Nonprescription Ophthalmic and Otic Disorders 2025 PDF

Nonprescription Ophthalmic and Otic Disorders Michael A. Zappone, Pharm.D. Assistant Professor, Department of Pharmacy Practice February 6, 2025 Learning Objectives Recall exclusions for self-care of ophthalmic and otic disorders Distinguish patients...

Nonprescription Ophthalmic and Otic Disorders Michael A. Zappone, Pharm.D. Assistant Professor, Department of Pharmacy Practice February 6, 2025 Learning Objectives Recall exclusions for self-care of ophthalmic and otic disorders Distinguish patients that will need referral to a medical provider vs. self-care treatment Understand indications and dosing for commonly used medications Evaluate a patient presenting with an ophthalmic or otic complaint Select an appropriate drug therapy for self-care treatment Drugs to Know Antazoline phosphate Naphazoline Artificial tears Oxymetazoline Carbamide peroxide Pheniramine maleate Non-medicated ointments Pheylephrine Isopropyl Tetrahydrozoline alcohol/anhydrous glycerin Olopatadine Ketotifen fumarate Hyperosmotic solutions (sodium chloride) Ophthalm ic Disorders Eye Anatomy Lacrimal sac: highly vascularized epithelium Topically administered eye medications can produce systemic effects Sclera: external portion of the eye (white portion) Tough, collagenous layer Cornea: contains vascular tissue Protective layer of the eye 3 layers – epithelium, stromal, and endothelial layer Anterior chamber is behind the cornea and regulates intraocular pressure (IOP) https://www.ncbi.nlm.nih.gov/books/NBK65754/figure/ CDR0000258033__141/  Eye pain Blurred vision not associated with use of ophthalmic ointments Sensitivity to light Overall History of contact lens wear* Exclusions Blunt trauma to eye to Self- Chemical/heat exposure to eye Care Signs/symptoms of infection (infective conjunctivitis, shingles) Symptoms that have persisted for > 72 hours Macular degeneration Head Lice Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Dry Eye Disease Most common anterior eye disorder Deficient tear production, increased tear evaporation Can be exacerbated by allergens, dry, dusty conditions Presentation Drugs that exacerbate White or mildly red Antihistamines sclera Antidepressants Sandy, gritty feeling Decongestants Burning, stinging, Diuretics watery eyes Treatment Goals of Dry Eye 1. Alleviate the dryness of the ocular surface 2. Relieve symptoms of irritation 3. Prevent possible tissue damage Treatment Avoid/limit triggers Dusty environments Rubbing eyes Prolonged use of computer screens Elimination of offending medications Warm compress Ocular lubricants Artificial tears Non-medicated ointments Non-medicated gels Artificial Tears “Lubricating drops” Used 2-4 times/day depending on severity Can be given hourly if needed All vary in preservatives, electrolytes, buffering agents, pH Artificial tears without preservatives are less likely to irritate the ocular surface Advice from an optometrist: - Use oil based eye drops that will stay in the eye longer (wont evaporate as quickly) - Look for the words “lubricating eye drops” - Preservatives may be more irritating if used often or if you have severe dry eye Choosing a Product 1. Demulcents - soothe mucous membranes and provide lubrication in the form of a mucoprotective film A. Examples: cellulose derivatives (carboxymethylcellulose), dextran 70, gelatin, liquid polyols, polyvinyl alcohol (PVA) such as PEG or glycerin and povidone 2. Emollients (fats or oils) increase the lipid layer thickness of the tear film, stabilize the tear film and reduce evaporation A. Examples: mineral oil, castor oil, flaxseed oil i. Systane Balance and Systane Complete (mineral oil, Alcon), Refresh Optive Advanced (castor oil, Allergan) and Refresh Optive Mega-3 (castor oil and flaxseed oil), Soothe XP (mineral oil and light mineral oil) and Retaine MGD (mineral oil and light mineral oil, Ocusoft) B. Require shaking C. May be superior to those without oils Artificial Tears Commonly used lubricants Common Brand Names: Hydroxypropyl Bion Tears methylcellulose Refresh Carboxymethylcellulose Systane Lubricant Eye Drops Polyvinyl alcohol TheraTears Povidone Polyethylene glycol Propylene glycol Glycerin Ophthalmic Preservatives Preservatives are incorporated into multi-dose products Inhibit/minimize growth of