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Oxymetazoline (Nasal)

Pronunciation

(oks i met AZ oh leen)

Index Terms

  • Oxymetazoline HCl
  • Oxymetazoline Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Nasal, as hydrochloride:

12 Hour Nasal Relief Spray: 0.05% (15 mL, 30 mL)

12 Hour Nasal Spray: 0.05% (30 mL) [contains benzalkonium chloride]

12 Hour Nasal Spray: 0.05% (30 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol]

Afrin 12 Hour: 0.05% (30 mL) [contains benzalkonium chloride, disodium edta, polyethylene glycol, propylene glycol]

Afrin Extra Moisturizing: 0.05% (30 mL [DSC])

Afrin Menthol Spray: 0.05% (15 mL)

Afrin Nasal Spray: 0.05% (15 mL)

Afrin Nasal Spray: 0.05% (15 mL, 20 mL, 30 mL) [contains benzalkonium chloride, disodium edta]

Afrin NoDrip Extra Moisture: 0.05% (15 mL) [contains benzalkonium chloride]

Afrin NoDrip Original: 0.05% (15 mL) [contains benzalkonium chloride]

Afrin NoDrip Sinus: 0.05% (15 mL) [contains benzalkonium chloride, menthol]

Afrin Sinus: 0.05% (15 mL)

Dristan Spray: 0.05% (15 mL) [contains benzalkonium chloride, disodium edta]

Long Lasting Nasal Spray: 0.05% (30 mL) [contains benzalkonium chloride]

Mucinex Nasal Spray Full Force: 0.05% (22 mL) [contains benzalkonium chloride, disodium edta, menthol, polysorbate 80]

Mucinex Nasal Spray Moisture: 0.05% (22 mL) [contains benzalkonium chloride, edetate disodium, propylene glycol]

Mucinex Sinus-Max Full Force: 0.05% (22 mL) [contains benzalkonium chloride, edetate disodium, menthol, polysorbate 80, propylene glycol]

Mucinex Sinus-Max Moist Smart: 0.05% (22 mL [DSC]) [contains benzalkonium chloride, disodium edta, propylene glycol]

Nasal Decongestant Spray: 0.05% (15 mL, 30 mL) [contains benzalkonium chloride]

Nasal Decongestant Spray: 0.05% (15 mL, 30 mL) [contains benzalkonium chloride, edetate disodium, polyethylene glycol, propylene glycol]

Nasal Spray 12 Hour: 0.05% (30 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, propylene glycol]

Nasal Spray Extra Moisturizing: 0.05% (30 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol, propylene glycol]

Nasal Spray Max Strength: 0.05% (30 mL) [gluten free; contains benzalkonium chloride, benzyl alcohol, disodium edta]

Neo-Synephrine 12 Hour Spray: 0.05% (15 mL)

NRS Nasal Relief: 0.05% (15 mL) [contains benzalkonium chloride, benzyl alcohol, disodium edta, propylene glycol]

QlearQuil: 0.05% (15 mL) [contains benzalkonium chloride, disodium edta]

Sinus Nasal Spray: 0.05% (30 mL) [contains benzalkonium chloride, edetate disodium, menthol, polysorbate 80, propylene glycol]

Vicks Sinex: 0.05% (15 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polysorbate 80]

Vicks Sinex 12 Hour Decongest: 0.05% (15 mL) [contains benzalkonium chloride, disodium edta]

Vicks Sinex Moisturizing: 0.05% (15 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polysorbate 80]

Vicks Sinex Severe Decongest: 0.05% (15 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, menthol, polysorbate 80]

Generic: 0.05% (30 mL)

Brand Names: U.S.

