Eton Pharmaceuticals Announces U.S. FDA Approval of Biorphen® (phenylephrine HCI) Injection
~ Biorphen is the First and Only Ready-to-Use FDA-Approved Injectable Formulation of Phenylephrine ~
~ Biorphen Eliminates Need for Compounding, Reducing Risks for Unsafe Injection Practices, Medication Administration Errors, Sterility Breaches, and Waste ~
Prior to the
“Operating rooms, emergency departments and intensive care units are fast-paced and time-sensitive environments. Add to that the complexity of caring for patients with a wide range of critical conditions and the use of high-alert medications like phenylephrine – and you have an atmosphere primed for potential medication error,” said
“Providers at the bedside need reliable, easy to use, safe drugs that have a consistent supply. Many hospitals outsource unapproved ready-to-use phenylephrine from 503B compounders, however often have to navigate supply disruptions through these suppliers,” said
Biorphen® (phenylephrine HCI) Injection is the first and only
INDICATION & USAGE
BIORPHEN injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
IMPORTANT SAFETY INFORMATION
Intravenous administration of phenylephrine can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. BIORPHEN can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs as well as severe bradycardia and decreased cardiac output.
Extravasation during intravenous administration may cause necrosis or sloughing of tissue. The most common side effects of phenylephrine during treatment are nausea, vomiting, and headache. Interactions with concomitant medications may augment or antagonize the pressor effect.
Warnings and Precautions
- Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension
- Peripheral and Visceral Ischemia
- Skin and Subcutaneous Necrosis
Most common adverse reactions during treatment: nausea, vomiting, and headache.
- Agonistic Effects (increase in BIORPHEN blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids.
- Antagonistic Effects (decrease in BIORPHEN blood pressure effect) can occur 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
Overdose of BIORPHEN (phenylephrine hydrochloride) can cause a rapid rise in blood pressure. Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.
Please see full Prescribing Information
About Eton Pharmaceuticals
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Source: Eton Pharmaceuticals