1 INDICATIONS AND USAGE Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in the setting of anesthesia ( 1 )

6 ADVERSE REACTIONS The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature.

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: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders : Nausea, vomiting General disorders and administrative site conditions: Chest pain, extravasation Nervous system disorders : Headache, nervousness, paresthesia, tremor Psychiatric disorders: Excitability Respiratory : Pulmonary edema, rales Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders: Hypertensive crisis Most common adverse reactions: nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.