1 INDICATIONS AND USAGE Phenylephrine hydrochloride Injection, is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Phenylephrine hydrochloride 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.

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6 ADVERSE REACTIONS Adverse reactions to Phenylephrine hydrochloride are primarily attributable to excessive pharmacologic activity.

Adverse reactions reported in published clinical studies, observational trials, and case reports of Phenylephrine hydrochloride are listed below by body system.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias Gastrointestinal disorders: Epigastric pain, vomiting, nausea Nervous system disorders: Headache, blurred vision, neck pain, tremors Vascular disorders: Hypertensive crisis Respiratory, Thoracic and Mediastinal Disorders: Dyspnea Skin and subcutaneous tissue disorders: Pruritis Most common adverse reactions during treatment: nausea, vomiting, and headache.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .