CHAPTER 11

OVER-THE-COUNTER FOR TOBACCO CESSATION

OVER THE COUNTER DRUGS (OTC)

070115200
MSC Suhad Anabousi
 2
PATHOPHYSIOLOGY OF TOBACCO USE AND
DEPENDENCE

 Tobacco products are effective nicotine delivery systems capable of inducing and
sustaining chemical dependence.
 The primary criteria used to categorize nicotine as an addictive substance were its:

 Psychoactive effects,
 Use in a highly controlled or compulsive manner,

 Reinforcement of behavioural patterns of tobacco use.

 As with other addictive substances (e.g., opiates, cocaine, amphetamines), nicotine

stimulates the mesolimbic dopaminergic system in the midbrain, inducing
pleasant or rewarding effects that promote continued use.
 3
PATHOPHYSIOLOGY OF TOBACCO USE AND
DEPENDENCE

 Nicotine, the addictive component of tobacco, is distilled from burning tobacco and then
carried in tar droplets to the small airways of the lung, where it is absorbed rapidly into
the arterial circulation and distributed throughout the body.
 Nicotine readily penetrates the central nervous system and is estimated to reach the
brain within seconds after inhalation.
 Nicotine binds to receptors in the brain and other organs, inducing a variety of
predominantly stimulatory effects on the cardiovascular, endocrine, nervous, and
metabolic systems.
 Increases in the heart rate and blood pressure, Pleasure, Cognitive enhancement,
Appetite suppression, Learning and memory enhancement, Mood modulation,
Reduction of anxiety and tension.
 4
CLINICAL PRESENTATION OF TOBACCO USE AND
DEPENDENCE

 Most chronic tobacco users develop tolerance to the effects of nicotine, and abrupt
cessation precipitates symptoms of nicotine withdrawal.
 The symptoms and their severity vary from person to person but generally include irritability,
frustration, anger, anxiety, depression, difficulty concentrating, impatience, insomnia, and
restlessness.
 Other symptoms that patients may report include cravings, impaired performance, constipation,
cough, dizziness, and increased dreaming.
 Typically, the physiologic symptoms of nicotine withdrawal manifest within the first 1–2 days,
peak within the first week, and gradually dissipate over 2–4 weeks.
 Increased appetite and weight gain may persist for 6 or more months after quitting.
 5
CLINICAL PRESENTATION OF TOBACCO USE AND
DEPENDENCE
 Tobacco smoke interacts with medications through pharmacokinetic or pharmacodynamic
mechanisms that can lead to reduced therapeutic efficacy or, less commonly, increased toxicity.
 Most of the pharmacokinetic interactions are the result of induction of hepatic cytochrome
isoenzyme can increase the hepatic metabolism of certain drugs potentially resulting in a
reduced therapeutic response or a need for higher dosages in smokers; conversely, the dosages
of some drugs might need to be reduced in patients who quit smoking .
 A significant pharmacodynamic drug interaction occurs between tobacco smoke and combination
hormonal contraceptives (pills, patch, and ring).
 Increases the risk of serious adverse cardiovascular events in women using oral
contraceptives.
 Most experts consider use of hormonal contraceptives to be a contraindication in smokers and
recommend use of an alternative form of contraception
 Similarly, the clearance of caffeine is significantly increased (by 56%) in smokers. After cessation,
ex-smokers who drink caffeinated beverages should be advised to decrease their usual caffeine
intake to avoid higher levels of caffeine, which may induce symptoms similar to nicotine
withdrawal
 6

PHARMACOLOGIC THERAPY
 Non-regulated forms of nicotine delivery systems (e.g. electronic cigarettes) may significantly vary
from the labeled concentration and contain ingredients that lack sufficient safety testing.
 Currently, seven first line agents are approved by the U.S. Food and Drug Administration (FDA) for
smoking cessation: five formulations of nicotine replacement therapy (NRT), sustained-release
bupropion, and varenicline.
 Three of the NRT formulations—gum, lozenge, and transdermal patch—are non-prescription, but
the nicotine inhaler and nicotine nasal spray, as well as bupropion and varenicline, require a
prescription.
 Nicotine Replacement Therapy (NRT)
 Similar to the nicotine present in tobacco, the active agents in NRT stimulate the release of
dopamine in the central nervous system.
 NRT provides smokers with a nontobacco source of nicotine to reduce the physiologic
symptoms of nicotine withdrawal that typically occur after abstinence from tobacco.
 Compared with cigarettes, NRT formulations provide lower, slower, and less-variable plasma
nicotine concentrations, thereby eliminating the almost immediate reinforcing effects of nicotine
obtained through smoking.
 7

PHARMACOLOGIC THERAPY
 Patients should begin NRT on their quit date and discontinue use of all forms of tobacco
on initiation of the NRT regimen.
 Use of tobacco in combination with NRT may result in serum nicotine concentrations
that are higher than those achieved from tobacco products alone, increasing the
likelihood of nicotine-related adverse effects, including nausea, vomiting, hypersalivation,
perspiring, abdominal pain, dizziness, weakness, and palpitations.

 Referral
 The manufacturers of nicotine gum, lozenge, and patch products recommend that
patients taking a prescription medicine for asthma or depression speak with their
primary care provider before using non-prescription NRT.
 8

NICOTINE POLACRILEX GUM

 Nicotine polacrilex gum is a resin complex of nicotine and polacrilin in a sugarfree
(<3 calories/piece) chewing gum base.

 The product is available as 2 mg and 4 mg strengths, in original (tobacco-like,

peppery), cinnamon, fruit, and mint flavours.
 All gum formulations contain buffering agents (sodium carbonate and sodium
bicarbonate) to increase salivary pH, thereby enhancing absorption of nicotine across
the buccal mucosa.

1.6 mg and 2.2 mg of

 When the 2 mg and 4 mg gums are used properly, approximately
nicotine is absorbed from each dose, respectively. Peak serum concentrations of
nicotine are achieved approximately 30 minutes after chewing a single piece of gum
and then slowly decline over 2–3 hours.
 During the initial 6
weeks of therapy, patients should use 1 piece of gum every 1–2 hours
while awake. In general, this amounts to at least 9 pieces of gum daily, which improves
the overall chances of quitting.
 9

NICOTINE POLACRILEX GUM

 Proper administration technique is necessary when using this product.

 Nicotine from the gum is released using the “chew and park” method:

 Chew each piece of gum slowly several times.

 Stop chewing at the first sign of a peppery, minty, fruity, or citrus taste, or after experiencing a slight tingling
sensation in the mouth.
 This usually occurs after approximately 15 chews, but the time to effect onset varies.

 Park the gum between the cheek and gum to allow absorption of nicotine across the lining of the
mouth.
 When the taste or tingling dissipates (generally after 1–2 minutes), slowly resume chewing.

 When the taste or tingle returns, stop chewing and park the gum in a different place in the mouth.

 This will decrease the incidence of mouth irritation.

 The chew and park steps should be repeated until most of the nicotine is gone, which is when the taste
or tingle does not return after continued chewing.
 On average, each piece of gum lasts 30 minutes.
 10

NICOTINE POLACRILEX GUM

 Acidic beverages such as coffee, juices, wine, or soft drinks may transiently reduce the
salivary pH, resulting in decreased absorption of nicotine across the buccal mucosa.
 Do not eat or drink anything (except water) 15 minutes before or while using the nicotine gum.

 Have nicotine gum readily available at all times. Keep the nicotine gum in the same place
you previously kept your cigarettes (e.g., shirt pocket, purse, desk).
 Keep this product, including used pieces, out of the reach of children and pets.
 11

NICOTINE POLACRILEX GUM

 The most common adverse effects associated with the use of the nicotine gum include:
unpleasant taste, mouth irritation, jaw muscle soreness or fatigue, hypersalivation, hiccups,
and dyspepsia.
 Many of these effects can be minimized or prevented by using proper chewing technique.

 The nicotine polacrilin resin is more viscous than ordinary chewing gum and more likely to
adhere to fillings, bridges, dentures, crowns, and braces.
 Patients should be warned that chewing the gum too rapidly may result in excessive
release of nicotine, leading to lightheadedness, nausea, vomiting, irritation of the throat
and mouth, hiccups, and indigestion.
sodium-restricted diet,
 In addition, the manufacturer recommends that patients with
stomach ulcers, or diabetes contact their primary care provider before use of the
product because these more serious conditions may potentially necessitate further
monitoring.
 12

NICOTINE POLACRILEX LOZENGE

 The nicotine polacrilex lozenge is a resin complex of nicotine and polacrilin in a sugar-free mint- or
cherry-flavored lozenge.

 The lozenges are available in 2 mg and 4 mg strengths with two different physical sizes (regular
and mini); they should be used similarly to other medicinal lozenges or troches (i.e., suck and rotate it
within the mouth until it dissolves).
 Because the minilozenge is smaller, it is more easily concealed and dissolves more quickly.

 The pharmacokinetics of the nicotine lozenge and gum formulations are comparable, but a nicotine
lozenge delivers approximately 25% more nicotine than an equivalent dose of nicotine gum
because of complete dissolution of the dosage form.
 The lozenge form also contains buffering agents (sodium carbonate and potassium bicarbonate) to
increase salivary pH, enhancing the buccal absorption of nicotine.
 During the initial 6 weeks of therapy, patients should use 1 lozenge every 1–2 hours while awake.
In general, this amounts to at least 9 lozenges daily.
 Patients can use additional lozenges (up to 5 lozenges in 6 hours or a maximum of 20 lozenges
per day) if cravings occur between the scheduled doses.
 13

NICOTINE POLACRILEX LOZENGE

 Proper administration technique is necessary when using the nicotine lozenge:
 Place the lozenge in the mouth and allow it to dissolve slowly (20–30 minutes for standard lozenge;
10 minutes for mini-lozenge).
 As the nicotine is released from the lozenge, you may experience a warm, tingling sensation.

