Medically reviewed by Drugs.com. Last updated on June 21, 2020.
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 [DSC], 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 [DSC])
Nasal Four: 1% (29.6 mL) [contains benzalkonium chloride]
Neo-Synephrine Cold & Sinus: 0.25% (15 mL [DSC]); 0.5% (15 mL [DSC], 21 mL [DSC]); 1% (15 mL [DSC]) [contains benzalkonium chloride]
Neo-Synephrine Cold/Allrg Mild: 0.25% (15 mL) [contains benzalkonium chloride]
Neo-Synephrine Cold/Allrgy Ext: 1% (15 mL) [contains benzalkonium chloride]
Neo-Synephrine Cold/Allrgy Reg: 0.5% (15 mL) [contains benzalkonium chloride]
Rhinall: 0.25% (30 mL [DSC], 40 mL [DSC])
Brand Names: U.S.
- 4-Way Fast Acting [OTC]
- 4-Way Menthol [OTC]
- Afrin Childrens [OTC] [DSC]
- Nasal Four [OTC]
- Neo-Synephrine Cold & Sinus [OTC] [DSC]
- Neo-Synephrine Cold/Allrg Mild [OTC]
- Neo-Synephrine Cold/Allrgy Ext [OTC]
- Neo-Synephrine Cold/Allrgy Reg [OTC]
- Rhinall [OTC] [DSC]
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 (allergic rhinitis), or other upper respiratory allergies.
Off Label Uses
Topical vasoconstriction in nasal procedures
Data from a prospective randomized clinical trial in adult patients undergoing elective nasal septoplasty suggests that topical 0.5% phenylephrine is as effective as 4% cocaine for topical vasoconstriction during nasal surgery [AlHaddad 2013]. Use of phenylephrine spray followed by lidocaine jelly prior to nasal intubation was found to reduce procedural pain and discomfort in one study [Singer 1999]. Various administration techniques (eg, cotton soaked pledgets, spray) and combination with other local anesthetics (eg, lidocaine) are described in the literature [Higgins 2010]. Evidence, however, is limited to studies with small numbers of patients and case reports. Therefore, specific dosing cannot be provided. Additional data may be necessary to further define the role of topical phenylephrine in this setting.
Based on safety issues with topical phenylephrine in surgical settings, the amount of phenylephrine needed to achieve vasoconstriction should be minimized [Groudine 2000]. Some do not recommend the use of topical phenylephrine during endoscopic sinus surgery due to hypertension after application and some fatalities (especially in the pediatric population); instead other agents are recommended (eg, oxymetazoline) [Higgins 2010].
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.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Nasal congestion: Note: Therapy should not exceed 3 days:
Infants and Children <2 years: Limited data available: 0.5% solution: Intranasal: Instill 0.1 mL in each nostril as a single dose (Ralston 2008; Turner 1996). In a double-blind, placebo-controlled trial in 20 infants (mean age: 4 months) with bronchiolitis results showed, improved respiratory scores and oxygen saturation; however, statistical significance was not reached (Ralston 2008). In another randomized, double-blind, placebo-controlled trial, 23 pediatric patients (age range: 6 to 18 months) with the common cold showed improvement in nasal obstruction which was not considered significant; no effect on middle ear pressures was observed (Turner 1996).
Children ≥2 years:
2 to <6 years: 0.125% solution: Intranasal: Instill 1 drop in each nostril every 2-4 hours as needed. Note: Consult product specific information for further details.
Little Noses Decongestant: Instill 2 to 3 drops in each nostril every 4 hours as needed
6 to 12 years: 0.25% solution: Intranasal: Instill 1 to 3 sprays in each nostril every 4 hours as needed
Adolescents: 0.25% to 1% solutions: Intranasal: Instill 1 to 3 drops or sprays every 4 hours as needed
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Administration
For intranasal use only. Blow nose to clear nostrils before use; squeeze bottle with firm, quick pressure while inhaling into each nostril and 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. Monitor therapy
Cocaine (Topical): 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. Avoid combination
Esketamine: Decongestants (Nasally Administered) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal decongestant on an esketamine dosing day should administer the nasal decongestant at least 1 hour before esketamine. Consider therapy modification
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
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Monitor therapy
Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. 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
Monoamine Oxidase 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. Avoid combination
Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Management: Concomitant use of ozanimod with sympathomimetic agents is not recommended. If combined, monitor patients closely for the development of hypertension, including hypertensive crises. Consider therapy modification
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Monitor therapy
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 therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy
Adverse Reactions
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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.
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 recommended for the treatment of rhinitis during pregnancy (BSACI [Scadding 2017]). Use of phenylephrine nasal spray can be considered if acute relief is needed (Mazzotta 1999).
Patient Education
What is this drug used for?
• It is used to treat nose stuffiness.
• It may be given to you for other reasons. Talk with the doctor.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Burning
• Stinging
• Sneezing
• Runny nose
• Nasal irritation
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: nasal antihistamines and decongestants