Fresenius Kabi, an operating company of Fresenius, announced that Epinephrine Injection, USP, is now available in the United States in 30 mg per 30 mL multi-dose vials.
Epinephrine Injection 30 mg per 30 mL is a prescription medicine used for emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
The product launch adds to the company’s offerings of Epinephrine Injection. In December 2024, Fresenius Kabi introduced the first generic version of Epinephrine, USP, in a 1 mg per mL vial for U.S. customers.
“We are pleased to offer our customers a cost-effective solution that supports quality patient care,” said Arun Verma, president, Fresenius Kabi Region U.S. and Member of the Executive Leadership Team, Fresenius Kabi AG. “At Fresenius Kabi, we are continually striving for new solutions as a trusted partner with the healthcare community.”
Epinephrine Injection is manufactured in the U.S., reflecting the company’s commitment to domestic production. Since 2017, Fresenius Kabi has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. More than 70% of the units shipped by Fresenius Kabi in the U.S. are drugs listed on the FDA’s Essential Medicines List. To learn more, visit our More in America page.
WARNINGS AND PRECAUTIONS:
Do not inject into buttocks, digits, hands, or feet.
Avoid extravasation into tissues, which can cause local necrosis.
Monitor patient for acute severe hypertension.
Potential for pulmonary edema, which may be fatal.
May constrict renal blood vessels and decrease urine formation.
May induce potentially serious cardiac arrhythmias or aggravate angina pectoris, particularly in patients with underlying heart disease.
Presence of sulfite in this product should not deter use.
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. Arrhythmias, including fatal ventricular fibrillation, rapid rises in blood pressure producing cerebral hemorrhage, and angina have occurred.
DRUG INTERACTIONS
Drugs that counter the pressor effects of epinephrine include alpha blockers, vasodilators such as nitrates, diuretics, antihypertensives, ergot alkaloids, and phenothiazine antipsychotics.
Drugs that potentiate the effects of epinephrine include sympathomimetics, beta blockers, tricyclic antidepressants, MAO inhibitors, COMT inhibitors, clonidine, doxapram, oxytocin.
Drugs that increase the arrhythmogenic potential of epinephrine include beta blockers, cyclopropane and halogenated hydrocarbon anesthetics, quinidine, antihistamines, exogenous thyroid hormones, diuretics, and cardiac glycosides. Observe for development of cardiac arrhythmias.
Potassium-depleting drugs, including corticosteroids, diuretics, and theophylline, potentiate the hypokalemic effects of epinephrine.
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause fetal harm.
Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally.
INDICATIONS AND USAGE
Epinephrine is a non-selective alpha- and beta-adrenergic agonist indicated:
For emergency treatment of allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients.
To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock.
This Important Safety Information does not include all the information needed to use Epinephrine Injection, USP safely and effectively. Please see full prescribing information for Epinephrine Injection, USP.
For more information, please visit www.fresenius-kabi.com