 To reduce the risk of side effects (e.g., nausea, hiccups, and heartburn), do not chew or swallow the
lozenge.
 Occasionally rotate the lozenge to different areas of the mouth to decrease mouth irritation.
 To minimize withdrawal symptoms, use the nicotine lozenge on a scheduled basis rather than as
needed.
 Adverse effects associated with the nicotine lozenge include mouth irritation, nausea, hiccups, cough,
heartburn, headache, flatulence, and insomnia.
 Patients who use more than 1 lozenge at a time, continuously use 1 lozenge after another, or
chew or swallow the lozenge are more likely to experience heartburn or indigestion.
 14

NICOTINE POLACRILEX LOZENGE

 15
NICOTINE TRANSDERMAL SYSTEMS
(NICOTINE PATCH)

 Nicotine transdermal systems deliver continuous, low levels of nicotine through the
skin over 24 hours.
 The patch consists of a waterproof surface layer, a nicotine reservoir, an adhesive layer,
and a disposable protective liner.
 The provider should know how many cigarettes the patient smokes per day.

 In general, heavier smokers will require higher-strength formulations for a longer

duration of therapy.
 Patients who experience adverse effects such as dizziness, perspiration, nausea, vomiting,
diarrhea, or headache should consider a lower-strength patch.
 16
NICOTINE TRANSDERMAL SYSTEMS
(NICOTINE PATCH)

 Usage Guidelines for Nicotine Transdermal Systems (Nicotine Patch)

 Apply the patch to a clean, dry, hairless area of the skin on the upper body or the upper outer part
of the arm at approximately the same time each day.
 The patch should be applied to a different area of skin each day.
 To minimize the potential for local skin reactions, the same area should not be used again for at least 1 week.

 During application, apply firm pressure to the patch with the palm of the hand for 10 seconds.
 Be sure that the patch adheres well to the skin, especially around the edges; this is necessary for a good seal.

 Wash your hands after applying or removing the patch.

 The patch should not be left on the skin for more than 24 hours because prolonged use may lead to
skin irritation.
 • Any adhesive remaining on the skin after patch removal can be removed with rubbing alcohol.
 17
NICOTINE TRANSDERMAL SYSTEMS
(NICOTINE PATCH)

 Water will not reduce the effectiveness of the nicotine patch if it is applied correctly. You may
bathe, swim, shower, or exercise while wearing the patch.
 Do not cut patches in half or into smaller pieces to adjust or reduce the nicotine dosage.
 Nicotine in the patch may evaporate from the cut edges and the patch may be less effective.
 Local skin reactions (e.g., itching, burning, redness) are common with the nicotine patch.
 These reactions are generally caused by adhesives; they can be minimized by rotating
patch application sites and, if they occur, treated with non-prescription hydrocortisone
cream.
 Users experiencing troublesome dreams or other sleep disruptions should remove the patch
before bedtime.
 Keep new and used patches out of the reach of children and pets.
 18
PRESCRIPTION MEDICATIONS FOR
SMOKING CESSATION

 Nicotine Inhaler
 The nicotine inhaler consists of aplastic mouthpiece and a menthol-flavoured nicotine-
containing cartridge that delivers 4 mg of nicotine as an inhaled vapor, 2 mg of which is
absorbed across the oropharyngeal mucosa.
 The inhaler reduces nicotine withdrawal symptoms and may give some degree of
comfort by providing a hand-to-mouth ritual that emulates the act of smoking.
 However, reinforcing the hand-to-mouth ritual can make quitting more difficult.

 A gradual reduction in inhaler use is recommended.

 Adverse effects of the inhaler include mild mouth and throat irritation, cough, and
rhinitis.
 19
PRESCRIPTION MEDICATIONS FOR
SMOKING CESSATION
 Nicotine Nasal Spray
nasal spray is an aqueous solution of nicotine for administration to the
 The nicotine
nasal mucosa.
 Eachactuation delivers a 0.5 mg bolus of nicotine that is absorbed across the nasal
mucosa.
 Because of itsrapid onset of action (relative to other NRT formulations), the spray is a
potential option for patients who prefer a medication to manage withdrawal symptoms
rapidly; however, in 15%–20% of patients, use of the nasal spray can result in
dependence.
 The nasal spray is not recommended for patients with chronic nasal disorders.

 Initially, most patients will experience nose and throat irritation (peppery
sensation), watery eyes, sneezing, or coughing when using this product.
 This product is to be administered without sniffing (i.e., not administered using the same
technique as for standard allergy nasal sprays).
 20
PRESCRIPTION MEDICATIONS FOR
SMOKING CESSATION
 Sustained-Release Bupropion
 Sustained-release bupropion was the first non-nicotine medication approved for smoking
cessation.
 This agent is a prescription antidepressant medication that is believed to promote
smoking cessation by blocking the reuptake of dopamine and norepinephrine in the
brain, thereby decreasing the cravings for cigarettes and symptoms of nicotine withdrawal.
 Treatment should be started 1 week before the patient stops smoking.

started with a dose of 150 mg orally every morning for 3 days, followed by
 Therapy is
150 mg twice daily for 7–12 weeks.
 Because steady-state blood levels are reached after approximately 7 days of therapy,
patients set their quit date for 1–2 weeks after starting therapy.
 Insomnia and dry mouth are the most common adverse effects reported with bupropion.
 21
PRESCRIPTION MEDICATIONS FOR
SMOKING CESSATION
 Varenicline
 Varenicline is a partial agonist and is highly selective for the α4β2 nicotinic receptor.
 The efficacy of varenicline in smokingcessation is believed to be the result of sustained,
low-level agonist activity at the receptor site that is combined with competitive
inhibition of nicotine binding.
 The partial agonist activity induces modest receptor stimulation, leading to increased
dopamine levels that attenuate the symptoms of nicotine withdrawal.
 As with sustained-release bupropion, treatment with varenicline should be started 1
week before the patient stops smoking.
 Therapy is generally started at 0.5 mg daily on days 1–3;

 0.5 mg twice daily on days 4–7

 1 mg twice daily for weeks 2–12.
CHAPTER 12
OVER-THE-COUNTER DENTAL, OPHTHALMIC AND OTIC AGENTS
DENTAL AGENTS

OVER THE COUNTER DRUGS (OTC)

070115200
MSC Suhad Anabousi
 23
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS
 Improper oral hygiene is a direct cause of dental caries, periodontal disease
(gingivitis and periodontitis), halitosis oral malodor (bad breath), and some
cases of denture-related discomfort.
 The teeth and supporting structures are necessary for effective mastication
and articulation, as well as for normal appearance.
 Anatomically, the teeth are viewed grossly as having two parts, the roots
and the crown
 The roots, which extend below the gingival (gum) line or margin and thus
are normally concealed from view, are essential in supporting and attaching
the tooth to the surrounding tissues.
 The crown is the part of the tooth visible above the gingival margin and
provides appropriate surfaces for effective mastication. Each tooth has four
major structural components: enamel, dentin, pulp, and cementum.
 24
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS
 25
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS
 Enamel is composed of very hard, crystalline calcium phosphate salts (hydroxyapatite).
 its thickest part and protects the underlying tooth structure.
 It covers the crown of the tooth, ending around the gum line.
 Enamel’s hardness enables the crown to withstand the wear of mastication.
 Dentin, which is softer, lies just beneath the enamel and makes up the largest part of the
tooth structure.
 Transport nutrients from the dental pulp.
 Dentin protects the dental pulp from mechanical, thermal, and chemical irritation.
 The bone-like cementum is softer than dentin and covers the root of the tooth.
 The pulp occupies the pulp chamber and canal.
 The pulp consists primarily of vascular and neural tissues.
 The only nerve endings in the pulp, any type of stimulus to the pulp is interpreted as pain.
 26
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS
 The periodontium comprises the hard and soft tissues
that surround the teeth, including the periodontal
ligament, the encompassing alveolar bone, and the
gingiva.
 The tooth is suspended hammock-like in bone by the
periodontal ligament.
 The cementum’s major function is as a surface for
attachment of the tooth to the periodontal ligament.
 The periodontal ligament is connective tissue that
attaches the tooth to the surrounding alveolar bone and
gingival tissue.
 The periodontal ligament performs supportive,
formative, sensory, and nutritive functions.
 The alveolar bone forms the sockets of the teeth.
 27
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS

 The gingiva is the soft tissue surrounding the teeth.

 Gingiva is categorized as either attached gingiva or
unattached gingiva.
 Attached gingiva normally is pink and is attached to
the cementum by periodontal ligament fibers.
 Unattached gingiva (marginal) appears light pink is
not bound to the underlying tissue of the tooth, and is
the first tissue to respond to inflammation.
 28
PREVENTION OF HYGIENE-RELATED
ORAL DISORDERS

 The major salivary glands—parotid, submandibular, and sublingual—are responsible

for secreting saliva, an alkaline, slightly viscous, clear secretion that contains enzymes,
albumin, epithelial mucin, immunoglobulin, leukocytes, and minerals.
 Normal salivary gland function promotes good oral health in several ways.

