The FDA is warning health care providers not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC and Endo USA due to confusion with FDA-approved injectable epinephrine products. Similar packaging and containers make it difficult to distinguish the products, which can lead to accidental injection of the non-sterile nasal solution.
Further information, including recall status of the unapproved nasal solutions, can be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-health-care-professionals-not-use-epinephrine-nasal-solutions-bpi-labs-and-endo-usa
Dosage guidance:
Safety: Epinephrine nasal decongestant solution (1 mg/mL) is not approved for treatment of anaphylaxis. More concentrated epinephrine nasal sprays (1 mg per 0.1 mL and 2 mg per 0.1 mL [Neffy]) are indicated for treatment of anaphylaxis; refer to Epinephrine (Systemic) for detailed information on anaphylaxis.
Anaphylaxis and other severe immediate hypersensitivity reactions: A concentrated epinephrine nasal spray (1 mg per 0.1 mL, 2 mg per 0.1 mL [Neffy]) is approved for the treatment of anaphylaxis; refer to Epinephrine (Systemic) monograph for detailed information.
Nasal decongestant: Intranasal: Apply 1 mg/mL solution locally as drops or spray or with sterile swab as needed.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Epinephrine (adrenaline) decongestant (nasal): Pediatric drug information")
Dosage guidance:
Safety: Epinephrine nasal decongestant solution (1 mg/mL) is not approved for treatment of anaphylaxis. A more concentrated epinephrine nasal spray (1 mg/0.1 mL or 2 mg/0.1 mL [Neffy]) is indicated for anaphylaxis; refer to Epinephrine (Systemic) for detailed information on anaphylaxis.
Nasal congestion: Children ≥6 years and Adolescents: Intranasal: 1 mg/mL topical solution: Apply locally as drops or spray or with sterile swab; may also further dilute prior to application; consult product specific labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Postmarketing: Cardiovascular: Cardiomyopathy (Naddaf 2020)
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular diseases (eg, coronary artery disease, hypertension).
• Cerebrovascular disease: Use with caution in patients with cerebrovascular disease.
• Diabetes: Use with caution in patients with diabetes mellitus; may transiently increase blood glucose levels.
• Parkinson disease: Use with caution in patients with Parkinson disease; may cause temporary worsening of symptoms.
• Thyroid disease: Use with caution in patients with thyroid disease.
Special populations:
• Older adult: Use with caution in older adults.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Nasal, as hydrochloride:
Adrenalin: 0.1% (30 mL)
Generic: 0.1% (10 mL, 30 mL)
Yes
Solution (Adrenalin Nasal)
0.1% (per mL): $10.02
Solution (EPINEPHrine HCl (Nasal) Nasal)
0.1% (per mL): $10.00
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Nasal, as hydrochloride:
Adrenalin: 0.1% (30 mL) [contains chlorobutanol (chlorobutol), sodium metabisulfite]
Intranasal: May be diluted with isotonic saline for a less concentrated solution (refer to manufacturer's labeling).
Note: Epinephrine nasal decongestant solution (1 mg/mL) is not approved for treatment of anaphylaxis. More concentrated epinephrine nasal sprays (1 mg per 0.1 mL and 2 mg per 0.1 mL [Neffy]) are indicated for anaphylaxis; refer to Epinephrine (Systemic) for detailed information on anaphylaxis.
Note: Epinephrine nasal solution (1 mg/mL) is not approved for emergency treatment of anaphylaxis. A more concentrated epinephrine nasal spray (Neffy [1 mg/0.1 mL or 2 mg/0.1 mL]) is indicated for treatment of anaphylaxis; refer to Epinephrine (Systemic) for detailed information on anaphylaxis.
Intranasal: May administer undiluted or diluted in NS. Apply as drops or with sterile swab.
Nasal decongestant (nasal solution [Adrenalin]): Treatment of nasal congestion.
Note: Epinephrine nasal decongestant solution (1 mg/mL) is not approved for treatment of anaphylaxis. More concentrated epinephrine nasal sprays (1 mg per 0.1 mL and 2 mg per 0.1 mL [Neffy]) are indicated for anaphylaxis; refer to Epinephrine (Systemic) for detailed information on anaphylaxis.
EPINEPHrine may be confused with ePHEDrine
Neffy (nasal spray) may be confused with nalaxone (nasal sprays [Kloxxado, Narcan, Rextovy, ReVive])
Substrate of COMT;
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.
Alpha1-Blockers: May decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Beta-Blockers (Beta1 Selective): May decrease therapeutic effects of EPINEPHrine (Nasal). Risk C: Monitor
Beta-Blockers (Nonselective): May increase hypertensive effects of EPINEPHrine (Nasal). Risk C: Monitor
Beta-Blockers (with Alpha-Blocking Properties): May decrease therapeutic effects of EPINEPHrine (Nasal). Risk C: Monitor
Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Bromocriptine: May increase hypertensive effects of Alpha-/Beta-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 increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Chloroprocaine (Systemic): May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects 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
COMT Inhibitors: May increase serum concentration of COMT Substrates. Risk C: Monitor
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha-/Beta-Agonists. Risk X: Avoid
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Hexoprenaline: May increase adverse/toxic effects of Alpha-/Beta-Agonists. Risk X: Avoid
Inhalational Anesthetics: May increase arrhythmogenic effects of EPINEPHrine (Nasal). Risk C: Monitor
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects 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 increase hypertensive effects of Alpha-/Beta-Agonists. Risk X: Avoid
Pergolide: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor
Serotonin/Norepinephrine Reuptake Inhibitor: May increase tachycardic effects of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitor may increase vasopressor effects of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider Therapy Modification
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Spironolactone: May decrease vasoconstricting effects of Alpha-/Beta-Agonists. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Tricyclic Antidepressants: May increase vasopressor effects of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider Therapy Modification
Refer to the EPINEPHrine (Systemic) monograph.
Refer to the EPINEPHrine (Systemic) monograph.
Stimulates alpha-, beta1-, and beta2-adrenergic receptors resulting in local vasoconstriction and relief of nasal congestion
Onset of action: Local vasoconstriction (topical): 5 minutes
Duration of action: Local vasoconstriction (topical): <1 hour
Metabolism: Taken up into the adrenergic neuron and metabolized by monoamine oxidase and catechol-o-methyltransferase; circulating drug hepatically metabolized
Excretion: Urine (as inactive metabolites, metanephrine, and sulfate and hydroxy derivatives of mandelic acid, small amounts as unchanged drug)