Phenylephrine hydrochloride

Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless to yellow solution that is free of foreign matter. The chemical name is (R)-3-hydroxy-α(methylamino)methyl benzenemethanol hydrochloride, with a molecular formula of C9H13NO2.HCl and a molecular weight of 203.67 g/mol.

Each mL of the 2.5% solution contains 25 mg of Phenylephrine Hydrochloride as the active ingredient, along with inactive ingredients including Sodium Phosphate Monobasic Anhydrous, Sodium Phosphate Dibasic Anhydrous, and Water for Injection. Each mL of the 10% solution contains 100 mg of Phenylephrine Hydrochloride, with the same inactive ingredients. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust the pH to a range of 4.0 to 7.0. The tonicity of the 2.5% solution is 340 mOsm/kg, while the 10% solution has a tonicity of 985 mOsm/kg. Additionally, the solution 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For patients aged 1 year and older, it is recommended to apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution at a concentration of either 2.5% or 10% to the conjunctival fornix. This should be done at intervals of 3 to 5 minutes, with a maximum of 3 drops administered per eye. For those requiring a greater degree of mydriasis, the 10% strength is advised.

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

Contraindications

Use is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, the product should not be administered to pediatric patients under 1 year of age, as they are at 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 5 years of age, 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 observing 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 have been observed with the 10% strength formulation, including ventricular arrhythmias, some of which have been fatal.

In cases of overdosage, additional adverse reactions may occur, such as a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Rebound miosis has also been reported one day after instillation, indicating a potential for delayed effects.

Healthcare professionals should monitor patients for these adverse reactions and manage them appropriately to ensure patient safety.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 children within this age group due to potential safety concerns.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall differences in safety and effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population based on age alone.

However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may affect drug metabolism and response. It is essential to consider individual patient factors, including comorbidities and concurrent medications, when prescribing to elderly patients to ensure optimal therapeutic outcomes.

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 should 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% and 10% 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, particularly in relation to the possible effects on breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 recommended for individuals with compromised liver function. It is advised that healthcare professionals 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 warranted based on clinical judgment.

Overdosage

Overdosage of phenylephrine can lead to significant adverse effects, primarily characterized by a rapid increase in blood pressure. Healthcare professionals should be vigilant for symptoms that may include headache, anxiety, nausea, vomiting, and the potential for ventricular arrhythmias.

In the event of an overdosage, it is crucial to initiate prompt management. The administration of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine, is recommended to counteract the hypertensive effects. Monitoring of the patient's cardiovascular status is essential, and supportive care should be provided as necessary to address any additional symptoms that may arise.

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 have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided 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, particularly when their pupils are dilated. Patients should be counseled to take appropriate measures to protect their eyes in bright lighting conditions to avoid discomfort.

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) and protected from light and excessive heat.

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; do not use if the solution 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 Dr. Reddy's Laboratories Inc. ,. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)