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Management of Influenza Symptoms Using Over-the-Counter Products

Introduction

Influenza is a commonly occurring viral respiratory disease that can be mild to severe in nature, and can cause a wide range of symptoms such as fever, muscle pain, fatigue, sore throat, cough, and nasal congestion or rhinorrhea.1 The best way to avoid contracting influenza is through annual flu vaccination. People who do get influenza may seek treatment for their symptoms. Influenza is generally self-limiting and those with uncomplicated seasonal influenza who are not considered to be at high risk for complications may be managed with over-the-counter (OTC) therapies. These include analgesics to manage pain and fever, antihistamines or decongestants to relieve nasal rhinorrhea or congestion, expectorants, and cough suppressants.2 Pharmacists play a key role in influenza prevention by providing immunization services. Pharmacists are also an important resource for patients to evaluate whether self-care is appropriate and to help select appropriate OTC medications to treat their flu symptoms.

Influenza

Influenza is a viral respiratory disease that can be mild to severe and can lead to hospitalization and sometimes even death. In the 2018-2019 influenza season, approximately 35.5 million symptomatic cases of influenza, 16.5 million office visits, 490,500 hospitalizations, and 34,157 deaths related to influenza were reported to have occurred in the United States.3 Symptomatic influenza affects 8% of Americans on average each year, with a range of 3% to 11% according to a 2018 Centers for Disease Control and Prevention (CDC) analysis.1 Since 2010, the CDC estimates there have been between 9 and 45 million cases of flu with up to 810,000 hospitalizations and between 12,000 and 61,000 deaths annually.3

Flu is caused by the influenza virus, which is an RNA virus classified as type A, B, or C based on antigen presentation.4 Types A and B cause seasonal influenza affecting humans, with type A having the most severe impact. Influenza type C infections generally cause mild illness and are not thought to cause human flu epidemics. Influenza type A is subtyped, based upon two surface protein antigens: hemagglutinin (HA) and neuraminidase (NA). HA allows the virus into the cell, while NA helps with cell-to-cell transmission of the virus.5 Humans create antibodies to these antigens when infected, producing an immune response.4 H1N1 and H3N2 are the two types of influenza A viruses circulating in humans, with the latter being more serious. Influenza is named according to the type, the location of initial isolation, the strain designation, and the year of isolation. For example, A/Texas/50/2012 (H3N2), or H3N2, is influenza type A with origin in Texas, with strain No. 50, isolated in 2012 and of the H3N2 subtype.4

Influenza viruses continually change in response to human antibody production through antigenic drift and antigenic shift. Antigenic drift is an ongoing process in influenza A and B viruses when mutations occur within HA or NA genes, and is responsible for yearly flu epidemics. This is why seasonal influenza vaccines have to be changed annually. Antigenic shift occurs in influenza A; it is uncommon, unpredictable, and responsible for new virulent virus strains associated with worldwide pandemics.4

Symptoms and Diagnosis

Influenza infections commonly appear in October or November and generally last through March or April, often peaking between December and February.6 Flu signs and symptoms usually come on suddenly and may include:7

  • Fever (not a requirement for diagnosis)
  • Chills
  • Muscle or body ache
  • Fatigue
  • Cough
  • Sore throat
  • Runny or stuffy nose
  • Headaches
  • Vomiting and diarrhea may occur, though this is more common in children than adults.

The influenza virus is spread via respiratory secretions from a cough or sneeze that can be suspended in air or deposited on the ground or surfaces and infectious for multiple hours. The incubation period varies person to person but ranges from 1 to 4 days. About 50% of infected people will experience symptoms after the incubation period.8 Symptoms generally resolve in 2 to 5 days, although they can last a few weeks. Moderate and more severe complications from influenza may include sinus and ear infections and pneumonia. Other serious complications can include myocarditis, encephalitis, myositis, rhabdomyolysis, and multi-organ failure.7 Influenza impact can range in severity from season to season because of the circulating virus, flu season timing, vaccine effectiveness, and vaccination rates.

Diagnosing influenza on the basis of clinical criteria may be difficult because of the overlapping symptoms caused by the other upper respiratory tract infection viral infections, including colds. Risk factors to consider include travel to areas with known outbreaks and unusual comorbidities.9 Rapid diagnostic tests for influenza are available. There are currently 7 on the market that directly detect influenza A or B antigens in throat, nasal or nasal washes with results within 30 minutes. The United States Food and Drug Administration (FDA) has waived Clinical Laboratory Improvement Act (CLIA) requirements for these tests and they are becoming more widely accessible in pharmacies, along with many other point-of-care tests.9

Anyone can get sick from influenza, but a number of populations are at greater risk for serious complications from the flu, including children under 2, adults age 65 and over, pregnant women and those up to 2 weeks postpartum, those aged 18 or younger taking aspirin or salicylates due to the risk of Reye’s syndrome, those with a body mass index greater than 40 kg/m2, people with chronic lung diseases such as asthma and chronic obstructive pulmonary disease (COPD), diabetes, heart disease, kidney or liver disease, neurologic conditions, human immunodeficiency virus, cancer, and certain other long-term health conditions, those residing in long-term care or assisted living facilities, and American Indians and Alaska Natives.10 These are populations for whom it is very important for the community pharmacist to recommend and provide influenza vaccination.

Prevention

Prevention of influenza includes annual vaccination, which is recommended for all individuals over the age of 6 months.11 The Advisory Committee on Influenza Practices (ACIP) does not recommend one vaccine over another when more than one type is available for all patients but pharmacists should ensure patients receive age-appropriate vaccines. Vaccination reduces illness, clinic and doctor visits, and hospitalizations and can result in milder cases of illness if the patient still becomes ill after receiving vaccination.

A number of other actions can prevent the spread of infection, according to a published comprehensive literature review.12 These include:

  • Healthy habits;
  • Hand hygiene;
  • Masks;
  • Ventilation/high-efficiency particulate air, or HEPA, filtration;
  • Exhaust fans;
  • UV light; and
  • Humidity/temperature control.

These actions are thought to work by limiting virus transmission in a number of ways, including physical (eg, filtration and dilution) and biological (eg, humidity, disinfectants and ultraviolet UV light) decay of the virus particles that may be emitted when an infected person coughs, sneezes, talks, or breathes.12 Infection may spread through direct contact, indirect contact, and/or airborne spread. Viruses that cause colds and other infections can live up to 3 to 4 hours on contaminated skin or surfaces, while the influenza virus may survive up to 48 hours.12

Practicing healthy habits and good hygiene can help prevent the spread of infection. While the most common way of contracting the flu is by inhaling droplets in the air from infected persons, it can also be contracted less often by touching one's mucous membranes with contaminated hands from surfaces. Avoiding this and using proper hand-washing techniques and disinfecting surfaces can help prevent infection. While hand sanitizers often are used to help prevent the spread of infection, the CDC continues to recommend hand washing with soap and water as the preferred method to reduce microbes based on a review of the science behind sanitizers.13 Sanitizers contain a variety of ingredients, but alcohol is the primary active antimicrobial ingredient. The CDC recommends using sanitizers with an alcohol content of 60% or more if hand washing with soap and water is not practical.13 Evidence suggests a period of 20 seconds of washing/sanitizing is suitable for removal.12 Use of a mask may provide protection against the spread of infection by reducing the touching of mucous membranes or by helping block aerosol transmission of virus from an infected person.   

