OTIC PRODUCTS (1)

Before recommending any OTC product

to a person with an ear disorder, the
pharmacist should recognize the
symptoms of various disorders & their
corresponding pathophysiology for
accurate evaluation & treatment of the
case
OTC products use for the ear
• Home remedies and OTC products are usually
restricted to the self-limiting disorders that are
related ONLY to the external ear
• In such cases, OTC products may be used
effectively to aid the normal body defenses
and to improve the integrity of the skin that
lines the auricle and the external auditory
canal.
Anatomy & Physiology
• Keywords: auricle (pinna), external auditory canal,
cartilage, thin skin, highly vascularised, lobule, fatty
tissue, tragus;
• absence of subcutaneous layer  makes auricular
skin subject to frostbite despite rich supply of
superficial blood vessels;
• External auditory canal (24 mm in adults):
transmission & protection
• Skin in the farther portions of the canal, contains hair
follicles, exocrine glands & apocrine glands
 Tympanic membrane
• Normally: smooth, transluscent, pearl-gray
• Concave and oval with thickness of 0.074 mm
• The contineous skin layer of the EAC forms the
outer tympanic membrane layer
• The middle layer is fibrous tissue
• Internal layer is mucous membrane continous with
the lining of the middle ear
• Function: 1. transmits sound waves 2. protection
to middle ear
 Protection of the ear:
1. Hair: trap foreign material in a waxy network
2. Cerumen (ear wax)= milky fatty fluid (apocrine ceruminous
glands) + oily secretions (of sebaceous. exocrine glands) glands

(1) lubricates skin (2) traps foreign bodies

(3) Contains antimicrobials such as lysozymes
- semisolid: expelled to the outside by jaw
movement during talking & chewing
3. Skin of normal healthy ext auditory canal: waxy
water-resistant with pH 5-7.2 that prevents
pathologic bacterial and fungal growth
Ear Disorders
• Disorders of the ear are very common and
usually cause discomfort
• Patients often complain of earache,
impacted ear, running ear, cold in the ear or
itching in the ear or combination of the
symptoms

What causes ear disorder/discomfort?

 Causes of Ear Disorders
1. Disease of the auricle (the most external portion of
the ear)
2. Disease of the external auditory canal
3. Disease of the middle ear
4. Disease of the other area of the head & neck
(tongue, mandibles, oropharynx, tonsils or
paranasal sinuses) referred pain to the ear. In this
case, self-treatment is not suitable refer to doctor
 Causes of ear conditions
• Hairs, size of ear canal, its isthmus & cerumen provide
barrier protection against foreign bodies
• Acidic pH & integrity of skin layer  are defense
mechanisms against infection
1. Any predisposing factor that breaks down these mechanisms
(e.g. warm & humid climate, water, sweating) cause tissue
maceration breaks down protective barrier and changes
pH expose skin to infection
2. Trauma: e.g. improper cleaning of the ear or improper fitting
of ear plugs or hearing aids, involuntary scratching or
rubbing of the ear may cause fissures in the epidermis of ear
canal which creates culture area for bacteria & fungi
Notes:
• The skin that covers the auricle is especially
susceptible to bleeding because: (1) lack of
flexibility afforded by subcutaneous layer of
fat (2) large blood supply to the area
• The skin is highly innervated
disproportionate otalgia when inflammation is
present
• Children suffer from more middle ear
conditions that do adults (why?)
 Disorders of the External
Ear
Otitis Externa
• One of the most common diseases of the ear
• A v painful & annoying inflammation of the skin
lining ext auditory canal, often due to infection
• The ext auditory canal is a blind cul-de-sac lined
with skin: dark and very well suited to collect
moisture
• Prolonged exposure to moisture will disrupt the
integrity of epithelial cells & raise pH above 5-7
range more prone to bacterial & fungal infections
 Otitis Externa
• Causative organisms: pseudomonas, staphylococcus,
protues & bacillus. Fungi can be causative in some
cases (otomycosis)
• Complications: inflammation may lead to
inflammation & destruction of the tympanic
membrane may progress & perforate the
membrane spread infection to middle ear intense
pain and discomfort
• Inflammation that causes edema provokes severe pain
that is disproportionate to any visible swelling
• Pain increases during chewing
 1. Otitis Externa
Types of Otitis Externa:
1. Swimmer’s ear
2. Acute otitis externa
3. Chronic ~
4. Allergic ~
5. Malignant ~
 Swimmer’s Ear
• Bacterial infection caused by tissue maceration:
1. Accumulation of water in the tympanic recess
may contribute to tissue maceration
2. Also, the cerumen accumulated in the ext
auditory canal absorbs water & expands and the
trapped water provides a medium for bacterial
growth
 Swimmer’s Ear

Normal Abnormal

What are the symptoms of swimmer’s ear?

