Phenylephrine Hydrochloride
Phenylephrine Hydrochloride Prescribing Information
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.
In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.
In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.
• 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
In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
• 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
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution and free of foreign matter, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%: each mL contains 25 mg of phenylephrine hydrochloride.
Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless to yellow solution and free of foreign matter, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.
Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.
The 10% strength is contraindicated in:
• Patients with hypertension, or thyrotoxicosis (
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.
• Pediatric patients less than 1 year of age due to increased risk of systemic toxicity (
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
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Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection.
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There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.
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A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.
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Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.