醋酸钾注射，USPCONCENTRATE，4毫当量/毫升，是一种无菌，无热原的，浓缩的醋酸钾（C2H3KO2）的注射用水中的溶液。它必须在施用前稀释。 每次50毫升小瓶含有19.6克醋酸钾（无水），它提供了每个钾200毫克当量（K+）和醋酸（CH 3 COO - ）的。 将pH调节用乙酸中，溶液不含有抑菌剂或其它防腐剂。 该溶液是打算作为一种替代氯化钾为除了大体积输注液用于静脉使用提供钾（K+）。未使用部分应丢弃。 临床药理学 钾被发现在低浓度的血浆和细胞外液中。它是人体细胞的主要阳离子，是关心体液成分和电解质平衡的维持。钾的量主要是通过尿液排出体外。因此，肾脏通常决定了钾平衡。 的醋酸根离子在体内完全代谢，提供氢离子受体的来源。 适应症 醋酸钾注射，USPCONCENTRATEis表示在缺钾状态的治疗时，口服替代疗法是不可行的。 禁忌 钾的管理是禁忌可能在那里遇到的高钾含量的疾病。 警告 为了避免钾中毒，注入含解决方案慢慢钾。在严重肾功能不全或肾上腺皮质功能不全，醋酸钾给药注射，USPCONCENTRATEmay引起钾中毒。 本品含有铝，可能是有毒的。铝可能达到中毒水平与长期胃肠外给药，如果肾功能受损。早产儿的风险特别大，因为他们的肾脏都是不成熟的，他们需要大量的钙，磷的解决方案，其中包含铝。 研究表明，患者的肾功能受损，包括早产儿，谁接受肠外铝含量在大于4～5微克/公斤/天累积铝在中枢神经系统和骨骼相关的毒性水平。可能发生在给药率更低组织负荷。 注意事项 钾替代治疗应主要由串行心电图指导。血浆钾水平未必能反映组织钾水平。 钾的高血药浓度可通过心脏抑制，心律失常或逮捕导致死亡。醋酸钾注射，USPCONCENTRATEshould慎用心脏疾病的存在，特别是在数字化的患者或肾疾病的存在。 不良反应 恶心，呕吐，腹痛和腹泻的报道。钾中毒的症状和体征包括四肢感觉异常，弛缓性麻痹，精神萎靡，神志不清，四肢无力及腿的沉重感，低血压，心律失常，心脏传导阻滞，心电图异常如P波消失，扩散和口齿不清的QRS波群与发展的双相曲线，和心脏停搏。 SeeWARNINGS。 在怀孕期使用 在妊娠的安全使用尚未确立。使用醋酸生育能力的女性钾要求预期效益将针对可能产生的危害权衡。 剂量与用法 醋酸钾注射，USPCONCENTRATE（4毫当量/毫升），必须在给药前稀释。剂量和注射速率依赖于每个病人的个体状况。心电图和血清钾应监测为剂量的指南。撤回的计算量和无菌转移到适当的静脉注射液，以提供钾（K+）的毫克当量的期望数量与同等数量的醋酸毫当量的（CH 3 COO-）。 注射用的药品应肉眼检查有无颗粒物质和变色，在溶液及容器许可。 药物过量 在过量的情况下，立即停止输液，并制定整改强化治疗，以降低血钾水平。 如何提供 醋酸钾注射液，USP精华（4毫克当量/毫升） Potassium AcetateInjection, USP 100 mEq/50 mL (2 mEq/mL) (2 mEq K/mL and 2 mEq CHCOO/mL) CONCENTRATED SOLUTION – FOR INTRAVENOUS USE ONLY AFTER DILUTION AND THOROUGH MIXING. Glass Fliptop Vial Rx only Pharmacy Bulk Package – Not for Direct Infusion.  Potassium Acetate Injection, USP (2 mEq/mL) is a sterile, nonpyrogenic, concentrated solution of potassium acetate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted. Each mL contains 196.3 mg of potassium acetate which provides 2 mEq each of potassium (K) and acetate (CHCOO). The solution may contain acetic acid for pH adjustment. The pH is 6.2 (range: 5.5 to 8.0). The osmolar concentration is 4 mOsmol/mL (calc.); specific gravity is 1.089. The Pharmacy Bulk Package is a sterile dosage which contains multiple single doses for use only in a pharmacy bulk admixture program. The solution is intended as an alternative to potassium chloride to provide potassium ion (K) for addition to large volume infusion fluids for intravenous use. Potassium Acetate, USP is chemically designated CHCOOK, and is comprised of colorless crystals or a white crystalline powder that is very soluble in water. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures. The Pharmacy Bulk Package contains no bacteriostat, antimicrobial agent, or added buffer. Multiple single doses may be dispensed during continual aliquoting operations. As the principal cation of the intracellular fluid, potassium plays an important role in fluid and electrolyte balance. The normal potassium concentration in the intracellular fluid compartment is about 160 mEq/liter. The normal serum potassium range is 3.5 to 5.0 mEq/liter. The kidney normally regulates potassium balance but does not conserve potassium as well or as promptly as it conserves sodium. The daily turnover of potassium in the normal adult averages 50 to 150 mEq (milliequivalents) and represents 1.5 to 5% of the total potassium content of the body. Acetate (CHCOO), a source of hydrogen ion acceptors, is an alternate source of bicarbonate (HCO ) by metabolic conversion in the liver. This has been shown to proceed readily, even in the presence of severe liver disease. Potassium Acetate Injection, USP (2 mEq/mL) is indicated as a source of potassium, for the addition to large volume intravenous fluids, to prevent or correct hypokalemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. Potassium administration is contraindicated in patients with severe renal insufficiency or adrenal insufficiency and in diseases where high potassium levels may be encountered. Potassium Acetate Injection, USP (2 mEq/mL) must be diluted before use. To avoid potassium intoxication, infuse potassium-containing solutions slowly. Potassium replacement therapy should be monitored whenever possible by continuous or serial electrocardiography (ECG). Serum potassium levels are not necessarily dependable indicators of tissue potassium levels. Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. Solutions containing acetate ions should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Do not administer unless solution is clear and seal is intact. Discard unused portion. Potassium replacement therapy should be guided primarily by ECG monitoring and secondarily by the serum potassium level. High plasma concentrations of potassium may cause death by cardiac depression, arrhythmias or arrest. Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease. Solutions containing acetate ion should be used with caution as excess administration may result in metabolic alkalosis. Pregnancy Category C. Animal reproduction studies have not been conducted with potassium acetate. It is also not known whether potassium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium acetate should be given to a pregnant woman only if clearly needed. Pediatric Use: The safety and effectiveness of potassium acetate have been established in pediatric patients. Geriatric Use: An eva luation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Potassium ions are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Adverse reactions involve the possibility of potassium intoxication. The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest. See WARNINGS and PRECAUTIONS . In the event of overdosage, discontinue infusion containing potassium acetate immediately and institute corrective therapy as indicated to reduce elevated serum potassium levels and restore acid-base balance if necessary. See WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS . Potassium Acetate Injection, USP (2 mEq/mL) in the Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile nutrient admixtures. Potassium Acetate Injection, USP (2 mEq/mL) is administered intravenously only after dilution in a larger volume of fluid . The dose and rate of administration are dependent upon the individual needs of the patient. ECG and serum potassium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of potassium (K) with an equal number of milliequivalents of acetate (CHCOO). Maximum infusion rate:  The infusion rate should not exceed 1 mEq/kg/hr. Normal daily requirements:                   Newborn:         2-6 mEq/kg/24 hr.                   Children:         2-3 mEq/kg/24 hr.                   Adult:     40 – 80 mEq/24 hr.  Intraosseous infusion can be an alternate route for drug administration when intravenous access is not readily available. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS Directions for Dispensing From Pharmacy Bulk Package The Pharmacy Bulk Package is for use in the Pharmacy Admixtures Service only. For hanger application, peel off the paper liner from both ends of the tape hanger to expose 3/4 inch long adhesive portions. Adhere each end to the label on the bottle. The vials should be suspended as a unit in the laminar flow hood. A single entry through the vial closure should be made with a sterile dispensing set or transfer device. Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended as it may cause leakage and multiple entries will increase the potential of microbial and particulate contamination. The above process should be carried out under a laminar flow hood using aseptic technique. Discard any unused portion within  4  hours after initial closure entry. The 50mL (NDC-0409-3294-51) glass fliptop vial of Potassium Acetate Injection, USP (2 mEq/mL) is provided as a Pharmacy Bulk Package which provides multiple single doses for continuous admixture compounding procedures. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: February, 2010 Printed in USA                           EN-2395                                       Hospira, Inc., Lake Forest, IL 60045 USA Manufacturer Hospira, Inc. Active Ingredients Source U.S. National Library of Medicine DailyMed Last Updated: 2nd of March 2011 -------------------------------------------------------- 产地国家: 美国 原产地英文商品名: Potassium Acetate Injection 40 meq 20ml/vial 25 vials 中文参考商品译名: 醋酸钾注射液40毫克当量 20毫升/瓶 25瓶 生产厂家英文名: Hospira