 Swimmer’s Ear
Symptoms:
• Pain around the ear
• Itching
• Plugged ear
• Movement of the ear is painful (especially the
tragus)
• Discharge of yellowish-greenish thick liquid
from the affected ear
• Redness and tenderness around the ear and the
surrounding tissue
• Wisdom teeth may be painful
 Swimmer’s Ear
• With the spread of infection to the
surrounding bone, brain and the middle ear, a
severe infection called Malignant Otitis
Externa (MOE) can occur and contain the
following:
– Fever if the infection is severe

– Neurological symptoms (i.e., confusion,

headaches, balance problems, weakness or
paralysis on one side) that spread to the
inside of the brain and skull.
Malignant Otitis Externa
• The most progressive form of otitis
• Occurs mostly in elderly, patients with
chronic lymphocytic leukemia,
granulocytopenia or poorly controlled DM
• Symptoms: severe persistent pain &
swelling, ear is inflamed and may involve the
temporal bone area, persistent drainage and
tenderness of tragus & auricle
Acute Otitis Externa
• Symptoms related to severity of pathologic conditions
• Symptoms: mild to moderate pain, that is more
prominent upon pulling upward the auricle or
pressing the tragus

Chronic Otitis Externa

• Caused by persistence of predisposing factors
• In people whose ears are exposed to persistent
excessive moisture
• Most common symptoms: itching which prompt
scratching break skin
Allergic Otitis Externa
 Allergic Otitis Externa
= dermatitis of the external auditory canal
• Caused by: nickel in earrings, poison ivy, chemicals
used to process the rubber or plastic in the hearing
aid molds or earphones or type of soap
• Symptoms: itching, burning or stinging of the
lesions
• Often complaints >>> than visible signs
(maculopapular rash, formation of vesicles,
erythema)
 2. Impacted Cerumen
• Accumulation of the ear wax in the external
auditory canal
Causes:
1. Overactive ceruminous glands
2. Small abnormal narrowing of the canal
3. Secretion of abnormal cerumen (drier, as in
elderly)
4. Hearing aids or ear plugs prevent migration of
cerumen
The "Gripper" Foreign
Object Extractor
 2. Impacted Cerumen
Symptoms:
• the most common is sense of fullness or
pressure in the ear and
• gradual hearing loss
• Dull pain is sometimes associated with this
disorder
3. Foreign Object in the Ear
• Children often insert: small items, candy, pencil
erasers, peas, beads etc
• Symptoms: may be absent (accidentally) or may
cause hearing deficiency, pain during chewing,
exudates may form because of secondary bacterial
infection
• Dried peas or beans may swell during bathing or
swimming and become wedged in the bony
portion of the canal causing severe pain
Q: What should you do if
an insect enters in the
auditory canal?

A: Olive oil drops will suffocate the insect!

4. Otomycosis
• It is an external fungal infection of the ear
• It is more common in: warmer, tropical or
semitropical climates
• Most common causative agents: Asperigillus &
Candida
• Predisposing factors: antibiotics ( normal flora),
immunosuppression (disease or drug) & DM
• Primary complaint of patients with otomycosis is
intense itching
 4. Otomycosis
• Color may vary. Skin lining & canal maybe beefy red
and scaly, a musty smelling discharge. Skin maybe
eroded or ulcerated with fungal filaments
• Asperigellus niger: forms black growth in the canal
• If the infection is superficial: patient will experience
pruritis, feeling of fullness & pressure in the ear
• Fungus leads to the accumulation of debris, exudates
and cerumen. In acute cases, fungal infection/growth
may block the canal and hearing may be impaired
 Assessment of otitis externa
• The only means by which bacterial or fungal otitis
external can be confirmed is by microbiologic
culture which is not always practical or necessary

• Bacterial infections may be characterized by:

