Pharmacists are likely to encounter patients seeking recommendations for OTC products to treat otic conditions. These products should only be used to treat external otic conditions that affect the auricle and the external ear canal, such as excessive cerumen and water-clogged ears.1 Other self-treatable conditions involving the auricle include dermatitis (contact and allergic), psoriasis, and seborrhea. Nonprescription products used to treat these conditions when they occur on other parts of the body are also suitable for treating the auricle.1
Excessive or Impacted Cerumen
Excessive cerumen, commonly referred to as wax buildup, is one of the most prevalent otic disorders. Approximately 10% of the pediatric population and an estimated 30% of the elderly population experience episodes of impacted cerumen.1 It is also a major cause of temporary hearing loss among all age groups.1 Elderly patients may experience impacted cerumen due to atrophy of the ceruminous glands and may also secrete drier cerumen, which is more difficult to push out of the ear.1,2
Patients with excessive or impacted cerumen may present with symptoms that include a feeling of fullness, dull pain, or pressure in the ear. In some cases, they may experience a gradual loss of hearing as well.1 Individuals with abnormally narrow or misshapen external auditory canals, excessive hair growth in the ear canal, overactive ceruminous glands, and those who wear ear plugs or hearing aids may be more susceptible to episodes of impacted or excessive cerumen.1,2 Proper cleaning of ear devices may help decrease or prevent wax buildup.1
Carbamide peroxide 6.5% in anhydrous glycerin is currently the only FDA-approved nonprescription cerumen-softening agent for individuals 12 years and older.1 Cerumen-softening products can be used twice daily for up to 4 days. If symptoms persist after 4 days, patients should be referred to their primary health care provider for further treatment. After the use of cerumen-softening products, any remaining cerumen should be removed by gentle warm water irrigation with a rubber otic bulb syringe.1 Most commonly reported adverse effects include pain, rash, irritation, tenderness, discharge, and dizziness.1,2
During counseling, patients should be reminded that improper or excessive attempts to remove cerumen may cause damage to the external auditory canal.1 Patients should be reminded to never insert objects such as cotton-tipped applicators or bobby pins into the ear to remove cerumen.1,2
Other products, including mineral oil, olive oil, docusate sodium, glycerin, sodium bicarbonate, and dilute hydrogen peroxide, have also been used this otic condition.1 There are also a host of alternative or complementary products marketed as cerumen-softening agents. Patients should be advised to discuss these products with their primary health care provider before use (Table 1).
The shape of one’s ear canal or the presence of excessive cerumen can lead to an increased incidence of water-clogged ears.1 Excessive cerumen can cause swelling, which in turn can trap water in the ear. Other factors that can lead to water-clogged ears include excessive sweating, swimming, and high humidity.1 Symptoms of this condition include a sensation of wetness and fullness in the ear. If left untreated, water-clogged ears can cause tissue maceration, which can cause both inflammation and infection of the external auditory canal, typically referred to as external otitis media, or swimmer’s ear.1
OTC products for water-clogged ears have been reformulated to contain only FDA-approved ingredients, and manufacturers are no longer permitted to label a nonprescription product as preventing swimmer’s ear. Isopropyl alcohol 95% in anhydrous glycerin 5% is the only FDA-approved ear-drying agent that has been proved to be safe and effective.1 In addition, a 50:50 mixture of acetic acid and isopropyl alcohol 95% is commonly used to help dry waterclogged ears.1
These products are indicated for use in individuals 12 years and older. Prior to recommending any of them, pharmacists should determine whether self-treatment is appropriate and refer patients for medical care when warranted.
Nonpharmacologic measures can also be recommended to patients susceptible to water-clogged ears, including tilting the affected ear to drain excess water or using a hair dryer on the lowest setting to dry the ear canal immediately after bathing.1 Patients should be advised, however, to never blow air directly into the ear canal. A small portable device, Mack’s Ear Dryer (McKeon Products, Inc), is designed specifically for drying the external ear canal in approximately a minute.
During counseling, pharmacists should ensure that patients understand how to properly use these products and when to seek further medical care. Patients younger than 12 years should always be referred to their primary health care provider for further evaluation. Patients electing to use nonprescription otic products should be strongly advised to contact their primary health care provider if symptoms worsen or if they show no signs of improvement after 4 days of therapy.
Patients should also be advised to monitor their condition for any signs of infection, such as ear discharge, hearing loss, or fever, and to immediately seek medical attention if their symptoms show signs of worsening of if they experience severe pain, hearing loss, or dizziness.1
Patients should also be made aware of the importance of proper ear hygiene and should be reminded never to insert objects into their ears to remove ear wax, due to the risk of injuring the ear canal. Finally, patients should also be made aware of conditions for which self-treatment is not appropriate and for which they should seek immediate medical attention.
Pharmacists interested in the products their colleagues have most recommended for otic disorders can go to www.OTCGuide.net and click on EENT. The OTC Guide is also available as an iPad and iPhone app, and is available as a free download in the Apple store.
Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
1. Krypel L. Otic disorders. In: Krinsky D, Berardi R, Ferreri S, et al, eds. Handbook of Nonprescription Drugs. 17th ed. Washington, DC: American Pharmacists Association; 2012:557-569.
2. Debrox product information. GlaxoSmithKline website. www.debrox.com. Accessed January 29, 2012.