 First, saliva lubricates and facilitates the removal of carbohydrates and

microorganisms from the oral cavity.
 Second, saliva alsobuffers the decline in pH caused by the acid formed by
carbohydrate fermentation.
 Third, the mineral components of saliva have a protective role in the
demineralization and remineralization of tooth enamel.
 CARIES
 Strategies that have been successful in
 Risk for developing caries: reducing caries include:
 Patients with poor oral hygiene.
 Fluoridation of the municipal water supply,
 presence of orthodontic appliances,
 Topical fluoride treatments,
 Xerostomia (dry mouth),  Education on proper tooth brushing with a
 Use of tobacco products, fluoride dentifrice (tooth paste),

 Frequent alcohol use,  Mouth rinses,

 Diabetes,  Daily flossing,

recession  A proper diet,

 Gum tissue
surfaces.
that exposes root
29
 Regular dental office visits.
 30

PATHOPHYSIOLOGY OF CARIES
 Dental caries is considered an infectious disease caused by certain plaque bacteria
that affect the calcified tissues of the teeth.
 If oral hygiene is neglected, dental plaque (the biofilm containing these organisms)
remains on the tooth surfaces and over time attracts more bacteria, thereby
promoting decay.
 The carious process is characterized by an imbalance between the usual cycle of
destruction (demineralization) and repair (remineralization).
 Demineralization is caused by organic acids which are produced by microbial
metabolism of carbohydrates (sugars) that readily diffuse into plaque.
 The resulting reduction in pH on the tooth surface leads to demineralization of
dental enamel.
 Saliva, which is rich in calcium and phosphate ions, is crucial in remineralizing
enamel in early changes involved in developing carious lesions.
 31

PATHOPHYSIOLOGY OF CARIES
 Thepresence of fluoride ions in the mouth also promotes remineralization and slows
demineralization, thereby retarding enamel dissolution.
 A carious lesion starts slowly on the enamel surface and initially produces no clinical
symptoms.
 Once demineralization progresses through the enamel to the softer dentin, the
destruction proceeds much more rapidly, becoming clinically or radiographically evident
as a carious lesion. At this point, the patient can become aware of the lesion either by
observing it or by experiencing symptoms of sensitivity to stimuli (e.g., heat, cold, sweet
foods) or chewing.
 Ifuntreated, the carious lesion can progress to involve the dental pulp (with continuous
pain as a common symptom), with eventual necrosis of vital pulp tissue. In addition to pain
and difficulty chewing, untreated caries can lead to abscess formation, tooth loss, and
serious infections.
 32
CLINICAL PRESENTATION OF CARIES

 Plaque is commonly recognized as the source of microbes that cause caries and
periodontal disease.
 After meals, food residue may be incorporated into plaque by bacterial degradation, Left
undisturbed, plaque thickens, and bacteria proliferate.
 Plaque growth begins in protected cracks and fissures and along the gingival margin.
 If not removed within 24 hours, dental plaque begins to calcify by calcium salt
precipitation from the saliva, forming calculus, or tartar. This hardened, adherent
deposit is removable only by professional dental cleaning.
 Calculus is generally considered to be a substrate on which additional plaque can
develop and is not considered the primary causative factor in periodontal disease.
 Its assumed that supragingival and subgingival calculus can promote the progression
of periodontal disease by accumulating new bacterial plaque in contact with sensitive
tissue sites and by interfering locally with dental self-hygiene efforts to remove plaque.
 33
PREVENTION OF CARIES
GENERAL APPROACH
 The key to preventing caries is controlling dental plaque.

 Because a combination of diet high in carbohydrates, oral bacteria, and host resistance
is involved in developing caries, prevention should be aimed at modifying these factors.
 The amount and frequency of refined carbohydrate intake should be reduced; plaque
should be regularly removed, usually by mechanical means (e.g., brushing, flossing);
and host resistance should be increased through appropriate exposure to fluoride ion
(drinking water, dentifrices, and mouth rinses).
 Mechanical removal (brushing with a dentifrice and flossing) and chemical
management (e.g., using specific products to prevent plaque accumulation or aid its
removal) are two methods used to manage plaque.
 Plaque on interproximal (between the teeth) surfaces can be removed efficiently only
with dental floss and other interdental cleaning aids.
 34
NON-PHARMACOLOGIC THERAPY
DIETARY MEASURES
 Cariogenic foods and beverages, which predispose the tooth enamel to deleterious
effects (i.e., erosion), should be avoided in favor of those that are less cariogenic.
 A food is considered highly cariogenic if it contains more than 15% sugar, clings to
the teeth, and tends to remain in the mouth after it is chewed.
less cariogenic if they have a high water content (e.g., fresh fruit),
 Conversely, foods are
stimulate the flow of saliva (e.g., carrots, other fibrous foods that require a lot of
chewing), or are high in protein (e.g., dairy products).
 Both the water content of fresh fruit and the resulting flow of saliva tend to wash
away the fruit’s sugar and neutralize the acid it creates.
 Milk protein also raises pH and tends to inhibit binding of bacteria.
 Chewing sugarless gum for 20 minutes after meals can also help reduce tooth decay as
an adjunct to brushing and flossing in adults and children older than 5 years of age.
 The associated increase in salivary flow helps wash out food debris, and saliva
neutralizes acid produced by plaque bacteria.
 35

PLAQUE REMOVAL DEVICES

 Toothbrushes, dental floss, oral irrigating devices, and specialty aids (e.g.,
interproximal dental brushes) are the primary devices used in facilitating plaque removal.
 The toothbrush is the most universally accepted device available for removing dental plaque and
maintaining good oral hygiene. Tooth brushing removes plaque from the lingual (tongue side), buccal
(cheek side), and occlusal (biting) surfaces of the teeth.
 Brush teeth after each meal or at least twice a day.
 If using toothpaste, apply a small amount of paste to the toothbrush.
 Use a gentle scrubbing motion, with the bristle tips held at a 45-degree angle against the gum line so
that the tips of the brush do the cleaning.
 Do not use excessive force because it may result in bristle damage, cervical abrasion, irritation of
delicate gingival tissue, or gingival recession with associated hypersensitivity.
 Brush for at least 2 minutes, cleaning all tooth surfaces systematically.
 Gently brush the upper surface of the tongue to help remove debris, plaque, and bacteria that can cause
oral hygiene problems.
 Rinse the mouth, and spit out all of the water (do not swallow).
 The patient replace the toothbrush every 3–4 months  bristle wear and bacterial accumulation.
 36

PLAQUE REMOVAL DEVICES

 Toothbrush firmness is not standardized; toothbrushes designated as soft,
medium, or hard may not be comparable across manufacturers.
 Use of medium- or hard-bristle toothbrushes may result in damage to the
tooth enamel and gingival tissue.

 Softer bristles are more effective at working themselves into crevices and
spaces between the teeth, and they are less abrasive on teeth with exposed
areas of recession, as well as gentler on soft tissue.

 Many dental providers and dental hygienists prefer soft, rounded, multitufted,
nylon bristle brushes, both because nylon bristles are more durable and easier
to clean than natural bristles and because soft, rounded bristle tips are more
effective in removing plaque below the gingival margin and on proximal
tooth surfaces.

 Soft bristles are recommended for children’s toothbrushes. Children usually

can remove plaque more easily with a brush that has short and narrow
bristles.
 37

PLAQUE REMOVAL DEVICES

 Dental Floss
 Plaque accumulation in the interdental spaces contributes to proximal caries and
periodontal pocketing.
 Proper flossing also polishes the tooth surfaces and reduces gingival inflammation.

 Interdental plaque removal has been reported to reduce gingival inflammation and
prevent periodontal disease and dental caries.
 Proper flossing technique requires some finger dexterity and practice. If performed improperly,
flossing can injure gingival tissue and cause cervical wear on proximal root surfaces..

 Floss is a multifilament nylon yarn that is available in waxed or unwaxed form and in various
widths, ranging from thin thread to thick tape.

 Literature suggests that in addition to regular tooth brushing, interdental brushes may be more
effective than flossing; both interdental brushes and flossing reduce plaque better than tooth
brushing alone.
 38

PLAQUE REMOVAL DEVICES

 Oral Irrigating Devices

 Oral irrigators, also known as water flossers, work by directing a high-pressure stream of water
through a nozzle to the tooth surface.

 Such devices, however, remove only a minimal amount of plaque from tooth surfaces.

 Therefore, an irrigating device cannot be viewed as a substitute for a toothbrush, dental

floss, or other plaque removal devices, but their use should be considered as an adjunct in
maintaining good oral hygiene.
 useful for removing loose debris from those areas that cannot be cleaned
These devices are
with a toothbrush (e.g., around orthodontic bands or fixed bridges).
 39
PHARMACOLOGIC THERAPY
CHEMICAL MANAGEMENT OF PLAQUE
 Chemical management of plaque and calculus can enhance mechanical removal either
directly on the plaque bacteria or by disrupting components of plaque to aid in
by acting
its removal during routine oral hygiene.

 The use of chemical agents in plaque control may be particularly appropriate for selected patients
who may be unable to brush and floss effectively. and patients with orthodontic appliances (i.e.,
fixed prostheses) may benefit from adding antiplaque agents to their oral hygiene regimen.

 Desirable characteristics for antiplaque agents include the following:

 antibacterial activity; interference
Selective with the rate of accumulation or
metabolism of supragingival plaque
 Substantivity (sustained retention of the agent in the mouth).
 Compatibility with dentifrice ingredients.
 Lack of undesirable adverse effects for the user.
 Non-interference with the natural ecology of the normal oral microflora.
 40

USE OF FLUORIDE
 Fluoride is believed to help prevent dental caries through a combination of effects.
 When it is incorporated into developing teeth, fluoride acts systemically to reduce the
solubility of dental enamel by enhancing the development of a fluoridated hydroxyapatite,
which is more resistant to demineralizing acids, at the enamel surface.
 When applied topically, fluoride facilitates remineralization within early carious lesions
during repeated cycles of demineralization and remineralization.
 Fluoride that is chemically bound to organic constituents of plaque may interfere with
plaque adherence and may inhibit glycolysis (the process by which sugar is metabolized to
produce acid).
 Mouth rinses and gels that contain sodium fluoride are therapeutic topical applications of
fluoride for prevention of dental caries.
 Use of fluoride mouth rinses enables patients to apply fluoride interproximally.
 Patients who may benefit from these products include those with fixed orthodontic
appliances, those with decreased salivary flow, those at risk for developing root caries, and
anyone with difficulty maintaining good oral hygiene.
 41

USE OF FLUORIDE
 Guidelines for Using Topical Fluoride Treatments
 Use topical fluoride treatments no more than once a day.
 Brush teeth with a fluoride dentifrice before using a fluoride treatment.
 If using a fluoride rinse, measure the recommended dose (most commonly, 10 mL), and
vigorously swish it around the oral cavity, forcing it between the teeth, for 1 minute.
 If using a fluoride gel, brush the gel on the teeth. Allow the gel to remain for 1 minute.
 After 1 minute, spit out the fluoride product. Do not swallow it.
 Do not eat or drink for 30 minutes after the treatment.
 Supervise children receiving fluoride treatments as necessary.
 Instruct children younger than 12 years in good rinsing habits, to minimize swallowing of
the product.
 children younger than 6 years should avoid these products owing to the increased risk of
dental fluorosis, a mottled appearance of the surface enamel of the tooth, if the rinse is
repeatedly swallowed.
 42

