1. Otic Products (2)

2. Treatment of Ear disorders General Guidelines: Infection of the auricle or external ear canal is a skin infection and should be treated as such Surgical interventions maybe necessary for deep cuts, bruises or abrasions of the ear Severe infections usually require both systemic & local antibiotics

3. Treatment of Ear disorders In 1995, the FDA issued a statement that said that insufficient data exist to prove the safety & effectiveness of acetic acid, isopropyl alcohol, anhydrous glycerin or any other OTC otic product in prevention of swimmer’s ear or to dry water-clogged ears Because most bacteria, fungi do not thrive in acidic environment, an important feature of any otic solution  acidic pH

4. Why necessary to treat otitis externa? Otitis externa should always be treated promptly, to prevent spread to mastoid bone or middle ear cavity Severe cases may result in permanent hearing loss In mild cases of otitis externa  topical treatment is all that is necessary

5. Treatment of otitis externa 1.Topical antibiotics & hydrocortisone drops/cream applied to ear canal 2.If cellulitis & lymphadenopathy are present  use oral antibiotics 3.5% Aluminum acetate solution (Burow’s solution) 4.Soaking ear with saline, or Burow’s solution is useful in treatment of crusting & edema in auricle & surrounding tissue

6. Treatment of otitis externa 5.Irrigation with soft rubber bulb ear syringe maybe uncomfortable but should never be painful (if pain occurs  stop, if pain is severe & knife-like, there may be tympanic membrane perforation & vertigo may occur) The use of forced water spray (e.g. Water Pik) should be reserved for health professional trained in aural hygiene

7. Ear bulb syringe Water-Pik spray Contact dermatitisOtitis externa

8. Hydrocortisone Only the free alcohol or hydrocortisone-21-acetate are permitted in creams & ointments for OTC use These compounds have only mild potency, a short duration of action, weak side-effects & a greater safety profile in comparison to other topical corticosteroids Also, unlike more potent corticosteroids, hydrocortisone does not affect protein synthesis of human skin & is therefore unlikely to cause anti- proliferative side-effects such as thinning of the skin & telangiectasis (dilatation of superficial blood capillaries)

9. Facial telangiectasia

10. Thinning of the skin by systemic costrocosteroids

11. Hydrocortisone Mechanism of Action: 1.Stabilization of the lysosomal membranes resulting in a reduction in the release of inflammatory lytic enzymes (e.g. collagenase, elastase, acid hydrolases) 2.The inhibition of phospholipase A. This reduces the release of arachidonic acid from phospholipids in cell membranes with the consequent inhibition of prostaglandin synthesis

12. Acetic Acid Used in the form of household vinegar (5%) Has been used successfully for many years to treat mild forms of otitis externa & recommended for swimmer’s ear Advantages: 1. Has bactericidal & fungicidal properties (Candida, Aspergillus & Pseudomonas); 2.Well tolerated & nonsensitizing and does not induce resistant organisms

13. Acetic Acid Four drops of dilute acetic acid (2-3%) placed into the ear canal four times daily will lower the pH < 3. (NB. The optimal pH for bacterial growth 7.2-7.6) Solutions of <1% lack bactericidal properties Disadvantages: has an unpleasant vinegar- like odor, and can be very painful if applied to the middle ear

14. Acetic Acid How could you make easily and inexpensively in the pharmacy a 2.5% acetic acid solution from white distilled household vinegar? A 50:50 mixture of distilled household vinegar with either water, propylene glycol, AHNYDROUS glycerin, or rubbing alcohol (70% isopropyl or 70% ethyl alcohol) will provide a 2.5% acetic acid solution

15. Acetic Acid Application Technique: Tilt head downward, affected ear up If there is no possibility that there is a hole in the eardrum, carefully squeeze a medicine dropper full of the solution into the ear canal With one hand, move the ear back & forth to move the solution all the way into the ear Tilt the head to the other affected side, to let the solution out, gently tapping the unaffected side Repeat the procedure in the opposite ear

16. Aluminum Acetate solution (Burow’s Solution) Given as anti-inflammatory, antipruritic, astringent & limited antibacterial Widely used to treat external otitis or local itching of external ear caused by dermatitis or otomycosis, edema & crusting associated with acute moist ear canals A wet compress is used with a gauze dressing on the auricle. Drops may be instilled into the canal, 4-6 drops every 4-6 hrs until symptoms subsides

17. Aluminum Acetate solution (Burow’s Solution) 1.Has astringent properties: 1. dry the affected area by reducing the secretory function of the skin glands and, 2. toughen skin, help prevent re-infection 2.Its major value: acidity which restores the normal antibacterial pH of the ear canal Well tolerated, nonsensitizing. Rare adverse effects

