Hospital Pharmacy - April 2012 - (Page 289)

Hosp Pharm 2012;47(4):289–292 2012 Ó Thomas Land Publishers, Inc. doi: 10.1310/hpj4704-289 Case Report Extended Stability of Magnesium Sulfate Infusions Prepared in Polyolefin Bags Brian E. Sayre, PharmDp; Terrence Prettyman, BS Pharm†; and Gagan Kaushal, PhD‡ Abstract Purpose: To investigate the stability of extemporaneously compounded 50 g per 600 mL magnesium sulfate parenteral solution diluted in Lactated Ringer’s solution. Methods: The sterile preparations of magnesium sulfate were compounded in accordance with USP ,797. standards. To carry out the stability testing, these products were stored under 3 different temperature conditions of -20°C, 2°C to 6°C, and 22°C to 25°C. Under the stability studies, pH, particulate matter, and the active content were monitored for 30 days. Results: Magnesium sulfate infusions are stable for 30 days when stored at -20°C or 2°C to 6 °C and stable for 30 days under all the temperature conditions studied. These data demonstrate that magnesium sulfate infusions have an extended physical and chemical stability after preparation. Conclusions: The stability analysis results show that the shelf-life observed was far better than their recommended expiration dates. This will allow the hospitals to give longer dating to magnesium sulfate preparations, provided they are prepared in a sterile environment and are in compliance with USP ,797. guidelines. Key Words—infusion, magnesium sulfate, storage, time studies Hosp Pharm—2012;47(4):289–292 agnesium sulfate is indicated in the treatment of convulsions,1-3 treatment of hypomagnesemia,4 prevention or treatment of magnesium deficiency in patients receiving total parenteral nutrition,5,6 and treatment of uterine tetany.7,8 Magnesium sulfate is the drug of choice for treating eclamptic seizures and seizure prophylaxis in women with severe pre-eclampsia.3 To provide immediate therapeutic effect for seizures, magnesium sulfate is administered through intravenous (IV) route.9,10 The use of IV magnesium sulfate has also been reported to be useful as adjunct therapy to b-agonists for patients with acute asthma.3,11-13 For IV administration, magnesium sulfate may be given in 10% to 20% solution, with great caution, and the rate should not exceed 1.5 mL of 10% solution or equivalent per minute until relaxation is obtained. Magnesium sulfate is commercially available as an injection vial in the concentration M of 50%.14 This IV injection should be suitably diluted, because the final recommended concentrations are commercially unavailable. These IV solutions are prepared using aseptic conditions under the laminar flow hood and stored until needed. The recommended diluents used for the preparation of IV infusions are normal saline, 5% dextrose, and Lactated Ringer’s solution. There are few studies that provide the guidance regarding the short-term stability of extemporaneously compounded 10% magnesium sulfate solutions. The IV solutions are usually stored at room temperature with no defined duration of storage. Thus the hospital pharmacy is placed in the position of determining the ways to prepare these solutions, the time period for which this product can be stored, and ways to improve the compounding efficiency. At the same time, the goal of any health care facility is to find ways to minimize waste. No study has investigated the stability of magnesium sulfate *Pharmacy Operations Director, Charleston Area Medical Center, Charleston, West Virginia; †Pharmacist-In-Charge, CAMC Solutions, Charleston, West Virginia; ‡Associate Professor, Department of Pharmaceutical and Administrative Sciences, University of Charleston School of Pharmacy, Charleston, West Virginia. Corresponding author: Gagan Kaushal, PhD, Associate Professor, Department of Pharmaceutical and Administrative Sciences, University of Charleston School of Pharmacy, 2300 MacCorkle Avenue SE, Charleston, WV 25304; phone: 304-357-4351; e-mail: Hospital Pharmacy 289

Table of Contents for the Digital Edition of Hospital Pharmacy - April 2012

Hospital Pharmacy - April 2012
ISMP Medication Error Report Analysis
ISMP Adverse Drug Reactions
Cancer Chemotherapy Update
Off-Label Drug Uses
Original Article
Symptomatic Bradycardia, Syncope, and Prolonged Qtc Interval Associated With Dronedarone Therapy
Extended Stability of Magnesium Sulfate Infusions Prepared in Polyolefin Bags
Formulary Drug Reviews
Continuing Education Case Study Quiz (0.15 CEU)
Current FDA-Related Drug Information
Pharmacy Automation and Technology
Director’s Forum
Hospital Pharmacy Pulse
Index to Advertisers

Hospital Pharmacy - April 2012