Endo Launches First FDA-Approved Epinephrine Premixed IV Bag
MALVERN, Pa., May 15, 2025 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today the launch of ADRENALIN® (epinephrine in 0.9% sodium chloride injection) 8 mg/250 mL premixed bag and will begin shipping the product the week of May 19, 2025. ADRENALIN® is the first FDA-approved and currently the only commercially available manufacturer-prepared epinephrine premixed IV bag.
"Hospital pharmacists and healthcare providers are working harder than ever, and we are committed to supporting them with ready-to-use medicines that help reduce complexity and streamline operations so they can focus on what matters most—patient care," said Scott Sims, Senior Vice President and General Manager, Endo Injectable Solutions and Generics. "With this new ADRENALIN® premixed bag concentration, plus the additional concentrations in our pipeline, we are proud to offer options and choice through our TruDelivery® portfolio."
Key Product Benefits
- The ADRENALIN® premixed bag is part of Endo Injectable Solutions' TruDelivery® product line and platform.
- Ready-to-use products streamline operations for hospitals by eliminating the need to prepare or transfer the product before patient administration.
- This may reduce waste and costs, optimize convenience and workflow, and reduce the chance for preparation error—all of which support quality patient care.
In addition to the new 8 mg/250 mL bag, Endo offers ADRENALIN® 4 mg/250 mL premixed bag and plans to launch 5 mg/250 mL and 10 mg/250 mL concentrations. The company also offers ADRENALIN® (epinephrine injection, USP) 1 mL single-dose and 30 mL multi-dose vials.
Indication
ADRENALIN® is indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
Important Safety Information
Warnings and Precautions
Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension when given epinephrine.
Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema.
Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia in patients, especially patients suffering from coronary artery disease, or cardiomyopathy.
Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation of epinephrine into the tissues, to prevent local necrosis.
Antidote for Extravasation Ischemia: To prevent sloughing and necrosis in areas in which extravasation has taken place, infiltrate the area with 10 mL to 15 mL of saline solution containing from 5 mg to 10 mg of phentolamine, an adrenergic blocking agent.
Adverse Reactions
Most common adverse reactions to systemically administered epinephrine are headache; anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; peripheral coldness; nausea/vomiting; and/or respiratory difficulties.
About Endo
Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements including, but not limited to, the statements by Mr. Sims and any statements relating to product shipments, commercial availability, product benefits, reduction of waste, costs and errors, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts.
SOURCE Endo, Inc.