18. Other products Boric acid is an ingredient in some ear preparations (not FDA approved). It is a weak local anti-infective and nonirritating to intact skin in a solution of 1-5%. Alcohol-Boric acid solutions show improved bactericidal action over alcohol alone, because it increases acidity Because of toxicity, it should be used with caution especially in children or on open wounds

19. Cerumen-Softening agents Cerumen-softening & cerumenolytic agents only soften & loosen the cerumen. These agents do not readily remove cerumen Patients then can remove minor amounts of excessive ear wax by rinsing the ear canal with an ear syringe Hardened or impacted earwax  removed by doctor, or if pain is present  refer to doctor

20. Carbamide Peroxide (urea hydrogen peroxide) The effervescence caused by oxygen release mechanically assists in disintegrating wax accumulations in the ear Carbamide (urea) helps to increase penetration of solution into the plug Removal of the softened cerumen may be assisted by warm water irrigation using a soft rubber ear syringe Recognized by FDA as safe & effective for occasional OTC use

21. Carbamide Peroxide (urea hydrogen peroxide) FDA recommends use twice daily for up to 4 days if needed 5 drops of the solution should be instilled into the affected ear & allowed to remain at least 15 minutes, either by tilting the head up or by inserting small amount of cotton into the canal opening then irrigate with warm water using a soft rubber ear syringe

22. Carbamide Peroxide (urea hydrogen peroxide) If condition not improved after 4 days  consult a doctor 1.Procedure not recommended for children under 12 years of age 2.Should not be used if there is ear drainage, pain or dizziness or injury or perforation of the eardrum

23. Carbamide Peroxide (urea hydrogen peroxide) 3.Should not be used if surgery has been performed in the past 6 weeks 4.Carbamide peroxide should be discontinued whenever irritation or rash appears 5.Not recommended for treating pain of inflamed tissue, swimmer’s ear or itching of the ear canal

24. Other cerumen-softening products Occasional instillation of olive oil, turpentine oil, glycerin, diluted hydrogen peroxide (1:1 of 3% solution) or propylene glycol, sodium bicarbonate or docusate sodium may soften the cerumen and promote the normal process of removal These products should be used only under medical supervision if the tympanic membrane is perforated or is not known to be intact;

25. Other cerumen-softening products To prevent cerumen build-up: rinse ear canal every few days with a mixture of 20- 30% alcohol & water or aluminum acetate solution; Over-irrigation of the ear is not recommended as maceration of the skin may happen and may lead to infection

26. Not proven to be safe and effective by FDA Benzocaine Antipyrine Camphor Chloroform Menthol Ichthammol

27. Glycerin Used as a solvent, emollient or humeactant It is safe & nonsensitizing when applied to open wounds or abraded skin Olive oil (Sweet Oil) Used as an emollient & topical lubricant Alleviates itching & burning, softens earwax and smothers insects

28. Propylene Glycol A solvent that has preservative and humeactant properties Because it is viscous, increases contact with the skin Adding acetic-acid to it increases solution’s acidity, enhancing its anti-infective properties If used for a long period of time, may cause allergic dermatitis in susceptible individuals

29. Thymol A phenolic compound obtained from Thyme Has been traditionally used in topical preparations for its aromatic properties It has antibacterial & antifungal properties in a concentration of 1% Its effectiveness for treating ear disorders has not been well studied & objectively determined

30. Choline Salicylate Local analgesic, has a counterirritant effect Used for earache Hydrolysed by cutaneous esterases to salicylic acid that has anti-inflammatory effect However, The British National Formulary (2004) states that choline salicylate is of doubtful value when used topically

31. Ear Drop Administration

32. Pharmacist must make sure that patient understands the proper techniques of drug administration & use: Eardrops maybe applied as often as 4 times daily

33. Patient Counseling The involved ear should be tilted up for at least 2 minutes following placement of 2-4 eardrops to permit effective contact Apply a piece of cotton or gauze to the area A cotton wick may be inserted gently into ear canal to help medication maintain contact with the affected area in ear canal

34. Patient Counseling Patients should also fully understand the proper use of medicine dropper for administering ear drops & of ear syringes for irrigating the ear Eardrops should be warmed to body temperature by: (1) or (2) but not the microwave! WHY NOT?

35. Ear wick: about 1 by 10 mm of compressed cellulose, which is thin enough to slip into an occluded canal, but expands when wet Ear syringe

36. Patient Counseling Cotton wicks, however, usually require insertion using appropriate instruments & should be used only by trained personnel Gently pulling the auricle backward may allow medication to reach a greater depth into ear canal Patients should be advised that symptoms should subside 1-2 days following self- treatment. If symptoms persist or worsen, consult doctor