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Oxymetazoline (Nasal)


VA CLASSIFICATION
Primary: NT100

Commonly used brand name(s): 4-Way 12–Hour Nasal Spray; Afrin Cherry 12 Hour Nasal Spray; Afrin Extra Moisturizing 12 Hour Nasal Spray; Afrin Original 12 Hour Nasal Spray; Afrin Original 12 Hour Nose Drops; Afrin Original 12 Hour Pump Mist; Afrin Sinus 12 Hour Nasal Spray; Dristan 12-Hr Nasal Spray; Dristan Long Lasting Mentholated Nasal Spray; Dristan Long Lasting Nasal Mist; Drixoral Nasal Solution; Duramist Plus Up To 12 Hour Nasal Decongestant Spray; Duration 12 Hour Nasal Spray; Genasal Nasal Spray Up to 12 Hour Relief; Nasal Relief 12 Hour Nasal Spray; Neo-Synephrine 12 Hour Extra Moisturizing Spray; Neo-Synephrine 12 Hour Spray; Nostrilla 12 Hour Nasal Decongestant; Twice-A-Day Extra Moisturizing 12 Hour Nasal Spray; Twice-A-Day Soothing 12 Hour Nasal Spray; Vicks Sinex 12 Hour Nasal Spray; Vicks Sinex 12 Hour Ultra Fine Mist for Sinus Relief.

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)—Oxymetazoline is indicated for temporary relief of nasal congestion, up to 12 hours, due to the common cold , sinusitis, hay fever , or other upper respiratory allergies (allergic rhinitis). {01} {02} {04} {05} {06} {07} {08} {09} {11} {12} {13} {14} {15} {16} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}

[Congestion, sinus (treatment)]—Nasal oxymetazoline is used for the relief of sinus congestion {07}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    296.84 {32}


pH
    Approximately 6.4.

Mechanism of action/Effect:

Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce constriction, resulting in decreased blood flow and decreased nasal congestion, for up to 12 hours {05} {06} {28} {33} {34} {35} {37} {38} {39} {45}.


Precautions to Consider

Cross-sensitivity and/or related problems

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

Pregnancy/Reproduction

Oxymetazoline may be systemically absorbed. However, adequate and well-controlled studies in humans have not been done. {07}

Breast-feeding

Oxymetazoline may be systemically absorbed. However, problems in humans have not been documented.

Pediatrics

Children may be especially prone to systemic absorption of oxymetazoline with resulting side/adverse effects.


Geriatrics


Although appropriate studies on the relationship of age to the effects of oxymetazoline have not been performed in the geriatric population, 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{07} or
Maprotiline or
Monoamine oxidase inhibitors{05}{06}{07}    (if significant systemic absorption of nasal oxymetazoline occurs, concurrent use may potentiate the pressor effect of oxymetazoline)


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 due to drug-induced cardiovascular effects {01} {02} {04} {05} {06} {07} {08} {09} {11} {12} {13} {14} {15} {16} {18} {20} {21} {22} {21} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48})


Enlarged prostate    (difficulty of urination due to enlarged prostate may be exacerbated because of vasoconstrictive effects {01} {02} {04} {08} {09} {11} {12} {13} {14} {15} {16} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48})


Diabetes mellitus{01}{02}{04}{05}{06}{07}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{36}{37}{38}{39}{40}{45}{47}{48}
Glaucoma, narrow angle{05}{06}{07}
Hyperthyroidism{01}{02}{04}{05}{06}{07}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{36}{37}{38}{39}{40}{45}{47}{48}
Rhinitis, sicca{05}{06}{07}    (may exacerbate already dry mucous membranes)


Sensitivity to oxymetazoline or other nasal decongestants{05}{06}{07}    (may exacerbate side effects such as, sleepiness, dizziness, lightheadedness, weakness, tremulousness or cardiac arrhythmia)




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{01}{02}{04}{05}{06}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{37}{38}{45}{47}{48} (increase in runny or stuffy nose)
Symptoms of systemic absorption
{07}    
Blurred vision{05}{06}
    
fast, irregular, or pounding heartbeat
    
headache, dizziness, drowsiness, or lightheadedness
    
high blood pressure{05}{06}
    
nervousness{05}{06}
    
trembling
    
trouble in sleeping
    
weakness



Those indicating need for medical attention only if they continue or are bothersome
    
