Colds

PMPR 3270 – Nonprescription Pharmacotherapy, Natural

Medicines, and Self-Care I

Adam C. Welch, PharmD, MBA, FAPhA

 Allergies Colds Cough

Mast Cell Counter- Anti-

INCS Antihistamine Decongestants
irritants
Anesthetics Expectorant
Stabilizer tussive

Dietary Supplements Dietary Supplements Dietary Supplements

 Learning Objectives
• Describe the risk factors and minimization
strategies for colds
• Compare and contrast nonprescription
treatment options for the common cold
• Formulate a drug therapy plan for a patient
with a cold
“Clinicians should not prescribe
antibiotics for patients with the
common cold.”

~American College of Physicians

Harris et al. Ann Intern Med. 2016;164(6):425-34.
 Common Cold
Upper Respiratory Tract Infection
• Causative agent
usually rhinovirus or
coronavirus
– Over 200 viruses can
cause colds
• Rhinovirus has >100
different serotypes
 Pathophysiology
• Rhinovirus enter into
body through nasal
mucosa or eye
– Virus travel to
posterior nasopharynx
and begins to replicate
• Incubation period up to
2 days
– Peak in 2-4 days
 Pathophysiology
• Rhinovirus transmitted through respiratory
droplets (sneeze, cough)
– Can remain clinically relevant on a dry innate
surface from 2 hours – 7 days
 Probable risk factors for a cold Unlikely to cause a cold

• Poor sleep quality • Walking outside barefoot

• Increased population density (eg, • Enlarged tonsils
classroom) • Teething
• Smoking
• Sedentary lifestyle
 Cold Symptoms
• Nasal congestion, rhinorrhea, cough, sore
throat
– Less common: malaise, mild fever, weakness
• Symptoms typically peak days 3-4
– Resolve by day 7
– Some last several weeks
Days 1-2 (clear, thin) Days 3-5 (yellow/green thick) Days 6-7 (clear, thin)
 Cold v. Flu

https://www.cdc.gov/flu/about/qa/coldflu.htm
 Prevention
Counsel a patient on how to wash their hands

https://youtu.be/eZw4Ga3jg3E
 True or False
• Warm water is more effective than cool
water for hand washing.

• Using a towel to turn off the faucet after

washing your hands has been shown to
improve health.

https://www.cdc.gov/handwashing/show-me-the-science-handwashing.html
 Treatment Goals
• Prevent transmission
• Symptom control
 Nonpharmacologic Therapy
• The unproven but often recommended
options:
– Rest
– Hydration
– Humidified air
– Chicken soup (may have anti-inflammatory
effects)
• Chest 2000; 118:1150-57
 Question
• What is the difference between a
humidifier and a vaporizer?
 Nasal Strips
• Breathe Right
• Gently pulls up on nares through a spring-
like band and increases airflow through
nose
• For ages 5 and older
• Clear strips available for sensitive skin
 Saline
• Ocean, Ayr
• Sodium chloride 0.65% made isotonic with
other additives
• Spray or drop as needed
• One bottle per person
 Nasal Aspirator
• Manually removes nasal congestion
• Ideal for infants or children under 4 yrs
who cannot blow their nose

https://fridababy.com/products/nosefrida
 Camphor, Menthol
• Camphor
– Counter-irritant with mild antitussive effects
• Menthol
– External analgesic with mild antitussive
effects
– Menthol toxicity presents as ataxia, confusion,
coma, nausea, and vomiting
 Vicks Vapo Rub
• 4.8% camphor
• 1.2% Eucalyptus oil
• 2.6% Menthol
• Ages 2 years and older
• Applied to throat and chest up to three
times daily
– Not in mouth or nostrils
Where do we see menthol?

