Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Nasal, as hydrochloride:
12 Hour Decongestant: 0.05% (30 mL) [contains benzalkonium chloride, edetate disodium dihydrate, polyethylene glycol, propylene glycol]
12 Hour Nasal Decongestant: 0.05% (30 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, polyethylene glycol]
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 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 [DSC]) [contains benzalkonium chloride, disodium edta, menthol, polysorbate 80]
Mucinex Nasal Spray Moisture: 0.05% (22 mL [DSC]) [contains benzalkonium chloride, edetate disodium, propylene glycol]
Mucinex Sinus-Max Clear & Cool: 0.05% (22 mL) [contains benzalkonium chloride, edetate disodium, menthol, polyethylene glycol, polysorbate 80, propylene glycol]
Mucinex Sinus-Max Full Force: 0.05% (22 mL [DSC]) [contains benzalkonium chloride, edetate disodium, menthol, polysorbate 80, propylene glycol]
Nasal Decongestant Spray: 0.05% (15 mL [DSC], 30 mL [DSC]) [contains benzalkonium chloride]
Nasal Decongestant Spray: 0.05% (15 mL) [contains benzalkonium chloride, benzyl alcohol, edetate disodium, propylene glycol]
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 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 [DSC]) [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 [DSC]) [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)
Pharmacology
Mechanism of Action
Stimulates alpha-adrenergic receptors in the arterioles of the nasal mucosa to produce vasoconstriction
Pharmacokinetics/Pharmacodynamics
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.
Use: Off Label
Topical vasoconstriction in nasal proceduresc
Based on a systematic review, the use of topical oxymetazoline is recommended over phenylephrine during endoscopic sinus surgery given its safety record Higgins 2010 . Use prior to nasal intubation to reduce the chance of bleeding has also been described (Katz 1990). Various administration techniques (eg, cotton soaked pledgets, spray) and combination with other local anesthetics (eg, lidocaine) are described in the literature Higgins 2010, Johns 1994, Tarver 1993. 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 oxymetazoline in this setting.
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.
Dosage and Administration
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: Children ≥6 years and Adolescents: 0.05%: Intranasal: Instill 2 to 3 sprays into each nostril twice daily; therapy should not exceed 3 days. Note: Intranasal not recommended for use in children <6 years of age (especially in infants) due to CNS depression.
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 (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. 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
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. 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. Monitor therapy
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. 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. 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
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. Avoid combination
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Monitor therapy
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 therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic 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
Pregnancy Considerations
Adverse fetal/neonatal events have been noted in case reports following large doses or extended use of oxymetazoline nasal spray in the first trimester of pregnancy (Baxi 1985; Holm 1985; Menezes 2016). Fetal blood flow was not found to be affected by a one-time dose of oxymetazoline in noncomplicated, third trimester pregnancies (Rayburn 1990). 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
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
- Sneezing
- Burning
- Stinging
- Runny nose
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe nasal irritation
- 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.