Burning, dryness, or stinging of nasal mucosa{01}{02}{04}{05}{06}{07}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{36}{37}{38}{45}{47}{48}
    
increase in nasal discharge{01}{02}{04}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{36}{37}{38}{45}{47}{48}
    
sneezing{01}{02}{04}{05}{06}{07}{08}{09}{11}{12}{13}{14}{15}{16}{18}{20}{21}{22}{28}{33}{34}{35}{36}{37}{38}{45}{47}{48}




Overdose
In children, oxymetazoline may produce profound central nervous system depression. For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center listing ). {01} {02} {04} {05} {06} {07} {08} {09} {11} {12} {15} {16} {18} {20} {21} {22} {36} {45}


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

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

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

Pregnancy—Oxymetazoline may be systemically absorbed





Breast-feeding—Oxymetazoline may be systemically absorbed





Use in children—Children may be especially sensitive to the effects of oxymetazoline

Other medications, especially maprotiline, monoamine oxidase inhibitors, and tricyclic antidepressants
Other medical problems, especially coronary artery disease, diabetes mellitus, enlarged prostate, heart disease, hypertension, hyperthyroidism, open-angle glaucoma, and rhinitis sicca

Proper use of this medication
Proper administration technique

Preventing contamination: Wiping tip of applicator with clean, damp tissue; replacing cap right after use

Preventing spread of infection: Not using bottle for more than 1 person

» Importance of not using more medication than the amount recommended; not using medication for more than 3 days without checking with physician

» Proper dosing
Missed dose: If on scheduled dosing regimen—Using right away if remembered within an hour or so; if not remembered until later, skipping missed dose and returning to regular dosing schedule; not doubling doses

» Proper storage


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


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


Nasal Dosage Forms

OXYMETAZOLINE HYDROCHLORIDE NASAL SOLUTION USP

Usual adult and adolescent dose
Decongestant
Intranasal, 2 or 3 drops or sprays of a 0.05% solution into each nostril every ten to twelve hours. {01} {02} {04} {05} {06} {07} {08} {09} {10} {11} {12} {13} {14} {16} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}


Note: The nasal spray form of the medication is more effective and less likely to cause systemic absorption.


Usual adult and adolescent prescribing limits
Maximum of 2 doses in twenty four hours. {01} {02} {04} {05} {06} {07} {08} {09} {10} {11} {12} {13} {14} {16} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}

Usual pediatric dose
Decongestant
Children up to 6 years of age: Dosage has not been established. {01} {02} {04} {07} {08} {09} {10} {11} {12} {13} {14} {15} {16} {18} {20} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}

Children 6 years of age and older: See Usual adult and adolescent dose. {01} {02} {07} {08} {09} {10} {11} {12} {13} {14} {16} {18} {20} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}


Usual pediatric prescribing limits
Maximum of 2 doses in twenty four hours. {01} {02} {07} {08} {09} {10} {11} {12} {13} {14} {16} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38} {39} {40} {45} {47} {48}

Strength(s) usually available
U.S.—


0.05% (nasal drops) (OTC) [Afrin Original 12 Hour Nose Drops{08}{34}{41} (benzalkonium chloride) (edetate disodium) (polyethylene glycol 1450) (povidone) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)][Generic]