Yes or No – do the following

products contain menthol?
 Pharmacologic Therapy
Nasal Decongestants
• Direct Acting:
– Phenylephrine
– Oxymetazoline
– Naphazoline
– Tetrahydrozoline (ophthalmic)

• Indirect acting
– Epinephrine

• Mixed
– Pseudoephedrine
 Nasal Decongestants
• Topical
– Oxymetazoline (Afrin)
– Phenylephrine (4-Way)
– Naphazoline (Privine)

• Systemic
– Pseudoephedrine (Sudafed)
– Phenylephrine (Sudafed-PE)
 Mechanism
• Constricts blood vessels by stimulation of
alpha adrenergic receptors
– Sympathomimetics
– Adrenergic agonists

Vasoconstriction → decreased blood flow → decreased congestion

 Topical Decongestants
Short Acting Intermediate Acting Long Acting
Up to 4 hours 2-6 hours Up to 12 hours
Phenylephrine Naphazoline Oxymetazoline
Tetrahydrozoline Xylometazoline
Sprays/Drops Adults ≥12 y 6-12y 2-6 y
Naphazoline 0.05 1–2 drops/sprays in Not recommended for Not recommended for children <6
each nostril not more children <12 years except years except under advice of PCP
often than every 6 hours under advice of PCP
0.025 — 1–2 drops/sprays in each Not recommended for children <6
nostril not more often than years except under advice of PCP
every 6 hours
Oxymetazoline 0.05 2–3 drops/sprays in each 2–3 drops/sprays in each Not recommended for children <6
nostril not more often than nostril not more often than years except under advice of PCP
every 10–12 hours every 10–12 hours
(maximum: 2 doses/ 24 (maximum: 2 doses/ 24
hours) hours)
0.025 — — 2–3 drops/sprays in each nostril
not more often than every 10–12
hours (maximum: 2 doses/24
hours)
Phenylephrine 1.0, 0.5 2–3 drops/sprays in Not recommended for Not recommended for children <6
each nostril not more children <12 years except years except under advice of PCP
often than every 4 hours under advice of PCP
0.25 2–3 drops/sprays in 2–3 drops/sprays in each Not recommended for children <6
each nostril not more nostril not more often than years except under advice of PCP
often than every 4 hours every 4 hours
0.125 — — 2–3 drops/sprays in each nostril
not more often than every 4 hours

APhA Handbook of Nonprescription Drugs 19th ed Table 11-4.

 Afrin - Exercise
• Compare and contrast the available Afrin
products
– Afrin.com
– dailymed.nlm.nih.gov
• Product name
• Ingredients
• Marketing claim
• Use
https://www.afrin.com/how-to-and-faq/
 Afrin Pump Mist

Shake Prime spray 2-3 times Don’t tilt head Wipe

https://www.afrin.com/how-to-and-faq/
 Oxymetazoline
• Uses (temporarily relieves)
– Nasal congestion
– Sinus congestion
– Swollen nasal membranes
• Dosing
– 6 years to Adult: 2-3 sprays in each nostril
twice daily
– Do not use for more than 3 days
 Oxymetazoline
Warnings
• Heart disease
• Diabetes
• Hypertension
• Thyroid disease
• Enlarged prostate
 Adverse Effects (Topical)
• Burning, stinging, nasal dryness
• Trauma (due to bottle tip)
• Rhinitis medicamentosa
– Seen with continuous use beyond 3-5 days
• Maybe longer in some people
 Treating Rhinitis Medicamentosa

Overall approach:
• Slowly withdraw topical decongestant one nostril at a
time
• Topical corticosteroids or systemic decongestants may
be used
• Oral steroids may be used
• Consider replacing decongestant with topical saline
• May take 2-6 weeks

Journal of Allergy and Clinical Immunology

Volume 122, Issue 2, Supplement, August 2008, Pages S1-S84
https://nasalspray.com/how-rhinostat-works/
 Dosing
Pseudoephedrine (PSE) Phenylephrine (PE)
• Adults • Adults
– Immediate release in adults:
60mg (2 tablets) every 4-6
– immediate release in adults
hours 10mg (1 tablet) every 4
• max 240mg/day hours
• max 60mg/day
• Children • Children
– 4-5 yrs 15mg every 4-6 hours – 4-5 yrs 2.5mg every 4 hours
• max 60mg/day
• max 15mg/day
– 6-11yrs 30mg every 4-6 hours
• max 120mg/day – 6-11 yrs 5mg every 4 hrs
• max 30mg/day
 Adverse Effects (Systemic)
• Hypertension
• Anxiety
• Insomnia
• Atrial fibrillation
Heart Rate

po PSE on BP
Arch Intern Med
2005;165(15):1686
Systolic
Blood
Pressure

Arch Intern Med

2005;165(15):1686
Diastolic
Blood
Pressure

Arch Intern Med

2005;165(15):1686
Pseudoephedrine effects on BP
• PSE immediate-release increased systolic
blood pressure
▪ 1.53 mm Hg (95% CI, 0.49-2.56 mm Hg)
• PSE immediate-release increased heart
rate
▪ 2.30 beats/min (95% CI, 1.42-3.19 bpm)