DENTIFRICES(TOOTHPASTES)
 Using dentifrices (e.g., toothpastes) with a toothbrush has been associated with a greater
reduction of plaque than that obtained with mechanical brushing alone.
 Products are marketed as having properties such as caries prevention, plaque reduction,
antitartar activity, gingivitis reduction, remineralization induction, cosmetic effect (whitening
and stain removal), antisensitivity. Many products may offer multiple such benefits. Dentifrices are
available as pastes or gels commonly contain an abrasive, a surfactant, a humectant (moistening agent),
a binder or thickener, a sweetener, flavoring agents, and one or more therapeutic agents (e.g., fluoride)
for anticaries activity.
 Dentifrice abrasives are pharmacologically inactive and insoluble compounds.
 Common abrasives include silicates (Low-abrasive dentifrices (10%–25%)), dicalcium
phosphate, alumina trihydrate (high-abrasive dentifrices (40%–50%)) , calcium
pyrophosphate, calcium carbonate, and sodium metaphosphate.
 Baking soda, a mild abrasive found in many dentifrices, can prevent caries, reduce plaque, and
remove stains and has anti-tartar activity.
 The ideal abrasive would provide maximal cleaning while causing minimal damage to tooth
surfaces.
 43

DENTIFRICES(TOOTHPASTES)
 Fluoride Dentifrices
 Fluoride dentifrices are indicated for both preventing and treating carious lesions.
 Remineralize and strengthen weakened enamel, in addition to reducing gingivitis and sensitivity.
 Creates a protective mineral layer over the teeth to prevent plaque. Patients may experience slight
(but noticeable) tooth discoloration after using stannous fluoride dentifrices continuously for 2–3
months. The staining is not permanent and is readily removed at the next professional dental
cleaning.
 Tartar Control Dentifrices
 A number of fluoride dentifrices contain anticalculus compounds for tartar control.
 The ingredients of tartar control dentifrices that prevent or retard new calculus formation are zinc
chloride, zinc citrate, and soluble pyrophosphates, which act to inhibit crystal growth.
 Antiplaque and Antigingivitis Dentifrices
 Two toothpastes that are currently accepted by ADA for both antiplaque and antigingivitis
indications are Colgate Total, containing triclosan, and Crest Pro- Health, containing stannous
fluoride. These dentifrices are not intended for use in children younger than 6 years and 12 years,
respectively.
 44

DENTIFRICES(TOOTHPASTES)
 Whitening Dentifrices
 Although some whitening dentifrices are marketed as strictly cosmetic and do not make any
therapeutic claims, numerous products also provide anticaries and gingivitis reduction in
addition to effectively removing stains.

 Toothpastes containing baking soda have been shown to be effective at stain removal.

 Other products may contain a pigment (e.g., titanium dioxide, blue covarine) that produces a
temporary brightening effect.
 Whitening dentifrices that incorporate oxygenating agents or enzymes rely on a debriding
action to remove stained pellicle.

 Product Selection Guidelines

 Unless otherwise advised by their dental providers, patients (especially those with periodontal disease,
significant gum recession, and/or exposed root surfaces) should choose the least abrasive dentifrice
that effectively removes stained pellicle.
 45

MOUTH RINSES
 Mouth Rinses
 Regular use of a mouth rinse with plaque or calculus control properties is indicated as
an adjunct to proper flossing and tooth-brushing with fluoride toothpaste.
 Antiseptic mouth rinses have demonstrated effectiveness to reduce plaque and
gingivitis;
 Plaque control ingredients include:
 Aromatic oils (thymol, eucalyptol, menthol, and methyl salicylate), which are antibacterial
and have some local anesthetic activity.

 Agents with antimicrobial activity (e.g., quaternary ammonium compounds).

 Listerine, containing the active ingredients thymol, eucalyptol, methyl salicylate, and menthol, was
the first mouth rinse to be accepted by ADA as a non-prescription antiplaque/anti-gingivitis mouth
rinse.
 46
COMPLEMENTARY AND ALTERNATIVE THERAPIES
 Activated Charcoal
 Whitening properties. This effect presumably derives from the notable ability of
charcoal, with its high surface area, to absorb pigments and stains.
 Probiotics
 Because the accumulation of an oral biofilm containing microorganisms results in tooth
decay, oral probiotics have been hypothesized to be able to prevent or treat oral diseases
like caries, gingivitis, or periodontitis. They exert this action by altering the bacterial
biofilm composition and balancing the microflora antimicrobial activity against the
effects of pathogenic bacteria.
 Vitamin D
 Studies have demonstrated that a deficiency in vitamin D can result in low bone mineral
density and increased infectious and inflammatory diseases, which has been linked to
caries, gingivitis and periodontitis.
 Vitamin D is vital in the mineralization of bones and teeth, so attaining an optimal
vitamin.
 47

GINGIVITIS
 Periodontal disease (which may result in tooth loss).
 Curtailing buildup of plaque can prevent or control this common and
significant public health problem. Gingivitis
 All forms of periodontal disease are associated with oral hygiene status,
not with age.
 Gingivitis, the mildest form of periodontal disease, is a common and
reversible inflammation of the gingiva without loss or migration of
epithelial attachment to the tooth.
 Periodontitis occurs when the periodontal ligament attachment and Periodontitis
alveolar bone support of the tooth have been compromised or lost.
 Gingivitis may progress to more severe periodontal diseases such as acute
necrotizing ulcerative gingivitis and periodontitis, particularly if left
untreated.
 48

PATHOPHYSIOLOGY OF GINGIVITIS
 Gingivitis results from the accumulation of supragingival bacterial plaque.
 If this accumulation is not controlled, the plaque proliferates and invades subgingival
spaces.
 Controlling gingivitis is a reasonable approach to limiting periodontitis. supragingival

 Other possible etiologic factors include effects of medications such as calcium

channel blockers, cyclosporine, and phenytoin. Anticholinergics and
antidepressants may cause gingivitis by reducing the flow of saliva. The use of
tobacco (both smokeless and smoked) also has been linked to periodontal disease. subgingival
 Pregnant patients are more susceptible to the development of dental caries and
gingivitis.
 In addition to local factors, varying hormone levels in pregnancy may make gingival
tissue more sensitive to bacterial dental plaque. Pregnancy gingivitis can be prevented
or resolved thorough plaque control. The severity of the inflammatory response and
the resulting gingivitis decrease post partum, with a return to pre-pregnancy levels
after approximately 1 year.
 49
CLINICAL PRESENTATION OF GINGIVITIS
 The marginal gingiva (the border of the gingiva surrounding the neck
of the tooth) is held firmly to the tooth by a network of collagen
fibers.
 Microorganisms present in the plaque in the gingival sulcus (the
space between the gingiva and the tooth) are capable of producing
harmful products (e.g., acids, toxins, enzymes) that damage cellular
and intercellular tissue.

 Early-stage gingivitis signs and symptoms include dilation and

proliferation of gingival capillaries, increased flow of gingival fluid,
and increased blood flow with resulting erythema of the gingiva.

 The gingivae themselves also may enlarge, change contour, and

appear puffy or swollen as a result of the inflammation.
 50

PREVENTION OF GINGIVITIS
 Because prevention of gingivitis depends on calculus prevention and plaque
control, the same measures described for prevention of caries pertain to gingivitis.
 Active ingredients that prevent gingivitis and are commonly found in dentifrices
(tooth paste), mouth rinses, and other antiplaque products include triclosan,
cetylpyridinium chloride, and stabilized stannous fluoride.
 Brushing and flossing can cure early gingivitis that arises from irritating food
debris and plaque.
 The most important factors in reversing gingivitis and in preventing and
controlling periodontal disease are adequate removal and control of supragingival
plaque.
 Any signs or symptoms of gingivitis—swollen gums, gums that bleed with brushing
or flossing, receding gums, or gums that appear darker red than usual—warrant
referral to a dental care provider for evaluation and treatment.
 51
HYGIENE-RELATED DENTURE PROBLEMS
 Hygiene-Related Denture Problems
 Pain along the gingival ridge under a denture prosthesis suggests the presence
of denture stomatitis or a related condition.
 Denture stomatitis, an inflammation of the oral tissue in contact with a
removable denture, results from poor cleaning of dentures and can lead to
chronic candidiasis.
 Pathophysiology of Hygiene-Related Denture Problems
 Dentures accumulate plaque, stain, and calculus by a process very similar to
that occurring on natural teeth.
 Contact of the denture plaque mass with oral tissues leads to predictable toxic
results. Poor denture hygiene contributes to fungal and bacterial growth that
not only affects the patient aesthetically (with unpleasant odors and staining)
but also seriously compromises the patient’s oral health (from inflammation and
mucosal disease) and ability to wear the dentures successfully.
 52
HYGIENE-RELATED DENTURE PROBLEMS
 Prevention of Hygiene-Related Denture Problems
 Removing plaque from dentures helps prevent gum infections, staining of dentures,
and mouth odor.
 Specialty brushes and aids are available to remove plaque from hard-to-clean areas
on fixed orthodontic appliances (e.g., spaces around a bridge, implant, or orthodontic
band) and dentures.
 Dentures should be cleaned thoroughly at least once daily to remove unsightly stains,
debris, and plaque.
 A combination regimen of brushing dentures with an abrasive cleaner and soaking
them in a commercial cleaning solution is recommended.
 Do not sleep while wearing your dentures.