Studies have correlated higher infection rates and poorly ventilated air.12 Airborne virus concentration is reduced with the use of filters or fresh air entering rooms. High-efficiency particulate air (HEPA) filters can be used in home heating and air-conditioning systems and can remove nearly 98% of particles that are very small (≥ 0.3 μm). Portable air purifiers also can be used and may be purchased with UV lights, which also disinfect inside rooms. Creating negative pressure by using exhaust fans also is effective in reducing particles. Bathrooms can pose a special risk to infection spread, and it is recommended that bathroom windows be left partly open with the exhaust fan on. In homes with more than one bathroom, the pharmacist should counsel patients that infected individuals should use a dedicated single bathroom to help prevent the spread of infection.12

Mounting evidence shows that humidity levels can impact the level of airborne influenza virus.14,15 A recent model showed the concentration of airborne influenza A virus from a cough would be reduced by 10% by increasing relative humidity from 35% to 50% 10 minutes following the cough, and by 40% after one hour.14 Another review of the literature found supporting evidence that low absolute humidity is a key causal factor in winter-time influenza peaks in temperate climates.15 A humidity level of 40% to 60% is recommended to minimize the survival of viruses in the air and on surfaces.12,16

See Table 1 for strategies to discuss with patients and caregivers.17 Guidelines for home hygiene also have been developed by the International Scientific Forum on Home Hygiene.18 The pharmacist may download the guidelines, which include broader hygiene practices and guidelines and use them when appropriate (https://www.ifh-homehygiene.org/sites/default/files/publications/IFH-Guidelines-complete.pdf). The guidelines contain broader hygiene practices and guidance that pharmacists can use when appropriate.

Table 1. Healthy Habits and Hygiene Practices.11-12,16
Habits Assessment Questions
A balanced diet Tell me what you eat in a typical day.
Achievement of adequate sleep How much sleep do you usually get? Do you feel it is what you need?
Stress management How is the stress level you are experiencing lately?
Moderate physical activity How often do you engage in activity? What kind of activity do you enjoy?
Smoking cessation or a reduction of frequency; avoidance of second-hand smoke Tell me about your tobacco use.
Adequate relative home humidity maintenance (40-60%) What is the humidity level in your home?
HEPA (High Efficiency Particulate Air) filter use in furnace systems and the use of exhaust or ceiling fans to create circulation, negative pressure What kind of furnace filters do you use? How do you use the home’s furnace or air conditioner? What type of fans do you use?
Hygiene Assessment Questions
Avoid contact with infected people How can you limit your contact with people who have colds or the flu?
Practice good handwashing habits and techniques What do you know about how colds and flu viruses spread?
Use hand sanitizers if soap and water is not available for handwashing What are your thoughts about hand sanitizers?
Avoid touching the face with hands and potentially contaminated surfaces; consider mask use How can you avoid touching contaminated surfaces?
Disinfect surfaces What type of products do you use to help keep surfaces free from germs at home and at work?
Have infected individuals use only 1 bathroom in homes with multiple bathrooms How many bathrooms do you have at home? (In case a family member gets a cold or the flu, is there another bathroom they can use to help avoid others getting sick?)

Managing Influenza Symptoms

Influenza treatment goals include managing symptoms to improve patient comfort, reducing morbidity and mortality, decreasing absenteeism, and preventing the spread of infection.8 Prescription antiviral medications with influenza virus activity may be useful adjuncts in influenza prevention and treatment and are most effective when administered within 48 hours of symptom onset. They are considered a second line of defense after vaccination.19 There are 6 FDA-approved antiviral medications: amantadine, rimantadine, oseltamivir (Tamiflu®), zanamivir (Relenza®), peramivir (Rapivab®), and baloxavir marboxil (Xofluza®).20 The first 2 are adamantanes, the second 3 are neuraminidase inhibitors, and baloxavir, the newest agent, is a cap-dependent endonuclease inhibitor that interferes with viral RNA transcription and blocks virus replication. The neuraminidase inhibitors reduce the release of virus from infected cells, viral aggregation, and spreading within the respiratory tract.21 Peramivir is an intravenous infusion and not commonly seen in the community pharmacy setting.

The CDC recommends use of oseltamivir, zanamivir, or baloxavir in people at high risk for developing complications,22 including:

  • People with severe illness who have been hospitalized;
  • People younger than 19 years of age who are receiving long-term aspirin therapy; and
  • People with suspected or confirmed influenza who are at higher risk for complications, such as:
    • Children younger than 2 years of age;
    • Adults ages 65 years and older;
    • Pregnant women; and
    • People with certain chronic medical and immunosuppressive conditions.

Antiviral medication may shorten the duration of flu by less than one day.23 Dosage and side-effect information for 2019-2020 influenza season antiviral medications used in the community setting is in Table 2. Antiviral agents carry a C pregnancy rating, and there are limited data on their safe use in pregnancy. For elderly patients, oseltamivir dosage should be adjusted based on renal function. Zanamivir may be used in children ages 7 years and older. Oseltamivir is indicated for children ages 1 year and older. Baloxavir may be used in adolescents and adults age 12 and over.

Table 2. Influenza Antiviral Therapy.
Agent Dosage Form Dosing Dosage Guidelines Common Adverse Effects Drug Interactions / Cautions
Prophylaxis Treatment
Oseltamivir (Tamiflu®) Neuraminidase inhibitor Oral capsules: 30 mg, 45 mg, 75 mg Oral suspension: 6 mg/mL Infants ≥ 2 wk N/A 3 mg/kg/dose twice daily Vomiting, nausea, abdominal pain, diarrhea
  • Do not administer 48 h prior to and for 2 wk after receipt of Live attenuated influenza vaccine (LAIV)
  • Probenecid may increase serum concentrations of active metabolite(s)
  • Reduce dose in patients with renal impairment
Children 1-12 y:
≤ 15 kg

> 15 kg to ≤ 23 kg

> 23 kg to ≤ 40 kg

> 40 kg		 30 mg once daily*

45 mg once daily*

60 mg once daily*

75 mg once daily*		 30 mg twice daily†

45 mg twice daily†

60 mg twice daily†

75 mg twice daily†
Adolescents and adults ages 13 y and older 75 mg once daily* 75 mg twice daily†
Zanamivir (Relenza®)
Neuraminidase inhibitor		 Oral inhalation:
Aerosol powder breath-activated Diskhaler®
5 mg/blister		 Children ages 5 y older and adults 2 inhalations (10 mg) once daily‡ N/A Headache, throat/tonsil discomfort/pain, nasal signs and symptoms, cough, viral infection
  • Do not administer 48 h prior to and for 2 wk after receipt of LAIV
  • Powder contains lactose; avoid use in patients allergic to milk proteins
  • Safety and efficacy have not been established with severe hepatic or renal impairment
Children ages 7 y and older and adults N/A 2 inhalations (10 mg) twice daily±
Baloxivir Marboxil
(Xofluza®)
Cap-dependent endonuclease inhibitor 		 Oral tablets: 20 mg, 40 mg Adolescents and adults 12 y and older N/A 40 kg to < 80 kg*

(2) 20 mg as single dose

≥ 80 kg
(2) 40 mg as single dose		 Diarrhea, bronchitis, nausea, sinusitis, headache
  • Do not take with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements
  • Had not been studied with LAIV
  • Safety and efficacy have not been established with severe hepatic or renal impairment
* Initiate therapy within 48 hours of contact with infected individual. Ten days of treatment is recommended in households, while up to 6 weeks is recommended for community outbreaks.
† Initiate within 48 hours of symptom onset. Dose twice daily for 5 days.
‡ Initiate therapy within 36 hours following onset of signs/symptoms of infected individual. Ten days of treatment is recommended in households, while 28 days is recommended for community outbreaks (start within 5 days of outbreak).
± Initiate therapy within 2 days of sign/symptom onset. Dose twice daily for 5 days. Longer treatment may be considered for patients who remain severely ill after 5 days.
Reference: www.fda.gov.

