Phenylephrine - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Phenylephrine. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension: Phenylephrine hydrochloride injection can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
Peripheral and Visceral Ischemia: Phenylephrine hydrochloride injection can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs.
Skin and Subcutaneous Necrosis: Extravasation during intravenous administration may cause necrosis or sloughing of tissue.
Bradycardia: Phenylephrine hydrochloride injection can cause severe bradycardia and decreased cardiac output.
5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure effects, Phenylephrine hydrochloride injection can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
5.2 Peripheral and Visceral Ischemia Phenylephrine hydrochloride injection can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
5.3 Skin and Subcutaneous Necrosis Extravasation of Phenylephrine hydrochloride injection can cause necrosis or sloughing of tissue.
The infusion site should be checked for free flow.
Care should be taken to avoid extravasation of Phenylephrine hydrochloride injection.
5.4 Bradycardia Phenylephrine hydrochloride injection can cause severe bradycardia and decreased cardiac output.
5.5 Allergic Reactions Phenylephrine hydrochloride injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
5.6 Renal Toxicity Phenylephrine hydrochloride injection can increase the need for renal replacement therapy in patients with septic shock.
Monitor renal function.
5.7 Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including Phenylephrine hydrochloride injection, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
5.8 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine hydrochloride injection [ see Drug Interactions ] , with the potential for hemorrhagic stroke.
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