OTC 2015
REFERENCES
 Cough and the Common Cold. ACCP Evidence-Based Clinical Practice
Guidelines. Chest 2006;129;72S-74S.
 Cough Suppressant and Pharmacologic Protussive Therapy. ACCP
Evidence-Based Clinical Practice Guidelines. Chest 2006;129;238S-249S.
 Treatment of the Common Cold. American Academy of Family
Physicians. Am Fam Physician 2007;75:515-20, 522.
 The common cold. Lancet 2003; 361: 51–59.
 Examining the evidence for the use of vitamin C in the prophylaxis and
treatment of the common cold. American Academy of Nurse
Practitioners. Journal of the American Academy of Nurse Practitioners 21
(2009) 295–300
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OVERVIEW
 Pathophysiology of common cold.
 Diagnostic considerations for common cold.
 Non-pharmacologic management.
 Pharmacologic management.
 Tips to the pharmacist.
 Conclusions.
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Introduction.
The common cold is a conventional term for a mild
upper respiratory illness, the hallmark symptoms of
which are nasal stuffiness and discharge, sneezing,
sore throat and cough.
Every year, in the USA, about 25 million people visit
their family doctors with uncomplicated upper
respiratory infections and the common cold syndrome
results in about 20 million days of absence from work
and 22 million days of absence from school
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Children younger than 1 year experience an average of
6-8 episodes of common cold infections. This figure
decreases to 3-4 episodes per year by adulthood.
Some reports indicate a male predominance of
infection in children younger than 3 years, which
switches to a female predominance in children older
than 3 years. No difference in rates of infection in
adults is apparent.
 Common cold is one of the most common categories of
self-medication that requires pharmacist advice and
patient counseling.
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Incidence of common colds per age group
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Pathophysiology
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Rhinovirus infection begins with
the deposition of viruses in the
anterior nasal mucosa or in the
eye, from where they get to the
nose via the lacrimal duct. The
viruses are then transported to the
posterior
nasopharynx
by
mucociliary action. In the adenoid
area, the viruses gain entrance to
epithelial cells by binding to
specific receptors on the cells.
About 90% of rhinovirus serotypes
use
intercellular
adhesion
molecule-1 (ICAM-1) as their
receptor
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The absence of epithelial destruction during rhinovirus
infections has led to the idea that the clinical symptoms of
the common cold might not be caused by a direct
cytopathic effect of the viruses, but instead are primarily
caused by the inflammatory response of the host.
Extensive research into the role of inflammatory mediators
in the pathogenesis of the common cold has produced
evidence for increased concentrations of several mediators,
such as kinins, leukotrienes, histamine, interleukins 1, 6,
and 8, tumour necrosis factor, and RANTES (regulated by
activation normal T cell expressed and secreted) in the
nasal secretions of patients with colds. The
concentrations of interleukin 6 and interleukin 8 in
nasal secretions correlate with the severity of the
symptoms
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 Common cold is usually benign and self limiting.
 Typically symptoms begin slowly 18-48 hrs after exposure to
the virus, but could start as early as 10 hours after exposure.
 The 1st symptoms are typically scratchy, sore throat
followed by a runny nose, watery-itchy eyes, sneezing and
fatigue. The soreness of the throat usually disappears
quickly, whereas the initial watery rhinorrhoea turns
thicker and more purulent, tenacious consistency lasting
about 4-5 days.
 Symptoms gradually diminish and usually disappear after
10 days or so.
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Although the common cold is usually a selflimited illness of short duration, the viral infection
is sometimes accompanied by a bacterial
complication. In children, the most common
bacterial complication is acute otitis media,
which occurs in about 20% of children with
viral upper respiratory infections. The seasonal
incidence rates of otitis media closely parallel the
general occurrence of viral respiratory infections
and the complication is diagnosed most frequently
on days 3 or 4 after the onset of upper respiratory
symptoms.
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Diagnostic considerations.
 The soreness of the throat caused by streptococcal pharyngitis often
resembles the initial symptoms of the common cold. However, nasal
stuffiness and discharge, which are the primary symptoms of the
common cold, are not typical to streptococcal pharyngitis.
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How to differentiate between
bacterial & viral sore throat?
Bacterial sore throat
Viral sore throat
Rapid
Slower
Soreness
Marked
Less severe
Constitutional
symptoms
URT & LRT
symptoms
Lymph nodes
Marked
Mild
Not always present
Usually present
Large, tender
Slight enlargement,
not tender
Onset
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Non-pharmacologic management
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 Increase fluid intake.
