PHENYLEPHRINE HCL 2.5%-ML O/S 10 ML
Generic: phenylephrine hydrochloride
PHENYLEPHRINE HCL 2.5%-ML O/S 10 ML
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Identification
phenylephrine hydrochloride
Phenylephrine Hydrochloride
Paragon BioTeck, Inc.
HUMAN PRESCRIPTION DRUG
Administration
SOLUTION/ DROPS
OPHTHALMIC
NDA203510
Active Ingredients
| Ingredient | Strength |
|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 25 mg/mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
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 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ). 2.1 General Dosing Recommendations For patients 1 year of age or greater, apply one drop of either Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops. If necessary, this dose may be repeated. In order to obtain a greater degree of mydriasis, Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% may be needed. 2.2 Pediatric Patients Less Than 1 Year of Age 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.
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) ].
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated. Distributed by: Paragon BioTeck, Inc. Bridgewater, NJ 08807 USA © 2023 Bausch & Lomb Incorporated or its affiliates 9792900
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.