microorganisms Preservatives: Benzalkonium chloride (BAK) Long-term use in the eye can lead to damage Chlorhexidine is not as toxic to the eye as BAK Mercury based preservatives: Contain thimerosal and can cause toxicity Rapidly disappearing from the market Administration of Eye Drops 1. Wash hands and remove contact lenses 2. Shake well (if required) 3. Tilt head back 4. Gently pull lower eyelid to create a pouch 5. Look up and apply a single drop (without touching dropper to the eye) 6. Once drop is applied, release eyelid and close eyes for 1-3 minutes 7. Blot excess solution from around the eye 8. Wait at least 5 minutes between drops (if using both a solution and suspension formulation, instill suspension last) 9. Instill ointment at least 10 minutes after drops Non-medicated Ointments/Gels Have a longer retention time in the eye Administered twice daily (can be up to 4x/day) Many patients prefer to administer at bedtime to prevent morning symptoms of dry eye Often causes blurred vision Primary ingredients: White petrolatum: contains the lubricant Mineral oil: helps melt the ointment at body temperature Lanolin: prevents evaporation Administration of Ointments 1. Wash hands and remove contact lenses 2. Tilt head back 3. Gently pull lower eyelid to create a pouch 4. With a sweeping motion, place ¼ to ½ inch of ointment inside lower lid 5. Release lid and close eye for 1-2 minutes 6. Blot excess solution from around the eye 7. Vision may be temporarily blurred 8. Bedtime dosing is preferred 9. Administer at least 10 minutes after eye drops Dry Eye Disease Treatment Algorithm First line: artificial tears If recommending a preservative free agent, ensure patients understand they are single use products Second line: Non-medicated gels or ointments Nutritional supplements (omega-3 oils) Anti-inflammatory properties; improve lid function Patient Case MC is a 34-year-old male who comes to the pharmacy to talk to you, the pharmacist Eyes have been gritty, burning and a little red Has been going on for ~2 days Is MC eligible for self- care? What treatment would you recommend? What counseling points would you provide to MC?  Eye pain Blurred vision not associated with use of ophthalmic ointments Sensitivity to light Overall History of contact lens wear* Exclusions Blunt trauma to eye to Self-Care Chemical/heat exposure to eye Signs/symptoms of infection (infective conjunctivitis, shingles) Symptoms that have persisted for > 72 hours Macular degeneration Head Lice Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Allergic Conjunctivitis Exposure to allergens Pollen, animal dander, dust, etc. Presentation: Red eyes Watery eyes Itching Blurred vision (from excessive tears) Allergic Conjunctivitis Treatment Goals: 1. Remove/avoid allergens 2. Limit/reduce severity of allergic reaction 3. Provide symptomatic relief 4. Protect the ocular surface Allergic Conjunctivitis: Treatment Non-pharmacologic Pharmacologic Avoiding triggers/ Artificial tears (1st offending allergens line) Cold compresses for Ophthalmic itchy eyes antihistamines/ Keeping windows mast cell stabilizers closed, using air Decongestants conditioners Using air filters Treatment Algorithm First line: avoid the allergen Instill artificial tears as needed Ophthalmic antihistamines + mast cell stabilizers Ketotifen fumarate (Zaditor) Olopatadine (Pataday) Other options: Decongestants (in combination with antihistamines) Oral antihistamines Artificial Tears “Lubricating drops” - Review Dry Eye Treatment Options Used 2-4 times/day depending on severity Can be given hourly if needed All vary in preservatives, electrolytes, buffering agents, pH Artificial tears without preservatives are less likely to irritate the ocular surface Ophthalmic antihistamines and mast cell stabilizers Ketotifen fumarate (Zaditor): ophthalmic antihistamine + mast cell stabilizer Potent H-1 receptor antagonist and inhibits mast cell degranulation Does not contain decongestant (can be used > 72 hrs) Instill 1 drop into affected eye(s) 2-3x daily (every 8 to 12 hours) Approved for patients > 3 years old Side effects: burning, stinging Contraindicated in patients with angle-closure glaucoma Remove contacts before use, and wait 10 min after use to re-insert Ophthalmic antihistamines and mast cell stabilizers Pataday (Olopatadine): ophthalmic