OTCs Today
Daniel L. Krinsky, RPh, MS
Ear disorders affect pediatric and geriatric patients with greater frequency than other patients. Self-treatment with nonprescription medications should be restricted to external ear disorders, which include disorders of the auricle and the external auditory canal (EAC). Excessive cerumen (ear wax) and water-clogged ears are self-treatable EAC disorders for which FDA has approved nonprescription otic medications.
Ear wax
Sensation of ear fullness or dull pain are symptoms that may be associated with excessive or impacted cerumen. Patients may present with one or more common symptoms, including discomfort, itching, hearing loss, tinnitus, dizziness, ear fullness, vertigo, cough, and hearing aid malfunction or feedback.
Appropriate use of cerumen removal treatments should eliminate signs and symptoms of excessive or impacted cerumen. Assist your patients in selecting a product that is cost-effective and readily administered at home.
Therapeutic interventions include the use of cerumen-softening agents with or without irrigation. Patients should instill the agent into the ear for the appropriate amount of time (up to 15 minutes) and then rinse with warm water, often by using a bulb syringe.
The use of cotton-tipped swabs for ear cleansing may be associated with an increase in cerumen impaction with occlusion of the ear canal and is not recommended. Care should be taken in attempting removal of cerumen from the EAC.
If patients experience pain or bleeding after repeated attempts to remove excessive cerumen, or if their symptoms persist, pharmacists should immediately refer them to their primary care provider (PCP). If tympanic membrane rupture is suspected, patients should not attempt nonprescription treatment and should be referred to a PCP.
The only FDA-approved nonprescription ear wax–softening agent is carbamide peroxide 6.5% in anhydrous glycerin. It can be used alone or in conjunction with warm water irrigation to remove the loosened cerumen. This product can be used in children aged 12 years and older or in adults. Use in patients younger than 12 years should be done only under the advice of a physician. For correct administration, instill 5 to 10 drops of the solution into the affected ear(s), taking care to prevent the tip of the applicator from entering the ear canal.
Carbamide peroxide may be used twice daily for up to 4 days. Patients should contact their PCP if symptoms persist after 4 days of use, if adverse effects develop, or if the presence of infection is suspected. Reported adverse effects include pain, rash, irritation, tenderness, redness, discharge, and dizziness.
Exclusions for self-treatment include signs of infection, presence of tympanostomy tubes, bleeding or signs of trauma, or pain associated with ear discharge.
Any cerumen remaining after treatment may be removed with gentle, warm-water irrigation administered with a rubber otic bulb syringe. Other products such as docusate sodium, hydrogen peroxide, and olive oil have also been used, but none are FDA approved.
Water-clogged ears
Water-clogged ears constitute a disorder defined as the retention of water within the EAC. A variety of products intended to protect the ears from exposure to water, or to absorb water when present, are available. Nonpharmacologic measures include strategies to prevent exposure to and accumulation of moisture within the ear canal. Pharmacists can recommend the use of ear plugs or a bathing cap while swimming.
Only isopropyl alcohol 95% in anhydrous glycerin 5% base as the active ingredient is FDA approved as an ear-drying aid. This product is approved only to aid in ear drying after activities such as swimming, showering, bathing, or washing hair and not for prevention of moisture accumulation or treatment of an inflammatory process. Patients should apply four to five drops into the affected ear. Patients should contact their PCP if pain, burning, or irritation occurs with application or if symptoms persist after several days of use.
Exclusion criteria are the same as for treating ear wax except there is no age restriction.
For all ear drops, someone other than the patient should be instructed on the proper administration technique, as self-administration is very difficult and may lead to suboptimal treatment.