Published July 17, 2014 OTC Proper Use of Nonprescription Nasal Sprays W. Steven Pray, PhD, DPhBernhardt Professor, Nonprescription Products and DevicesCollege of PharmacySouthwestern Oklahoma State UniversityWeatherford, Oklahoma Gabriel E. Pray, PharmDWalmart PharmacyEdmond, Oklahoma US Pharm. 2014;39:8-11. Nasal sprays are useful dosage forms that yield medical benefits by allowing patients to place medications inside the nasal cavity, directly where they are needed. There are four types of nonprescription nasal sprays in common use—corticosteroids, nasal decongestants, sodium chloride, and cromolyn sodium. Corticosteroid Nasal Spray The nonprescription market recently expanded with the Rx-to-OTC switch of triamcinolone acetonide nasal spray (Nasacort Allergy 24HR) .1 The product is indicated for temporary relief of the following symptoms of allergic rhinitis or other upper respiratory allergies: nasal congestion, rhinorrhea, sneezing, and nasal pruritus. This is the first nonprescription product to relieve all four of the cardinal symptoms of allergic rhinitis. Each spray delivers 55 mcg of active ingredient.1 As Nasacort Allergy 24HR is the first nonprescription glucocorticoid, its labeling is radically different from that of other OTC products.1 First, it is contraindicated in those <2 years of age, and in patients who have had an allergic reaction to any of the ingredients. Second, patients who are pregnant or breastfeeding should speak to a healthcare professional before use. Patients who ask about the product should be directed to speak to a physician first if they have or have recently had ulcers in the nose, nasal surgery, an unhealed nasal injury, an ophthalmic infection, glaucoma, or cataracts, or if they are currently using a corticosteroid product for asthma, allergies, or a dermatologic rash.1 Pharmacists may be asked to clarify the product’s directions. Some specific steps are not on the outer package, but are found on a package insert that is inaccessible to the user prior to purchasing the product.2 First, the spray bottle must be primed. The patient does this by removing the cap, shaking the bottle, and repeatedly pressing and releasing the spray nozzle (taking care not to point it toward the face). After a few repetitions, a fine mist will be seen, and the product is ready to use. (If the product is not used for a period of >2 weeks, the priming steps must be repeated.) After priming, the patient must first blow the nose gently to clear the nostrils. The patient removes the cap and shakes the bottle. He or she holds the bottle with the thumb under the bottom of the bottle and the spray nozzle between the fingers. The patient next presses a finger against the outside of the nose to completely shut off one nostril, placing the tip of the spray nozzle into the other nostril. The spray nozzle should not be inserted so far that it reaches deeply into the nostril. The nozzle is aimed toward the back of the nose, not toward the nasal septum. The patient sprays the product into the nostril while sniffing gently and then repeats the procedure in the other nostril. The nose should not be blown for 15 minutes or more after use of the product.2 Before replacing the cap, the patient should wipe the nozzle with a tissue. If the nozzle is clogged, the patient should not attempt to clear it by using a pin or needle, but should remove the nozzle, rinse it under warm water, shake it to remove excess water, reattach it, and repeat all of the priming steps before the next use.2 Adults and children aged >12 years should spray Nasacort Allergy 24HR twice into each nostril once daily.1 Patients aged 6 to <12 years should spray only once into each nostril once daily and they may increase the dosage to two sprays in each nostril if allergy symptoms do not improve; however, the dosage should be reduced to one spray in each nostril once daily when the allergy symptoms have improved. Due to the complexity of this dosing process, an adult should supervise product use in patients <12 years of age. Patients should be instructed to always shake the bottle well before use, never to use more than directed, not to double the dose if a dose has been forgotten, not to spray the product into the eyes or mouth, and to stop use and speak to a physician if symptoms do not improve.1 They are not to use the product for the common cold. Potential purchasers should be cautioned that sharing the bottle with others can spread viral or bacterial infections. They should also report that they are using the product whenever they see a physician so it can be entered into their medical record. Because this is a steroid, the growth rate of children may be slowed. Patients should understand that the product may relieve some of their symptoms on the first day of use, but maximal relief may not occur until the patient has used it daily for a full week. Patients who have been using Nasacort Allergy 24HR should stop use and speak to a physician in the following situations: 1) they develop chickenpox, measles, or tuberculosis or contact someone who has them; 2) they have or develop symptoms of infection, such as persistent fever; 3) they experience any change in vision; or 4) they have severe or