 Decreased levels of saliva during sleep may contribute to plaque buildup on the
denture.
 53
HYGIENE-RELATED DENTURE PROBLEMS
 Alkaline peroxide products are the most commonly used chemical denture soaking
cleansers.
 These powders or tablets are dissolved in water to become alkaline solutions of
hydrogen peroxide, causing oxygen to be released for a mechanical cleaning effect.
These products are most effective on new plaque and stains when the denture is
soaked for 4 to 8 hours.
 Sodium hypochlorite (bleach) removes stains, and is both bactericidal and fungicidal.
 Hypochlorite cleansers act directly on the organic plaque matrix to dissolve its
structure, but they cannot dissolve calculus once it has formed.
 The most serious drawback with any hypochlorite product is that the bleach corrodes
metal denture.
 If using sodium hypochlorite or acid-containing cleansers, limit soaking to 10
minutes to avoid corrosion of metal denture components.
 To prevent irritation of oral tissues, thoroughly rinse the dentures after using an abrasive
cleaner or chemical cleanser.
CHAPTER 12
OVER-THE-COUNTER DENTAL AND OPHTHALMIC, OTIC AGENTS
OPHTHALMIC AGENTS

OVER THE COUNTER DRUGS (OTC)

070115200
MSC Suhad Anabousi
 OPHTHALMIC DISORDERS
 The external location of the eye, with concomitant exposure of vulnerable tissues,
makes it susceptible to environmental and microbiologic contamination.
 Self-treatable Conditions involving the eye surface:

1. Dry eye,
2. Pingueculae
3. Pterygium
4. Allergic conjunctivitis,
5. Corneal edema of known etiology,
6. Presence of loose foreign Substances in the eye.
 Self-treatable Conditions affecting the eyelids:
 Contact Dermatitis of the Eyelid 55
 56
ANATOMY OF THE EYELID AND EYE
SURFACE.
 The visible external portion of the eye is composed of:
 The normally white, noninnervated sclera,
 The normally clear, innervated cornea.
 The sclera is a tough, collagenous layer that gives the
eye rigidity and encases the internal eye structures.
 The visible sclera is covered by two epithelial layers:
 The episclera and the bulbar conjunctiva.
 The episcleral and bulbar conjunctival layers
(which contain the vascular and lymphatic
systems of the anterior eye surface) are the
affected tissues in eye redness from ocular
irritation or inflammation.
 57
ANATOMY OF THE EYELID AND EYE
SURFACE.
 the lacrimal gland found underneath the outer portion of the upper eyelid, secretes
the bulk of nonstimulated tears.
 The tear layer keeps the ocular surface lubricated, provides a mechanism for
removing debris that touches the ocular surface, and has potent antimicrobial
activity conferred by specific enzymes and a number of immunoglobulin proteins.
 Abnormalities within any one of the tear layers can result in ocular discomfort.
 Commercial artificial tear products often are formulated to mimic the properties of
natural tears, to provide effects that are as physiologic as possible.
 During episodes of ocular irritation, reflex tearing is stimulated by the lacrimal
gland, and tear production increases to greater than 300% of the non-stimulated
production rate.
 Reflex tearing occurs immediately on instillation of a drug into the eye, diluting the
drug’s concentration. Drug penetration into the eye is reduced because of this
increase in tear production.
 58
CONSIDERATIONS WITH USE OF TOPICAL
OPHTHALMIC PRODUCTS

 Beyond the specific effects of topical ophthalmic products, other factors to consider in
the use of these agents include pH, sterility, stability, and expiration date.

 The pH of the tear film is approximately 7.4 (i.e., physiologically neutral).

 Pharmacologic agents given topically or systemically can affect uptake of topical

ophthalmic agents because of their effects on tissue permeability, fluid secretion,
and blood flow.
 Systemic agents such as antihistamines may decrease tear film production, thereby also
affecting absorption of topical ophthalmic products.
 59
CONSIDERATIONS WITH USE OF TOPICAL
OPHTHALMIC PRODUCTS
 Sterile products are required for topical ophthalmic formulations to be used in the
eyes.
 The U.S. Food and Drug Administration (FDA) requires the manufacturer to
demonstrate that at least 90% of the labelled concentration of a drug is present
in the active form after storage at room temperature for the specified shelf life.
 Once a sealed bottle is opened, the contents are subject to the risk of microbial
contamination or oxidation from light exposure.
 Preservatives are essential in multi-dose topical products to prevent
contamination. Some new ophthalmic medication bottles have filtration
systems that may allow the contents of the bottle to be preservative free.
 The combination of active drug, vehicle, and preservative may result in a hypotonic
Buffering agents, salts, and certain sugars often are added to adjust osmolarity of
the solution. The tear film has a wide tolerance to osmotic pressure variation.
 60
PATHOPHYSIOLOGY AND CLINICAL PRESENTATION OF
DRY EYE DISEASE

 Dry eye disease is among the most common disorders affecting the anterior eye.

 Associated with the aging process (especially in postmenopausal women), dry eye also can be
the result of lid or corneal defects, loss of lid tissue turgor, Sjögren syndrome, Bell’s palsy,
thyroid disorder–related eye disease, or various collagen diseases (e.g., rheumatoid arthritis)
and has been associated with use of certain ocular and systemic medications.
 Most people with symptoms related to ocular surface disease (OSD) suffer from tear under
production (i.e., aqueous-deficient dry eye disease)
 Patients who have undergone refractive surgery may complain of transient dry eyes for weeks to
months after the procedure.
 Drugs with anticholinergic properties (e.g., antihistamines, antidepressants), decongestants,
diuretics, and beta blockers are some of the more common pharmacologic agents that may cause
dry eye.
 The condition may be exacerbated by allergens or other environmental conditions (e.g., dry or
dusty working situations), or by exposure to heating and air conditioning systems that reduce
relative humidity, thereby increasing the evaporation of tears.
 61
CLINICAL PRESENTATION OF
DRY EYE DISEASE

 Dry eye disease typically is characterized by a normal-appearing white sclera or a

mildly red eye, often associated with patient complaints of a sandy, gritty feeling or a
sensation that something is in the eye.
 Contrary to what its name suggests, this condition often may manifest with excessive
tearing initially.
 Abnormalities in the tear layer cause less-than-optimal lubrication of the ocular
surface, with subsequent inadequate tear production.
 Without proper and timely diagnosis and treatment, dry eye disease can eventuate in
severe damage to ocular tissues, particularly the corneal surface.
 62

TREATMENT GOALS

 The goals of self-treatment of dry eye disease is:

 Early stages of dry eye disease often lend themselves to self-treatment,
but as disease severity increases, medical intervention is required.
 To alleviate the dryness of the ocular surface, thereby relieving the
symptoms of irritation and preventing possible corneal and non-corneal
tissue damage.
 63

GENERAL TREATMENT APPROACH

 The primary modality of self-treatment for dry eye disease is the use of ocular
lubricants.
 With disease of mild to moderate severity, however, treatment also may include other
pharmacologic and non-pharmacologic recommendations, including patient
education, environmental modifications, eyelid-specific therapies, elimination of
offending topical or systemic medications, and use of systemic omega-3 fatty acid
supplements (e.g., flaxseed oil).
 The availability of synthetic chemicals suitable for topical application to the eye led to
the development of various solutions, so-called artificial tears, to help alleviate
dryness of the ocular surface.
 64

GENERAL TREATMENT APPROACH

 Artificial tears products vary by viscosity in accordance with the ingredients used in
their preparation.
 With these products, higher viscosity allows more prolonged ocular contact time
and greater resistance to tear dilution.
 Mild cases of dry eye disease may show improvement with less viscous products
whereas more severe cases may require more viscous products.
 Bland (i.e., non-medicated) ophthalmic ointments (e.g., petrolatum) or gels
constitute another type of ocular lubricant.
 Because ointment preparations tend to cause blurred vision, they typically are
reserved for use only at bedtime or for severe cases of dry eye.
 As with ointments, the more viscous the artificial tears are, the greater their
blurring effect becomes.
 65

NON-PHARMACOLOGIC THERAPY
 Non-pharmacologic measures (e.g., applying warm compresses, discontinuing any
offending agents, maintaining good eyelid hygiene) also may increase eye comfort for
patients with this disorder.
 Dietary modification including supplementation with omega-3 oils or flaxseed oil in the
normal doses recommended by the manufacturer is thought to improve lid function,
possibly because the products have some anti-inflammatory properties.
 The primary nondrug measure in self-care for dry eye disease is avoiding environments
that increase evaporation of the tear film. If possible, patients should avoid dry or dusty
places.
 Using humidifiers or repositioning workstations away from heating and air conditioning
vents may help alleviate dry eye symptoms.
 In addition, avoiding prolonged use of computer screens and wearing eye protection
(e.g., sunglasses, goggles) in windy, outdoor environments may further help alleviate dry
eye problems.
 66

PHARMACOLOGIC THERAPY
 Whereas patients with mild dry eye disease may require only relief of ocular surface
dryness, patients with moderate to severe disease may benefit from a combined approach
incorporating immunomodulating agents (e.g., topical cyclosporine in conjunction with
ocular surface lubrication). Accordingly, signs and symptoms suggestive of moderate to
severe dry eye disease dictate referral to an eye care specialist.
 Non-medicated ointments are commonly used in treating minor ophthalmic disorders,
including dry eye.
 Because ointments can cause blurred vision (resulting in severe visual limitations),
combination therapy with a non-medicated ointment plus artificial tears to help
offset this undesired effect usually is recommended.
 Gels offer some clinical advantage in that they disturb vision less compared with
ointments and are better tolerated by the patient.
 The effectiveness of retinol solutions for treating dry eye remains speculative.
 67

ARTIFICIAL TEAR SOLUTIONS

 Lubricants that are formulated as artificial tear solutions consist of:
 Preservatives,
 Inorganic electrolytes to achieve tonicity and maintain pH,

 Water-soluble polymeric systems.

 The lubricating agents in artificial tears products are similar in palliative effect in that
they all provide ocular lubrication, but buffering agents, preservatives, pH, and other
formulation components may vary.

