Phenylephrine hydrochloride

Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow solution intended for topical ophthalmic use. The active ingredient is (R)-3-hydroxy-α(methylamino)methylbenzenemethanol hydrochloride, with a molecular formula of C₉H₁₃NO₂·HCl and a molecular weight of 203.67 g/mol. Each milliliter of the solution contains 25 mg of Phenylephrine Hydrochloride, corresponding to a concentration of 2.5%. Inactive ingredients include Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, and Water for Injection. The pH of the solution is adjusted to a range of 4.0 to 7.5 using Phosphoric Acid and/or Sodium Hydroxide. The solution exhibits a tonicity of 340 mOsm/kg and contains Benzalkonium Chloride as a preservative at a concentration of 0.1 mg (0.01%).

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution is indicated for the dilation of the pupil. This medication acts as an alpha-1 adrenergic receptor agonist, facilitating the necessary pharmacological response for procedures requiring pupil dilation.

There are no teratogenic or nonteratogenic effects associated with the use of this ophthalmic solution.

Dosage and Administration

For patients aged 1 year and older, it is recommended to apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% strength) to the conjunctival fornix at intervals of 3 to 5 minutes, with a maximum of 3 drops per eye. For a greater degree of mydriasis, a 10% strength solution may be utilized.

In pediatric patients under 1 year of age, one drop of the 2.5% strength solution should be instilled into the conjunctival fornix at 3 to 5 minute intervals, also with a maximum of 3 drops per eye.

Contraindications

The 10% strength is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, its use is contraindicated in pediatric patients under 1 year of age because of an increased risk of systemic toxicity.

Warnings and Precautions

Topical ophthalmic use is the only approved route for administration; this product is not intended for injection.

Healthcare professionals should be aware of the potential for serious cardiovascular reactions associated with the 10% strength formulation. These reactions may include ventricular arrhythmias, some of which have resulted in fatal outcomes. It is imperative to monitor blood pressure in patients with pre-existing cardiovascular disease to mitigate risks.

Significant elevations in blood pressure have been observed, particularly in pediatric patients under the age of 5, as well as in individuals with cardiovascular disease or hyperthyroidism. For patients identified as high risk, it is recommended to monitor blood pressure following treatment to ensure patient safety.

Additionally, rebound miosis has been reported as a potential effect occurring one day after instillation. Healthcare providers should be vigilant in monitoring for this reaction and counsel patients accordingly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication, categorized by seriousness and frequency.

Ocular adverse reactions are commonly reported and include eye pain and stinging upon instillation, temporary blurred vision, and photophobia. These reactions are generally mild but may cause discomfort for patients.

Cardiovascular adverse reactions can be more serious and include an increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage. Notably, serious cardiovascular reactions such as ventricular arrhythmias have been reported, with some cases resulting in fatal outcomes. Significant elevations in blood pressure have been observed, particularly in pediatric patients under 5 years of age, as well as in patients with pre-existing cardiovascular disease or hyperthyroidism. It is advised that blood pressure be monitored post-treatment in patients identified as high risk.

Rebound miosis has been reported as an adverse reaction occurring one day after instillation, which may require further evaluation.

Additionally, overdosage of the medication may lead to a rapid rise in blood pressure, accompanied by symptoms such as headache, anxiety, nausea, vomiting, and ventricular arrhythmias. These potential effects underscore the importance of adhering to prescribed dosages and monitoring patients closely for any adverse reactions.

Drug Interactions

Atropine-like drugs may enhance the adrenergic pressor response when administered concurrently. Clinicians should monitor patients for increased blood pressure and consider dosage adjustments of adrenergic agents as necessary.

Potent inhalation anesthetic agents have the potential to amplify cardiovascular depressant effects. It is advisable to closely monitor cardiovascular status in patients receiving these agents, and dosage adjustments may be warranted based on the patient's response.

Packaging & NDC

The table below lists all NDC Code configurations of Phenylephrine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age. Caution should be exercised when considering the use of this medication in younger populations, as safety and efficacy have not been established in this age group.

Geriatric Use

Elderly patients have been evaluated in clinical studies, and no overall differences in safety and effectiveness have been observed when compared to younger adult patients. Therefore, dosage adjustments based solely on age are not necessary.

However, it is important for healthcare providers to consider the individual health status and comorbidities of geriatric patients, as these factors may influence the overall treatment plan and monitoring requirements. Regular assessment and careful monitoring are recommended to ensure optimal therapeutic outcomes in this population.

Pregnancy

Animal reproduction studies have not been conducted with topical phenylephrine. Therefore, it is not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Given the lack of data, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether phenylephrine hydrochloride ophthalmic solution 2.5% is excreted in human breast milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering this medication to lactating mothers. Healthcare professionals should consider the risks and benefits of treatment in nursing women and monitor breastfed infants for any adverse effects.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of phenylephrine can lead to significant cardiovascular and neurological effects. A notable consequence of overdosage is a rapid increase in blood pressure, which may pose serious health risks to the patient.

In addition to hypertension, symptoms may include headache, anxiety, nausea, vomiting, and the potential for ventricular arrhythmias. These manifestations require immediate attention to mitigate further complications.

Management of phenylephrine overdosage should involve the prompt administration of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine. This intervention is critical in reversing the hypertensive effects and stabilizing the patient's condition. Healthcare professionals are advised to monitor the patient closely for any evolving symptoms and to provide supportive care as necessary.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with topical phenylephrine. The potential for phenylephrine to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed.

No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

Healthcare providers should advise patients not to touch the dropper tip to any surface, as this may lead to contamination of the solution. It is important for patients to understand that maintaining the sterility of the dropper is crucial for their safety and the effectiveness of the treatment.

Additionally, healthcare providers should inform patients that they may experience sensitivity to light following the use of the medication. Patients should be counseled to protect their eyes in bright illumination, especially while their pupils are dilated, to avoid discomfort and potential harm.

Storage and Handling

Phenylephrine Hydrochloride Ophthalmic Solution, USP is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. The solution must be protected from light and excessive heat to ensure its stability.

Once opened, the solution can be used until the expiration date indicated on the bottle. It is important to inspect the solution prior to use; it should not be used if it appears brown or contains any precipitate.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Phenylephrine Hydrochloride as submitted by NorthStar RxLLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)