There are limitations to antiviral therapy. Resistance is a cause for concern, and the CDC tracks the issue. For the 2019-2020 influenza season, data indicate that the vast majority of currently circulating influenza virus strains were sensitive to these medications, based upon viral surveillance and resistance data from the influenza season summary.24 Antiviral therapy is more effective when started within 48 hours of developing symptoms. Additionally, cost can be a barrier.

 A 2013 Cochrane review of neuraminidase inhibitors for influenza treatment demonstrated the modest benefit of therapy but authors concluded that “the combination of diagnostic uncertainty, the risk for virus strain resistance, possible side effects, and financial cost outweigh the small benefits of oseltamivir or zanamivir for the prophylaxis and treatment of healthy individuals.”25 Self-treatment with OTC medications may be most appropriate for those with self-limiting or mild-to-moderate influenza.

Nonpharmacologic Management of Influenza

Nonpharmacologic treatment includes adequate rest and nutrition, hydration, and humidification. Saline drops and nasal sprays also can relieve congestion by loosening encrusted mucus and drawing fluid from the nasal passages, acting as decongestants. Because it has minimal side effects, saline can be used in children. They do not cause rebound congestion like decongestant nasal sprays. The recommended dosage for saline drops is 1 to 2 drops into each nostril 15 to 20 minutes before feeding and bedtime, with a repeated dose 10 minutes later. For sprays, it is 2 sprays in each nostril as needed. Use of saline nasal sprays or drops should be followed by aspiration with a nasal bulb syringe to clear the nasal passageways. The bulb should be squeezed while gently putting the tip into the nostril and slowly releasing the pressure to draw out the fluid. The bulb should be disassembled and thoroughly cleaned with warm, soapy water after each use.2 A nasal aspirator also may be used.

Nasal rinses and nasal pots (eg, neti pots) also may be used to relieve nasal symptoms associated with flu. However, they need to be used carefully to avoid bacterial contamination, and the pharmacist should counsel patients to use distilled water with the device. Tap water may be boiled for at least 1 minute and used when cool, but this carries a risk of injury if the water is not cooled enough.26 While the procedure for nasal rinsing may vary by device, generally the pharmacist may counsel use as follows:

  • Leaning over a sink, the patient should tilt his or her head sideways with the forehead and chin roughly level to avoid liquid flowing into the mouth.
  • Breathing through the open mouth, the patient should insert the spout of the saline-filled container into the upper nostril so that the liquid drains through the lower nostril.
  • The patient should clear the nostrils and repeat the procedure on the other side.

Nasal strips also can be used in adults, and pediatric nasal strips can be used in children ages 5 years and older. The strips consist of an adhesive-backed plastic band with a liner that is removed. The strip is centered between the bridge and the tip of the nose, just above the flare of each nostril. Placement is important for the FDA-approved device to work properly; gentle pressure should be exerted on the nostril, opening it and providing relief of nasal congestion. Strips may be used up to 12 hours per day and are single-use. Patients allergic to latex should not use them.27

Humidification

Humidifiers may be used to increase the amount of moisture in inspired air. Increasing air humidity may clear secretions and soothe irritated airways. However, care should be taken not to over-humidify air, which may increase mold and dust mite activity, making allergies worse. A humidity level of 40% to 60% is recommended to minimize the survival of airborne viruses and bacteria in the air and on surfaces, yet remain nonoptimal for mold and mites.12,14-16 This humidity level has been shown in laboratory studies to reduce the survival rate of infectious influenza A viruses. No field studies have been reported.12 There are different types of humidifiers and vaporizers, both cool- and warm-mist. Vaporizers are humidifiers that have a cup to place medicated liquids that create medicated vapor.28 Regardless of type, humidifiers should be cleaned each day and disinfected weekly. Some parents and caregivers prefer cool-mist humidifiers and vaporizers because there is less risk of injury if they are tipped over. The majority of cool-mist devices use distilled water, although some brands now are made that are designed for use with regular water. Water should be changed daily.

Cool moisture29

Evaporative humidifiers use a wick system to draw water from a reservoir while a fan blowing over the wick releases water into the air. Because they use cool mist, wicks may come treated with antibacterial agents, or water may have antibacterial additives or use UV technology to inhibit bacterial growth. Impeller humidifiers use a rotating disc to fling water at a comb-like diffuser. The diffuser breaks the water into fine droplets that float into the air. Ultrasonic humidifiers use a metal diaphragm vibrating at an ultrasonic frequency to create water droplets. These humidifiers usually are silent.

Warm moisture

Steam vaporizers boil water and release the warm steam into the room.30 This is the most simple and least expensive technology for humidification. However, their use with children is not recommended because of the risk of injury should the unit be tipped. Medicated inhalants may be used with the unit to help reduce coughs. Steam inhalers release the warm steam for personal cough-cold relief. The amount and temperature of the steam is controlled by the amount of cool air that mixes with the steam. There are two versions: one that heats the water electrically and can be used with medicated inhalant pads, and one that requires adding hot water and can be used with liquid medicated inhalant. Warm-mist humidifiers boil water in a small cup using an electrical heater element. This type of heater produces steam that usually is mixed with air in a cooling tower. Medicated inhalants may be used with the unit to help reduce coughs.

Some humidifiers use a germ-free process that uses a patented ultraviolet light technology to kill up to 99.999% of bacteria, mold, and fungi in the unit’s water. The technology is available in both cool- and warm-moisture units. When using medicated inhalants—usually made with FDA-approved menthol or camphor—refer to product-specific directions on use. Use of these products is not recommended in children younger than 2 years of age. Commonly used inhalant examples are Vicks® VapoSteam® and Kaz® inhalant liquid, which contain camphor as a cough suppressant, along with other essential oils. Commonly used inhalant pads include Vicks® VapoPads® refills and Kaz® Aromatic Inhalant Pads. Other products may contain only aromatic oils, such as lavender and rosemary. In addition, inhalant pads have been developed for use with plug-in vaporizer nightlights (eg, Vicks Soothing Vapors Plug-In Waterless Vaporizer and Nightlight). The pharmacist may help patients and caregivers find an appropriate humidification device and discuss proper use and device care.29

OTC Agents for Symptomatic Treatment

OTC agents can address the most common flu symptoms, including antipyretics and analgesics for fever, muscle or body ache, and headaches, decongestants and antihistamines for stuffy and runny nose, and cough suppressants and expectorants for cough and congestion. There are a number of combination products that contain medication to treat multiple symptoms.

