TA的每日心情 | 2020-7-30 14:47 |
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Stability
Amiodarone hydrochloride should be stored at room temperature and protected from light and excessive heat. Light protection is not necessary during administration 1-10/04, but exposure to direct sunlight should be avoided. 2258 It is recommended that amiodarone hydrochloride be added only to dextrose 5%. 1-10/04 Information on the drug's compatibility in sodium chloride 0.9% has been conflicting. Amiodarone hydrochloride 0.6 mg/mL in sodium chloride 0.9% precipitated in 24 hours at room temperature. 1443 In another study, a 1.8-mg/mL concentration in sodium chloride 0.9% was physically and chemically compatible for 24 hours at 24 °C. This difference could have been due to higher polysorbate 80 concentrations in the latter admixtures. 1031 Amiodarone hydrochloride 0.6 mg/mL in dextrose 5% is stable for five days at room temperature. 1443 Solutions containing less than 0.6 mg/mL of amiodarone hydrochloride in dextrose 5% are unstable and should not be used. 1442 Amiodarone hydrochloride (Wyeth-Ayerst) 2 mg/mL in dextrose 5% and also in sodium chloride 0.9% in amber glass containers was stored at 40 °C, being representative of the highest temperature to which drug solutions may be exposed. The solutions turned cloudy after 18 days of storage. HPLC analysis showed that 6 to 10% loss had occurred in sodium chloride 0.9% and dextrose 5%, respectively, in 18 days, with losses increasing to 11 to 14% in 24 days. 2110 Precipitation — Amiodarone hydrochloride may precipitate when diluted. Studies found little or no precipitation when the formulation was diluted to very small or very large concentrations. In the middle range, however, at concentrations between 45 mg/mL (90% amiodarone hydrochloride formulation) and about 0.0025 mg/mL in phosphate buffer (pH 7.4), the drug concentration exceeds the solubility of amiodarone hydrochloride in the mixture. Precipitation may occur immediately or on standing. Such precipitation may occur when the drug enters the bloodstream, contributing to the phlebitis associated with amiodarone hydrochloride. 1818, 1819 The aqueous solubility of amiodarone hydrochloride is not substantially altered over the pH range of 1.5 to 7.5 925, but precipitation may occur in alkaline media. 791, 1032 Sorption — At concentrations of 1 to 6 mg/mL in dextrose 5% in polyolefin or glass containers, amiodarone hydrochloride is physically compatible, with no loss in 24 hours. In PVC containers, however, the amiodarone hydrochloride loss due to sorption occurs; acceptable potency (less than 10% loss) exists for two hours. Consequently, the manufacturer recommends that all infusions longer than two hours be made from glass or polyolefin containers only. 1-10/04 Amiodarone hydrochloride (Labaz) 0.6 mg/mL in dextrose 5% did not exhibit any loss due to sorption in rigid PVC containers (PVC Container Corp.) or glass bottles (Travenol). However, losses were observed in flexible PVC bags (Travenol). The losses totaled approximately 25% in 24 hours at room temperature. 1443 Similarly, amiodarone hydrochloride is lost due to sorption to PVC infusion sets. 1-10/04, 1443 However, the manufacturer states that these losses are accounted for by the recommended dosage schedule. Consequently, PVC sets should be used with this drug, but the recommended infusion regimen must be followed. 1-10/04 Plasticizer Leaching — Amiodarone hydrochloride leaches diethylhexyl phthalate (DEHP) plasticizer from PVC tubing. The degree of plasticizer leaching depends on the concentration and rate of administration. Higher concentrations and slower administration rates leach more plasticizer. 1-10/04 Filtration — Amiodarone hydrochloride (Labaz) 0.6 mg/mL in dextrose 5% and sodium chloride 0.9% was filtered through a 0.22-um cellulose ester membrane filter (Ivex-HP, Millipore) over six hours. No significant drug loss due to binding to the filter was noted. 1034 The use of an inline filter during administration is recommended. 1-10/04, 4
以上信息 摘自 HID 14th
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By stonejang@cpteamHRByd2
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PS:盐酸胺碘酮 属于 High-Alert Medications 的一种。应该针对各种 高危药物 制定 相关的使用指南 保证临床安全用药,并做好不良反应的监护工作!哎,我也就是说一说,有心无力,呵呵!
[ 本帖最后由 stonejang 于 2007-11-27 21:29 编辑 ] |
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