FDA Label for Phenylephrine Hydrochloride

1 Indications And Usage

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

2.1 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.

2.2 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.

3 Dosage Forms And Strengths

Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution, 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, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.

4.1 Cardiac 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.

4.2 Pediatric 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)] .

5.1 Topical Ophthalmic Use Only

Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection.

5.2 Cardiovascular Reactions

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.

5.3 Elevation Of Blood Pressure

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.

5.4 Rebound Miosis

Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-instillation of the drug produced a lesser mydriatic effect.

6 Adverse Reactions

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.

6.1 Ocular Adverse Reactions

Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.

6.2 Systemic Adverse Reactions

A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.

Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [ See Warnings and Precautions ( 5.2and 5.3)].

7.1 Agents That May Exaggerate Pressor Response

Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.

8.1 Pregnancy

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.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is administered to a nursing woman.

8.4 Pediatric Use

Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [ See Contraindications ( 4.2) ].

8.5 Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

10 Overdosage

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.

11 Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical - adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure

Chemical Structure - molecule

Chemical Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride.
Molecular Formula: C ₉H ₁₃NO ₂.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 Dibasic, Sodium Phosphate Monobasic, 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; 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 Dibasic, Sodium Phosphate Monobasic, 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; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).

12.1 Mechanism Of Action

Phenylephrine hydrochloride is an -1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.

12.2 Pharmacodynamics

Maximal mydriasis occurs in 20 to 90 minutes with recovery after 3 to 8 hours. Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which maybe accompanied by a reflex atropine-sensitive bradycardia.

12.3 Pharmacokinetics

The systemic exposure following topical administration of phenylephrine hydrochloride ophthalmic solution has not been studied. A higher systemic absorption is expected for the 10% solution than the 2.5% solution and when the corneal barrier function is compromised.

14 Clinical Studies

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.

16 How Supplied/Storage And Handling

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 70512-865-02         2 mL in 5mL bottle
NDC 70512-865-15         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 70512-866-05         5 mL in 10 mL bottle

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

Storage And Handling

Storage:Store at 20° to 25°C (68° to 77°F).
[see USP Controlled Room Temperature.]

Keep container tightly closed.
Protect from light and excessive heat.
Do not use if solution is brown or contains precipitate.

17. Patient Counseling Information

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 for
SOLA Pharmaceuticals
Baton Rouge, LA 70810
Made in India
Code: TN/Drugs/TN00003457
Rev. 02/2024
22200794

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 70512-865-02

Phenylephrine Hydrochloride
Opthalmic Solution, USP

2.5%

For eye use only

Rx only 2mL

After opening, Phenylephrine HCI
Opthalmic Solution, USP can be used
until the expiration date on the bottle.
Usual Dosage:See package insert for
dosage information.
Note:Bottle filled to 1/3 capacity for
proper drop control.

DO NOT USE IF TAMPER EVIDENT
SEAL IS MISSING OR NOT INTACT.

22200772 Code TN/Drugs/TN00003457

Each mL contains:
Active:Phenylephrine Hydrochloride (2.5%)
Preservative: Benzalkonium Chloride
0.1 mg (0.01%)
Storage:Store at 20° to 25°C (68° to 77°F).
Keep container tightly closed. Do not use if
solution is brown or contains a precipitate.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810
Made in India

LOT:

EXP:

2mL label - 2ml label

Principal Display Panel Text for Carton Label:

NDC 70512-865-02

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

2.5%

For Eye Use Only

SOLA

Rx Only 2 mL

Each mL contains:
Active: Phenylephrine Hydrochloride
25 mg (2.5%)
Inactives:Sodium Phosphate Dibasic
Sodium Phosphate Monobasic, Sodium
Hydroxide and/or Phosphoric Acid may
be added to adjust pH (4.0 to 7.5) and
Water for Injection q.s.
Preservative: Benzalkonium Chloride
0.1 mg (0.01%)

Do not use if solution is brown or
contains a precipitate.

KEEP OUT OF REACH OF CHILDREN.

Usual Dosage:See package insert for
dosage information.

Storage:Store at 20° to 25°C (68° to
77°F). [see USP Controlled Room
Temperature]

DO NOT USE IF TAMPER EVIDENT
SEAL IS MISSING OR NOT INTACT.

Do not touch dropper tip to any surface,
as this may contaminate the solution.

Keep container tightly closed. Protect
from light and excessive heat.

