Important Safety information
IMPORTANT SAFETY INFORMATION
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 may cause necrosis or sloughing of tissue. Can cause severe bradycardia and decreased cardiac output, renal toxicity, augmented pressor effect in patients with autonomic dysfunction, and 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.
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.
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.
Indications and Usage
Biorphen® (phenylephrine hydrochloride) is indicated for patients with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Adjust dosage according to the blood pressure goal.