Common concentration now available exclusively in FDA-approved
ready-to-administer prefilled syringe
LAKE ZURICH, Ill.–(BUSINESS WIRE)–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.
Contacts
Media contact
Matt Kuhn, (847) 550-5751
matt.kuhn@fresenius-kabi.com