Pronunciation

(fen il EF rin)

Index Terms

• Phenylephrine HCl
• Phenylephrine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Nasal, as hydrochloride:

4-Way Fast Acting: 1% (14.8 mL, 29.6 mL) [contains benzalkonium chloride]

4-Way Menthol: 1% (14.8 mL, 29.6 mL) [contains benzalkonium chloride, menthol, polysorbate 80]

Afrin Childrens: 0.25% (15 mL)

Nasal Four: 1% (29.6 mL) [contains benzalkonium chloride]

Neo-Synephrine: 0.25% (15 mL [DSC]); 0.5% (15 mL [DSC]); 1% (15 mL [DSC]) [contains benzalkonium chloride]

Neo-Synephrine Cold & Sinus: 0.25% (15 mL); 0.5% (15 mL, 21 mL); 1% (15 mL) [contains benzalkonium chloride]

Rhinall: 0.25% (30 mL, 40 mL)

Brand Names: U.S.

• 4-Way Fast Acting [OTC]
• 4-Way Menthol [OTC]
• Afrin Childrens [OTC]
• Nasal Four [OTC]
• Neo-Synephrine Cold & Sinus [OTC]
• Neo-Synephrine [OTC] [DSC]
• Rhinall [OTC]

Pharmacologic Category

• Alpha-Adrenergic Agonist
• Decongestant

Pharmacology

Potent, direct-acting alpha-adrenergic agonist with virtually no beta-adrenergic activity; produces local vasoconstriction resulting in nasal decongestion.

Onset of Action

Intranasal: ≤2 minutes (Chua 1989)

Duration of Action

Intranasal: 2.5 to 4 hours (dose dependent) (Chua 1989)

Use: Labeled Indications

Nasal congestion: Temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Contraindications

OTC labeling: When used for self-medication, do not use if hypersensitive to phenylephrine or any component of the formulation.

Dosing: Adult

Nasal congestion: Intranasal: 0.25% to 1% solution: Instill 2 to 3 sprays in each nostril no more than every 4 hours for ≤3 days.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Nasal congestion: Intranasal:

Children 2 to <6 years: 0.125% solution: Instill 2 to 3 drops in each nostril no more than every 4 hours for ≤3 days.

Children 6 to <12 years: 0.25% solution: Instill 2 to 3 sprays in each nostril no more than every 4 hours for ≤3 days.

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in manufacturer’s labeling.

Administration

For intranasal use only. Blow nose to clear nostrils before use; spray or drop solution into each nostril while gently occluding the other. Wipe nozzle clean after each use.

Storage

Store at 20ºC to 25ºC (68ºF to 77ºF); protect from light.

Drug Interactions

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Cocaine: May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha1-Agonists may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

MAO Inhibitors: May enhance the hypertensive effect of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid; Tedizolid. Avoid combination

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the vasopressor effect of Alpha1-Agonists. Monitor therapy

Adverse Reactions

Frequency not defined.

Nasal: Burning, nasal discharge, sneezing, stinging

Warnings/Precautions

Concerns related to adverse effects:

• Local nasal effects: Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur.

• Rebound nasal congestion: Frequent or prolonged use may cause nasal congestion to recur or worsen.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with hypertension or heart disease.

• Diabetes mellitus: Use with caution in patients with diabetes mellitus.

• Thyroid disease: Use with caution in patients with thyroid disease.

• Prostatic hyperplasia/Urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), do not use >3 days; discontinue use and notify health care provider if nervousness, dizziness, or sleeplessness occurs or if symptoms do not improve within 3 days; do not use if solution is brown or contains precipitates; do not exceed recommended dosages or use with other products containing decongestants.

Pregnancy Considerations

When administered intravenously, phenylephrine crosses the placenta. Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy. Short-term use (<3 days) of intranasal phenylephrine may be beneficial to some patients, although its safety during pregnancy has not been studied (Wallace, 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience burning, stinging, or nasal irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.