色
Color 
形  狀
Shape 
劑  型針劑/注射
Dose Form 
大  小
Size
 
標  示
outward
 
廠商名稱
Manufacturer
輝瑞大藥廠股份有限公司
製 造 商
Manufacturer
PFIZER MANUFACTURING BELGIUM NV
字  號
Product ID
衛署藥輸字第004922號
藥理分類
Pharmacologic Category
Endocrine & metabolic/Corticosteroids/
作用機轉
Mechanism of action
In a tissue-specific manner, corticosteroids regulate gene expression subsequent to binding specific intracellular receptors and translocation into the nucleus. Corticosteroids exert a wide array of physiology effects including modulation of carbohydrate,
用途/適應症類固醇製劑
Use 腎上腺皮質機能不全、劇烈休克、支氣管性氣喘、膠原疾病、過敏反應、泛發性感染
衛福部核准適用症狀
MOHW approved indications
腎上腺皮質機能不全、劇烈休克、支氣管性氣喘、膠原疾病、過敏反應、泛發性感染
常用劑量每天一次,早飯後使用500mg
(藥品劑量會因人或病情增減,請依照醫師指示服用。)
Dose Adults
Only sodium succinate may be given I.V.; methylprednisolone sodium succinate is highly soluble and has a rapid effect by I.M. and I.V. routes. Methylprednisolone acetate has a low solubility and has a sustained I.M. effect.
Anti-inflammatory or immunosuppressive:
I.M. (sodium succinate): 10-80 mg/day once daily
I.M. (acetate): 10-80 mg every 1-2 weeks
I.V. (sodium succinate): 10-40 mg over a period of several minutes and repeated I.V. or I.M. at intervals depending on clinical response; when high dosages are needed, give 30 mg/kg over a period ≡30 minutes and may be repeated every 4-6 hours for 48 hours.
Status asthmaticus: I.V. (sodium succinate): Loading dose: 2 mg/kg/dose, then 0.5-1 mg/kg/dose every 6 hours for up to 5 days
Acute spinal cord injury: I.V. (sodium succinate): 30 mg/kg over 15 minutes, followed in 45 minutes by a continuous infusion of 5.4 mg/kg/hour for 23 hours
Dermatitis, acute severe: I.M. (acetate): 80-120 mg as a single dose
Dermatitis, chronic: I.M. (acetate): 40-120 mg every 5-10 days
Lupus nephritis: High-dose ※pulse§ therapy: I.V. (sodium succinate): 1 g/day for 3 days
Aplastic anemia: I.V. (sodium succinate): 1 mg/kg/day or 40 mg/day (whichever dose is higher), for 4 days. After 4 days, change to oral and continue until day 10 or until symptoms of serum sickness resolve, then rapidly reduce over approximately 2 weeks.
Pneumonia in AIDS patients due to Pneumocystis: I.V.: 30 mg twice daily for 5 days, then 30 mg once daily for 5 days, then 15 mg once daily for 11 days
Arthritis: Intra-articular (acetate): Administer every 1-5 weeks.
Large joints: 20-80 mg
Small joints: 4-10 mg
Intralesional (acetate): 20-60 mg every 1-5 weeks
懷孕分級
Pregnancy Risk Factor
C-
[FDA(美國食品及藥物管理局)懷孕分級說明:
A:對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B:動物試驗無法證實對胎兒有害,但缺乏人類對照試驗;或動物試驗有副作用報告,但無法證實對懷孕初期及後期之胎兒有害。
C:動物實驗中對胎兒有害但缺乏孕婦對照實驗;或無動物及孕婦試驗。
D:證實對胎兒有害,但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X:證實對胎兒有害,且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
禁忌症 1. 全身性黴菌感染症。2. 已知對本藥成分過敏者。
Contraindications Hypersensitivity to methylprednisolone or any component of the formulation; systemic fungal infection (except intra-articular injection in localized joint conditions); administration of live virus vaccines. methylprednisolone formulations containing benzyl alcohol preservative are contraindicated in infants; I.M. administration in idiopathic thrombocytopenia purpura; intrathecal administration of methylprednisolone acetate suspension
常見副作用食慾增加,消化不良,坐立不安。
Common adverse drug reactionsAppetite increase, Indigestion, Restlessness.
Adverse Reactions Adverse Reactions Significant Frequency not defined. Cardiovascular: Arrhythmias, bradycardia, cardiac arrest, cardiomegaly, circulatory collapse, congestive heart failure, edema, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture (post MI), syncope, tachycardia, thromboembolism, vasculitis Central nervous system: Delirium, depression, emotional instability, euphoria, hallucinations, headache, intracranial pressure increased, insomnia, malaise, mood swings, nervousness, neuritis, personality changes, psychic disorders, pseudotumor cerebri (usually following discontinuation), seizure, vertigo Dermatologic: Acne, allergic dermatitis, alopecia, dry scaly skin, ecchymoses, edema, erythema, hirsutism, hyper-/hypopigmentation, hypertrichosis, impaired wound healing, petechiae, rash, skin atrophy, sterile abscess, skin test reaction impaired, striae, urticaria Endocrine & metabolic: Adrenal suppression, amenorrhea, carbohydrate intolerance increased, Cushing`s syndrome, diabetes mellitus, fluid retention, glucose intolerance, growth suppression (children), hyperglycemia, hyperlipidemia, hypokalemia, hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, pituitary-adrenal axis suppression, protein catabolism, sodium and water retention Gastrointestinal: Abdominal distention, appetite increased, bowel/bladder dysfunction (after intrathecal administration), gastrointestinal hemorrhage, gastrointestinal perforation, nausea, pancreatitis, peptic ulcer, perforation of the small and large intestine, ulcerative esophagitis, vomiting, weight gain Hematologic: Leukocytosis (transient) Hepatic: Hepatomegaly, transaminases increased Local: Postinjection flare (intra-articular use), thrombophlebitis Neuromuscular & skeletal: Arthralgia, arthropathy, aseptic necrosis (femoral and humoral heads), fractures, muscle mass loss, muscle weakness, myopathy (particularly in conjunction with neuromuscular disease or neuromuscular-blocking agents), neuropathy, osteoporosis, parasthesia, tendon rupture, vertebral compression fractures, weakness Ocular: Cataracts, exophthalmoses, glaucoma, intraocular pressure increased Renal: Glycosuria Respiratory: Pulmonary edema Miscellaneous: Abnormal fat disposition, anaphylactoid reaction, anaphylaxis, angioedema, avascular necrosis, diaphoresis, hiccups, hypersensitivity reactions, infections, secondary malignancy
監測
Monitoring
Blood pressure, blood glucose, electrolytes
警語與注意事項請遵照醫師或藥師指示使用;本品不適用於Epidural administration。
Warnings & precautionsPlease follow the instruction of physician and pharmacist.Do not use as epidural administration.
針劑溶解條件 於無菌條件下將所附之稀釋液加至內含無菌粉末的小瓶。
針劑稀釋條件 D5W、生理食鹽水、5%葡萄糖/0.45%氯化鈉
針劑不相容性 為避免相容性與安定性問題,建議與其他藥品分開投藥,這包括靜脈推注、靜脈medication chamber或靜脈piggy-back溶液的投藥途徑。
針劑施打條件 靜脈注射、肌肉、靜脈輸注
針劑保存安定性 於30℃下儲存。調製妥的溶液可維持物理與化學性質安定達48小時。
最近修改日期時間
Updated
12/15/2020 9:54:49 AM
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