Phenylephrine Hydrochloride
Generic: PHENYLEPHRINE HYDROCHLORIDE
Basic Information
Manufacturer
Paragon BioTeck, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
a4d3fe20-f063-11e0-ac29-0002a5d5c51b
Indications & Usage
1 INDICATIONS AND USAGE Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil.
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1 ).
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1 ).
Adverse Reactions
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) ].
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) ].