Note:Bottle filled to 1/3 capacity
for proper drop control.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810

Made in India

Code: TN/Drugs/TN00003457

22200787

Principal Display Panel Text for Container Label:

NDC 70512-865-15

Phenylephrine
Hydrochloride
Opthalmic
Solution, USP

2.5%

For eye use only

Rx only 15mL

After opening, Phenylephrine
HCI Opthalmic Solution,
USP can be used until the
expiration date on the bottle.
Usual Dosage:See package
insert for dosage information.

DO NOT USE IF TAMPER
EVIDENT SEAL IS MISSING
OR NOT INTACT.

Each mL contains:
Active:Phenylephrine Hydrochloride (2.5%)
Inactives: Sodium Phosphate Dibasic Sodium
Phosphate Monobasic, Sodium Hydroxide and/or
Phosphoric Acid may be added to
adjust pH (4.0 to 7.5) and Water for
Injection q.s.
Preservative: Benzalkonium Chloride
0.1 mg (0.01%)
Storage:Store at 20° to 25°C (68° to
77°F). Keep container tightly closed.
Do not use if solution is brown or
contains a precipitate.
Protect from light and excessive heat.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810
Made in India

22200784 Code: TNDRUGS/TN0003457

LOT:

EXP:

Principal Display Panel Text for Carton Label:

NDC 70512-865-15

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

2.5%

For Eye Use Only

SOLA

Rx Only 15 mL

Each mL contains:
Active: Phenylephrine Hydrochloride
25 mg (2.5%)
Inactives: Sodium Phosphate
Dibasic, Sodium Phosphate
Monobasic, Sodium Hydroxide
and/or Phosphoric Acid may
be added to adjust pH (4.0 to 7.5)
and Water for Injection q.s.
Preservative: Benzalkonium
Chloride 0.1 mg (0.01%)

Do not use if solution is brown or
contains a precipitate.

KEEP OUT OF REACH OF
CHILDREN.

Usual Dosage: See package insert for
dosage information.

Storage: Store at 20° to 25°C (68°
to 77°F). [see USP Controlled
Room Temperature]

DO NOT USE IF TAMPER EVIDENT
SEAL IS MISSING OR NOT INTACT.

Do not touch dropper tip to any
surface, as this may contaminate
the solution.

Keep container tightly closed.
Protect from light and excessive
heat.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810

Made in India

Code: TN/Drugs/TN00003457

22200789

Principal Display Panel Text for Container Label:

NDC 70512-866-05

Phenylephrine Hydrochloride
Opthalmic Solution, USP

10%

For eye use only

Rx only 5mL

After opening, Phenylephrine
HCI Opthalmic Solution, USP
can be used until the
expiration date on the bottle.
Usual Dosage:See package
insert for dosage information.
Note:Bottle filled to 1/2
capacity for proper drop control.

DO NOT USE IF TAMPER
EVIDENT SEAL IS MISSING
OR NOT INTACT.

Each mL contains:
Active:Phenylephrine Hydrochloride (10%)
Preservative: Benzalkonium Chloride
0.1 mg (0.01%)
Storage:Store at 20° to 25°C
(68° to 77°F).
Keep container tightly closed. Do not use if
solution is brown or contains a precipitate.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810
Made in India

Code: TN/Drugs/TN00003457 22200778

LOT:

EXP:

Principal Display Panel Text for Carton Label:

NDC 70512-866-05

Phenylephrine
Hydrochloride
Ophthalmic
Solution, USP

10%

For Eye Use Only

SOLA

Rx Only 5 mL

Each mL contains:
Active: Phenylephrine Hydrochloride
100 mg (10%)
Inactives: Sodium Phosphate Dibasic,
Sodium Phosphate Monobasic,
Sodium Hydroxide and/or Phosphoric
Acid may be added to adjust pH (4.0 to
7.5) and Water for Injection q.s.
Preservative: Benzalkonium Chloride
0.1 mg (0.01%)

Do not use if solution is brown or
contains a precipitate.

KEEP OUT OF REACH OF
CHILDREN.

Usual Dosage: See package insert for
dosage information.

Storage: Store at 20° to 25°C (68° to
77°F). [see USP Controlled Room
Temperature]

DO NOT USE IF TAMPER EVIDENT
SEAL IS MISSING OR NOT INTACT.

Do not touch dropper tip to any
surface, as this may contaminate
the solution.

Keep container tightly closed. Protect
from light and excessive heat.
Note: Bottle filled to 1/2 capacity for
proper drop control.

Manufactured for:
SOLA Pharmaceuticals
Baton Rouge, LA 70810

Made in India

Code: TN/Drugs/TN00003457

22200788