 Humidifiers and Vaporizers.
 Intranasal saline sprays/drops/washes.
 Breathe Right nasal strips.
 Lozenges and demulcents.
 Warm salt gargles.
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Vitamin C
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Vitamin C& common cold
 Walker and Schwartz, gave half of their volunteers
a placebo and the rest 3,000 mg of vitamin C daily
for several days before inserting live cold viruses
directly into their noses; and then continued 3,000
mg of vitamin C (or placebo) for seven more days.
 All of the volunteers got colds, which were of equal
severity
Zinc
The use of zinc has been shown to inhibit viral growth,
and an RCT suggested that zinc could reduce the
duration of cold symptoms. However, this has not
been substantiated in subsequent RCTs. Specifically,
four of eight subsequent trials showed no benefit, and
the other four may have been biased by the patients’
ability to recognize the adverse effects of zinc. Because
of these inconsistent study results, zinc cannot be
recommended for adults.
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Echinacea
Echinacea purpurea has recently been studied and did not show any differences
in rates of infection or severity of illness when compared with placebo. Although
reports of improved symptoms have been described, validation and
standardization of products is necessary.
Echinacea angustifolia has also been examined in the prophylaxis and treatment
of experimental rhinoviral infection. Neither the rate of infection nor the severity
of symptoms were found to be statistically significantly affected when E
angustifolia was used either prophylactically or at the time of challenge.
In contrast, a recent meta-analysis of echinacea indicated that, in properly
designed studies, patients receiving placebo were 55% more likely to experience
cold symptoms than patients taking echinacea. The most striking part of this
meta-analysis was that 231 of 234 articles identified were excluded because they
did not control for the type of viruses causing the colds. Echinacea extracts will
continue to be evaluated.
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Pharmacologic Management
26
overview
 Drugs used in the symptomatic treatment include nonsteroidal anti-
inflammatory drugs (NSAIDs), antihistamines, and anticholinergic
nasal solutions. These agents have no preventive activity and appear to
have no impact on complications. The combined effect of NSAIDs and
antihistamines often relieves nasal obstruction; therefore,
decongestion therapy may not be needed. Oral (pseudoephedrine) and
topical (oxymetazoline and phenylephrine) decongestants are
commonly used for symptomatic relief.
 First-generation antihistamines reduce rhinorrhea by 25-35%, as do
topical anticholinergics and ipratropium bromide.
 Second-generation or nonsedating antihistamines appear to have no
effect on common cold symptoms. Corticosteroids may actually
increase viral replication and have no impact on cold symptoms.
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ACCP Practice Guidelines 2006
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 As a result of viral infection; kinins are released which
cause inflammation in the lining of the nose.
 The cold symptoms are believed to be a result of kinin
release not histamine so the rationale for the use of
antihistamines is generally viewed as questionable.
 Observations indicate that antihistamines may decrease
symptoms like sneezing and runny nose.
 FDA announced in 2000 that it will allow the indications of
sneezing and runny nose caused by common cold to be
part of the monographs of the first generation
antihistamines.
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First generation antihistamines are classified based on their
chemical structures into.
Alkylamines:
 Brompheniramine : 4 mg q4-6 hrs.
 Dexbrompheniramine: 6 mg q12 hrs.
 Chlorpheniramine: 4 mg q4-6 hrs.
 Pheniramine: 12.5-25 mg q4-6 hrs.
 Triprolidine: 2.5 mg q 6-8 hrs.
 Have lower incidence of drowsiness and may cause CNS
stimulation in children.
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Ethylenediamines.
 Pyrilamine: 25-50 mg q 6-8 hrs.
 Thonzylamine: 50-100 mg q 6-8 hrs.
Ethanolamines.
 Diphenhydramine: 25-50 mg q 4-6 hrs.
 Doxylamine: 7.5 mg q 4-6 hrs.
 Clemastine: 1.34 mg q 12 hrs.
 Carbinoxamine: 4-8 mg 3-4 times daily.
 The most sedative of first generation antihistamines.
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Piperidines and piperazines.
 Phenindamine: 25 mg q 4-6 hrs.
 Hydroxyzine HCL: 50-100 mg daily in divided doses.
 Side effects may include dry mouth, blurred vision,
difficulty urination, constipation, irritation, dizziness and
drowsiness.
