药品信息:
说明
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）
DESCRIPTION
Potassium Acetate for Injection, USPCONCENTRATE, 4 mEq/mL, is a sterile, non-pyrogenic, concentrated solution of Potassium Acetate (C2H3KO2) in Water for Injection. It must be diluted prior to administration.
Each 50 mL vial contains 19.6 grams of Potassium Acetate (anhydrous) which provides 200 mEq each of Potassium (K+) and Acetate (CH3COO-).
The pH is adjusted with acetic acid and the solution contains no bacteriostatic agent or other preservative.
The solution is intended as an alternative to Potassium Chloride to provide potassium (K+) for addition to large volume infusion fluids for intravenous use. Unused portion should be discarded.
CLINICAL PHARMACOLOGY
Potassium is found in low concentration in plasma and extracellular fluids. It is the chief cation of body cells, and is concerned with the maintenance of body fluid composition and electrolyte balance. The major amount of potassium is excreted in the urine. Therefore, the kidney normally determines potassium balance.
The acetate ion is completely metabolized in the body, providing a source of hydrogen ion acceptors.
INDICATIONS AND USAGE
Potassium Acetate for Injection, USPCONCENTRATEis indicated in the treatment of potassium deficiency states when oral replacement therapy is not feasible.
CONTRAINDICATIONS
Potassium administration is contraindicated in diseases where high potassium levels may be encountered.
WARNINGS
To avoid potassium intoxication, infuse potassium containing solutions slowly. In patients with severe renal insufficiency or adrenal insufficiency, administration of Potassium Acetate for Injection, USPCONCENTRATEmay cause potassium intoxication.
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.
PRECAUTIONS
Potassium replacement therapy should be guided primarily by serial electrocardiograms. Plasma potassium levels are not necessarily indicative of tissue potassium levels.
High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest. Potassium Acetate for Injection, USPCONCENTRATEshould be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.
ADVERSE REACTIONS
Nausea, vomiting, abdominal pain and diarrhea have been reported. 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. SeeWARNINGS.
USE IN PREGNANCY
Safety for use in pregnancy has not been established. Use of potassium acetate in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
DOSAGE AND ADMINISTRATION
Potassium Acetate for Injection, USPCONCENTRATE(4 mEq/mL), must be diluted before administration. The dose and rate of injection are dependent upon the individual condition of each patient. ECG and serum potassium should be monitored as a guide to dosage. Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluids to provide the desired number of milliequivalents of potassium (K+) with an equal number of milliequivalents of acetate (CH3COO-).
Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.
OVERDOSAGE
In the event of overdosage, discontinue the infusion immediately, and institute intensive corrective therapy to reduce the serum potassium levels.
HOW SUPPLIED
Potassium Acetate for Injection, USP Concentrate (4 mEq/mL) |
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