- increased pain with chewing or touching the
tragus or auricle;
- other characteristics: lymphadenopathy, feeling
of fullness, malaise
 Disorders of the Middle
Ear
• Should not be treated with OTC otic products
• Should be promptly evaluated and treated by a
doctor
• The usual treatment is systemic antibiotic therapy

- Otitis Media
- Chronic Otitis Media
- Tympanic Membrane Perforation
Otitis Media
• Inflammation of the middle ear that occurs
most commonly during childhood
• Caused by any condition that interferes with
the Eustachian tube function, e.g. URT
infection, allergy, adenoid lymphadenopathy,
cleft palate
• Symptoms of Eustachian tube blockage: mild,
intermittent pain, mild hearing loss & fullness
in the ear.
 Otitis Media
Recurrent Otitis Media:
• In children: recurrent episodes of Eustachian tube
blockage usually are caused by masses of
adenoids that become edematous & block the
Eustachian tube opening resulting in otitis media.
Adenoidectomy usually prevents future
occurrence
• In adults: recurrent otitis media may be caused by
nasopharyngeal tumors
 Otitis Media
• Avoid: nose blowing & sneezing against occluded
nostrils worsen condition
Serous otitis media:
• of viral origin
• Symptoms: sensation of fullness in ear, hearing
loss, voice resonance, a hollow sound or popping
or cracking noise in the ear during swallowing
or yawning
• These symptoms are not present in otitis externa
 Otitis Media
• Purulent (Suppurative) otitis media:
• infection by bacteria purulent discharge
• Symptoms: pain, hearing loss and fever (>40°C)
• The acute pain is sharp, knifelike & steady (caused
by high fluid production in a short period of time), the
pressure of fluids in middle ear causes outward tension
on the tympanic membrane causes pain.
• Steady: pain usually doesn’t worsen with mastication,
or with traction applied to auricle or tragus
• Nose blowing may force additional purulent mucus
into Eustachian tube worsen condition
Chronic Otitis Media
• It occurs most often in young children
• Causes: inadequate treatment of previous otitis
media or recurrent URT infections
• It is also called “glue ear” as long-standing fluid
may become more and more viscous.
• The most common symptom is sudden onset of
impaired hearing (without acute symptoms)
• Diagnosis: visual inspection of tympanic
membrane which appear to be yellow or orange &
less flexible- not perforated but retracted
 Assessment of otitis media
1. The only conclusive means of diagnosing otitis
media is via complete patient history & physical
examination using a pneumatic otoscope
2. Most commonly in children
3. Patients may be asymptomatic or feel fullness,
cracking or hollow sounds in the ear
4. Effect is usually bilateral
5. A bloody purulent foul-smelling discharge flows
from infected ear only if tympanic membrane is
perforated, after which patient experiences
sudden relief from pain
How to differentiate between
otitis media & otitis externa?
 Acute Otitis Acute otitis media
Externa
Season Summer Winter
Movement of Yes No
tragus painful
Ear canal Swollen Normal
Eardrum Normal (or red) Perforated or bulging
Discharge Yes Yes (but through a
perforation)
Nodes Frequent Less frequent
Fever Yes Yes
Hearing Normal or decreased Always decreased
 Tympanic Membrane
Perforation
1. The most common cause: water sports e.g.
diving, water skiing etc
2. Any corrosive agent introduced into the ear
3. Sudden explosion
4. Other causes:
- Blows to head with cupped hand
- foreign objects entering ear canal
- forceful irrigation of ear canal
 Management of tympanic
perforation
• If the perforation is very small, otolaryngologists may
choose to observe the perforation over time to see if it
will close spontaneously.
• They also might try to patch a cooperative patient's ear-
drum in the office.
• Surgery (tympanoplasty): there are a variety of surgical
techniques, but all basically place tissue across the
perforation allowing healing.
• Surgery is typically quite successful in closing the
perforation permanently, and improving hearing. It is
usually done on an outpatient basis.
 Tympanic Membrane
Perforation
Symptoms:
• Pain: severe at moment of injury, decreases
gradually with time
• Hearing acuity diminishes quickly and if not
treated, it may lead to otitis media
• Other: Nausea, tinnitus, vertigo
• Refer to doctor immediately if you suspect a
perforated tympanic membrane
 Finally!
• Patients with fever, malaise,
lymphadenopathy associated with any
ear condition should be thoroughly
evaluated by a doctor