persistent nosebleeds.1 ,2 Decongestant Nasal Sprays Patients with nasal congestion may choose either oral or topical nasal decongestants.3 Topical nasal decongestants are formulated as inhalers, drops, or sprays. Nasal decongestant sprays contain such ingredients as oxymetazoline (e.g., Afrin), phenylephrine (e.g., Neo-Synephrine), or naphazoline (limited availability). The label of Afrin Original Nasal Spray serves as an example of FDA-approved patient instructions for a nasal decongestant.4 ,5 The product provides temporary relief of nasal congestion due to the common cold, hay fever, or upper respiratory allergies. It temporarily relieves sinus congestion and pressure and also shrinks swollen nasal membranes so the patient can breathe more freely. Nasal decongestant sprays should not be used if the patient has heart disease, diabetes mellitus, hypertension, thyroid disease, or trouble urinating due to an enlarged prostate gland. Patients who are pregnant or breastfeeding should speak to their physician before use. Package warnings caution patients not to share the container to prevent the spread of infection, and also warn users that the product may cause temporary discomfort, such as burning, stinging, sneezing, or an increased nasal discharge.4 ,5 If nasal decongestant sprays are used too often and/or for an extended period of time, they can cause nasal congestion to worsen, a well-documented rebound condition known as rhinitis medicamentosa.6-9 A possible etiology behind this phenomenon is that the mechanical vasoconstriction induced by the topical decongestant allows waste products to build in nasal tissues that are also experiencing decreased oxygenation. As the product wears off, nasal tissues undergo a process known as reactive hyperemia, in which blood vessels dilate to correct the effects of the decongestant. The patient perceives this as worsening of nasal congestion and readministers the topical decongestant. But this aggravates the underlying cause of the problem, so continuing to use the spray is counterproductive. In the worst cases, patients become psychologically addicted to nasal sprays and may use several bottles weekly in an attempt to open the nasal passages. To help patients avoid this vicious cycle, product labels warn users not to exceed the recommended dosage, and not to use the spray for more than 3 days. To treat the problem, patients must be cautioned to immediately halt use of the product. Although the nasal passages will become fully congested during withdrawal, eventually they will open again.6-9 Directions for use of nasal decongestant sprays vary somewhat, but the label of oxymetazoline 0.05% spray (Afrin) advises patients aged >6 years to spray the product two to three times in each nostril not more often than every 10 to 12 hours, and not to exceed two applications in any 24-hour period.4 ,5 Exceeding that regimen often leads to rhinitis medicamentosa. Parents who purchase these products must be warned to keep them away from children, as accidental ingestion can cause serious, life-threatening events such as decreased respiration, bradycardia, hypertension/hypotension, sedation, stupor, and coma.10 Saline Nasal Sprays Hypotonic sodium chloride nasal sprays are a third type of nonpre-scription nasal spray.11 ,12 These products (e.g., Ayr, Ocean) are 0.65% sodium chloride sprays, also available as drops or gels. The products are advertised for several beneficial purposes: 1) relieving nasal dryness due to allergies, colds, flu, rhinitis, and sinusitis; 2) thinning mucus to relieve congestion; 3) reducing the incidence of dryness-induced nosebleeds; 4) moisturizing and irrigating nasal membranes after nasal surgery; 5) relieving dryness associated with oxygen treatments and continuous positive airway pressure (CPAP) equipment used for sleep apnea; 6) providing nasal moisture in cold and dry climates; and 7) moisturizing the nasal passages when the patient must spend time in enclosed spaces such as airplanes.12 The directions for Ocean Nasal Spray are to squeeze the bottle twice in each nostril as often as needed or as directed by a physician.12 If the patient is an infant, the bottle can be inverted and used as a nasal drop. However, the product can be held upright to produce a spray for older children and adults. Patients should not touch nasal mucosa while spraying these products to prevent contamination of the contents. Each bottle should only be used on one patient to prevent viral and/or bacterial cross-contamination among users.11, 12 Cromolyn Nasal Spray Cromolyn nasal spray (e.g., NasalCrom) is indicated for prevention and relief of nasal allergy symptoms, including rhinorrhea, nasal pruritus, sneezing, and allergic stuffy nose.13 Patients should be advised to speak to a physician before use if they have fever, sinus pain, discolored nasal discharge, or wheezing, and are cautioned to speak to a healthcare professional before use if they are pregnant or breastfeeding. Patients >2 years of age spray the product once into each nostril and repeat three to four times daily (every 4-6 hours). If needed, the product can be used up to six times daily. For prevention, the patient can initiate pretreatment 1 to 2 weeks before exposure