What is Phenylephrine?

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical α-1 adrenergic agonist for ophthalmic use.

What are the features and benefits of Phenylephrine?

  • Doesn’t require refrigeration
  • Convenient 3 fill sizes
  • The only FDA approved product on the market 
  • 24 month shelf life.

What is Phenylephrine indicated for?

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil.

How is Phenylephrine dosed and administered?

  • General Dosing Recommendations
    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.
  • Dosing in Pediatric Patients Less Than 1 Year of Age
    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.

What are the ingredients of Phenylephrine 2.5% and 10%?

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%

  • Actives: Phenylephrine Hydrochloride 25 mg (2.5%);
  • Preservative: Benzalkonium Chloride 0.1 mg (0.01%);
  • Inactives: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg.

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%

  • Actives: Phenylephrine Hydrochloride 100 mg (10%);
  • Preservative: Benzalkonium Chloride 0.1 mg (0.01%);
  • Inactives: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg.

How is Phenylephrine packaged?

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

NDC 17478-201-02 2 mL in 6 cc bottle
NDC 17478-201-15 15 mL in 15 cc bottle

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

NDC 17478-206-05 5 mL in 10 cc bottle

What are contraindication of Phenylephrine?

  • 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.
  • 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)].

How should Phenylephrine be stored?

  • Storage: Store at 20° to 25°C (68° to 77°F).
  • Keep container tightly closed.
  • Protect from light and excessive heat.
  • Do not use if solution is brown or contains precipitate.