Get Expert Advice for controlling your Severe Allergies

Phenylephrine (Nasal)


VA CLASSIFICATION
Primary: NT100{06}

Commonly used brand name(s): Alconefrin Nasal Drops 12; Alconefrin Nasal Drops 25; Alconefrin Nasal Drops 50; Alconefrin Nasal Spray 25; Doktors; Duration; Neo-Synephrine Nasal Drops; Neo-Synephrine Nasal Jelly; Neo-Synephrine Nasal Spray; Neo-Synephrine Pediatric Nasal Drops; Nostril Spray Pump; Nostril Spray Pump Mild; Rhinall; Rhinall-10 Children's Flavored Nose Drops; Vicks Sinex.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Decongestant (topical)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Congestion, nasal (treatment)—Nasal phenylephrine is indicated for the symptomatic relief of nasal congestion due to the common cold or hay fever , sinusitis, or other upper respiratory allergies. {21}

[Congestion, sinus (treatment)]—Nasal phenylephrine is used for relief of sinus congestion.

Congestion, eustachian tube (treatment)—Nasal phenylephrine may be useful in the adjunctive therapy of middle ear infections by decreasing congestion around the eustachian ostia.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    203.67 {02}

Mechanism of action/Effect:

Phenylephrine is primarily a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce constriction, resulting in decreased nasal congestion.

Duration of action:

30 minutes to 4 hours.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other nasal decongestants may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented; however, nasal phenylephrine may be systemically absorbed.

Breast-feeding

Problems in humans have not been documented; however, nasal phenylephrine may be systemically absorbed.

Pediatrics

Children may be especially prone to systemic absorption of nasal phenylephrine and resulting side/adverse effects. {03} {04}


Geriatrics


Appropriate studies on the relationship of age to the effects of phenylephrine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Antidepressants, tricyclic or
Maprotiline or
Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (if significant systemic absorption of nasal phenylephrine occurs, concurrent use of these medications may potentiate the pressor effect of phenylephrine; nasal phenylephrine should not be administered within 14 days following the administration of MAO inhibitors)


Guanadrel or
Guanethidine    (if significant systemic absorption of nasal phenylephrine occurs, concurrent use of guanadrel or guanethidine may potentiate the pressor effect of phenylephrine, possibly resulting in hypertension and/or cardiac arrhythmias)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Coronary artery disease or
Heart disease, including angina or
Hypertension    (condition may be exacerbated because of drug-induced cardiovascular effects {21})


Diabetes mellitus{21}
Hyperthyroidism{21}
Sensitivity to phenylephrine or other nasal decongestants


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
    
Rebound congestion (increase in runny or stuffy nose)
Symptoms of systemic absorption
    
Fast, irregular, or pounding heartbeat
    
headache or dizziness
    
increased sweating
    
nervousness
    
paleness
    
trembling
    
trouble in sleeping



Those indicating need for medical attention only if they continue or are bothersome
    
Burning, dryness, or stinging of nasal mucosa{21}




Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Phenylephrine (Nasal).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to phenylephrine or other nasal decongestants





Use in children—Children may be especially prone to systemic absorption of nasal phenylephrine and resulting side/adverse effects


Proper use of this medication
Proper administration technique

Preventing contamination:
Replacing cap right after use

For nasal drops
After using—Rinsing dropper with hot water and drying with clean tissue

For nasal spray
After using—Rinsing tip of spray bottle with hot water, taking care not to suck water into bottle, and drying with clean tissue

For nasal jelly
After using—Wiping tip of tube with clean, damp tissue
Preventing spread of infection: Not using container for more than one person

» Importance of not using more medication than the amount recommended

» Proper dosing
Missed dose: If on scheduled dosing regimen—Using right away if remembered within an hour or so; not using if remembered later; not doubling doses

» Proper storage


Side/adverse effects
Signs of potential side effects, especially rebound congestion and sympathomimetic systemic effects


General Dosing Information
Prolonged or excessive use of this medication will cause rebound congestion with chronic swelling of nasal mucosa.

To reduce the chance of rebound congestion and systemic side effects, the weakest strength that is effective should be used.


Nasal Dosage Forms

PHENYLEPHRINE HYDROCHLORIDE NASAL JELLY USP

Usual adult and adolescent dose
Decongestant, topical
Intranasal, a small quantity of a 0.5% jelly placed into each nostril and sniffed well back into the nasal passages every three or four hours as needed.


Usual pediatric dose
Pediatric strength not available.