0.05% (nasal spray) (OTC) [Afrin Cherry 12 Hour Nasal Spray{09}{38}{41} (artificial cherry flavor) (benzalkonium chloride) (benzyl alcohol) (edetate disodium) (polyethylene glycol 1450) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)] [Afrin Extra Moisturizing 12 Hour Nasal Spray{01}{28}{41} (benzalkonium chloride) (edetate disodium) (sodium phosphate dibasic) (sodium phosphate monobasic) (Soothate™ [glycerin, polyethylene glycol 1450, propylene glycol]) (water)] [Afrin Original 12 Hour Nasal Spray{12}{33}{41} (benzalkonium chloride) (edetate disodium) (polyethylene glycol 1450) (povidone) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)] [Afrin Original 12 Hour Pump Mist{18}{35}{41} (benzalkonium chloride) (edetate disodium) (polyethylene glycol 1450) (povidone) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)] [Afrin Sinus 12 Hour Nasal Spray{02}{37}{41} (benzalkonium chloride) (benzyl alcohol) (edetate disodium) (polysorbate 80) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (Vapornase™ [camphor, eucalyptol, menthol]) (water)] [Dristan 12-Hr Nasal Spray{21}{30} (benzalkonium chloride) (dibasic sodium phosphate) (hydroxypropyl methylcellulose) (monobasic potassium phosphate) (purified water) (sodium chloride) (thimerosal)] [Duramist Plus Up To 12 Hour Nasal Decongestant Spray{36}{44} (benzalkonium chloride) (glycerin) (potassium phosphate) (sodium chloride) (sodium phosphate)] [Duration 12 Hour Nasal Spray{11}{42}{45} (benzalkonium chloride) (edetate disodium) (polyethylene glycol 1450) (povidone) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)] [Genasal Nasal Spray Up to 12 Hour Relief{13}{43} (benzalkonium chloride) (edetate disodium) (polyethylene glycol 1450) (povidone) (propylene glycol) (sodium phosphate dibasic) (sodium phosphate monobasic) (water)] [Nasal Relief 12 Hour Nasal Spray{15}{46} (benzalkonium chloride) (disodium edetate) (disodium phosphate) (monosodium phosphate) (phenylmercuric acetate 0.02%) (purified water) (sorbitol)] [Neo-Synephrine 12 Hour Extra Moisturizing Spray{16}{26}{39} (benzalkonium chloride) (glycerin) (glycine) (phenylmercuric acetate) (purified water) (sodium chloride) (sorbitol)] [Neo-Synephrine 12 Hour Spray{14}{26}{40} (benzalkonium chloride) (glycerin) (glycine) (phenylmercuric acetate) (purified water) (sodium chloride) (sorbitol)] [Nostrilla 12 Hour Nasal Decongestant{04}{27}] [Twice-A-Day Extra Moisturizing 12 Hour Nasal Spray{20}{23} (benzalkonium chloride) (glycerin) (purified water) (sodium chloride) (sodium phosphate dibasic) (sodium phosphate monobasic)] [Twice-A-Day Soothing 12 Hour Nasal Spray{22}{23} (benzalkonium chloride) (purified water) (sodium chloride) (sodium phosphate dibasic) (sodium phosphate monobasic)] [Vicks Sinex 12 Hour Nasal Spray{25}{47}] [Vicks Sinex 12 Hour Ultra Fine Mist for Sinus Relief{25}{48} (aromatic vapors [camphor, eucalyptol, menthol]) (benzalkonium chloride) (chlorhexidine gluconate) (disodium EDTA) (potassium phosphate) (purified water) (sodium chloride) (sodium phosphate) (tyloxapol)] [4-Way 12–Hour Nasal Spray{10}{19} (benzalkonium chloride) (glycine) (phenylmercuric acetate 0.002%) (sorbitol) (water)][Generic]{29}{31}{51}

Canada—


0.05% (nasal spray) (OTC) [Dristan Long Lasting Nasal Mist{05} (benzalkonium chloride) (cellulose) (potassium phosphate) (purified water) (sodium chloride) (sodium phosphate) (thimerosal)] [Dristan Long Lasting Mentholated Nasal Spray{06} (alcohol) (camphor) (cellulose) (eucalyptol) (menthol) (potassium phosphate) (purified water) (sodium chloride) (sodium phosphate) (thimerosal)] [Drixoral Nasal Solution{07} (water)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 2 and 30 °C (36 and 86 °F), unless otherwise specified by manufacturer {02} {04} {09} {11} {15} {18} {20} {21} {22} {28} {33} {34} {35} {36} {37} {38}. Store in a tight container. Protect from freezing. Protect from light. {16}

Auxiliary labeling:
   • For the nose.



