Phenylephrine Hydrochloride

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil.

• For patients 1 year of age and older, apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% at 3 to 5 minute intervals up to a maximum of 3 drops per eye (
  
  2.1).
  
• In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye (
  
  2.2).
  

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%.

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.

Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% should be given to a pregnant woman only if clearly needed.

• Not for injection. Phenylephrine Hydrochloride Ophthalmic Solution, USP is indicated for topical ophthalmic use (
  
  
  5.1 Topical Ophthalmic Use

  Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is not indicated for injection.
  ).
  
• 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 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.
  ).
  
• 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 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.
  ).
  
• Rebound miosis has been reported one day after instillation (
  
  
  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.
  ).