Important Safety Information
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.
PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%.
Initial U.S. Approval: 1939
________________________________ INDICATIONS AND USAGE _________________________________
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1)
______________________________DOSAGE AND ADMINISTRATION_______________________________
For patients 1 year of age and older: (2.1)
- Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% or 10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
- To obtain a greater degree of mydriasis, use 10% strength.
For pediatric patients less than 1 year of age: (2.2)
- Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
_____________________________DOSAGE FORMS AND STRENGTHS______________________________
Ophthalmic solution (sterile): (3)
- 25 mg of phenylephrine hydrochloride in one mL of solution (2.5%)
- 100 mg of phenylephrine hydrochloride in one mL of solution (10%)
The 10% strength is contraindicated in:
- Patients with hypertension, or thyrotoxicosis (4.1)
- Pediatric patients less than 1 year of age due to increased risk of systemic toxicity (4.2)
______________________________WARNINGS AND PRECAUTIONS_______________________________
- Not for injection: Topical ophthalmic use only (5.1)
- Serious cardiovascular reactions with 10% strength: Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease (5.2).
- Significant elevations in blood pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment (5.3).
- Rebound miosis: Reported one day after instillation (5.4)
__________________________________ ADVERSE REACTIONS___________________________________
- 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 Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
- Atropine-like drugs: May exaggerate the adrenergic pressor response (7.1)
- Potent inhalation anesthetic agents: May potentiate cardiovascular depressant effects (7.1)
See 17 for PATIENT COUNSELING INFORMATION.
See Full Prescribing Informations .