 The newer artificial tear substitutes have important properties, including the ability
to stabilize the tear film, protect the corneal and conjunctival cells, reduce tear
evaporation with the incorporation of lipids, and enhance wound healing and
lubrication of the ocular surface.
 68

ARTIFICIAL TEAR SOLUTIONS

 One class of ophthalmic vehicles or ocular lubricants, in their commonly used ophthalmic
formulation concentrations, is the substituted cellulose ethers, which include:
 Colorless solution and vary in viscosity depending on the grade and concentration of the
cellulose ether.
 Hydroxypropyl methylcellulose 0.3%–0.8%,
 Carboxymethylcellulose (CMC) 0.5% and 1.0%,
 CMC 1% often is classified as a “gel” because of its higher viscosity.
 Other vehicles commonly used as ocular lubricants.
 Polyvinyl alcohol (PVA) 1.4%, povidone 0.6%–2.0%, polyethylene glycol 400, propylene
glycol 0.3%–0.6%, glycerine 0.5%–1.0%.
 Carbomer polymers (e.g., Carbopol 980) often are added as inactive ingredients but may
contribute to increasing viscosity, providing the “gel” component of artificial tears.
 Sodium hyaluronate also is classified as an inactive ingredient,
 it may promote healing of the corneal epithelium
 69

ARTIFICIAL TEAR SOLUTIONS

 Studies have shown that formulations of artificial tears products without preservatives
are less likely than those with preservatives to irritate the ocular surface.
 Providers and patients should be aware, however, that preservative-free products should
be discarded immediately after being opened and used.
 This precaution is needed because the remaining product in the opened container can readily
become contaminated, potentially causing infection if applied to the ocular surface.

 In most mild cases of dry eye disease, the patient instills drops of artificial tears once or
twice a day, typically on arising in the morning and/or before retiring at night.
 A regimen of at least twice-daily drops is a good starting point.

 The viscosity of the drops and amount used can then be adjusted according to the
patient’s clinical response.
 For more severe cases, the dosage can be increased to 3–4 times daily.

 If the patient’s clinical needs and response to therapy indicate the need for more
frequent use, these solutions may be given as often as hourly.
 70

ARTIFICIAL TEAR SOLUTIONS

 In many cases, use of artificial tears may be continued indefinitely, depending on
patient response.
 Preservative-free products or those with less toxic preservatives are preferred in:
 Patients with moderate to severe dry eye disease.
 Those who are sensitive to such agents.

 Use of ocular lubricants requires balancing

the number of instillations (i.e.,
drops) per day with the viscosity of the recommended solution and the
presence of a preservative.
daily dosage increases, toxicity from preservatives
 Specifically, as the
becomes more likely.
 71

NON-MEDICATED OPHTHALMIC OINTMENTS

 The primary ingredients in commercial non-prescription ophthalmic ointments are:

 White petrolatum 60% (which contains a lubricant and an ointment base), mineral oil 40%
(which helps the ointment melt at body temperature), and lanolin (which facilitates incorporation
of water-soluble medications and also prevents evaporation).
 The principal advantage of non-medicated (bland) ointments is their longer retention time in the
eye, which appears to enhance the integrity of the tear film.
 Ointment formulations usually are administered twice daily. However, depending on the patient’s
clinical needs and therapeutic response, ointments may be administered as often as every few hours
or only occasionally, as needed. Many patients prefer to instill the ointment at bedtime, to keep the
eyes moist during sleep and to help prevent morning symptoms of dry eye.
 Because of the viscosity of the melted ointment base in the tear film, many patients complain of blurred
vision with use of these products. This problem usually can be managed by decreasing the amount of
ointment instilled or by administering the ointment at bedtime. Providers should routinely counsel
patients to expect blurring of vision with use of eye ointments. Preservative-free products are
particularly helpful for use in long-term treatment. As a rule, pharmacists should recommend
preservative-free, non-medicated ointments for the treatment of dry eye to avoid the potential
problems associated with preservatives.
 72
FORMULATION CONSIDERATIONS FOR OCULAR
LUBRICANTS AND OTHER OPHTHALMIC PRODUCTS
 Ocular lubricants and other non-prescription ophthalmic products are formulated to reduce the stinging,
burning, and other adverse effects commonly associated with some conventional ophthalmic drugs.
 With these products, lack of (or minimal) ocular discomfort on instillation is a major advantage, deriving
from carefully controlled pH and the presence of buffers, tonicity adjusters, and preservative systems;
patients are therefore more likely to adhere to recommended self-treatment regimens.
 Ophthalmic Preservatives
 Preservatives are incorporated into multi-dose ophthalmic products.
 These components are intended to destroy or limit the growth of microorganisms inadvertently
introduced into the product.
 Surfactants, is a distinct groups of preservatives, usually are bactericidal, meaning that they disrupt the
bacterial plasma membrane.
 Of the quaternary surfactants, benzalkonium chloride (BAK) and benzethonium chloride are preferred
by many manufacturers because of their stability, excellent antimicrobial activity, and long shelf-lives.
 Unfortunately, both agents can have toxic effects on the tear film and the corneal epithelium.
 Long-term use of topical products containing BAK can lead to damage of conjunctival and corneal
epithelial cells.
 73
FORMULATION CONSIDERATIONS FOR OCULAR
LUBRICANTS AND OTHER OPHTHALMIC PRODUCTS
 Preservative-Free Formulations
 In recent years, artificial tears preparations have been introduced in preservative-
free formulations and, more recently, in disappearing preservative formulations.
 These preparations are beneficial for patients who are sensitive to preservatives
such as BAK, those who use drops frequently, and those with compromised
corneas.
 Refresh Optive, Refresh Tears uniquely formulated to allow the preservative to
rapidly dissociate into nontoxic components on the ocular surface.
 True preservative-free artificial tears are available in a variety of unit-dose
dispensers.
 Preservative-free formulations are more expensive than preserved artificial tear
solutions
 Discard any unused product immediately after opening and using it.
 74
FORMULATION CONSIDERATIONS FOR OCULAR
LUBRICANTS AND OTHER OPHTHALMIC PRODUCTS

 Ophthalmic Excipients
 Other useful excipients are antioxidants, wetting agents, buffers, and tonicity
adjusters.
 Antioxidants prevent or delay deterioration of products that are exposed to oxygen.
 Wetting agents reduce surface tension, allowing the drug solution to spread more easily
over the ocular surface.
 Buffers are added to help maintain a pH range of 6.0–8.0, thereby preventing ocular
discomfort on product instillation.
 Tonicity adjusters allow the medication to be isotonic with the physiologic tear film.
Products in the sodium chloride equivalence range of 0.9%–1.2% are considered
isotonic; use of these products helps limit ocular irritation and tissue damage.
 75

ASSOCIATED LESIONS
 Pingueculae are yellowish bumps, often located on
the midportion of the sclera between the eyelids that
is exposed to the sun.
 They are believed to be caused by UV light from the
sun and exposure to dust and wind.
 Dry eye disease may contribute to enlargement or
exacerbation of these lesions.
 Recommended treatment may include use of
artificial tears to alleviate symptoms of dry eye,
including itching, burning, and foreign body
sensation.
 Wearing sunglasses to protect the eye from UV light,
even on overcast days, also is recommended.
 76

ASSOCIATED LESIONS
 A pterygium is a benign, elevated growth, often triangular in shape, on the
eye surface that typically starts on the sclera and continues to grow onto the
cornea.
 These lesions also are believed to be caused by UV light from sun exposure,
dust, and wind.
 Reduced UV sunlight exposure with sunglasses and protection from dust and
wind also are warranted.
 Small pterygia often can be managed with use of artificial tears or
lubricants.
 Occasionally a pterygium can become inflamed, with consequent hyperemia.
 Continued growth onto the cornea may even cause astigmatism and affect
vision.
 Larger lesions may be of concern because of their cosmetic appearance
and/or may require surgical removal.
 77

ALLERGIC CONJUNCTIVITIS
 Pathophysiology of Allergic Conjunctivitis
 The list of antigens that can cause ocular allergy is virtually
endless, but the most common allergens include pollen, animal
dander, and topical eye preparations.
 Patients with ocular allergy often report seasonal allergic rhinitis
as well.
 Clinical Presentation of Allergic Conjunctivitis
 Allergic conjunctivitis is characterized by a red eye with watery
discharge.
 The hallmark symptom of ocular allergy is pruritus (itching).
 Vision usually is not impaired but may be blurred because of
excessive tearing.
 Contact lenses should not be used until the allergic symptoms resolve
 78

ALLERGIC CONJUNCTIVITIS
 Treatment of Allergic Conjunctivitis
 General Treatment Approach
 Treatment often is directed at the root cause of the symptoms.
 Questioning the patient about exposure to allergens may help identify the offending substance.
 Removal or avoidance of the responsible allergen is the best therapeutic strategy,
 Non-prescription medication:
 Ocular lubricants,
 Ophthalmic antihistamine/mast cell stabilizer.
 Histamine type 1 (H1) receptor antagonist
 Ocular decongestants,
 Ocular decongestants (often in combination with antihistamines).
 Oral antihistamines, and application of cold compresses will help relieve symptoms.
 Use of such agents has been associated with dry eye and can worsen the condition.
 79

ALLERGIC CONJUNCTIVITIS
 First-line treatment for allergic conjunctivitis is instillation of artificial tears (possibly
refrigerated, in accordance with pharmacist recommendations) as needed.
 Artificial tears may help wash out the allergens and provide some symptom relief.
 If symptoms persist, the patient should switch to:

 An ophthalmic antihistamine/mast cell stabilizer (Ketotifen fumarate, Olopatadine)

 Or possibly ahistamine type 1 (H1) receptor antagonist (Pheniramine maleate 0.3%,

antazoline phosphate 0.5%)
 Other non-prescription ophthalmic products designated specifically for treatment of allergic
conjunctivitis include ocular decongestants (often in combination with
antihistamines). (phenylephrine 0.12%, naphazoline (0.1, 0.12, 0.02, 0.03)%;
tetrahydrozoline 0.05%, oxymetazoline 0.025%, and brimonidine 0.025%).
 An oral antihistamine can be added to the second treatment option, if needed.