 Ehthylenediamines have more frequent GI side effects like
nausea, stomach upset.
 Diphenhydramine has antitussive properties. It acts
centrally on the cough center in a way similar to codiene.
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Decongestants are classified as adrenergic agonists
that stimulate alpha-adrenergic receptors to
constrict blood vessels. This consequently results
in decreased mucosal edema. Pseudoephedrine
(Sudafed) and phenylephrine (Sudafed PE) are
common systematic decongestants found in OTC
preparations.
Topical decongestants such as naphazoline,
oxymetazoline,
phenylephrine,
and
xylometazoline are also available.
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Expectorants, mucloytics and antitussives
 Cough is a protective reflex to rid the host of inhaled
irritants, foreign debris and mucus.
 Common cold causes cough by stimulating the cough
receptors located within the epithelial lining of the
tracheobronchial tree.
 Cough center in the medulla coordinates the cough
response.
 Productive cough is commonly treated by increasing fluid
intake and an expectorant / mucolytic. Dry cough is
commonly treated by an anti-tussive.
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 Anti-tussives act centrally by inhibiting the cough center.
Dextromethorphan, Butamirate citrate, codeine.
 Volatile oils (Camphor, menthol) act as anti-tussives by
inhibiting peripheral sensory nerve receptors within the
respiratory tract.
 Codeine 10-20 mg q 4-6 hrs has been used, but recent
studies show no benefit in common cold. It can still be
used
as
antitussive
for
other
indications.
Dextromethorphan 30 mg q 6-8 hrs has been used in
common cold. A dose of 30 mg dextromethorphan
produces an equi-antitussive action as 20 mg of codiene.
 Camphor and menthol 4.7%-5.3% camphor and a 2.6-2.8%
menthol in petrolatum or 6.2% camphor and 3.2% menthol
in steam vaporizer.
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 Expectorants
decrease
the
viscosity
of
thickened
secretions.
 Action is best obtained by pushing fluids (8-10 glasses of
water per day).
 Their major pharmacological action is to irritate receptors
in the gastric mucosa. This promotes increased output
from secretory glands of the GI and reflexively increases
flow of fluids from glands lining the respiratory tract.
 Guaifenesin is the only expectorant approved by FDA for
OTC due to safety and efficacy considerations.
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Am Fam Physician
2007;75:515-20, 522.
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Common Cold in Children
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NON-medicated
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Dimethindene maleate

Dosage per Novartis:
Average daily dosage (in three doses spread over the day):
Drops:
Infants up to 1 year, 10-30 drops;
Infants of 1 to 3 years, 30-45 drops;
Children over 3 years, 45-60 drops;
Adults, 60-120 drops.
Syrup:
Infants up to 1 year, 1-3 teaspoons;
Infants of 1 to 3 years, 3-4 teaspoons;
Children over 3 years, 4-6 teaspoons;
Adults, 6-12 teaspoons.
Coated tablets:
Adults, 3-6 tablets.

NOT FDA APPROVED
NOT INDICATED FOR
COMMON COLD
Capsule:
Once Daily
50
Dimethindene maleate + Phenylephrine
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Guaiacol is a naturally occurring organic compound
with the formula C6H4(OH)(OCH3), Guaiacol is a
precursor to various flavorants such as eugenol and
vanillin Its derivatives are used medicinally as an
expectorant, antiseptic, and local anesthetic.
‫اسم الدواء‬
Coldex-D Syrup
‫المكونات الفعالة‬
Pseudoephedrine 30 mg
Chlorpheniramine Maleate 1.25 mg
Dextromethorphan 10 mg
guaiacol 50 mg
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Tips to the pharmacist and conclusions
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Unless otherwise contraindicated, NSAIDs should be a part of pharmacologic
management of common cold EVEN IF THE PATIENT HAS NO FEVER OR PAIN.
Naproxen is preferred in adults, ibuprofen in children less than 12 years of age.
Paracetamol is inferior to NSAIDs and should not be recommended unless NSAIDs
are contraindicated.
Centrally acting anti-tussives are superior to expectorants and mucolytics in
suppressing acute cough and should be preferred over the latter agents in case of
severe coughing regardless whether the cough is productive or not.
Decongestants: Do not use in patients less than 6 months.
PLEASE PAY ATTENTION TO THE ALCOHOLIC CONTENT IN THE
FORMULATION.
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