Seasonal Allergies and OTC Nasal Sprays

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Allergic rhinitis (AR) is an IgE-mediated disorder that is defined as the presence of one or more of the following symptoms: rhinorrhea, itching, sneezing, and nasal congestion. Allergic rhinitis can be both perennial and seasonal in nature and is the fifth most common chronic disease in the United States.¹ Seasonal AR may be caused by pollen from trees, grasses, or weeds as well as outdoor mold spores, and is associated with extranasal symptoms such as allergic conjunctivitis, itchy ears, itchy palate, and asthma.¹ This article will focus on the over-the-counter (OTC) nasal treatments of AR.

Incidence of Allergic Rhinitis

The incidence of provider-diagnosed AR in the United States is approximately 60 million people, including both adults and children.² The incidence is even higher when patients self-report AR: between 10% to 30% of the adult population and up to 40% of children report that they have seasonal AR.^1,2

Symptoms of AR can significantly alter patients’ quality of life. Patients with AR, and particularly those with seasonal exacerbations, may experience disrupted sleep patterns, daytime drowsiness, altered mood (specifically irritability), as well as difficulty with concentration, memory, and ability to learn.³ Patients report that these symptoms have at least a moderate effect on their daily life; some experience a decrease in sense of smell and taste, which may lead to consumption of greater quantities of salt or sweeteners that can have an adverse effect on their general health.³

Seasonal AR contributes to missed work or school days and decreased work productivity or school performance, resulting in absenteeism or presenteeism (defined as being present but unproductive).⁴ The combined direct and indirect cost of AR was estimated to be $5.3 billion per year in 2018.⁵

Diagnosis of Allergic Rhinitis

Allergic rhinitis often goes undetected or unaddressed in the primary care setting. A thorough history, physical examination, and allergen skin testing are essential for proper diagnosis, although some providers make the diagnosis by history alone. If a patient uses OTC treatments without relief of their AR symptoms, they should be reevaluated in the office and the clinician should consider referral to an allergist.

Avoidance of Allergens

Patients can practice avoidance and environmental control measures to lessen the impact of AR. When working or playing outside, patients should be instructed to wear a hat and sunglasses during pollen season to keep pollen out of their eyes and hair. They should rinse their hair at night before going to bed. Keeping windows closed and air conditioning on at home and in the car can help prevent exposure to pollen. Air purifiers have been found to be effective in lowering pollen concentrations indoors.⁶

The US Centers for Disease Control and Prevention advise that patients stay indoors on dry, windy days when pollen counts are often at their highest. Pollen peak times are often from 10:00 am to 2:00 pm. When coming inside, patients should wash their hands and avoid rubbing their eyes. If patients are affected by grass pollen, they should avoid mowing the lawn and keep the windows closed during this activity. If they have to mow their lawn they can wear a mask and goggles to prevent the pollen from going into their nose and eyes.⁷

Allergic Rhinitis Treatments

Numerous pharmaceutical options for the treatment of AR are now available in OTC formulations. The use of first-generation antihistamines to treat symptoms of AR can increase somnolence and affect mental function. Therefore, intranasal corticosteroids (INCS) and second-generation antihistamines have been the gold standard for treatment of AR (Table).^2,4,8,9

Table. Currently Available OTC Nasal Sprays for the Treatment of Seasonal Allergic Rhinitis⁹

Generic Name	Brand Name	Class	Usual Dosage
Azelastine	Astepro Allergy (0.15%)	Antihistamine	Age 6-11 y: 1 spray each nostril twice a day Age ≥12 y: 1-2 sprays each nostril 1-2 times daily
Budesonide	Rhinocort Aqua	Nasal steroid	Age 6-11 y: 1-2 sprays each nostril per day Age ≥12 y: 1-2 sprays each nostril per day
Cromolyn sodium	Nasalcrom Nasal Spray	Mast cell inhibitor	Age ≥2 y: 1 spray each nostril 3-4 times a day; can be used every 4 hours up to 6 times a day
Fluticasone furoate	Flonase Sensimist	Nasal steroid	Age 2-11 y: 1 spray each nostril per day Age ≥12 y: 2 sprays each nostril per day
Fluticasone propionate	Flonase Allergy Relief	Nasal steroid	Age 4-11 y: 1 spray each nostril once a day Age ≥12 y: 1-2 sprays each nostril once a day
Mometasone	Nasonex 24HR Allergy	Nasal steroid	Age 2-11 y: 1 spray each nostril once a day Age ≥12 y: 2 sprays each nostril once a day
Oxymetazoline	Afrin	Decongestant	Age ≥6 y: 2-3 sprays each nostril per day Not recommended. If used, do not use for more than 3 days in a row.
Triamcinolone	Nasacort Allergy 24HR	Nasal steroid	Ages 2-5 y: 1 spray each nostril once a day Ages ≥6 y: 1-2 sprays each nostril once a day