Analgesics/Antipyretics

Pain and fever associated with influenza may be treated with analgesics and antipyretics. These include aspirin, acetaminophen, ibuprofen, and naproxen. The pharmacist should advise patients to read the drug facts label carefully to be sure they understand the product’s strength and if it contains any other ingredients. The pharmacist should ask the patient if they are taking any other medications to ensure maximum dosages of pain relievers are not being exceeded due to combination or duplicate therapy. Acetaminophen and ibuprofen are the preferred analgesics for children. Liquid OTC acetaminophen formulations for infants and children have been standardized to contain 160 mg/5 mL. Ensure that the caregiver is using new infant liquid 160 mg/5 mL before providing this dosing. Old infant drops (80 mg/0.8 mL dropper) can be used until the expiration date; however, remind caregivers they are 3 times as concentrated and should be dosed accordingly. The pharmacist should caution parents and caregivers about appropriate dosage while reviewing the dose and dosage device with them. The recommended dose remains 10 to 15 mg/kg/dose for acetaminophen. Ibuprofen is restricted to children ages 6 months and older. Aspirin should not be used in a child younger than 18 years with a fever, due to the risk of Reye's syndrome. The commonly used analgesics for adults are in Table 3.

Liver toxicity with acetaminophen may occur and is a serious, dose-dependent effect. The maximum recommended dosage is 75 mg/kg/day (adults not to exceed 4 g/d), and products carry warnings about exceeding this dose. Signs associated with acetaminophen toxicity can mimic influenza symptoms and may include nausea, vomiting, diarrhea, and excessive sweating. This may lead parents and caregivers to administer more medication to the child. Care should be taken not to exceed this threshold by administering higher doses more frequently than recommended. In 2011 and 2012, the manufacturer of brand-name Tylenol® products voluntarily reduced the maximum daily dosage to 3000 mg (6 tablets), with the dosing interval changed from 2 tablets every 4 to 6 hours to 2 tablets every 6 hours; the maximum daily dosage for Regular Strength Tylenol has been reduced to 3250 mg.30,31 However, generic manufacturers may still have a maximum dose of 4000 mg on the product label. Allergic reactions can occur and the pharmacist should counsel the patient to discontinue the medication if they experience skin reddening, blisters, or rash.26

The most common side effects with the nonsteroidal anti-inflammatory drugs (NSAIDs) are gastrointestinal (GI)-related and include heartburn, nausea, anorexia, and dyspepsia. These can occur among children using pediatric formulations. Pharmacists should counsel patients to take NSAIDs with food, milk, or antacids to minimize potential GI side effects and to take with a full glass of liquid. Suspension formulations should be shaken thoroughly, and enteric-coated or sustained-release preparations should not be crushed or chewed.

In 2015, the FDA strengthened warnings regarding the risk for heart attack and stroke for prescription and OTC nonaspirin NSAIDs, including ibuprofen and naproxen.32 Pharmacists should counsel patients to watch for symptoms that may suggest heart attack and stroke, including chest pain, trouble breathing, weakness in one part or side of the body, or slurred speech. The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID and clinical evidence shows it extends indefinitely. The risk may increase with longer use of the NSAID and at higher doses. The American Heart Association recommends that patients with cardiovascular disease or those at high risk for cardiac events avoid NSAIDs and should be used with caution in patients with moderate risk.26

A new combination OTC analgesic with 500 mg acetaminophen and 250 mg ibuprofen was approved by the FDA in February 2020.33 Seven clinical studies were the basis of the FDA approval of the combination. Three were pivotal efficacy studies in pain relief. The study results support a pain relief indication and showed superior efficacy than either drug alone. The new product is called Advil® Dual Action.28 The product is expected to become available in 2020.

Finally, adult product formulations should be avoided in children. Tables 3 and 4 outline recommended dosages of OTC analgesics for adults and children.

Table 3. Recommended Adult Dosages of Nonprescription Analgesics.
Agent Usual Adult Dosage (Maximum Daily Dosage)
Acetaminophen*  325-650 mg every 4-6 h or 1000 mg every 6 h (3000 mg for extra-strength; 3250 mg for regular strength; 3900 mg for arthritis) 
Ibuprofen  200-400 mg every 4-6 h (1200 mg) 
Naproxen sodium  220 mg every 8-12 h (660 mg) 
Aspirin  325-1000 mg every 4–6 h (4000 mg) 
* The maximum daily dosage of these products sold in the United States was voluntarily reduced by the manufacturer in mid-2011. Extra Strength Tylenol now carries a 3000 mg (6 tablets) maximum daily dosage, with a 6-hour dosing interval.  Some generic acetaminophen products maximum daily dosage warnings of 4000 mg/d.
Table 4. Pediatric Dosing of Acetaminophen and Ibuprofen.
Acetaminophen: dose may be repeated every 4 hours, not to exceed 5 doses in 24 hours.
Age Weight (lbs) Infant Liquid**
160 mg/5 mL 		Children’s Suspension
160 mg/5 mL		 Children’s Chewable Tablets
160 mg each		 Children’s Dissolve Packs
160 mg each powder pack
0-3 mo* 6-11 Dose: 40 mg
1.25 mL in syringe		      
4-11 mo* 12-17 Dose: 80 mg
2.5 mL in syringe		 2.5 mL    
12-23 mo* 18-23 Dose: 120 mg
3.75 mL in syringe		 3.75 mL    
2-3 y 24-35 Dose: 160 mg
5 mL in syringe		 5 mL 1 tablet *
4-5 y 36-47 240 mg 7.5 mL 1½ tablets *
6-8 y 48-59 320 mg 10 mL 2 tablets 2 packets
9-10 y 60-71 400 mg 12.5 mL 2½ tablets 2 packets
11 y 72-95 480 mg 15 mL 3 tablets 3 packets
* The FDA does not allow manufacturers to provide dosage recommendations for children under age 2 on the bottles or packaging
** Ensure that caregiver is using new infant liquid 160 mg/5 mL before providing this dosing. Old infant drops (80 mg/0.8 mL dropper) can be used until expiration date; however, remind caregivers they are 3 times as concentrated and should be dosed accordingly.
Ibuprofen: dose may be repeated every 6 to 8 hours, not to exceed 4 doses per day.
Age Weight (lbs) Infant Drops
40 mg/mL		 Children’s Suspension
100 mg/5 mL		 Children’s Chewable
100 mg each
0-5 mo   Not recommended    
6-11 mo* 12-17 1.25 mL 2.5 mL  
12-23 mo* 18-23 1.875 mL 3.75 mL  
2-3 y 24-35   5 mL 1 tablet
4-5 y 36-47   7.5 mL 1½ tablets
6-8 y 48-59   10 mL 2 tablets
9-10 y 60-71   12.5 mL 2½ tablets
11 y 72-95   15 mL 3 tablets
Source: Manufacturer’s product labeling and drugs@fda.gov.

Decongestants/Antihistamines

For nasal congestion or rhinitis, use of topical or systemic decongestants and antihistamines may be considered. See Table 5 for dosage guidelines for decongestants and antihistamines. New formulations of pseudoephedrine are now available that include methamphetamine-deterring technology. The technology disrupts the extraction and conversion of the product to methamphetamine but does not adversely impact the product’s decongestant properties.

