Neo-Synephrine Hydrochloride

Description

Neo-Synephrine® is a sterile injectable formulation containing phenylephrine hydrochloride at a concentration of 10 mg/mL, equivalent to a 1% solution. This product is manufactured by Hospira, Inc., located in Lake Forest, IL 60045, USA.

Uses and Indications

Neo-Synephrine (phenylephrine HCl) is indicated for use as a vasoconstrictor in the treatment of hypotension occurring in the setting of anesthesia. Additionally, it is indicated for the treatment of nasal congestion associated with colds, allergies, and hay fever.

There are no specific teratogenic or nonteratogenic effects associated with this drug as per the available data.

Dosage and Administration

Each milliliter of the formulation contains 10 mg of phenylephrine hydrochloride. For the usual dosage and specific route of administration, healthcare professionals should refer to the package insert for detailed guidance.

The medication may be administered via subcutaneous, intramuscular, or intravenous routes. It is essential to follow the recommended administration techniques for each route to ensure optimal efficacy and safety.

Contraindications

There are no specific contraindications listed for this product. Healthcare professionals should exercise clinical judgment when considering the use of this product in patients with a history of substance abuse, dependence, or any other relevant medical conditions that may pose a risk. It is essential to evaluate each patient's individual circumstances to ensure safe and effective use.

Warnings and Precautions

The product contains sulfites, which may cause allergic reactions in sensitive individuals. Healthcare professionals should be vigilant for signs of hypersensitivity, including hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. In the event of such reactions, immediate emergency medical assistance is warranted.

Patients should be advised to discontinue use and consult their healthcare provider if they experience severe headaches, blurred vision, or any other changes in vision. Additionally, symptoms such as chest pain, rapid or pounding heartbeats, or feelings of light-headedness should prompt immediate medical evaluation.

Currently, there are no specific laboratory tests recommended for monitoring the safe use of this product. However, healthcare professionals should remain attentive to the clinical presentation of patients and manage any adverse effects accordingly.

Side Effects

Patients receiving Neo-Synephrine Hydrochloride (Phenylephrine Hydrochloride Injection) may experience a range of adverse reactions, which can vary in severity and frequency.

Serious adverse reactions include severe allergic reactions such as anaphylaxis, angioedema, and urticaria. Cardiovascular events may also occur, including hypertension, reflex bradycardia, arrhythmias, and palpitations. In some cases, postmarketing experience has reported cardiac arrest and ischemic events.

Common adverse reactions observed in clinical settings encompass a variety of systems. Cardiovascular effects such as hypertension and palpitations are frequently noted. Central nervous system effects may include anxiety, tremors, headache, and dizziness. Gastrointestinal disturbances such as nausea and vomiting have also been reported. Additionally, dermatologic reactions, including skin rashes, and respiratory issues like dyspnea, may occur.

It is important to note that the presence and severity of these side effects can differ among patients. Furthermore, the product contains sulfites, which may pose additional risks for individuals with sulfite sensitivity.

Drug Interactions

Phenylephrine has several notable drug interactions that healthcare professionals should consider when prescribing or administering this medication.

Pharmacodynamic Interactions

Phenylephrine may interact with monoamine oxidase inhibitors (MAOIs), which can lead to a hypertensive crisis. It is advisable to avoid concurrent use of phenylephrine with MAOIs to mitigate this risk. Additionally, the concurrent use of phenylephrine with other sympathomimetic agents may heighten the risk of cardiovascular side effects. Monitoring of cardiovascular status is recommended in patients receiving these combinations.

Pharmacokinetic Interactions

Phenylephrine may interfere with certain laboratory tests, particularly those measuring blood glucose levels. This interference could result in false results, which may affect clinical decision-making. Healthcare providers should be aware of this potential interaction and consider alternative testing methods if necessary.

Packaging & NDC

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

Pediatric Use

Pediatric use has not been specifically addressed in the available data. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for pediatric patients, including infants, children, and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the lack of specific information.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of phenylephrine hydrochloride. This heightened sensitivity necessitates careful consideration when prescribing this medication to geriatric patients.

Due to the potential for reduced kidney function commonly observed in this population, dosage adjustments may be required to ensure safety and efficacy. It is essential for healthcare providers to monitor renal function and adjust the dosage accordingly to mitigate the risk of adverse effects.

Special precautions should be taken when administering phenylephrine hydrochloride to elderly patients. Close monitoring for any signs of increased sensitivity or adverse reactions is recommended to ensure optimal therapeutic outcomes while minimizing potential risks.

Pregnancy

Safety during pregnancy has not been established for phenylephrine. The use of phenylephrine is contraindicated in pregnancy due to potential risks to the fetus. There may be associated risks with the use of phenylephrine during this period; therefore, healthcare providers should consult with patients regarding alternative treatment options.

Dosage adjustments may be necessary for pregnant patients, and healthcare providers should carefully evaluate the risks versus benefits before prescribing phenylephrine. Special precautions are advised when administering this medication to pregnant women, and monitoring for any adverse effects is recommended to ensure maternal and fetal safety.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with the use of Neo-Synephrine Hydrochloride (phenylephrine hydrochloride injection). Therefore, healthcare professionals may consider its use in lactating mothers without additional concerns related to breastfeeding. However, as with any medication, the benefits and risks should be evaluated on a case-by-case basis.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments when receiving Neo-Synephrine hydrochloride. Special monitoring of renal function is recommended for these patients. Specifically, those with reduced creatinine clearance may require a reduced dose of phenylephrine hydrochloride. It is essential to conduct renal function tests to assess the need for dosage modifications in patients with renal impairment.

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 Neo-Synephrine hydrochloride can result in significant cardiovascular complications, including severe hypertension and reflex bradycardia. Healthcare professionals should be vigilant for symptoms that may arise from overdosage, which can include headache, anxiety, tremors, and palpitations.

In cases of suspected overdosage, it is imperative to implement supportive measures and ensure close monitoring of the patient. This monitoring should focus on cardiovascular status and any emerging symptoms that may require intervention.

If deemed necessary, treatment may involve the administration of an alpha-adrenergic antagonist to mitigate the effects of overdosage. It is essential for healthcare providers to assess the patient's condition continuously and adjust treatment protocols as needed to ensure patient safety and effective management of symptoms.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, adverse developmental outcomes were not noted, and there was no increase in fetal malformations in the evaluated animal studies. These findings suggest a favorable safety profile regarding developmental toxicity in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed several adverse reactions associated with the use of the product. Notable events reported voluntarily or through surveillance programs include hypertension, reflex bradycardia, and arrhythmias. Additional adverse reactions reported encompass headache, dizziness, and anxiety.

Severe allergic reactions, including anaphylaxis, have been documented, along with skin reactions such as rash and urticaria. Instances of gastrointestinal disturbances, including nausea and vomiting, have also been noted. Furthermore, some patients have reported visual disturbances, including blurred vision, and there have been documented cases of respiratory complications, including difficulty breathing.

Patient Counseling

Healthcare providers should advise patients to protect the medication from light to ensure its efficacy and stability. It is also important to inform patients that the medication contains sulfites, which may cause allergic reactions in sensitive individuals. Patients should be made aware of the potential for such reactions and instructed to report any signs of an allergic response.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20 to 25°C (68 to 77°F), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from light to maintain its integrity and efficacy.

Additional Clinical Information

Patients may receive the medication via subcutaneous, intramuscular, or intravenous routes. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

FDA Insert (PDF)

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

View full prescribing information (PDF)