Adrenergic and dopaminergic agents
Phenylephrine Hydrochloride
The FDA lists this product in 60 strengths and forms.
Indications
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 ).
Contraindications
Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients ( 4.1 ). Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients ( 4.2 ).
4.1Cardiac and Endocrine Disease Phenylephrine Hydrochloride Ophthalmic Solution, USP
10% is contraindicated in patients with hypertension, or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.
4.2Pediatric Patients Less Than 1 Year of Age Phenylephrine Hydrochloride Ophthalmic Solution, USP
10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients [See Dosage and Administration ( 2.2 )].
Warnings and precautions
Not for injection. Phenylephrine Hydrochloride Ophthalmic Solution, USP is indicated for topical ophthalmic use ( 5.1 ). Reports of serious cardiovascular reactions, some fatal, with Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% solution. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure have been reported. Caution in pediatric patients less than 5 years of age, and in patients with elevated blood pressure ( 5.3 ).