Decongestants may worsen such chronic conditions as hypertension, hyperthyroidism, diabetes, heart disease, glaucoma, and benign prostatic hyperplasia. The pharmacist must assess patients and make recommendations accordingly. Current evidence suggests that antihistamine-analgesic-decongestant combinations have some general benefit in adults and older children. As noted, these benefits must be weighed against the risk of adverse effects.34

  Table 5. OTC Decongestants and Antihistamines.2  
  Medication/
Commonly Available Strengths		 Adults/Children  ≥ 12 y

Children  6­-12 y

Children 4-6 y

 Common Side Effects Drug Interactions  
  Oral decongestants  
  Pseudoephedrine

 
Syrup: 15 mg/5 mL, 30 mg/5 mL
Tabs: 30 mg
Extended-release tabs: 120 mg, 240 mg		 60 mg every 4-6 h (240 mg maximum) 30 mg every 4-6 h
(120 mg maximum) 		15 mg every 4-6 h
(60 mg maximum) 		Cardiovascular and CNS stimulation MAO inhibitors, methyldopa, and tricyclic antidepressants  
  Phenylephrine

Liquid: 2.5 mg/5 mL, 2.5 mg/1 mL (in combination)
Tabs: 10 mg 		Adults 10-20 mg every 4 h
(60 mg maximum) ≤ 7 d Children 12-17 y: 10 mg every 4 h 		5 mg every 4 h (30 mg maximum)
≤ 7 d  		2.5 mg every 4 h (15 mg maximum) ≤ 7 d Cardiovascular and CNS stimulation MAO inhibitors, methyldopa, and tricyclic antidepressants  
  Topical decongestants     Children 2-6 y      
  Oxymetazoline 0.05% nasal spray/drops 
(eg, Afrin®, Mucinex®, and Vicks® Sinex® Zicam®) 		2-3 sprays twice daily 2-3 sprays twice daily Avoid in this age group. CNS stimulation and rebound congestion when used longer than 3 days MAO inhibitors and tricyclic antidepressants  
  Phenylephrine nasal spray/drops (eg, Little Noses®) 0.25-1% solution; 2-3 sprays no more than every 4 h for not more than 3 d 0.25% solution; 2-3 sprays no more than every 4 h for not more than 3 d 0.125% solution
2-3 drops; not more than every 4 h 		Burning, itching, sneezing, dryness, local irritation rebound congestion when used longer than 3 d    
  Saline nasal spray
Sodium chloride 0.65% (eg, Ayr®, Simply Saline and Ocean® Premium Saline Nasal Spray)		 2 sprays as needed 2 sprays as needed 2 sprays as needed      
  Nasal Decongestant Inhalers     Children 2-6 y      
  Propylhexedrine 250 mg (Benzedrex®) 2 inhalations; not more than every 2 h. Do not use for longer than  3 d. 2 inhalations; no more than every 2 h. Do not use for longer than    3 d. Avoid in this age group. Burning and stinging in nose MAO inhibitors and tricyclic antidepressants  
  Levmetamfetamine 50 mg/inhaler (Vicks® Vapor Inhaler) 2 inhalations; not more than every 2 h. Do not use for longer than  7 d. 1 inhalation; not more than every 2 h. Do not use for longer than    7 d. Avoid in this age group. Burning and stinging in nose; sneezing Avoid use with other nasal decongestants.  
  Oral antihistamines     Children 2-6 y      
  First-generation            
  Brompheniramine
11 mg extended release
12 mg/5 mL suspension
1 mg/1 mL liquid
2 mg/5 mL liquid		 4 mg every 4-6 h (24 mg maximum) 2 mg every 4-6 h (12 mg maximum) 1 mg every 4-6 h Drowsiness, dry mouth, nervousness, and dizziness CNS depressants (eg, alcohol and sedatives)  
  Chlorpheniramine
4 mg, 8 mg, 12 mg tablets
2 mg/5 mL liquid		 4 mg every 4-6 h (24 mg maximum) 2 mg every  4-6 h
(12 mg maximum)		 1 mg every   4-6 h
(6 mg maximum) 		Drowsiness, dry mouth, nervousness, and dizziness CNS depressants (eg, alcohol and sedatives), phenytoin  
  Doxylamine succinate 25 mg tablet 25 mg 30 min prior to bed once daily Avoid in this age group. Avoid in this age group. Drowsiness, dry mouth, nervousness, and dizziness CNS depressants (eg, alcohol and sedatives)  
  Diphenhydramine HCl
25 mg, 50 mg tablet/capsule
12/5 mg/5 mL liquid		 25-50 mg every 6-8 h (300 mg maximum) 12.5-25 mg every 4-6 h 
(150 mg maximum) 		Avoid in this age group. Drowsiness, dry mouth, nervousness, and dizziness CNS depressants (eg, alcohol and sedatives)  
  Second-generation     Children 6 mo to 6 y      
  Cetirizine (Zyrtec®)
5 mg, 10 mg tablet, and chewable tablet
10 mg oral disintegrating tablet
5 mg/5 mL liquid		 10 mg every 24 h 10 mg every 24 h 6-12 mo: 2.5 mg every 24 h
12 mo to younger than 2 y: 2.5 mg every 24 h, may increase to 2.5 mg every
12 h for perennial allergic rhinitis
2-6 y: 2.5 mg every 24 h, may increase to 2.5 mg every 12 h or 5 mg every
24 h		 Abdominal pain, somnolence, and nausea CNS depressants (eg, alcohol and sedatives)  
  Fexofenadine (Allegra®)
30 mg, 60 mg, 180 mg tablets
30 mg oral disintegrating tablet
30 mg/5 mL oral suspension		 60 mg every 12 h or 180 mg every 24 h (180 mg maximum)  30 mg every 12 h (60 mg maximum)  6 mo to younger than 2 y: 15 mg every 12 h for chronic idiopathic urticaria
2-6 y: 30 mg every 12 h for oral suspension (60 mg maximum) 		 Headache and vomiting in children CNS depressants (eg, alcohol and sedatives) and SSRIs  
  Loratadine (Claritin®)
10 mg tablet/capsule
5 mg chewable tablet
5 mg, 10 mg oral disintegrating tablet
5 mg/5 mL syrup		 10 mg every 24 h 10 mg every 24 h 2-6 y: 5 mg every 24 h Headache, somnolence, nervousness, and fatigue CNS depressants (eg, alcohol and sedatives) and SSRIs  
  Desloratadine (Clarinex®)
5 mg tablet
2.5 mg, 5 mg oral disintegrating tablet
0.5 mg/1 mL syrup		 5 mg every 24 h 2.5 mg every 24 h 1-5 y: 1.25 mg every
24 h		 Headache, somnolence, nervousness, and fatigue CNS depressants (eg, alcohol and sedatives) and SSRIs  
  Levocetirizine (Xyzal®) 5 mg every 24 h 2.5 mg every 24 h 2-6 y: 1.25 mg every 24 h Sedation, vomiting, nasopharyngitis, fever CNS depressants (eg, alcohol and sedatives) and SSRIs  
* Extended-release formulations are available, and care should be taken to read the label carefully and follow directions, especially to swallow whole.
Abbreviations: CNS, central nervous system; MAO, monoamine oxidase; SSRIs, selective serotonin reuptake inhibitors.

