PHENYLEPHRINE HYDROCHLORIDE

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

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.

The following serious adverse reactions are described below and elsewhere in the labeling:
• Cardiovascular Effects [See Warnings and Precautions (5.2)]
• Elevation in Blood Pressure [See Warnings and Precautions (5.3)]

The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow solution and free of foreign matter, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure

Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl] benzenemethanol hydrochloride.

Molecular Formula: C₉H₁₃NO₂. HCl

Molecular Weight: 203.67 g/mol

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic Anhydrous, Sodium Phosphate Dibasic Anhydrous, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.0). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic Anhydrous, Sodium Phosphate Dibasic Anhydrous, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.0). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides.

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 68083-593-01                                      2 mL in 5 mL bottle

NDC 68083-680-01                                      15 mL in 15 mL 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 68083-594-01                                      5 mL in 10 mL Bottle

After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

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.

Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.

Manufactured by:
Gland Pharma Limited
Hyderabad-500 043, INDIA

Revised: 12/2024

Package-Carton-Label-2-mL

NDC 68083-593-01
Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

2.5%

For Topical Application
in the Eye.
Not for Injection.
2 mL
Rx only

Package-Container-Label-2-mL

NDC 68083-593-01

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP
2.5%
For Topical Application
in the Eye.
Not for Injection.
2 mL
Rx only

Package-Carton-Label-5-mL

NDC 68083-594-01
Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP
10%
For Topical Application
in the Eye.
Not for Injection.
5 mL
Rx only

Package-Container-Label-5-mL

NDC 68083-594-01
Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP
10%
For Topical Application
in the Eye.
Not for Injection.
5 mL
Rx only

5-ml-container-label

Package-Carton-Label-15-mL

NDC 68083-680-01
Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

2.5%

For Topical Application
in the Eye.
15 mL
Rx only

Package-Container-Label-15-mL

NDC 68083-680-01

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP
2.5%
For Topical Application in the Eye.
15 mL
Rx only

15-ml-container-label