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“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
About Biorphen
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.
Contraindications
None.
Warnings and Precautions
- Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension
- Peripheral and Visceral Ischemia
- Skin and Subcutaneous Necrosis
- Bradycardia
Adverse Reactions
Most common adverse reactions during treatment: nausea, vomiting, and headache.
Drug Interactions
- 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
Overdosage
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
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the
Company Contact:
dkrempa@etonpharma.com
847-805-1077
Media Contact:
Elixir Health PR
lrocco@elixirhealthpr.com
862-596-1304
REFERENCES
1. 2018 Compounding Policy Priorities Plan.
PR-ETON-001 10/2019
Source: Eton Pharmaceuticals