Cough Suppressants/Expectorants

FDA-approved OTC systemic cough suppressants include codeine, dextromethorphan, diphenhydramine, and chlophedianol. Hydrocodone and benzonatate are approved for prescription use.23 Codeine, dextromethorphan, diphenhydramine, and chlophedianol are indicated for the suppression of nonproductive cough caused by chemical or mechanical respiratory tract irritation. Guaifenesin is indicated for symptomatic relief of acute, ineffective productive cough. It should not be used for chronic cough associated with chronic lower respiratory tract diseases, such as asthma, COPD, emphysema, or smoker’s cough. Authors of a 2014 Cochrane review of OTC medications for acute cough in children and adults in ambulatory settings concluded there is no good evidence for or against the effectiveness of their use.35 Briefly, 3 trials compared the expectorant guaifenesin with placebo; 1 indicated significant benefit, whereas the other 2 did not. Two of the studies reviewed compared an antihistamine/decongestant combination with placebo and found equivocal findings. Four others compared different combinations of agents to placebo with some minor benefit in reducing cough. Three studies with antihistamines showed they were not more effective than placebo in cough relief. In children, two studies with dextromethorphan and dextromethorphan/codeine, two studies with antihistamines, two studies with antihistamine/decongestant combinations, and one study with a bronchodilator/cough suppressant combination showed no effectiveness compared to placebo.30 Table 6 outlines names, dosages, side effects, and drug interactions for oral antitussive and expectorants. For coughs due to other chronic conditions, such as asthma or chronic bronchitis, oral or inhaled corticosteroids and inhaled bronchodilators may be appropriate.

Table 6. Oral Cough Suppressants and Expectorants.
Drug Common Trade Names Adults/Children > 12 y Children 6-12 y Children < 6 y Common Side Effects Drug Interactions**
Dextromethorphan* 
15 mg tablet/capsule
7.5 mg/5 mL oral gel
7.5 mg/5 mL, 10 mg/5 mL, 15 mg/ 5 mL oral liquid

30 mg/5 mL extended release liquid

5 mg/ 5 mL, 7.5 mg/5 mL, 10 mg/5 mL, 15 mg/5 mL, 20 mg/5 mL oral syrup

5 mg, 7.5 mg, 15 mg lozenge		 Delsym®, various Robitussin® formulations, various Vicks® formulations Extended-release suspension
60 mg every 12 h as needed.
Capsules or long-acting liquid
30 mg every 6-8 h as needed.
Liquid and syrup (immediate release)
20 mg every 4 h as needed.
Lozenges
10 mg every 4 h as needed (120 mg maximum).
Strips
30 mg every 6-8 h as needed
(120 mg maximum).		 Extended-release suspension
30 mg every 12 h as needed (60 mg maximum).		 Under 4 y: Not for OTC use
4-6 y:
Extended-release suspension
4 to < 6 y of age
15 mg every 12 h as needed
(30 mg maximum).		 Drowsiness, nausea, vomiting, stomach discomfort, and constipation Avoid MAO inhibitors, disulfiram, methotrimeprazine.
Guaifenesin Mucinex®, Robitussin® and Tussin® Expectorant Immediate release: 200-400 mg every 4 h

Extended release: 600 mg to 1200 mg every 12 h
(2.4 g/d maximum)		 100-200 mg every 4 h (1.2 g/d maximum) 4-6 y: 50-100 mg every
4 h (600 mg/d maximum) 		Nausea, vomiting, dizziness, headache, rash, diarrhea, drowsiness, and stomach pain None reported
Guaifenesin in combination with codeine Cheratussin AC, Robitussin® AC Based upon formulation Based upon formulation Based upon formulation See individual agents. See individual agents.
Guaifenesin in combination with dextromethorphan Cheracol® D, Diabetic Tussin® DM, Mucinex® DMMax, various Robitussin® formulations, various Vicks® formulations Based upon formulation Based upon formulation Based upon formulation See individual agents. See individual agents.
Hydrocodone and chlorpheniramine TussiCaps®, Tussionex® Immediate release for adults: 5 mg/4 mg every 4-6 h

Extended release for ages 12 and older: 10 mg/8 mg every 12 h 		Extended release: 5 mg/4 mg every 12 h Contraindicated in children younger than 6 y Chest tightness, anxiety, dizziness, drowsiness, sedation, rash, constipation, nausea, vomiting, respiratory depression, and thickening of bronchial secretions Avoid alcohol and other CNS depressants.
Hydrocodone bitartrate and homatropine methylbromide Hydromet® Hydrocodone 5 mg/homatropine 1.5 mg (1 tablet or 5 mL) every 4-6 h as needed. Max dose: Hydrocodone 30 mg/homatropine 9 mg (6 tablets or 30 mL) per
24 h 		Not indicated in patients under 18 y Not indicated in patients under 18 y Chest tightness, anxiety, dizziness, drowsiness, sedation, rash, constipation, nausea, vomiting, and respiratory depression Avoid alcohol and other CNS depressants.
* Safety and efficacy as an antitussive in children not established.
Abbreviations: CNS, central nervous system; MAO, monoamine oxidase.
References 23 and Lexi-Comp, Inc Version 5.4.3. Lexi-Drugs for Android. Wolters Kluwer Clinical Drug Information, Inc.

The American College of Chest Physicians has evidence-based guidelines for the diagnosis and management of cough, which are reflected in this lesson.36 The guidelines note that central cough suppressants are ineffective in cough associated with the common cold. They recommend use of a first-generation antihistamine and a decongestant to treat the virus-induced postnasal drip that often is the cause of the cough. The guidelines recommend codeine or dextromethorphan for the short-term symptomatic relief of cough associated with bronchitis, acute and chronic, and postinfectious subacute cough. Guaifenesin is not recommended for any indication. In recent years, dextromethorphan has been increasingly used for illicit purposes, particularly by adolescents. FDA panels considered moving dextromethorphan to prescription status due to its potential for abuse, but voted against the recommendation in September 2010, citing lack of evidence that making it prescription-only would curb abuse.37 Some states have restricted the sale of dextromethorphan to adults or put other restrictions on its purchase in place, similar to those for pseudoephedrine.

Topical antitussives approved by the FDA include camphor and menthol. Most topical antitussive formulations contain 4.7% to 5.3% camphor and 2.6% to 2.8% menthol in rub, cream, or ointment formulations.29 These products are rubbed on the throat or chest in a thick layer up to 3 times daily. Examples include Vicks® VapoRub® and BabyRub™, and Mentholatum® chest rub. The pharmacist should counsel patients to loosen clothing around the throat and chest so vapors reach the nose and mouth. The application site may be covered with a warm, dry cloth. The pharmacist should counsel against the use of a heating pad with the products because of the potential for a burn injury. The pharmacist should also counsel not to use the product in the nostrils, under the nose, by the mouth, on damaged skin, or with tight bandages to avoid accidental ingestion. The products are not recommended for use in children younger than 2 years of age.

Combination Products

Combination products may offer patients convenient dosing and day/night formulations to help better control some influenza symptoms. These products may be used frequently by patients according to a 2017 published study that assessed data from Twitter using machine learning to perform surveillance regarding medications commonly used by patients to treat influenza.38 The evaluation revealed the most widely used drugs that patients tweeted about using and included the influenza vaccine, Theraflu®, vitamins, Vicks® NyQuil™, acetaminophen, oseltamivir, and Vicks® DayQuil™, 3 of which are combination OTC products. Table 7 lists the ingredients of commonly used combination products. The pharmacist should assess the patient’s symptoms and help them pick out the most appropriate product for their condition. Pharmacists should pay particular attention to specific ingredients as many of these products use product extensions to capitalize on familiar branding. A vast variety of products are available that will differ from one pharmacy to another. Products differ in dosage form, combination of active ingredients, and doses of each active ingredient. Familiarity with the appropriate individual ingredients is crucial to help patients adequately treat symptoms. Patients can be reassured that off-brand products contain the same active ingredients as their brand name counterparts.

