中文药名：乙酰半胱氨酸注射液

英文药名：ACETADOTE(acetylcysteine)

药品介绍
ACETADOTE（乙酰半胱氨酸）注射
美国首次批准时间：2004年
适应症及用法
8至10小时内，静脉内给药后，摄入的一个潜在的肝毒性的量的对乙酰氨基酚，acetadote表示，以防止或减轻肝损伤。
剂量与用法
年龄≥40千克：
在200毫升在60分钟内给药的稀释剂中剂量：150毫克/公斤
剂量：50毫克/公斤超过4小时给药的稀释剂在500ml
剂量：100毫克/公斤1000毫升稀释剂管理超过16小时
患者> 20 - <40公斤：
中在60分钟内给药的稀释剂在100毫升的剂量：150毫克/公斤
剂量2：50毫克/公斤，在管理超过4小时的稀释液250毫升
剂量：100毫克/千克500毫升稀释剂管理超过16小时
患者≤20公斤：
中剂量：150毫克/公斤，3 mL / kg的体重，给药的稀释剂，在60分钟
剂量：50毫克/公斤，7毫升/千克体重，给药的稀释剂在4小时内
剂量：100毫克/千克，14毫升/公斤体重给药的稀释剂超过16小时
剂型和规格
小瓶：200毫克/毫升，30毫升（20％溶液）
禁忌
患者先前的过敏性反应，乙酰半胱氨酸。
警告和注意事项
监测急性的皮肤潮红，红斑可能发生通常与负荷剂量，经常自发地解析尽管持续输注。
监测严重的过敏反应，输液治疗过敏性症状可能会被中断，直到已启动。
应使用与哮喘患者慎用，或那里是一个历史支气管痉挛。
总成交量管理应调整为患者小于40公斤，对于那些需要限制液体。
不良反应
最常见的不良反应（发生率> 2％），皮疹，荨麻疹/面部潮红和瘙痒。
报告疑似不良反应的接触坎伯兰制药公司1-877-484-2700或FDA在1-800-FDA-1088 orwww.fda.gov / MedWatch通报。
药物相互作用
无药物间相互作用的研究已进行。
在特定人群中使用
怀孕：在怀孕期间使用此药只有在明确需要。
哺乳母亲：未知的，如果药物在人类乳汁中排泄
儿童用药：患者调整剂量<40公斤
完整使用说明附件：http://www.drugs.com/pro/acetadote.html
ACETADOTE
(acetylcysteine) Injection
DRUG DESCRIPTION
Acetylcysteine injection is an intravenous (I.V.) medication for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine, NAC). The compound is a white crystalline powder, which melts in the range of 104° to 110° C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2.
Acetylcysteine has the following structural formula:
Acetadote (acetylcysteine injection) is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetadote (acetylcysteine injection) contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Sterile Water for Injection, USP.
INDICATIONS
Acetadote (acetylcysteine injection) , administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury [see DOSAGE AND ADMINISTRATION and Acetaminophen Assays –Interpretation and Methodology].
On admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.
Acetadote (acetylcysteine injection) should be administered within 8 hours from acetaminophen ingestion for maximal protection against hepatic injury for patients whose serum acetaminophen levels fall above the “possible” toxicity line on the Rumack-Matthew nomogram (line connecting 150 mcg/mL at 4 hours with 50 mcg/mL at 12 hours); [see Acetaminophen Assays – Interpretation and Methodology]. If the time of ingestion is unknown, or the serum acetaminophen level is not available, cannot be interpreted, or is not available within the 8 hour time interval from acetaminophen ingestion, Acetadote (acetylcysteine injection) should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion of an overdose of acetaminophen, regardless of the quantity reported to have been ingested.
The aspartate aminotransferase (AST, SGOT), alanine aminotranferase (ALT, SGPT), bilirubin, prothrombin time, creatinine, blood urea nitrogen (BUN), blood glucose, and electrolytes also should be determined in order to monitor hepatic and renal function and electrolyte and fluid balance.
NOTE: The critical ingestion-treatment interval for maximal protection against severe hepatic injury is between 0 – 8 hours. Efficacy diminishes progressively after 8 hours and treatment initiation between 15 and 24 hours post ingestion of acetaminophen yields limited efficacy. However, it does not appear to worsen the condition of patients and it should not be withheld, since the reported time of ingestion may not be correct.
Acetaminophen Assays Interpretation and Methodology – Acute Ingestion
The acute ingestion of acetaminophen in quantities of 150 mg/kg or greater may result in hepatic toxicity. However, the reported history of the quantity of a drug ingested as an overdose is often inaccurate and is not a reliable guide to therapy of the overdose. Therefore, plasma or serum acetaminophen concentrations, determined as early as possible, but no sooner than four hours following an acute overdose, are essential in assessing the potential risk of hepatotoxicity. If an assay for acetaminophen cannot be obtained, it is necessary to assume that the overdose is potentially toxic.
Sensitivity to acetylcysteine: Patients should be advised to report to their physician any history of sensitivity to acetylcysteine [see CONTRAINDICATIONS].
Asthma: Patients should be advised to report to their physician any history of asthma [see WARNINGS AND PRECAUTIONS].