to the cause of allergies (e.g., pollen, mold, pets, dust mites). Patients should be cautioned to discontinue use and contact a physician in any of the following situations: if they experience shortness of breath, wheezing, or chest tightness; if hives or swelling of the mouth or throat occurs; if symptoms worsen or new symptoms develop; if symptoms do not begin to improve in 2 weeks; or if the product needs to be used for more than 12 weeks.13 PATIENT INFORMATION Cromolyn Nasal Spray Cromolyn nasal spray (NasalCrom) helps prevent and relieve symptoms of hay fever and other nasal allergies, specifically runny nose, itching of the nose, sneezing, and stuffy nose due to allergies. If possible, you should start using it 1 to 2 weeks before contacting such allergens as pollen, mold, dust, or animal dander. However, the spray can also give some relief if symptoms have already occurred. It is only for use in patients aged 2 years and above. Speak to your physician before use if you have fever, discolored nasal discharge, sinus pain, or wheezing. Triamcinolone Nasal Spray Triamcinolone nasal spray (Nasacort Allergy 24HR) is a newly released OTC product for patients 2 years and older. It is the first nasal corticosteroid available without a prescription. Nasacort relieves symptoms of hay fever or other upper respiratory allergies, specifically nasal congestion, runny nose, sneezing, and itching of the nose. Speak to your doctor before use if you: 1) have a history of recent nose ulcers or nose surgery; 2) have a nose injury that has not healed or an eye infection; 3) presently have or ever had glaucoma or cataracts; or 4) are using a steroid medication for such conditions as asthma, allergies, or skin rash. Nasal Decongestants Nasal decongestants only treat the congestion symptoms of the common cold or hay fever. They include such nasal sprays as Afrin, Nostrilla Spray, and Neo-Synephrine. Read the label of each product to make sure it is appropriate for the patient’s age. Speak to a physician before use if you have diabetes mellitus, thyroid disease, heart disease, hypertension, or benign prostatic hyperplasia (trouble urinating due to an enlarged prostate gland). Be sure not to use too much of the product, or exceed 3 days of use, as these sprays can actually cause nasal congestion if they are used incorrectly. Saline Nasal Sprays Saline nasal sprays (e.g., Ocean, Ayr) rehydrate the inner nostrils when they are dry or occluded by thick mucus. When used properly, they can help thin the crusted mucus so it can be removed more easily. The spray dosage forms are more appropriate for older children and adults. When to See a Physician for Nasal Congestion Medical authorities recommend seeing a physician when you have nasal congestion in several circumstances. For instance, medical care is advisable when you also have blurred vision or swelling of the forehead, eyes, side of the nose, or cheek(s). Medical care is also necessary if you have increased throat pain, white or yellow spots on the tonsils or other parts of the throat, coughing episodes that last longer than 10 days, or a cough that produces yellow-green or gray mucus. Finally, see a doctor if the nasal congestion lasts longer than 2 weeks or significantly impacts your life. Remember, if you have questions, Consult Your Pharmacist. REFERENCES 1. Nasacort Allergy 24HR. Chattem, Inc. http://nasacort.com/otc-nasal-spray.aspx. Accessed May 27, 2014. 2. Nasacort Allergy 24HR (triamcinolone acetonide nasal spray) package insert. Chattanooga, TN: Chattem, Inc; 2014. 3. Nasal congestion. Stuffy or runny nose—adult. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003049.htm. Accessed May 27, 2014. 4. Afrin Original Nasal Spray drug facts. MSD Consumer Care, Inc. www.afrin.com/afrin/products/index.jspa. Accessed May 27, 2014. 5. Oxymetazoline nasal spray. MedlinePlus. www.nlm.nih.gov/medlineplus/druginfo/meds/a608026.html. Accessed May 27, 2014. 6. Black MJ, Remsen KA. Rhinitis medicamentosa. Can Med Assoc J. 1980 ;122(8):881-884. 7. Graf P. Rhinitis medicamentosa: a review of causes and treatment. Treat Respir Med. 2005 ;4:21-29. 8. Graf P. Rhinitis medicamentosa: aspects of pathophysiology and treatment. Allergy. 1997 ;52(40 suppl):28-34. 9. Ramey JT, Bailen T, Lockey RF. Rhinitis medicamentosa. J Investig Allergol Clin Immunol. 2006 ;16(3):148-155. 10. FDA. Over-the-counter eye drops and nasal sprays: drug safety communication—serious adverse events from accidental ingestion by children. October 25, 2012. www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical-Products/ucm325729.htm. Accessed May 27, 2014. 11. Rabago D, Zgierska A. Saline nasal irrigation for upper respiratory symptoms. Am Fam Physician. 2009 ;80(10):1117-1119. 12. Ocean Nasal Spray. Valeant Consumer Products. www.oceannasalcare.com/ocean-saline-nasal-spray. Accessed May 27, 2014. 13. Nasalcrom Nasal Allergy Spray product description. Prestige Brands, Inc. http://nasalcrom.com/~/media/files/nasalcrom/nasalcromproduct-information.pdf. Accessed May 27, 2014. 14. Nasal saline irrigation and neti pots. WebMD. www.webmd.com/allergies/sinus-pain-pressure-11/neti-pots. Accessed May 27, 2014. To comment on this article, contact rdavidson@uspharmacist.com.