Arch Intern Med 2005;165(15):1686

Arch Intern Med 2005;165(15):1686
 Decongestant Precautions
• Hypertension
• Coronary heart disease
• Ischemic heart disease
• Diabetes mellitus
• Hyperthyroidism
• Ocular hypertension
• Benign prostatic hypertrophy
Decongestants and Kids
 Pseudoephedrine restrictions
• Concern for at-home conversion to
methamphetamine
 Methamphetamine manufacturing
• Multiple methods
• Pseudoephedrine or ephedrine are precursor
ingredients
– Hydriotic acid (iodine tincture)
– Red phosphorous (match sticks)
– Ammonium nitrate (fertilizer sticks, cold packs)
– lithium (AA batteries)
– Lye
– Strong acid (sulfuric or hydrochloric found in
some drain cleaners)
 2005 Combat Methamphetamine Act
• Pseudoephedrine containing products must be kept
behind a pharmacy counter
• Valid identification needed to purchase
• Document product, quantity, patient’s name and
address, time and date of sale
• Federal Limits of 3.6 g/day and 9 g/month per patient
– TN Limits 5.76 g/30 consecutive days or 28.8 g per one
year
– Contribute to NPLex (National Precursor Log Exchange
http://www.appriss.com/nplex.html )
– Tenn. Code Ann. ง 39-17-431
 Local Anesthetics
• Benzocaine (Chloraseptic, Cepacol)
• Pectin (Halls Breezers)
• Menthol (Vicks VapoDrops)
Halls
 Chloraseptic Spray
• 1.4% phenol

• Adults use 5 sprays, hold in mouth, then

spit

• Repeat every 2 hours for up to 2 days

 Dietary Supplements - Zinc
• Essential mineral found in some foods. RDA of 8-11 mg in adults

• Available in a variety of dosage forms

– Lozenge (usually about 13.3mg zinc dosed every 2-3 wakeful hours)
– Nasal spray
– Nasal gel
– Tablet/capsule

• Nasally administered zinc has had reports of anosmia (loss of smell), sometimes
permanent
• Acute zinc intake may lead to nausea, vomiting, loss of appetite, diarrhea, headaches

“Zinc acetate lozenges releasing zinc ions at doses of about 80 mg/day may be
a useful treatment for the common cold, started within 24 hours, for a time
period of less than two weeks”

~Hemila H, Chalker E. BMC Fam Pract 2015;16:24

 Vitamin C
• L-ascorbic acid used in the synthesis of collagen, some neurotransmitters, and
protein metabolism
– RDA for adults is 75mg – 90mg.
• Adverse effects
– Diarrhea, nausea, abdominal cramps

• Based on a 2013 Cochrane Review:

– 200mg/day of Vitamin C had no effect on common cold incidence in general
population
• n=11,206 RR 0.97 (95% CI 0.94-1.00)

• Regular supplementation may reduce duration of cold symptoms (and severity)

– 8% in adults (95% CI 3%-12%)
– 14% in children (7%-21%)

• Runners, skiers, soldiers it decreased incidence

– n=598 RR 0.48 (95% CI 0.35-0.64)

Cochrane Database Syst Rev, (1), CD000980 2013 Jan 31

 Echinacea
• Purple coneflower native to North America
• Caution in daisy or ragweed allergy
• Thought to boost immune system to prevent and shorten common cold

• A 2014 Cochrane Review

– Identified 24 controlled trials with 4631 participants
– Trials used different parts of the plant and had different methods (higher
heterogeneity) so conclusions were difficult.
• May see a 10-20% relative risk reduction of developing a cold

• Authors conclusions:
“Echinacea products have not here been shown to provide benefits for treating colds,
although, it is possible there is a weak benefit from some Echinacea products: the results
of individual prophylaxis trials consistently show positive (if non-significant) trends,
although potential effects are of questionable clinical relevance.”
 Echinacea
• Variety of dosage forms
• 325-650 mg po TID
• Dosed for 10-day periods