Table 7: Select Combination OTC Flu Products
Alcohol-Free Nyquil™ Cold & Flu Nighttime Relief Liquid Per 30 mL:
Acetaminophen 650 mg
Chlorpheniramine Maleate 4 mg
Dextromethorphan HBr 30 mg
Alka-Seltzer® Plus Severe Cold And Flu Night Per Packet:
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg  
Doxylamine Succinate 12.5 mg  
Phenylephrine HCl 10 mg           
Coricidin® HBP Day and Night Multi-Symptom Cold Tablets Acetaminophen 500 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hbr 15 mg
Children’s Dimetapp® Multi-Symptom
Cold & Flu		 Per 10 mL:
Acetaminophen 320 mg
Diphenhydramine 12.5 mg
Phenylephrine HCI 5 mg
Mucinex® Fast-Max Cold, Flu and Sore Throat
 Per 20 mL:
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg  
Guaifenesin 400 mg       
Phenylephrine HCl 10 mg              
Mucinex® Fast-Max Cold & Flu Day Gels Acetaminophen 325 mg
Dextromethorphan HBr 10 mg  
Guaifenesin 200 mg       
Phenylephrine HCl 5 mg
Mucinex® Fast-Max Cold & Flu Night Gels Acetaminophen 325 mg
Dextromethorphan HBr 10 mg  
Doxylamine Succinate 6.25 mg  
Phenylephrine HCl 5 mg
Theraflu® Flu & Sore Throat Hot Liquid Powder In each packet:
Acetaminophen 650 mg
Pheniramine maleate 20 mg
Phenylephrine HCl 10 mg
Theraflu® ExpressMax® Severe Cold & Flu Syrup Per 30 mL:
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg  
Guaifenesin 400 mg       
Phenylephrine HCl 10 mg           
Theraflu® ExpressMax® Severe Cold & Flu Caplets Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Vicks Dayquil™ Cold & Flu Relief Liquid Per 15 mL:
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Vicks Dayquil™ Severe Vapocool Daytime Cough, Cold and Flu Relief
 Per 30 mL:
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg  
Guaifenesin 400 mg       
Phenylephrine HCl 10 mg           
Vicks Nyquil™ Cold & Flu Nighttime Relief Liquid Per 30 mL:
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine Succinate 12.5 mg
Vicks Nyquil™, Nyquil™ Severe, Vapocool™ Nighttime Cough, Cold and Flu Relief Per 30 mL:
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCl 10 mg
References: Manufacturer labeling at www.fda.gov and  Lexi-Comp, Inc Version 5.4.3. Lexi-Drugs for Android. Wolters Kluwer Clinical Drug Information, Inc.

Use in Special Populations

The FDA’s Nonprescription Drugs Advisory and Pediatric Advisory committees have recommended OTC cough-cold products not be used in children younger than 2 years of age and recommends against their use in children ages 2 years to 6 years. The majority of manufacturers have voluntarily relabeled their products over the last 5 years to reflect they should not be used in children younger than 6 years of age.39 The American Academy of Pediatrics (AAP) also recommends the use of fluids and humidity to control cough in children, based upon its determination that no well-controlled studies are available to support the safety and efficacy of codeine and dextromethorphan in children.40 In May 2011, the FDA released guidelines to address inaccurate dosing issues of liquid OTC products that contain any dispensing device.41 The guidance requires a dosing device be included for all oral, liquid OTC products, that it be calibrated to the product’s dosage directions, be used only with the product it is packaged with, and have visible markings even if liquid is in the device. It is very important for the pharmacist to educate the parent or caregiver on how to calculate the appropriate dose for the child and how to administer the medication properly, including demonstrating the use of the measuring device. Parents should be advised not to use household teaspoons or tablespoons to give medications because the volume they deliver varies. The pharmacist should keep a variety of dosing devices at the pharmacy, including oral syringes and dosing spoons, and counsel parents and caregivers on the appropriate dose and use when recommending OTC products or counseling on oral medications at the pick-up window.

Additional caution is warranted for children and adults with regard to acetaminophen toxicity, and care needs to be taken to avoid concomitant use of combination products with single-ingredient acetaminophen products. Additionally, sedating antihistamines can produce excitation in children and should be avoided. Patients should also be counseled regarding the risk of heart attack and stroke with NSAIDs.27

For pregnant women, all FDA-approved cold medications carry a pregnancy category B or C rating, meaning their use may be considered if the benefits outweigh the risk. Decongestants might decrease fetal blood flow, and some—pseudoephedrine, for example—may be linked to abdominal wall defects.2 Breastfeeding mothers may use pseudoephedrine according to the AAP. However, decongestants can reduce milk production, including pseudoephedrine, but naphazoline and xylometazoline should be avoided. For analgesia, acetaminophen is the preferred choice in both pregnant and breast-feeding patients. For runny nose, chlorpheniramine is the preferred choice due to its long safety profile with loratadine and cetirizine alternates. However, antihistamines can pass into breast milk and are contraindicated during breastfeeding.2 The pharmacist should use patient-centered communication techniques to help guide the patient to a decision on cough treatment based on risks and benefits of pharmacologic approaches, including offering nonpharmacologic alternatives.

The elderly also should avoid use of sedating antihistamines, as their effects may be potentiated. Side effects include confusion and hypotension, all of which may increase a person’s risk for falls. Loratadine is among the better antihistamine choices for the elderly because of nonsedating and lack of anticholinergic effects.2 The elderly may be more likely to experience the sedating effects of dextromethorphan and diphenhydramine. Dosages should be started at the low end of the range, and patients should be monitored carefully.29,42 If older patients present with questions about cough treatment, the pharmacist should use this as an opportunity to see if medication management services may be helpful and covered by the patient’s health plan. Seeking treatment for cough may indicate other underlying conditions, and self-treatment may not be appropriate.

Exclusions for Self-Treatment

Patients and parents/caregivers of children should consult a health care provider if they develop symptoms associated with severe illness from the flu. The CDC describes emergency warning signs as difficulty breathing or shortness of breath, pain or pressure in the chest or abdomen, sudden dizziness, confusion, severe or persistent vomiting, flu-like symptoms that improve but then return with fever, and worsening cough.46

Additional signs in children include fast breathing or trouble breathing, bluish skin color, not drinking enough fluids or infants who have fewer wet diapers than normal, not waking up or interacting, irritability that prevents them from being held, having diarrhea lasting longer than two days, have severe abdominal cramping, have seizures or who have a fever with a rash.43

Resources

The pharmacist should stay abreast of seasonal flu strains, flu recommendations and resistance. The flu area of the CDC website (https://www.cdc.gov/Flu/Professionals/) is an excellent resource. Another helpful resource is the Immunization Action Coalition’s website (https://immunize.org/).

Summary

During the influenza season, the pharmacist should provide education, assessment, and recommendations for patients and caregivers regarding prevention and treatment. The pharmacist serves an important public health role by providing immunization services, contributes to improving patient outcomes, and improving health quality measures. Ensuring immunization services are ready to be delivered and addressing patient concerns about vaccination are critical. Yet not all patients will be vaccinated and even some of who do will contract influenza. As trusted patient advisors, the pharmacist can provide guidance to patients about self-treatment of influenza symptoms and triage patients who experience more serious complications to further care. The pharmacist should be able to recommend appropriate OTC products based on patient symptoms, preferences, and other considerations.