antihistamine + mast cell stabilizer Potent H-1 receptor antagonist and inhibits mast cell degranulation Does not contain decongestant (can be used > 72 hrs) Instill 1 drop into affected eye(s) 1-2x daily Approved for patients > 2 years old Side effects: burning, stinging Contraindicated in patients with angle-closure glaucoma Remove contacts before use, and wait 10 min after use to re-insert Ophthalmic antihistamines OTC antihistamine products are combined with a decongestant Pheniramine maleate + naphazoline (Naphcon A, Opon-A, Visine-A) Antazoline phosphate + naphazoline (not available in the US) Act as specific histamine-1 (H1) receptor antagonist and provides rapid relief of symptoms Instill 1-2 drops in affected eye(s) up to 4 times daily for 3 days Side effects: burning, stinging Does have anticholinergic activity and can cause pupillary dilation Contraindicated in patients with or with a risk for angle-closure glaucoma Ophthalmic Decongestants Decongestants reduce ocular redness and act as local vasoconstrictors Act on alpha-adrenergic receptors of the ophthalmic vasculature to constrict eye vessels and reduce redness Have no effect on the allergic response OTC agents available for topical eye application: Phenylephrine Naphazoline (All Clear, Clear Eyes, Naphcon) Tetrahydrozoline (Visine, Visine Advanced) Oxymetazoline Brimonidine (Lumify) DO NOT USE > 72 hours due to rebound redness Ophthalmic Decongestants Use greater than 72 hours can cause rebound conjunctival hyperemia (rebound congestion) Less likely with naphazoline and tetrahydrozoline If used as directed will not induce ocular or systemic adverse events Ingestion of these medications can cause coronary emergencies and death Caution use in patients with hypertension, cardiovascular disease, diabetes, hyperthyroidism, or pregnancy Contraindicated in patients with angle-closure glaucoma Product Selection Guidelines Artificial tears Ophthalmic Ketotifen safe for 3+ antihistamines + years old mast cell stabilizers Olopatadine safe for 2+ years old Ophthalmic antihistamines + decongestants Can cause rebound hyperemia Ophthalmic decongestants (naphazoline and tetrahydrozoline less likely) Patient ST 34 year old female with a PMH of HTN She states that yesterday her eyes were very itchy, red, and watering Has been using artificial tears, but not really helping Is ST eligible for self- care? What treatment would you recommend? What counseling points would you provide to ST?  Eye pain Blurred vision not associated with use of ophthalmic ointments Sensitivity to light Overall History of contact lens wear* Exclusions Blunt trauma to eye to Self-Care Chemical/heat exposure to eye Signs/symptoms of infection (infective conjunctivitis, shingles) Symptoms that have persisted for > 72 hours Macular degeneration Head Lice Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Corneal Edema Must be diagnosed by an eye care provider prior to self-treatment initiation Often occurs from over-wear of contact lenses, surgical damage, or inherited corneal dystrophies Patients may subjectively see halos or starbursts around lights Corneal Edema Provider MUST diagnose and recommend self-care treatment Treatment Goals: 1. Draw fluid from cornea 2. Relieve symptoms Corneal Edema: Treatment Topical hyperosmotic formulations Only sodium chloride is available without a prescription Solutions (2% and 5%), and ointments (5%) First line: 2% solution Continuous symptoms: Add 5% nighttime ointment to first-line therapy No improvement: switch to 5% solution and continue 5% nighttime ointment If no symptom improvement in 1-2 weeks, medical referral is indicated Hyperosmotics Increase the tonicity of the tear film, which promotes movement of fluid from the cornea to tear film Helps to eliminate excessive fluid 1-2 drops every 3-4 hours Sodium chloride ointment is used less frequently and typically reserved for bedtime to minimize blurred vision Stinging and burning more common with 5% sodium chloride Contraindicated in patients with traumatic injury of corneal epithelium Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Loose Foreign Substance in the Eye Foreign substances can sometimes contact the ocular surface Immediate symptoms: pain and tearing Self-treatment is appropriate if there is only minor irritation