Phenylephrine Hydrochloride

5 WARNINGS AND PRECAUTIONS Not for injection. Phenylephrine Hydrochloride Ophthalmic Solution, USP is indicated for topical ophthalmic use ( 5.1 ). Reports of serious cardiovascular reactions, some fatal, with Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% solution. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure have been reported. Caution in pediatric patients less than 5 years of age, and in patients with elevated blood pressure ( 5.3 ). Rebound miosis has been reported one day after instillation ( 5.4 ). 5.1 Topical Ophthalmic Use Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is not indicated for injection. 5.2 Cardiovascular Reactions There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients. 5.3 Elevation in Blood Pressure A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored. 5.4 Rebound Miosis Rebound miosis has been reported one day after receiving phenylephrine ophthalmic solution, and re instillation of the drug produced a lesser mydriatic effect.

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Cardiac Disease [See Warnings and Precautions (5.2) ]. Elevation in Blood Pressure [See Warnings and Precautions (5.3) ]. The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1 ). Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Paragon BioTeck, Inc. at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Adverse Reactions Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur. 6.2 Systemic Adverse Reactions A marked increase in blood pressure has been reported particularly, but not limited to, low weight premature neonates, infants and hypertensive patients. Cardiovascular reactions which have occurred primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [See Warnings and Precautions (5.2 and 5.3) ].