Intranasal Corticosteroids

Intranasal corticosteroids are a safe and effective treatment for AR.² Fluticasone propionate was the first INCS approved by the US Food and Drug Administration (FDA) in 1994.¹⁰ It has a well-established safety profile and became available OTC in July 2014 under the name Flonase Allergy Relief. It is indicated for the relief of symptoms of seasonal and perennial AR including nasal congestion, rhinorrhea, sneezing, itchy nose as well as ocular symptoms including itchy and watery eyes. Other OTC nasal corticosteroid sprays include Nasacort Allergy 24 HR (triamcinolone), Rhinocort Aqua (budesonide), and Flonase Sensimist (fluticasone furoate).⁹ In April 2022, the FDA approved Nasonex (mometasone) to be transitioned to OTC and marketed under the name Nasonex 24HR Allergy.¹¹

Intranasal corticosteroids should be the initial treatment for nasal symptoms of AR.⁸ For moderate to severe symptoms, a combination of an INCS and a second-generation antihistamine may be used.² Intranasal corticosteroids are most effective when used regularly. Onset of action is generally at 7 to 12 hours, and these agents reach maximum efficacy within 2 weeks. Providers should advise patients to begin using the nasal spray at least 2 weeks prior to the onset of the allergy season.²

Local adverse effects of INCS include epistaxis, nasal drying, and rarely septal perforation. These symptoms are usually attributed to poor technique, so making sure the patient knows how to appropriately use the device is important. Using INCS with a lower dose and lower systemic bioavailability reduces the risk for systemic side effects. Overall efficacy does not significantly vary among the steroid nasal sprays within the class.²

Intranasal Mast Cell Stabilizer and Antihistamine

Nasalcrom (cromolyn sodium), a mast cell stabilizer, is also available OTC and is effective in treating runny nose, sneezing, and nasal itching associated with AR. This medication prevents mast cell degranulation and, therefore, inhibits cytokines from being released. Common adverse reactions to this medication include nasal burning, foul taste, and epistaxis.⁹

Astepro Allergy (azelastine HCL) is the first OTC antihistamine nasal spray approved by the FDA for use in adults and children at least 6 years of age. The FDA initially approved Astepro in 2008 as a prescription-only medication.¹² Astepro dosing can vary: the 0.1% dose will remain available by prescription only, and the 0.15% dose is available OTC. The medication should be sprayed into each nostril 1 to 2 times daily as needed.¹²

Azelastine differs from INCS in its mechanism of action. It is not a steroid but is still effective in treating nasal congestion, runny nose, itchy nose, and sneezing associated with AR. Some patients experience a bitter taste, epistaxis, nasal discomfort, and headache with this medication. Appropriate nasal spray technique can help reduce the bitter taste. Clinicians should advise patients to point their nose downward (nose over toes) to avoid runoff down the back of the throat and to point the nasal spray toward the outside ear to help reduce irritation of the nasal septum. Somnolence was observed in 4% of patients taking azelastine. Patients should be cautioned to avoid use of alcohol or central nervous system suppressants when using azelastine.¹³

In cases of moderate to severe allergic rhinitis, providers can recommend the concomitant use of INCS with azelastine. As increased epistaxis and septal perforations may occur with this combination of medications, patient use should be monitored by the provider.^2,4 Patients should be educated on the possible side effects of all nasal sprays and when a visit with their provider is warranted.

