Fresenius Kabi Introduces Neostigmine Methylsulfate Injection, USP Simplist® Prefilled Syringe in 3 mg per 3 mL Presentation
Common concentration now available exclusively in FDA-approved ready-to-administer prefilled syringe
June 10, 2019
LAKE ZURICH, Ill., June 10, 2019 – Fresenius Kabi announced today the immediate availability in the United States of Neostigmine Methylsulfate Injection, USP in 3 mg per 3 mL Simplist® ready-to-administer prefilled syringes.
Fresenius Kabi is a global health company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.
The Fresenius Kabi Simplist Neostigmine Injection prefilled syringe is the first manufacturer-prepared, ready-to-administer prefilled syringe on the market. Fresenius Kabi has sold Neostigmine Injection, USP in 0.5 mg per 1 mL and 1 mg per 1 mL vial presentations since 2015.
“Fresenius Kabi is pleased to continue the expansion of our convenient Simplist prefilled syringe portfolio,” said John Ducker, president and CEO of Fresenius Kabi USA. “This is the fourth Simplist product we’ve introduced this year and represents the strength of our pipeline of important therapies and delivery systems that can help physicians practice more efficiently.”
About Simplist Neostigmine Methylsulfate Injection, USP
Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for intravenous use for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery.
Important Safety Information
An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with neostigmine methylsulfate.
Neostigmine is contraindicated in patients with:
• Hypersensitivity to neostigmine.
• Peritonitis or mechanical obstruction of the urinary or intestinal tracts.
Neostigmine has been associated with bradycardia: Atropine or glycopyrrolate should be administered prior to administration of neostigmine methylsulfate injection to lessen risk of bradycardia.
Coexisting Conditions: Patients with known cardiac disease, cardiac arrhythmias, or recent coronary artery occlusion may be particularly sensitive to the hemodynamic effects of neostigmine; their blood pressure and electrocardiogram should be continuously monitored with the initiation of neostigmine treatment and for a duration sufficient to assure hemodynamic stability.
Neuromuscular Dysfunction: Can occur if large doses of neostigmine methylsulfate are administered when there is minimal neuromuscular blockade; reduce the dose if recovery from neuromuscular blockade is nearly complete.
The most common adverse reactions include bradycardia, nausea, and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Neostigmine Methylsulfate Injection, USP safely and effectively. Please click on this link (https://tinyurl.com/y6t6reh6) for the full prescribing information for Neostigmine Methylsulfate Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.com/us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at https://www.fresenius-kabi.com/us/join-us.