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Product Information

Download Product Information Sheet

Additional Resources

2018 Compounding Priorities Plan | Food and Drug Administration
Compounding Risk Alerts | Food and Drug Administration
High-Alert Medications in Acute Care Settings | Institute for Safe Medication Practices
FDA Requests Ready-to-Use Concentration of Phenylephrine Hydrochloride Injection | Food and Drug Administration
Evaluation Of Perioperative Medication Errors and Adverse Drug Events | Karen Nanji-Amit Patel-Sofia Shaikh-Diane Seger-David Bates
A Survey Of Medication Preparation and Administration Practices Among Members Of the Canadian Anesthesiologists’ Society | Sophie Breton-Janet van Vlymen-Sean Xia-Ronald Holden-Rachel Phelan-Selena Sagan-Melanie Jaeger

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

Biorphen can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure. Can also cause excessive peripheral and visceral vasoconstriction, and ischemia to vital organs. Extravasation during intravenous administration can cause necrosis or sloughing of tissue. Can cause severe bradycardia and decreased cardiac output, and can increase the need for renal replacement therapy in patients with septic shock, increased pressor effect in patients with autonomic dysfunction, and increased pressor effect with concomitant oxytocic drugs.

Overdose of Biorphen 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.

ADVERSE REACTIONS

Most common adverse reactions during treatment: nausea, vomiting, and headache. To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals at 855-224-0233 or FDA at 1-800-FDA-1088.

DRUG INTERACTIONS

Agonistic Effects (increase in Biorphen blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytoxin, oxytocin, and oxytocic drugs, tricyclic antidepressants, angiotensin, 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, ACE inhibitors, and centrally acting sympatholytic agents.

For more information, please see
Biorphen Full Prescribing Information.

Indications and Usage

Biorphen® (phenylephrine hydrochloride) is indicated for patients with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

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