  • 12 Hour Nasal Relief Spray [OTC]
  • 12 Hour Nasal Spray [OTC]
  • Afrin 12 Hour [OTC]
  • Afrin Extra Moisturizing [OTC] [DSC]
  • Afrin Menthol Spray [OTC]
  • Afrin Nasal Spray [OTC]
  • Afrin NoDrip Extra Moisture [OTC]
  • Afrin NoDrip Original [OTC]
  • Afrin NoDrip Sinus [OTC]
  • Afrin Sinus [OTC]
  • Dristan Spray [OTC]
  • Long Lasting Nasal Spray [OTC]
  • Mucinex Nasal Spray Full Force [OTC]
  • Mucinex Nasal Spray Moisture [OTC]
  • Mucinex Sinus-Max Full Force [OTC]
  • Mucinex Sinus-Max Moist Smart [OTC] [DSC]
  • Nasal Decongestant Spray [OTC]
  • Nasal Spray 12 Hour [OTC]
  • Nasal Spray Extra Moisturizing [OTC]
  • Nasal Spray Max Strength [OTC]
  • Neo-Synephrine 12 Hour Spray [OTC]
  • NRS Nasal Relief [OTC]
  • QlearQuil [OTC]
  • Sinus Nasal Spray [OTC]
  • Vicks Sinex 12 Hour Decongest [OTC]
  • Vicks Sinex Moisturizing [OTC]
  • Vicks Sinex Severe Decongest [OTC]
  • Vicks Sinex [OTC]

Pharmacologic Category

  • Adrenergic Agonist Agent
  • Decongestant
  • Imidazoline Derivative

Pharmacology

Stimulates alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce vasoconstriction

Onset of Action

Within 10 minutes (Chua 1989)

Duration of Action

Up to 12 hours (Chua 1989)

Use: Labeled Indications

Nasal congestion: Temporary relief of nasal congestion (due to a cold, hay fever, or other upper respiratory allergies) and sinus congestion/pressure.

Contraindications

OTC labeling: When used for self-medication, do not use for more than 3 days.

Documentation of allergenic cross-reactivity for ophthalmic sympathomimetics is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Nasal congestion: Intranasal: Instill 2 to 3 sprays into each nostril twice daily for ≤3 days (maximum dose: 2 doses/24 hours)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Nasal congestion: Intranasal: Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

For intranasal use only. Before using for the first time, prime the pump by firmly depressing the rim several times. Keep head upright and insert nozzle into nostril, depress rim firmly, and inhale deeply.

Storage

Store at room temperature.

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. Exceptions: Cannabidiol. Monitor therapy

Cocaine: 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. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

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

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. 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

MAO 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; Tedizolid. Avoid combination

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 vasopressor effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the vasopressor effect of Alpha1-Agonists. Monitor therapy

Adverse Reactions

Frequency not defined.

Respiratory: Dry nose, nasal congestion (rebound; chronic use), nasal mucosa irritation (temporary), sneezing

Warnings/Precautions

Concerns related to adverse effects:

• Local nasal effects: Temporary discomfort such as burning, stinging, sneezing, or an increased 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: 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.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Accidental ingestion: Accidental ingestion by children of over-the-counter (OTC) imidazoline-derivative eye drops and nasal sprays may result in serious harm. Serious adverse reactions (eg, coma, bradycardia, respiratory depression, sedation) requiring hospitalization have been reported in children ≤5 years of age who had ingested even small amounts (eg, 1 to 2 mL). Contact a poison control center and seek emergency medical care immediately for accidental ingestion (FDA Drug Safety Communication 2012).

• Self-medication (OTC use): When used for self-medication (OTC), do not exceed recommended dosages; use of this container by more than one person may spread infection.

Pregnancy Considerations

Adverse fetal or neonatal effects have not been observed following normal maternal doses of oxymetazoline during the third trimester of pregnancy. Adverse events have been noted in case reports following large doses or extended use. Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy. Short-term (<3 days) use of intranasal oxymetazoline may be beneficial to some patients although its safety during pregnancy has not been studied (Wallace 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience sneezing, burning, stinging, or rhinorrhea. Have patient report immediately to prescriber angina, tachycardia, passing out, severe headache, or severe nasal irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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