Revised: 6/14/2000



References
  1. Afrin extra moisturizing 12 hour nasal spray package labeling (Schering-Plough—US), Rec 5/13/99.
  1. Afrin sinus 12 hour nasal spray package labeling (Schering-Plough—US), Rec 5/13/99.
  1. Open.
  1. Nostrilla 12 hour nasal decongestant package labeling (Heritage—US), Rec 5/19/99.
  1. Dristan long lasting nasal mist (Whitehall-Robins). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 34th ed. Ottawa: Canadian Pharmacists Association; 1999. p. 556.
  1. Dristan long lasting mentholated nasal spray (Whitehall-Robins). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 34th ed. Ottawa: Canadian Pharmacists Association; 1999. p. 556.
  1. Drixoral Nasal Solution (Schering). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 34th ed. Ottawa: Canadian Pharmacists Association; 1999. p. 558.
  1. Afrin original 12 hour nose drops package labeling (Schering-Plough—US), Rec 5/13/99.
  1. Afrin cherry12 hour nasal spray package labeling (Schering-Plough—US), Rec 5/13/99.
  1. 4-Way 12 Hour Nasal Spray package labeling (Bristol-Myers Squibb—US), Rec 6/9/99.
  1. Duration 12 hour nasal spray package labeling (Schering-Plough—US), Rec 5/13/99.
  1. Afrin original 12 hour nasal spray packge labeling (Schering-Plough—US), Rec 5/13/99.
  1. Genasal nasal spray up to 12 hour relief package labeling (Zenith Goldline—US), Rec 5/7/99.
  1. Neo-synephrine 12 hour spray package labeling (Bayer—US), Rec 5/7/99.
  1. Nasal relief package labeling (Altaire—US), Rec 5/19/99.
  1. Neo-synephrine 12 hour extra moisturizing spray package labeling (Bayer—US), Rev 12/9/97, Rec 5/10/99.
  1. Open.
  1. Afrin original 12 hour pump mist package labeling (Scherin-Plough—US), Rec 5/13/99.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Bristol-Myers) p. 614.
  1. Twice-A-Day extra moisturizing 12 hour nasal spray package labeling (Major—US), Rec 5/10/99.
  1. Dristan 12-hour nasal spray package labeling (Whitehall-Robins—US), Rec 5/7/99.
  1. Twice-A-Day soothing 12 hour nasal spray package labeling (Major—US), Rec 5/10/99.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Major) p. 876.
  1. Lacy CF, Armstrong LL, Ingrim NB, etal. editors. APhA Drug information handbook. 6th ed. Hudson, OH: Lexi-Corp Inc; 1998. p. 941.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Procter & Gamble) p. 887.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Bayer) p. 787.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Heritage) p. 793.
  1. Afrin extra moisturizing 12 hour nasal spray (Schering-Plough). In: PDR Physicians' desk reference for nonprescription durgs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. p. 614.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Whitehall-Robins) p. 701.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. p. 802.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 542.
  1. Afrin original 12 hour nasal spray (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Afrin original 12 hour nose drops (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Afrin original 12 hour pump mist (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Duramist Plus Up to 12 Hour Nasal Decongestant Spray package labeling (Pfeiffer—US), Rec 5/28/99.
  1. Afrin sinus 12 hour nasal spray (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Afrin cherry 12 hour nasal spray (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 754-5.
  1. Neo-synephrine maximum strength 12 hour extra moisturizing nasal spray (Bayer). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 619.
  1. Neo-Synephrine 12 hour (Bayer). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 619.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Schering-Plough) p. 624.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Schering-Plough) p. 703.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Zenith Goldline) p. 726.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Pfeiffer) p. 703.
  1. Duration 12 hour nasal spray (Schering-Plough). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 763.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. (Altaire) p. 786.
  1. Vicks Sinex 12-hour nasal spray (Procter & Gamble). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 749.
  1. Vicks Sinex 12-hour ultra fine mist for sinus relief (Procter & Gamble). In: PDR Physicians' desk reference for nonprescription drugs. 19th ed. Montvale, NJ: Medical Economics Co Inc; 1998. p. 749.
  1. Open.
  1. Open.
  1. Red Book 1999. Montvale, NJ: Medical Economics Co Inc; 1999. p. 614.
  1. Open.

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