Strength(s) usually available
U.S.—


0.5% (OTC) [Neo-Synephrine Nasal Jelly]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light. Protect from freezing.

Stability:
Prolonged exposure to air, strong light, or heat results in oxidation and some loss of potency. Do not use if jelly is brown.

Incompatibilities:
Medication is incompatible with butacaine, alkalies, ferric salts, oxidizing agents, and metals.

Auxiliary labeling:
   • For the nose.


PHENYLEPHRINE HYDROCHLORIDE NASAL SOLUTION USP

Usual adult and adolescent dose
Decongestant, topical
Intranasal, 2 or 3 drops or sprays of a 0.25 to 0.5% solution into each nostril every four hours as needed {05} {10} {19} {20} {21}

Note: The nasal spray form of this medication is more effective and less likely to cause systemic absorption than is the drop form.
In cases of extreme nasal congestion, the 1% solution may be used initially. {17} {18}



Usual pediatric dose
Decongestant, topical
Infants and children up to 2 years of age: Dosage must be individualized by physician.

Children 2 to 6 years of age: Intranasal, 2 or 3 drops of a 0.125 or 0.16% solution into each nostril every four hours as needed. {22} {25}

Children 6 to 12 years of age: Intranasal, 2 or 3 drops or sprays of a 0.25% solution into each nostril every four hours as needed. {10} {19}

Children 12 years of age and over: See Usual adult and adolescent dose. {05} {17} {18} {20}


Strength(s) usually available
U.S.—


0.125% (drops) (OTC) [Neo-Synephrine Pediatric Nasal Drops]


0.16% (drops) (OTC) [Alconefrin Nasal Drops 12]


0.2% (drops) (OTC) [Rhinall-10 Children's Flavored Nose Drops]


0.25% (drops) (OTC) [Alconefrin Nasal Drops 25] [Doktors] [Neo-Synephrine Nasal Drops] [Rhinall][Generic]


0.25% (spray) (OTC) [Alconefrin Nasal Spray 25] [Doktors] [Neo-Synephrine Nasal Spray] [Nostril Spray Pump Mild] [Rhinall]


0.5% (drops) (OTC) [Alconefrin Nasal Drops 50] [Neo-Synephrine Nasal Drops]


0.5% (spray) (OTC) [Duration] [Neo-Synephrine Nasal Spray] [Nostril Spray Pump] [Vicks Sinex][Generic]


1% (drops) (OTC) [Neo-Synephrine Nasal Drops]


1% (spray) (OTC) [Neo-Synephrine Nasal Spray][Generic]

Canada—


0.25% (drops) (OTC) [Neo-Synephrine Nasal Drops]


0.25% (spray) (OTC) [Neo-Synephrine Nasal Spray]


0.5% (drops) (OTC) [Neo-Synephrine Nasal Drops]


0.5% (spray) (OTC) [Neo-Synephrine Nasal Spray]


1% (drops) (OTC) [Neo-Synephrine Nasal Drops]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Stability:
Prolonged exposure to air, strong light, or heat results in oxidation and some loss of potency. Do not use if solution is brown or contains a precipitate.

Incompatibilities:
Medication is incompatible with butacaine, alkalies, ferric salts, oxidizing agents, and metals.

Auxiliary labeling:
   • For the nose.



Revised: 05/16/1994



References
  1. Open.
  1. The United States pharmacopeia. The national formulary. USP 21st revision (January 1, 1985). NF 16th ed (January 1, 1985). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1985.
  1. Olin BR, editor. Drug facts and comparisons. St Louis: Facts and Comparisons Inc., 1985: 184a.
  1. Oxymetazoline (Nasal) monograph, USP DI 1986.
  1. Neo-Synephrine nasal spray 1/2% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Heller WM, editor. USAN 1988. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1987.
  1. Open.
  1. Open.
  1. Open.
  1. Neo-Synephrine nasal spray 1/4% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Neo-Synephrine nasal spray 1% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Neo-Synephrine nasal drops 1% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Neo-Synephrine nasal drops 1/4% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Neo-Synephrine nasal drops 1/2% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Nostril package label (Boehringer Ingelheim—US), Rec 1990.
  1. Neo-Synephrine pediatric nasal drops 1/8% package insert (Sterling Winthrop—US), Rec 10/93.
  1. Open.
  1. Open.
  1. Alconefrin nasal drops 12 (Alcon). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data Production Company, 1994: 2486.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
  1. Open.
Hide
(web3)