Fresenius Kabi USA LLC
Fresenius Kabi USA LLC
30/08/2019 | Press release | Archived content
Fresenius Kabi Introduces Phenylephrine Hydrochloride Injection, USP
"Fresenius Kabi is pleased to expand our anesthesia and analgesia portfolio with these three presentations of Phenylephrine Hydrochloride Injection," said John Ducker, president and CEO of Fresenius Kabi USA. "Generic alternatives like these play a vital role in patient care and support efforts to make medicines more affordable and accessible."
About Phenylephrine Hydrochloride Injection, USP
Single Dose Vials
INDICATIONS AND USAGE
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.
IMPORTANT SAFETY INFORMATION
Phenylephrine Injection is contraindicated in patients with a hypersensitivity to it or any of its components.
Phenylephrine can cause severe bradycardia and decreased cardiac output.
Extravasation: during intravenous administration may cause necrosis or sloughing of tissue.
Concomitant use with oxytocic drugs: pressor effect of sympathomimetic pressor amines is potentiated.
The most common adverse reactions are nausea and vomiting, headache, and nervousness.
Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2-adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate.
Antagonistic effects on and by α-adrenergic blocking agents, including phenothiazines and amiodarone.
Pharmacy Bulk Package
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
IMPORTANT SAFETY INFORMATION
Extravasation during intravenous administration may cause necrosis or sloughing of tissue.
Phenylephrine can cause severe bradycardia and decreased cardiac output.
Concomitant use with oxytocic drugs: pressor effect of sympathomimetic pressor amines is potentiated.
The most common adverse reactions during treatment are nausea and vomiting, and headache.
Agonistic effects with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transport inhibitors, ergot alkaloids.
Antagonistic effects with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents.
Pregnancy: Based on animal data, may cause fetal harm.
This Important Safety Information does not include all the information needed to use Phenylephrine Injection, USP, safely and effectively. Please click on this link (https://tinyurl.com/y2fla2e5) for the full prescribing information for Phenylephrine Injection, USP. Full prescribing information is also available at www.fresenius-kabi.com/us.
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.