and no abrasion of the eye surface Reflexing tearing will often help to remove the foreign substance If not, eye may need to be flushed with irrigants or copious amounts of water Non-medicated ophthalmic petrolatum ointment can be applied at bedtime Ocular Irrigants Used to cleanse ocular tissues and help maintain moisture These solutions must be physiologically balanced in terms of pH and osmolality Goal of irrigants is to clear away unwanted material or debris from the ocular surface Ocular irrigants should not be used for open wounds in or near the eyes Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Chemical Burn Chemical burns can occur from exposure to alkalis (oven cleaners), acids (battery acid, vinegar), solvents and irritants (Mace, tear gas) Considered an ophthalmic emergency  Call 911 Emergency treatment with sterile ocular irrigants or tap water and continued until an eye specialist can be seen Ophthalmic Disorders 1. Dry eye disease 2. Allergic conjunctivitis 3. Corneal edema 4. Foreign substance in the eye 5. Chemical burns 6. Contact dermatitis Contact Dermatitis Reaction to an allergen or irritant Symptoms: swelling, scaling, redness of the eyelid, and itching Common Causes: New cosmetics or soap Eye medications Contact with other foreign substances Contact Dermatitis: Treatment Discontinue the suspected offending substance More severe cases: Swelling of the eyelid: non-prescription oral antihistamine Itching and inflammation: cold compress 3-4 times/day Symptoms > 72 hours  refer to provider Key Points Many ophthalmic products are available to manage symptoms of minor disorders of the eye and eyelid Nonprescription ophthalmic products should be used in cases of minor discomfort, and if in doubt, the pharmacist should refer the patient to seek medical care Patients with narrow-angle glaucoma should not use topical ocular decongestants Educate patients about overuse of topical ocular decongestants Properly counsel patients on appropriate eye drop/ointment applications Otic Disorders Ear Pathophysiology External Ear: Auricle (pinna) External Ear Canal (EAC) Middle Ear: Separated by the tympanic membrane Includes ossicles and middle ear space Fluid drains via Eustachian tube into the nasopharynx Inner Ear: Incudes cochlea, internal auditory canals and Eustachian tubes Children are more prone to ear infections due to a shorter and flatter Eustachian tube Cerumen (ear wax) Mix of oily and fatty fluids excreted in the outer portion of the EAC Lubricates the surface Traps foreign particles and dust Barrier to pathogens EAR WAX IS NORMAL AND OK! Many factors can cause disruption of the flow of cerumen to the outer ear Narrow/irregular shape of the EAC Excessive hair Irritation from foreign objects (hearing aids, ear plugs) Use of cotton-swabs Ear Disorders Typically more common in the pediatric and geriatric population Most common cause of hearing loss in all groups Self-treatment with OTC medications should be limited to external ear disorders Excessive cerumen, water-clogged ears, atopic dermatitis, psoriasis and contact dermatitis are self-treatable  Age < 12 years old (impacted cerumen) Signs of infection Pain with ear discharge Ear Disorder Exclusions Bleeding or signs of trauma to Self-Care Presence of ruptured tympanic membrane Ear surgery within prior 6 weeks Tympanostomy tubes present Excessive or Impacted Cerumen Clinical Presentation Treatment Goals Treatment Approach Dull pain Remove the Cerumen-softening Itching cerumen agents Hearing loss Prevent adverse Irrigation Tinnitus effects Dizziness Eliminate signs and Ear fullness symptoms Vertigo Severe pain = referral Pharmacologic Therapy Carbamide peroxide 6.5% in anhydrous glycerin Anhydrous glycerin: softens the earwax Carbamide peroxide: mechanically breaks down and loosens cerumen through effervescence caused by oxygen release when exposed to air Can be used alone, or in combination with warm water irrigation Only used in patients > 12 years old < 12 must be done under advice of a physician Pharmacologic Therapy Instill 5-10 drops into the affected ear(s) Caution to prevent the tip from entering the ear canal Keep solution in the ear for about ~15 minutes for effective softening Can be used twice daily for up to 4 days Contact PCP if symptoms persist after 4 days, adverse