Phenylephrine

Pharmacologic Category

Alpha-Adrenergic Agonist; Decongestant

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: Renal Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

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

Dosing: Renal Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Use: Labeled Indications

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

Use: Off-Label: Adult

Topical vasoconstriction in nasal proceduresLevel of Evidence [C]

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 ^Ref. Use of phenylephrine spray followed by lidocaine jelly prior to nasal intubation was found to reduce procedural pain and discomfort in one study ^Ref. Various administration techniques (eg, cotton soaked pledgets, spray) and combination with other local anesthetics (eg, lidocaine) are described in the literature ^Ref. 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 ^Ref. 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) ^Ref.

Level of Evidence Definitions

Level of Evidence Scale

Class and Related Monographs

Nasal Decongestants

Administration: Intranasal

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.

Administration: Pediatric

For intranasal use only. Spray or apply drops into each nostril while gently occluding the other.

Storage/Stability

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

Medication Patient Education with HCAHPS Considerations

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.

Frequently reported side effects of this drug

• Burning

• Stinging

• Sneezing

• Runny nose

• Nasal irritation

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• A significant reaction like 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. 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

Contraindications

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

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.

Geriatric Considerations

Evaluate the patient's or caregiver's ability to safely administer the correct dose of nasal medication. Use with caution in patients with cardiovascular disease (eg, hypertension).

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).

Breast-Feeding Considerations

It is not known if phenylephrine is excreted in breast milk.

Lexicomp Pregnancy & Lactation, In-Depth

• Phenylephrine (Nasal)

Briggs' Drugs in Pregnancy & Lactation

• Phenylephrine

Adverse Reactions

Frequency not defined.

Nasal: Burning, nasal discharge, sneezing, stinging

Toxicology

• Sympathomimetic Decongestants

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

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

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

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: 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. Risk D: Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: 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. Risk X: 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. Risk D: 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. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: 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. Risk X: 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. Risk D: 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. Exceptions: Linezolid. Risk X: Avoid combination

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Risk C: Monitor therapy

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

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

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

Genes of Interest

• Alpha-1A Receptor

Advanced Practitioners Physical Assessment/Monitoring

Ensure patient is not using chronically; may cause rebound congestion when discontinued.

Nursing Physical Assessment/Monitoring

Ensure patient is not using chronically; may cause rebound congestion when discontinued.

Dosage Forms: US

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]

Rhinall: 0.25% (30 mL [DSC], 40 mL [DSC])

Anatomic Therapeutic Chemical (ATC) Classification

• R01AA04

Generic Available (US)

Yes

Pricing: US

Solution (4-Way Fast Acting Nasal)

1% (per mL): $0.21

Solution (4-Way Menthol Nasal)

1% (per mL): $0.25

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

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

Pharmacodynamics/Kinetics

Onset of action: Intranasal: ≤2 minutes (Chua 1989)

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

Local Anesthetic/Vasoconstrictor Precautions

Use with caution since phenylephrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Phenylephrine HCl; Phenylephrine Hydrochloride

References

4 Way Fast Acting (phenylephrine) [prescribing information]. Parsippany, NJ: Novartis; June 2014.

Alhaddad ST, Khanna AK, Mascha EJ, Abdelmalak BB. Phenylephrine as an alternative to cocaine for nasal vasoconstriction before nasal surgery: a randomised trial. Indian J Anaesth. 2013;57(2):163-169. doi: 10.4103/0019-5049.111844.[PubMed 23825816]

Chua SS, Benrimoj SI, and Triggs EJ. Pharmacokinetics of non-prescription sympathomimetic agents. Biopharm Drug Dispos. 1989;10(1):1-14.[PubMed 2647163]

Groudine SB, Hollinger I, Jones J, DeBouno BA. New York State guidelines on the topical use of phenylephrine in the operating room. The Phenylephrine Advisory Committee. Anesthesiology. 2000;92(3):859-864.[PubMed 10719965]

Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011;121(2):422-432. doi: 10.1002/lary.21286.[PubMed 21271600]

Little Noses (phenylephrine) [prescribing information]. Irvington, NY: Medtech Products; February 2011.

Neo-Synephrine Cold and Sinus Mild Strength Spray 0.25% (phenylephrine) [prescribing information]. Whippany, NJ: Bayer; July 2013.

Neo-Synephrine Cold and Sinus Regular Strength Spray 0.5% (phenylephrine) [prescribing information]. Whippany, NJ: Bayer; July 2013.

Neo-Synephrine Cold and Sinus Extra Strength Spray 1% (phenylephrine) [prescribing information]. Whippany, NJ: Bayer; July 2013.

Phenylephrine HCl Injection [prescribing information]. Irvine, CA: Teva Parenteral Medicines Inc; October 2008.

Ralston S and Roohi M, "A Randomized, Controlled Trial of Nasal Phenylephrine in Infants Hospitalized for Bronchiolitis," J Pediatr, 2008, 153(6):795-8.[PubMed 18657831]

Singer AJ, Konia N. Comparison of topical anesthetics and vasoconstrictors vs lubricants prior to nasogastric intubation: a randomized, controlled trial. Acad Emerg Med. 1999;6(3):184-190.[PubMed 10192668]

Turner RB and Darden PM, "Effect of Topical Adrenergic Decongestants on Middle Ear Pressure in Infants With Common Colds," Pediatr Infect Dis J, 1996, 15(7):621-4.[PubMed 8823858]

Wallace DV, Dykewicz MS, Bernstein DI, et al. The diagnosis and management of rhinitis: An updated practice parameter. J Allergy Clin Immunol. 2008; 122(2 Suppl):S1-84.[PubMed 18662584]

Brand Names: International

Ada Spray (ES); Denason (BR); Humex Nosni (CZ); Humoxal (FR); Nasenspray (CH); Nazol (UA); Neo-Sinifrina (PT); Neo-Synephrine (AE, IT); Phenepirin (KR); Quranasal (AR); Rhinofrin (QA, SA); Vibrocil (SK)

Last Updated 2/5/2