 Medical referral is indicated if symptoms do not resolve after 72 hours of appropriate treatment.
 80
COMBINATION OPHTHALMIC ANTIHISTAMINE/MAST CELL
STABILIZER.

 Ketotifen fumarate is a combination ophthalmic antihistamine/mast cell stabilizer.

 It has very potent H1 receptor antagonist activity, thereby preventing acute histamine-
mediated allergy symptoms.
 The mast cell stabilization activity inhibits mast cell degranulation, preventing the
release of inflammatory mediators, including histamine. Ketotifen also inhibits
eosinophils, which in turn inhibits the release of late-phase mediators.
 Ketotifen provides relief within minutes, its effects may last up to 12 hours.
 Ketotifen fumarate 0.025% is very safe and can be used in patients 3 years of age and
older; it is dosed twice daily and is very effective in relieving the signs and symptoms of
allergic conjunctivitis.
 Another recently approved non-prescription combination antihistamine/mast cell stabilizer
is olopatadine HCl. is approved for the temporary relief of ocular itching and redness due to
pollen, ragweed, grass, and animal hair or dander.
 Olopatadine 0.1%, 0.2% solution are safely used in patients 2 years of age and older.
 81

OPHTHALMIC ANTIHISTAMINES
 Two non-prescription antihistamines are available for topical ophthalmic use:
 Pheniramine maleate 0.3%;and antazoline phosphate 0.5%.
 Using a decongestant with either of these topical antihistamines has been shown to be more
effective than using either agent alone.
 Pheniramine 0.3%/naphazoline 0.025
 Antazoline 0.5%/naphazoline 0.025%.
 Pheniramine and antazoline are in different antihistamine classes, but both act as specific H1
receptor antagonists.
 Topical antihistamines are used for rapid relief of symptoms associated with seasonal or atopic
conjunctivitis.
 Ophthalmic antihistamines have anticholinergic properties and may cause pupillary dilation.
This effect is seen most commonly in people with lightcolored irises or compromised corneas
(e.g., from contact lens wear).
 Contraindicated  In susceptible patients, pupillary dilation can lead to angle-closure
glaucoma.
 82
OPHTHALMIC DECONGESTANTS/ALPHA-ADRENERGIC AGONISTS

 Five non-prescription decongestants are available for topical application to the eye:
phenylephrine 0.12%, naphazoline (0.1, 0.12, 0.02, 0.03)%;, tetrahydrozoline 0.05%,
oxymetazoline 0.025%, and brimonidine0.025%.
 Decongestants reduce ocular redness by acting as local vasoconstrictors.
 Phenylephrine acts primarily on alpha-adrenergic receptors of the ophthalmic
vasculature to constrict conjunctival vessels, thereby reducing eye redness.
 The imidazoles (Naphazoline, tetrahydrozoline, and oxymetazoline) also have
greater alpha- than beta-receptor activity and are therefore clinically useful in
constricting conjunctival blood vessels but they do not diminish the allergic
response.
 Brimonidine 0.025% is a recently approved non-prescription ocular decongestant
for the treatment of ocular redness in adults and children older than 5 years.
 This selective alpha-2 adrenergic receptor agonist dosed at 4 times daily.
 83
OPHTHALMIC DECONGESTANTS/ALPHA-ADRENERGIC AGONISTS

 Adverse effect associated with phenylephrine, naphazoline, tetrahydrozoline, oxymetazoline:

 When used excessively or for other than brief periods, ocular decongestants have the potential
to produce rebound conjunctival hyperemia (i.e., rebound redness due to conjunctival
congestion), allergic conjunctivitis, and allergic blepharitis.
 Accordingly, they should not be used for more than 72 hours.
 Rebound congestion appears to be less likely with topical ocular use of naphazoline or
tetrahydrozoline than with use of oxymetazoline or phenylephrine.
 Rebound congestion may be experienced within a few days of initiating treatment,
 Use of these products in angle-closure glaucoma is contraindicated
 Indiscriminate use of most decongestants in an irritated eye can induce papillary dilation and
may precipitate angle-closure glaucoma in eyes.
 Caution is warranted with use of ocular decongestants by patients with systemic hypertension,
arteriosclerosis, other cardiovascular diseases, or diabetes, hyperthyroidism.
 During pregnancy, women should be advised to use ocular decongestants only sparingly, if at all.
 84

CORNEAL EDEMA
 Pathophysiology and Clinical Presentation of Corneal Edema
 Corneal edema may occur with any of a variety of conditions, including:
 Over wear of contact lenses,
 Surgical damage to the cornea,
 Inherited corneal dystrophies.

 Because the accumulated fluid distorts the optical properties of the cornea, subjective
perception of halos or starbursts around lights is a hallmark symptom of corneal
edema.
 An eye care specialist must diagnose this disorder before self-treatment is attempted.
 85

CORNEAL EDEMA
 Treatment Goals  The goal in treating corneal edema is to draw fluid from the cornea,
thereby relieving the associated symptoms.
 General Treatment Approach
 Once the diagnosis is established, patients can use topical hyperosmotic formulations to treat
corneal edema.
 Of the topical ophthalmic hyperosmotic agents available, only sodium chloride can be
obtained without a prescription in both solution and ointment formulations. sodium
chloride is available as a 2% or 5% solution and as a 5% ointment.
 Hyperosmotics
 Hyperosmotic agents increase the tonicity of the tear film, promoting movement of fluid
from the cornea to the more highly osmotic tear film.
 Normal tear flow mechanisms then eliminate the excessive fluid.
 Many patients with mild to moderate corneal epithelial edema may experience subjective
improvement in comfort and vision after appropriate use of these medications.
 86

CORNEAL EDEMA
 First-line treatment is instillation of a 2% solution 4 times per day.
 Usually, 1–2 drops of the solution are instilled every 3–4 hours.

 If symptoms persist for more than 1–2 weeks, night-time use of a 5% hyperosmotic ointment
should be added to the regimen.
 The ointment formulation, however, requires less frequent instillation and usually is reserved
for use at bedtime to minimize symptoms of blurred vision.

 If symptoms do not abate after 1–2 weeks of the augmented regimen, the patient should
switch to a 5% hyperosmotic solution and continue night-time use of the ointment.
 If symptoms still persist without relief after another 1–2 weeks, medical referral is necessary.

 Because vision associated with corneal edema often is worse upon awakening, several
instillations of the solution during the first few waking hours may be helpful.
 87

CORNEAL EDEMA
 The most important contraindication to the use of topical hyperosmotic sodium chloride is
traumatic injury of the corneal epithelium.
 In such cases, this agent must not be given to treat associated corneal edema.
 The intact corneal epithelium permits only limited permeability to inorganic ions;
therefore, an absent or compromised corneal epithelium will result in increased
corneal penetration of the hyperosmotic product, reducing its osmotic effect.
 If the clinical history or the physical appearance of the eye suggests a damaged
corneal epithelium, the affected person should be referred to an eye care specialist
immediately.
 It is essential to warn patients against preparation of homemade saline solutions for
use in the eye because of the associated risk of infection.
 88

PRESENCE OF LOOSE SUBSTANCES IN THE EYE

 Pathophysiology and Clinical Presentation of Presence of loose Substances in the Eye

 Despite the protective effect of the eyelids, foreign substances often contact the
ocular surface.
 The immediate clinical manifestations are pain and watering (tearing).
 If exposure to the substance causes only minor irritation, with no abrasion of the
eye surface, self-treatment is appropriate.
 Treatment for Loose Foreign Substances in the Eye
 The goal in treatment for loose foreign substances in the eye is to remove the
irritant by copious irrigation.
 If a known foreign substance is a fragment of wood or metal, prompt attention
from an eye care specialist is imperative because of the associated potential for
penetrating injuries.
 89

PRESENCE OF LOOSE SUBSTANCES IN THE EYE

 General Treatment Approach
 If reflex tearing does not remove the foreign substance, the eye may need to be
flushed.
 Lint, dust, and similar materials usually can be removed by rinsing the eye with
sterile specific eyewash preparations (irrigants).
 Outside of a clinical setting, loose particles can be washed away by flushing the
eyes with copious amounts of water from a sink faucet or even a garden hose.
 If needed, non-medicated ophthalmic petrolatum ointment can be applied at
bedtime.
 Ophthalmic petrolatum provides prolonged duration of protection, and the
associated blurry vision does not pose a problem while the patient is sleeping.
 90

PRESENCE OF LOOSE SUBSTANCES IN THE EYE

 Ocular Irrigants (Boric acid; sodium borate; Sodium acetate; sodium citrate)
 An ocular irrigant is used to cleanse ocular tissues while maintaining their
moisture; these solutions must be physiologically balanced with respect to pH
and osmolality.
 To reduce risk of contamination, patients should use ocular irrigants only on a
short-term basis, and they should be alert to any further signs or symptoms
that may point to other pathologic processes involving the eye.
 All ophthalmic irrigating solutions are available without a prescription .
 When to seek immediate medical attention
 Ocular irrigants should not be used for open wounds in or near the eyes.
 If the patient experiences unremitting eye pain, changes in vision, continued
redness, irritation of the eye, or if the ocular condition persists or worsens.
 91
CONTACT DERMATITIS OF THE EYELID

 Pathophysiology and Clinical Presentation of Contact dermatitis of the eyelid

 Contact dermatitis of the eyelid can be a reaction to either an allergen or an
irritant.
 Recognized etiologic factors include a change in cosmetics or soap,
adverse effects of eye medications, and contact with other foreign
substances.
 The involvement of both eyelids suggests allergy because such
reactions typically follow general exposure rather than localized
irritation.
 Common clinical manifestations include swelling, scaling, or
redness of the eyelid, along with severe pruritus (itching).
 92