effects develop, or infection is suspected Adverse effects: pain, rash, irritation, redness, discharge, dizziness Administration of Ear Drops 1. Wash hands with soap and water before and after use 2. Wash outside of the ear with a damp washcloth; caution not to get water in the ear canal 3. Tilt your head to the side or lie down with the affected ear up 4. Position the tip near, but not inside the ear canal opening. Do not allow the dropper to touch the ear 5. Pull your ear backward and upward to open the ear canal (A) If the patient is < 3 years old, pull the ear backward and downward (B) Administration of Ear Drops 6. Place proper dose into ear canal and press the tragus over the ear canal opening to force out air bubbles and push the drops down the ear canal 7. Stay in the same position for the length of time indicated on the product instructions 8. If child can’t stay still for recommended time, can consider placing a piece of cotton in the ear, BUT must be large enough to remove and cannot stay in ear for > 1 hour 9. Gently wipe excess medication off the outside of ear 10. Repeat procedure for other ear, if necessary Other agents: Not recommended Docusate sodium has been used off-label to soften earwax by topical application in the ear canal Not recommended due to conflicting studies on efficacy Hydrogen peroxide 3% has been used to flush the ear canal Not FDA-approved to treat excessive/impacted cerumen Contains water, which can increase risk for infections, due to excess water in the ear canal Olive oil used as an emollient and home remedy to soften earwax Water-Clogged Ears Defined as retention of water within the EAC Not the same as swimmer’s ear (externa otitis) Water-clogged ears can result from excessive moisture in the ear canal due to: Excessive hair growth Narrowing of the canal Wax/debris build up Overproduction/absence of cerumen Excessive sweating, high humidity, swimming Symptoms: Hearing impairment Localized discomfort Sensation of fullness in the ear canal Treatment Treatment Goals: 1. Dry out the ear in a safe and effective way 2. Prevent recurrence Nonpharmacologic Therapy: Tilt affected ear downward and manipulate auricle Blow-dryer on low setting Use of ear plugs Clear-Ears water absorbing ear plugs (> 17 years old) Remove after 10 minutes and discard Use after exposure Pharmacologic Treatment Isopropyl alcohol in anhydrous glycerin Acetic acid and isopropyl alcohol Refer to medical provider if symptoms > 4 days Signs of infection, pain or bleeding from ear Isopropyl alcohol 95% in anhydrous glycerin 5% FDA approved “ear drying aid” No minimum age Alcohol is highly miscible with water for drying and exhibits antimicrobial properties Glycerin prevents over-drying with repeated use Apply 4-5 drops into the affected ear Side effects: stinging when applied to open skin, overuse may cause excessive drying Keep away from fire (flammable) Acetic acid 5% and isopropyl alcohol (50:50) Antimicrobial properties due to alcohol and acidity May cause mild stinging/burning with open/abraded skin Patients must compound Use white vinegar only Discard remainder after use Patient MA 73 year-old female who began to feel ear fullness ~ 2 days ago after swimming at the community pool Feels as though she might have some slight hearing loss Uses cotton swabs daily Is NoMA ear pain or eligible recent for self- trauma/surgery care? What treatment would you recommend? What counseling points would you provide to MA? Patient BQ BQ is a 7 year old boy who is complaining of ear fullness He notes some dull pain, and is constantly itching his right ear Is BQ eligible for self- care?  Age < 12 years old (impacted cerumen) Signs of infection Ear Disorder Pain with ear discharge Exclusions Bleeding or signs of trauma to Self-Care Presence of ruptured tympanic membrane Ear surgery within prior 6 weeks Tympanostomy tubes present Key Points Limit self-treatment of otic disorders for minor symptoms Sense of fullness, pressure or wetness in the ears Refer for further evaluation patients < 12 years old with impacted cerumen and those with signs/symptoms of ear infection, bleeding, signs of trauma Instruct patients on proper use of otic products Advise patients to see healthcare provider if symptoms don’t improve in 4 days Educate patients on proper ear hygiene Questions?