Oral Antihistamines and Nasal Decongestants

Second-generation oral antihistamines such as Zyrtec (cetirizine), Claritin (loratadine), Allegra (fexofenadine), and Xyzal (levocetirizine) are also effective for AR and can be used in combination with INCS. Second-generation antihistamines do not target nasal congestion and can cause somnolence, sore throat, and headache in some patients.^2,4

Nasal decongestant sprays are not recommended for symptoms of AR, especially for more than 3 days in a row, as they can cause rebound rhinitis medicamentosa. Most allergists recommend against the use of nasal decongestant sprays in general, as they have not been proven effective in the treatment of seasonal AR and may worsen symptoms if not used as directed.^1,2,4

Immunotherapy

Patients who do not experience relief of symptoms of AR with OTC medications can be referred to an allergist, who can confirm the diagnosis and consider allergen immunotherapy as an alternative treatment. Allergen immunotherapy is an effective treatment for patients for whom standard treatments are not effective or tolerated, or if the patient prefers not to take medications.⁴

Counseling Key Points

• Warn patient that symptoms of AR can significantly alter quality of life; specifically, symptoms may disrupt sleep patterns and cause daytime drowsiness and altered mood (specifically irritability) as well as difficulty with concentration, memory, and ability to learn.
• Discuss avoidance and environmental control measures to lessen the impact of AR.
• Discuss the many OTC treatment options available, including antihistamines and nasal sprays; note that INCS are a safe and effective treatment for AR and are largely considered the gold standard of therapy. The first OTC antihistamine nasal spray approved by the FDA has been found to be effective for the relief of sneezing, nasal itching, and postnasal drip.
• Educate patients on possible side effects of all nasal sprays and instruct them to visit their clinician if symptoms do not improve.

Leslie A. Stefanowicz, MSN, FNP-BC, is a family nurse practitioner with more than 20 years of clinical experience.  She is currently working in allergy, asthma, and immunology, and has been a subinvestigator for the Center for Clinical Research at Asthma & Allergy Physicians in Brockton, Massachusetts.

References

1. Scarupa M, Kaliner M. In-depth review of allergic rhinitis. World Allergy Organization. Updated October, 2020. Accessed June 3, 2022. https://www.worldallergy.org/education-and-programs/education/allergic-disease-resource-center/professionals/in-depth-review-of-allergic-rhinitis.
2. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: a practice parameter update. J Allergy Clin Immunol. 2020;146(4):721-767. doi:10.1016/j.jaci.2020.07.007
3. Nathan RA, Meltzer EO, Derebery J, et al. The prevalence of nasal symptoms attributed to allergies in the United States: findings from the burden of rhinitis in an America survey. Allergy Asthma Proc. 2008;29(6):600-608. doi:10.2500/aap.2008.29.3179
4. Bernstein DI, Schwartz G, Bernstein JA. Allergic rhinitis: mechanisms and treatment. Immunol Allergy Clin North Am. 2016;36(2):261-278. doi:10.1016/j.iac.2015.12.004
5. Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol. 2011;106(2 Suppl):S12-16.
6. Park KH, Sim DW, Lee SC, et al. Effects of air purifiers on patients with allergic rhinitis: a multicenter, randomized, double-blind, and placebo-controlled study. Yonsei Med J. 2020;61(8):689-697. doi:10.3349/ymj.2020.61.8.689
7. Pollen and your health. Centers for Disease Control and Prevention. Accessed June 15, 2022. https://www.cdc.gov/climateandhealth/effects/pollen-health.htm
8. Trangsrud AJ, Whitaker AL, Small RE. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy. 2002;22(11):1458-1467. doi:10.1592/phco.22.16.1458.33692
9. Nasal sprays. American Academy of Allergy Asthma & Immunology. February 2022. Accessed June 12, 2022. https://www.aaaai.org/Tools-for-the-Public/Drug-Guide/Nasal-Sprays
10. Flonase. Prescribing information. GlaxoSmithKline; 2019. Accessed June 12, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020121s045lbl.pdf
11. Parks B. FDA approves Rx-to-OTC switch for nasal allergy spray. MPR. March 18, 2022. Accessed June 15, 2022. https://www.empr.com/home/news/fda-approves-rx-to-otc-switch-for-nasal-allergy-spray/
12. Park B. FDA approves Rx-to-OTC switch for Astepro Allergy nasal spray. MPR. June 18, 2021. Accessed June 14, 2022. https://www.empr.com/home/news/fda-approves-rx-to-otc-switch-for-astepro-allergy-nasal-spray/
13. Astepro Allergy OTC. Seasonal allergic rhinitis. Clinical Studies. Accessed June 14, 2022. https://www.accessdata.fda.gov/spl/data/ee5bbe07-1c13-49bb-ab68-2a7ab854563e/ee5bbe07-1c13-49bb-ab68-2a7ab854563e.xml#section-13

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