CONTACT DERMATITIS OF THE EYELID

 Treatment of Contact Dermatitis of the Eyelid

 Questioning the patient about the use of eye medications or new personal
care products (e.g., eyeliner, eye shadow) may help identify the offending
substance quickly.
 Discontinuing use of the suspected product is the best treatment strategy.
 Ifswelling of the eyelid is marked, nonprescription oral antihistamines
(e.g., diphenhydramine) along with application of cold compresses 3–4 times
per day will help reduce the inflammation and itching.
CHAPTER 12
OVER-THE-COUNTER DENTAL, OPHTHALMIC, OTIC AGENTS
OTIC AGENTS

OVER THE COUNTER DRUGS (OTC)

070115200
MSC Suhad Anabousi
 94

OTIC DISORDER
 Self-treatment with non-prescription
medications and complementary therapies
should be restricted to minor External
Auditory Canal (EAC) disorders.
 Excessive cerumen and water-clogged ears
are self-treatable EAC disorders for which Auricle Tympanic Eustachian
the U.S. Food and Drug Administration membrane tube
(FDA) has approved non-prescription otic
medications. External Auditory Canal (EAC)
 The primary impact of excessive cerumen
is transient hearing loss, which affects
patients of all ages.
 95

PATHOPHYSIOLOGY OF OTIC DISORDERS

 The anatomy of the ear is conducive to certain types of otic disorders, especially in children;
 The external ear consists of the auricle (pinna), the EAC, and the tympanic membrane
(eardrum), which separates the external ear from the middle ear.
 The EAC consists of an outer cartilaginous portion, which makes up one third to one half of its
length, plus an inner body, or osseous portion. At the end of the canal is the tympanic
membrane.
 The EAC in children is shorter, straighter, and flatter than that in adults, in whom the canal
tends to lengthen and form an S shape.
 Eustachian tube (within the inner ear) in a child also is shorter and flatter than that in an
adult.
 By adulthood, the eustachian tube lengthens downward from the middle ear to the
nasopharynx.
 This conformation helps promote drainage and inhibits aspiration of pharyngeal and nasal
contents into the middle ear, which may help explain why children have more frequent middle
ear infections than adults.
 96

PATHOPHYSIOLOGY OF OTIC DISORDERS

 Cerumen, or earwax, present in the EAC consists of a mixture of sebum, an oily secretion from
the exocrine glands, and a milky, fatty fluid from the apocrine glands.
 It lines the skin surface in the outer half of the EAC. The canal skin sheds continuously and
mixes with cerumen.
 The debris-laden cerumen slowly migrates outward with jaw movements (in chewing and
talking). This migration serves as a process of self-cleaning.
 Cerumen may appear dry and flaky (gray color) or have an oily or paste-like consistency
(honey color).
 Cerumen lubricates the canal, traps dust and foreign materials, and provides a waxy,
waterproof barrier to the entry of pathogens.
 Within the cerumen are various antimicrobial substances (lysozymes), and it has an acidic
pH, which helps inhibit bacterial and fungal growth.
 Because the EAC forms a blind cul-de-sac, it is prone to collecting moisture.
 Its dark, warm, moist environment is ideal for fungal and bacterial growth.
 97
PATHOPHYSIOLOGY AND CLINICAL PRESENTATION OF
EXCESSIVE OR IMPACTED CERUMEN
 Pathophysiology of Excessive or Impacted Cerumen
 Impacted cerumen is defined as “lodged, wedged, or firmly packed” cerumen in the EAC.
 Various factors can disrupt the normal flow of cerumen toward the outer EAC,
 These causes include anatomic variability resulting in a narrow or irregularly shaped
EAC, Presence of excessive hair,
 Irritation from foreign objects used to assist in amplification or blocking of sound
(hearing aids or ear plugs),
 Use of cotton-tipped swabs, can push wax deeper into the ear or damage the EAC or
tympanic membrane, potentially resulting in otitis media. Atrophy of the ceruminous
glands with aging, or a genetic tendency.
 Clinical Presentation of Excessive or Impacted Cerumen
 The sensations of ear fullness, dull pain, or itching may be associated with excessive or
impacted cerumen. Other common symptoms may include discomfort, tinnitus,
dizziness, vertigo, cough, hearing loss, and hearing aid malfunction or feedback, ear
discharge and an odor may be present.
 98
TREATMENT FOR EXCESSIVE OR IMPACTED
CERUMEN
 Appropriate use of cerumen removal treatments can be expected to eliminate signs and
symptoms specific to the condition and other associated symptoms. The health care
provider should assist the patient to choose a product that is cost-effective and readily
administered at home.
 Therapeutic interventions include the use of cerumen-softening agents with or without
irrigation.
 Manual removal of cerumen is an option for primary care providers with the proper skills
and instrumentation, but caution is warranted with patient attempts, which are associated
with greater risk of EAC damage (bleeding, pain, or perforation).
 Guidelines state that if the presence of excessive cerumen is asymptomatic, active
management is not required. Manual removal of cerumen is stated as optional rather than
recommended treatment.
 The earwax–softening agent should be instilled into the ear for the appropriate amount of
time, followed by rinsing with warm water, often done using a bulb syringe. Drying of the
ear canal can be hastened by gently toweling off the outer ear structures or with use of a
handheld blow.
 99
TREATMENT FOR EXCESSIVE OR IMPACTED
CERUMEN
 Non-pharmacologic Therapy
 Earwax should only be removed when it has
migrated to the outermost portion of the EAC.
 The non-pharmacologic method to eliminate
cerumen is with an ear-cleaning tool, or curette.

 Referral
pain or bleeding after repeated
 if patients experience
tries or if symptoms persist, an immediate medical
referral is necessary. Medical referral also is warranted
and non-prescription treatment is contraindicated in
patients with previous ear surgery or a suspected
tympanic membrane rupture
 100
TREATMENT FOR EXCESSIVE OR IMPACTED
CERUMEN
 Pharmacologic Therapy
 Currently the only FDA-approved non-prescription earwax-softening agent/ removal of
hardened or impacted cerumen within the EAC is carbamide peroxide 6.5% in
anhydrous glycerine.
 It can be used alone or in conjunction with warm water irrigation to remove the
loosened cerumen.
 This product can be used in children 12 years of age and older and adults.
 For correct administration, 5 to 10 drops of the solution are instilled into the
affected ear(s), with care to prevent the applicator tip from entering the EAC.
 The solution should remain in the EAC for several minutes for effective softening of
excessive earwax.
 As carbamide peroxide is exposed to moisture, hydrogen peroxide and oxygen
release slowly, resulting in a weak antibacterial effect and mechanical loosening of
cerumen.
 101
TREATMENT FOR EXCESSIVE OR IMPACTED
CERUMEN

 Anhydrous glycerin acts to soften and penetrate cerumen to help loosen

excessive earwax.
 Any cerumen remaining after treatment may be removed with gentle,
warm-water irrigation administered with a rubber otic bulb syringe.
 Carbamide peroxide may be administered twice daily for up to 4 days.
 Patients should contact a primary care provider 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.
 No special consideration for use is necessary in pregnant or lactating
women or in older adults.
 102

WATER-CLOGGED EARS
 Water-clogged ears constitutes a disorder defined as the retention of
water within the external auditory canal (EAC).
 Lead to hearing impairment.
 Localized discomfort.
 A sensation of fullness in the ear canal.
 Only isopropyl alcohol 95% in anhydrous glycerin 5% base as the
active ingredient is recognized by FDA to be safe and effective when
used as an ear-drying agent
 Of note, these products are approved only to aid in ear drying after
such activities and not for prevention of moisture accumulation or
treatment of an inflammatory process.
 103
PATHOPHYSIOLOGY AND CLINICAL PRESENTATION OF
WATER-CLOGGED EARS

 Pathophysiology of Water-Clogged Ears

1. Physical or anatomic changes within the EAC, such as excessive
hair growth and canal narrowing, may lead to wax or debris
buildup, which can lead to moisture retention.
2. Excessive moisture may become trapped within the ear from
sweating, high humidity, or swimming.
 Clinical Presentation of Water-Clogged Ears
 The presence of water in the ear can cause transient hearing
impairment or a sensation of localized discomfort or fullness.
 104

PATHOPHYSIOLOGY OF WATER-CLOGGED EARS

 Referral
 Patients with a history of ear surgery or those experiencing pain, dizziness, or ear
drainage, or who display symptoms suggestive of otitis externa, infection, or
inflammation within the EAC, should receive a medical referral.
 If pain, burning, or irritation occurs with application or if symptoms persist after
several days of use.
 Treatment Goals
 The goals of treating a water-clogged ear are to dry the EAC using a safe and effective
agent and prevent recurrences in persons who are prone to retaining moisture in the
ears.
 General Treatment Approach
 Before recommending an agent to treat water-clogged ears, the health care provider
should determine whether the patient has a ruptured tympanic membrane or a
tympanostomy tube in place  Ear-drying agents are very painful if instilled in either of
these situations.
 105
NON-PHARMACOLOGIC THERAPY
 Non-pharmacologic measures include tactics to prevent exposure and accumulation of
moisture within the EAC:
 For “waterproofing” the ears,
 Earplugs or a bathing cap can be recommended when swimming.
 Inserting petroleum jelly–coated cotton balls in the outer ear canal (max. 15 min.)
 The Clear Ears water-absorbing earplugs are inserted into the ear canal to absorb
trapped water; adult supervision is required for use in children younger than 11 years.
 The earplugs are left within the canal for 5 to 10 minutes to absorb any trapped
water and then gently removed and discarded.
 One maneuver to dispel excessive moisture from the ear canal is to pull the ear lobe
gently while tilting the head downward; this action straightens the EAC, which
promotes gravity drainage.
 Another method is using a blow dryer on the lowest heat setting to help dry the EAC.
 106

PHARMACOLOGIC THERAPY

 Isopropyl alcohol 95% in anhydrous glycerin 5%

 Patients are instructed to instill 4 or 5 drops in the affected ear.
 Highly miscible with water and acts as a drying agent.

 It is safe but stings when applied to open wounds or abraded skin.

 No special consideration is necessary for use of these preparations in

pregnant, lactating, or geriatric patients.
 No minimum age is listed on the ear-drying products generally accepted for use
when the ears are exposed to moisture.