Phenylephrine Hydrochloride
Generic: PHENYLEPHRINE HYDROCHLORIDE
Basic Information
Manufacturer
Lifestar Pharma LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
1767c4b7-36a0-4e64-9091-2af22161402f
Indications & Usage
1 INDICATIONS AND USAGE Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%, is indicated to dilate the pupil.
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
Phenylephrine Hydrochloride Ophthalmic Solution 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: Cardiovascular Effects [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 Lifestar Pharma LLC at 1-888-995-4337 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 effects which have been seen 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 )].
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 Lifestar Pharma LLC at 1-888-995-4337 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 effects which have been seen 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 )].