• Well tolerated, but may cause nausea,

vomiting
• Avoid in immunosuppressed patients
 Activity
Group Therapeutic Option
• Search the Cochrane 1, 2 Humidified Air
Database for 3 Vaccines
4,5 Zinc
“common cold” 6,7 Nasal decongestants alone
• Report back on results 8 Garlic
– Study size 9 Acetaminophen
10 NSAIDs
– Date
11 Corticosteroids
– Conclusions
12 Antihistamines
13 Vitamin C
14 Echinacea
15,16 Antihistamine + Decongestant
 ACP Recommendations:
Common Cold
• Patients should be educated that
symptoms can last up to 2 weeks
• Antibiotics should not be prescribed
• 1 out of 4 patients treated with combo
antihistamine, analgesic, decongestant
has significant relief
• Zinc may be effective within 24 hours of
symptom onset
 Exclusions for Self-Treatment
• Fever > 100.4oF
• Chest pain
• Shortness of breath
• Certain chronic medical conditions
– AIDS (chronic immunosuppression)
– Heart failure
– Asthma
– COPD
• Less than 3 months old
• Frail patients of advanced age
 Pregnancy Resources
• Websites & electronic resources:
– www.motherisk.org
– https://mothertobaby.org
– www.infantrisk.com
• Mommymeds app for Mothers
• InfantRisk Center for Health Care Providers
– LactMed: https://www.ncbi.nlm.nih.gov/books/NBK501922/?report=classic
– LexiComp© Pregnancy & Lactation database
– Micromedex® Pregnancy and Lactation sections
• Reference books:
– Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and
lactation. 11th ed, 2017.
– Hale TW. Medications and Mother’s Milk. 17th ed, 2017.

Source: Dr. Larissa Bossaer

Cases
 Case A
• A mother asks for a recommendation for her
8 month old child.
– Child is on a combination of table food and breast
milk
• Symptoms include runny nose, congestion,
and difficulty feeding.
• The child does not have a fever.

• What recommendation would you make to

the mother?
 Case B
• A 52 year old male with hypertension is
asking for a recommendation for a cold.

• What questions would you ask the

patient?
• What recommendation would you have for
the patient?
 References
• Herrier R, Apgar D, Boyce R, Foster S. Chapter 7, Symptoms related to the ears, nose, and throat. In: Patient Assessment in Pharmacy
2015; McGraw-Hill.
• Centers for Disease Control and Prevention. Common colds: protect yourself and others. 2016 https://www.cdc.gov/features/rhinoviruses/
• Centers for Disease Control and Prevention. Show me the science – how to wash your hands. 2017.
https://www.cdc.gov/handwashing/show-me-the-science-handwashing.html
• Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC
Infectious Diseases 2006;6(130).
• Scolaro KL. Colds and allergy. Ch 11. In Krisky et al. Handbook of nonprescription drugs, 19th ed. 2017; American Pharmacists
Association.
• Barnes PJ. Pulmonary Pharmacology. Ch 40. In Goodman and Gilman’s: The Pharmacologic Basis of Therapeutics, 13th ed, 2017.
• Deckx L, De Sutter AIM, Guo L, Mir NA, van Driel ML. Nasal decongestants in monotherapy for the common cold. Cochrane Database of
Systematic Reviews 2016, Issue 10. Art. No.: CD009612. DOI: 10.1002/14651858.CD009612.pub2.
• Salerno SM, Jackson JL, Berbano EP. Effect of oral pseudoephedrine on blood pressure and heart rate – A meta analysis. Arch Intern
Med. 2005;165(15):1686-94.
• Hemila H, Chalker E. The effectiveness of high dose zince acetate lozenges on vaiorus common cold symptoms: a meta-analysis. BMC
Fam Pract. 2015l16(24).
• Hemilä H, Chalker E. Vitamin C for preventing and treating the common cold. Cochrane Database of Systematic Reviews 2013, Issue 1.
Art. No.: CD000980. DOI: 10.1002/14651858.CD000980.pub4
• Karsch-Völk M, Barrett B, Kiefer D, Bauer R, Ardjomand-Woelkart K, Linde K. Echinacea for preventing and treating the common cold.
Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD000530. DOI: 10.1002/14651858.CD000530.pub3.
• Harris AM, Hicks LA, Qaseem A, Appropriate antibiotic use for acute respiratory tract infection in adults: Advice for high-value care from
the American College of Physicians and the Centers for Disease Control. Ann Intern Med. 2016;164(6):425-434