Key Points

  • Prevention is the best strategy for fighting influenza. Share information with patients on strategies to prevent the spread of infection, such as:

            - Practicing healthy habits and good personal and home hygiene can reduce the transmission of
               cold and flu viruses;
            - Everyone older than 6 months of age should be vaccinated against flu; and
            - Maintaining home humidity between 40% and 60% to minimize the survival of viruses in the air
               and on surfaces.

  • Pharmacists should assess influenza symptoms and their duration in patients to determine the appropriate treatment approach, including appropriate product selection and when needed, referral for further medical treatment.
  • Pharmacists should educate patients and caregivers that all current treatments are aimed at easing symptoms and that many nonpharmacological approaches exist. Adequate rest, nutrition, and hydration are important elements that should be emphasized when treating influenza.
  • Once a product and/or medication has been selected, pharmacists should review the product’s name and purpose with the patient or caregiver. The appropriate dose, frequency, and dose measurement should be explained carefully. Oral syringes should be recommended and demonstrated for dosing accuracy.
  • Download the latest flu information (https://www.cdc.gov/Flu/Professionals/) (https://immunize.org/). Offer every patient a flu shot. Use motivational interviewing techniques to help patients make immunization decisions.

Case Studies

Case Study 1

Mr. Stevens, a 48-year-old male, approaches your pharmacy with symptoms consistent with uncomplicated influenza (fever, myalgia, and cough). The patient states these symptoms have been going on for approximately 24 hours. Your community pharmacy has the equipment for CLIA-waived point-of-care Rapid Influenza Diagnostic Test (RIDT) and this patient is a candidate for an RIDT. As part of the intake process, you gather the following information from the patient:

Past Medical History: Hypertension x 4 years
Current Medications: Amlodipine 10 mg by mouth once daily
Allergies: No Known Drug Allergies (NKDA)
Onset and duration of flu-like symptoms: Myalgia and cough for 24 hours
Vaccination History: (+) Inactivated Influenza Vaccine (IIV4) 4 months ago

Blood Pressure: 132/82 mm Hg
Pulse: 90 beats/min
Respiratory Rate: 22 breaths/min
Temperature: 101.2°F (take orally)
Weight: 96 kg (211.2 lbs)

After completing the RIDT, the patient tests negative (Influenza A and B). As a result, the pharmacist recommends supportive care including OTC agents for symptomatic treatment. What recommendation(s) are appropriate for this patient?

Answer:

While this patient could be eligible for appropriate and timely antiviral therapy given time to symptom onset, the patient lacks diagnostic confirmation and may be a better candidate for self-care including OTC treatment. 

Examples for nonpharmacologic management of influenza include adequate rest, nutrition, hydration, and humidification. The patient does not have significant nasal symptoms and may not benefit from saline nasal sprays or rinses. Adequate humidification using cool or warm moisture to increase the level of humidity to 40% or 60% is optimal to minimize the survival of viruses and bacteria in the air.

Appropriate OTC agents for symptomatic treatment including analgesics/antipyretics to treat the patient’s fever and myalgia symptoms and a cough suppressant/expectorant with or without an antihistamine would be appropriate. Care should be taken to avoid combination products with decongestants to not worsen the patient’s hypertension. Example products from Table 7 that would be appropriate include:

  • Vicks® Nyquil™ Cold & Flu Nighttime Relief Liquid (acetaminophen 650 mg, dextromethorphan Hbr 30 mg, doxylamine Succinate 12.5 mg)
  • Alcohol-Free Nyquil™ Cold & Flu Nighttime Relief Liquid (acetaminophen 650 mg, chlorpheniramine maleate 4 mg, dextromethorphan Hbr 30 mg)
  • Coricidin® HBP Day and Night Multi-Symptom Cold (acetaminophen 500 mg, chlorpheniramine maleate 2 mg, dextromethorphan Hbr 15 mg).

Case Study 2

Ms. Hassel, a regular patient at your pharmacy, asks for your recommendations for her daughter, Tobi Hassel, a 7-year-old female, who just left the pediatrician’s office with mild influenza-like symptoms (malaise, sore throat, and rhinitis). The patient stated these symptoms began approximately 3 days ago and Ms. Hassel treated Tobi with a liquid antihistamine, cetirizine (Zyrtec®). After providing her daughter with 5 mg (5 mL) by mouth once daily for the past 2 days, she noted no symptom relief and scheduled a follow-up visit with the pediatrician.

At the pediatrician’s office, Tobi was provided a Rapid Influenza Diagnostic Test for influenza A and B. Tobi was positive for Influenza B but negative for Influenza A. Given the length of symptoms and the mild nature of the clinical symptoms, she was diagnosed with a mild, self-limiting infection and was referred to your pharmacy for symptomatic treatment. As part of the intake process, you gather the following information from the patient’s mother:

Past Medical History (PMH): None
Current Medications: No chronic medications; cetirizine 5 mg by mouth once daily x 2 days
Allergies: No Known Drug Allergies (NKDA)
Onset and duration of flu-like symptoms: Malaise, sore throat, and rhinitis for 72 hours that did not respond to cetirizine
Vaccination History: (+) Live-attenuated Influenza Vaccine (LAIV4) 3 months ago; Patient has received regular influenza vaccinations since she was 6-months-old and is up-to-date on all pediatric vaccines.

From the pediatrician’s paperwork given to Ms. Hassel:

Blood Pressure: 108/68 mm Hg
Pulse: 68 beats/min
Respiratory Rate: 20 breaths/min
Temperature: 99.8°F (taken orally)
Weight: 22 kg (48.4 lbs)

As the pharmacist, what recommendation(s), including over-the-counter agents for symptomatic treatment, are appropriate for this patient?

Answer:

Given the patient’s current course of disease, symptom onset, and the fact that patient is at low risk for complications, the pediatrician has recommended against the use of antiviral treatment despite the positive RIDT for influenza B. This patient may be a better candidate for self-care including OTC treatment. 

All patients, including pediatrics, can benefit from adequate rest, nutrition, hydration, and humidification—this is the best treatment for the patient’s malaise. Depending on the severity of nasal symptoms, Tobi may benefit from saline nasal sprays or rinses. While adequate humidification is important to minimize the survival of viruses and bacteria in the air, steam vaporizers are not recommended with children because of the risk of injury if unit was tipped.

Appropriate OTC agents for symptomatic treatment including analgesics/antipyretics to treat the patient’s sore throat symptoms and a first-generation antihistamine may be more effective for rhinitis symptoms given the lack of efficacy with cetirizine. Care should be taken to ensure products, including combination products, are appropriately dosed based on age and weight. 

The patient could also be treated with an analgesic and antihistamine as individually dosed ingredients as both are available as liquids. The pharmacist should counsel patients that all oral, liquid OTC products should be measured only with the product with which it is packaged. Example dosages include: ibuprofen (5-10 mg/kg/dose every 6-8 h); acetaminophen (10-15 mg/kg/dose every 4-6 h); diphenhydramine (12.5 mg every 4 h). For this patient, potential examples include:

  • Children’s Benadryl® Allergy 5 mL (12.5 mg) by mouth every 4 to 6 hours with no more than 6 doses in 24 hours
  • Children’s Motrin® 10 mL (200 mg) by mouth every 6 to 8 hours with no more than 4 doses in 24 hours
  • Children’s Tylenol® 10 mL (320 mg) by mouth every 4 to 6 hours with no more than 5 doses in 24 hours

REFERENCES

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