Drug Facts
Composition & Profile
Identifiers & Packaging
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: 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.; 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; 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 2mL Carton; 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 15mL Label 15mL Carton 5mL Label 5mL Carton
- 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: 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.
- 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
- 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 2mL Carton
- 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 15mL Label 15mL Carton 5mL Label 5mL Carton
Overview
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 Name: (R)-3-hydroxy- [(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9 H 13 NO 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%). Chemical Structure
Indications & Usage
Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%, is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil ( 1 )
Dosage & Administration
For patients 1 year of age and older : ( 2.1 ) 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 For pediatric patients less than 1 year of age : ( 2.2 ) 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 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.
Warnings & Precautions
Not for injection : Topical ophthalmic use only ( 5.1 ) Serious cardiovascular reactions with 10% strength : Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease ( 5.2 ). Significant elevations in blood pressure : Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment ( 5.3 ). Rebound miosis : Reported one day after instillation ( 5.4 ) 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.
Contraindications
The 10% strength is contraindicated in: Patients with hypertension, or thyrotoxicosis ( 4.1 ) Pediatric patients less than 1 year of age due to increased risk of systemic toxicity ( 4.2 ) 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 )] .
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. Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia ( 6.1 ) Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact SOLA Pharmaceuticals at 1-866-747-7365 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 ( 5.2 and 5.3 )].
Drug Interactions
Atropine-like drugs : May exaggerate the adrenergic pressor response ( 7.1 ) Potent inhalation anesthetic agents : May potentiate cardiovascular depressant effects ( 7.1 ) 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.
Storage & 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.
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