FDA
Phenylephrine Hydrochloride
The FDA lists this product in 60 strengths and forms.
Indications
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 )
Contraindications
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 )
4.1Cardiac and Endocrine Disease
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
4.2Pediatric Patients Less Than 1 Year of Age
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration (2.2) ].
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 )