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Phenylephrine (nasal): Pediatric drug information

Phenylephrine (nasal): Pediatric drug information
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For additional information see "Phenylephrine (nasal): Drug information" and "Phenylephrine (nasal): Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • 4-Way Fast Acting [OTC];
  • 4-Way Menthol [OTC];
  • Neo-Synephrine Cold/Allrg Mild [OTC];
  • Neo-Synephrine Cold/Allrgy Ext [OTC];
  • Neo-Synephrine Cold/Allrgy Reg [OTC]
Therapeutic Category
  • Adrenergic Agonist Agent;
  • Alpha-Adrenergic Agonist;
  • Nasal Agent, Vasoconstrictor;
  • Sympathomimetic
Dosing: Pediatric
Nasal congestion

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.

Dosing: Kidney 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.

Dosing: Adult

(For additional information see "Phenylephrine (nasal): Drug information")

Nasal congestion

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

Duration: Generally, limit to 3 to 5 days of consecutive use due to risk of rhinitis medicamentosa (Ref). In patients with persistent symptoms despite use of first-line therapies, some guidelines suggest intranasal decongestants may be offered in combination with an intranasal corticosteroid for up to 4 weeks with low risk of rhinitis medicamentosa (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Nasal, as hydrochloride:

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

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

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]

Generic Equivalent Available: US

No

Pricing: US

Solution (4-Way Fast Acting Nasal)

1% (per mL): $0.21

Solution (4-Way Menthol Nasal)

1% (per mL): $0.25

Solution (Neo-Synephrine Cold/Allrg Mild Nasal)

0.25% (per mL): $0.26

Solution (Neo-Synephrine Cold/Allrgy Ext Nasal)

1% (per mL): $0.29

Solution (Neo-Synephrine Cold/Allrgy Reg Nasal)

0.5% (per mL): $0.26

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.

Administration: Pediatric

For intranasal use only. 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.

Administration: Adult

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/Stability

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

Use

Symptomatic relief of nasal and nasopharyngeal mucosal congestion (OTC products: FDA approved in adults; refer to product specific information regarding FDA approval in pediatric patients)

Medication Safety Issues
Sound-alike/look-alike issues:

Neo-Synephrine (phenylephrine, nasal) may be confused with Neo-Synephrine (oxymetazoline)

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

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

Atropine (Systemic): May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

Bromocriptine: May enhance the hypertensive effect of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. 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 (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha1-Agonists. 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: Decongestants may decrease the serum concentration of FentaNYL. 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

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider therapy modification

Lisuride: May enhance the hypertensive effect of Alpha1-Agonists. Risk X: Avoid combination

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. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic 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

Zavegepant: Decongestants (Nasally Administered) may decrease the serum concentration of Zavegepant. Management: Avoid the concurrent administration of intranasal decongestants with zavegepant. If combined use is unavoidable, intranasal decongestants should be administered at least 1 hour after zavegepant administration. Risk D: Consider therapy modification

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).

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

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

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AU) Australia: Neo synephrine;
  • (FR) France: Nostril
  1. 4 Way Fast Acting (phenylephrine) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; 2017.
  2. 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]
  3. Chua SS, Benrimoj SI, and Triggs EJ. Pharmacokinetics of non-prescription sympathomimetic agents. Biopharm Drug Dispos. 1989;10(1):1-14. [PubMed 2647163]
  4. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: a practice parameter update. J Allergy Clin Immunol. 2020;146(4):721-767. doi:10.1016/j.jaci.2020.07.007 [PubMed 32707227]
  5. Good Sense Nasal Four (phenylephrine) [prescribing information]. Allergan, MI: Perrigo; August 2016.
  6. 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]
  7. 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]
  8. Mazzotta P, Loebstein R, Koren G. Treating allergic rhinitis in pregnancy. Safety considerations. Drug Saf. 1999;20(4):361‐375. doi:10.2165/00002018-199920040-00005 [PubMed 10230583]
  9. Phenylephrine HCl Injection [prescribing information]. Irvine, CA: Teva Parenteral Medicines Inc; October 2008.
  10. 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]
  11. Scadding GK, Kariyawasam HH, Scadding G, et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy. 2017;47(7):856‐889. doi:10.1111/cea.12953 [PubMed 30239057]
  12. Seidman MD, Gurgel RK, Lin SY, et al; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: allergic rhinitis. Otolaryngol Head Neck Surg. 2015;152(1 suppl):S1-43. doi:10.1177/0194599814561600 [PubMed 25644617]
  13. 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]
  14. 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]
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