OTC Cough and Cold Medication: Keeping Children Safe Background

Detail-Document #270105
−This Detail-Document accompanies the related article published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
January 2011 ~ Volume 27 ~ Number 270105
OTC Cough and Cold Medication: Keeping Children Safe
In January 2008, the FDA recommended that
all over-the-counter (OTC) cough and cold
medicines be avoided in children under two years
Health
Canada
made
similar
old.1
recommendations.2 As a result, manufacturers of
infant cough and cold products voluntarily
removed them from the market. Products affected
included antitussives (dextromethorphan), nasal
decongestants
(pseudoephedrine,
ephedrine,
phenylephrine), antihistamines (diphenhydramine,
chlorpheniramine,
brompheniramine),
and
combination cough and cold products. This
document reviews issues associated with pediatric
OTC cough and cold preparations and provides
alternatives to cough and cold medications for
infants and young children. The differences
between humidifiers and vaporizers are also
discussed.
(which may alter the pharmacokinetics of the
medications). These differences could lead to
differences in efficacy.3
Efficacy data that are available are not
impressive.
Dextromethorphan
and
diphenhydramine have been studied in subjects
between the ages of two and eighteen years.
Neither drug significantly improved cough or
sleep quality compared to placebo. A systematic
review of studies looking at OTC cough remedies
in adults and children suggests there’s not good
evidence for or against the effectiveness of OTC
cough remedies.
Another systematic review
suggests that single-ingredient antihistamines are
not effective in improving nasal symptoms in
children or adults with the common cold. Studies
have also shown a lack of significant effect of
antihistamine/decongestant combinations in small
children.4
Efficacy of OTC Cough and Cold Products
in Children
Safety of OTC Cough and Cold Products in
Children
Very limited information is available to
support the efficacy of cough and cold products in
the pediatric population. This is because the
majority of the data on efficacy has been
extrapolated from the adolescent and adult
population.
Determining the efficacy of a
medication in children, especially young children,
is difficult, because self-reported improvement of
symptoms is impossible to elicit. In addition, it is
unclear if extrapolation of efficacy from
adolescents and adults to young children is valid.3
The extrapolation of efficacy assumes that the
underlying mechanisms and physiology of viralinduced symptoms such as congestion, mucous
production, fever, coughing, and sore throat are
the same in adults and young children. However,
there are a variety of differences between young
children and adults. These include differences in
respiratory anatomy and maturation differences in
respiratory muscles, chest wall structure,
immunological responses, and hepatic enzymes
When used appropriately, the ingredients
contained in OTC cough and cold preparations are
safe in most children. However, these products
are often unintentionally misused leading to
serious adverse effects and even death.5 Although
reporting of adverse effects was not required for
OTC products, from 1969 to the fall of 2006,
there were 69 reported cases of death associated
with antihistamines, and 54 reported cases of
death with the use of decongestants. This likely
underestimates the incidence of death and
provides no information on the potentially higher
rate of serious adverse effects.3
The removal of cough and cold products for
children younger than two years old from the
market has had a beneficial effect. In a recently
published study, investigators tracked the number
of visits to the emergency department for 14
months before OTC cough medications were
taken off the market and for the 14 months
thereafter. For children younger than two years,
Background
More. . .
Copyright © 2011 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #270105: Page 2 of 6)
the estimated number of emergency department
visits for adverse events were less than one-half
what they had been before the medications were
taken off the market. Of concern however, the
total number of visits for OTC cough and cold
medication side effects for all children younger
than 12 years of age remained the same.17
There are a number of factors which lead to
misuse of OTC cough and cold products in
children. Problems often occur due to use of
multiple combination products which may contain
the same ingredients. Consequently, parents using
more than one product may be unaware of this
duplication of ingredients.
For example,
pseudoephedrine was a component of many
products. If a parent administered two or three
products containing pseudoephedrine, the child
could potentially receive two to three times the
recommended dose, leading to tachycardia, left
ventricular dysfunction, and even death.3
Many of the components commonly contained
in OTC cough and cold products lack proper
pediatric dosage guidelines. Instead, the labeling
states, “consult your doctor” or “ask your doctor,”
but data regarding the appropriate dosing are
lacking, even to healthcare professionals.
Additionally, parents may not adhere to
instructions to consult a healthcare professional.
Instead, they may calculate a dose based on
product dosing recommendations for older
children.
Caregivers must understand that
children should not be considered “little adults.”
Caregivers sometimes mistakenly assume that a
fraction of the adult dose is the appropriate dose
for young children.3
To find appropriate doses, see our healthcare
professional resource, Pediatric Doses for
Commonly Used OTCs (U.S. subscribers
#220107)(Canadian subscribers #220117).
Another reason for unintentional overdose is
giving the wrong formulation.
Many OTC
products are available in more than one
concentration or strength. A well-known example
is with products containing acetaminophen.
Concentrated acetaminophen infant drops
(80 mg/0.8 mL in U.S. and 80 mg/1 mL in
Canada) are used instead of children’s suspension
(160 mg/5 mL in U.S. and Canada), or an adultstrength tablet (325 mg) is used instead of a
children’s chewable (80 mg) or junior-strength
tablet (160 mg). Caregivers should understand the
differences among various product formulations,
and the importance of using a calibrated
measuring
device
to
administer
liquid
medications.3
Finally, dosing inaccuracies can occur when
kitchen silverware spoons are used to give oral
liquid medicines.
However, many parents
continue to use teaspoons from their kitchen to
measure medication doses. Depending on their
size, typical household teaspoons can hold
between 2 mL and 10 mL, leading to significant
underdosing or overdosing, a phenomenon which
can have serious consequences in a young child.
Caregivers should be counseled to use the
measuring devices that come with the medicine.
Counseling is vital to prevent errors. A recent
study showed that although measuring devices are
often included with pediatric nonprescription
medications, there are often inconsistencies
between the dosing directions and markings on
the measuring device.6 For example, measuring
devices may be missing markings, contain
superfluous markings, may be too small to
measure labeled doses, lack markings to measure
labeled
doses,
and
contain
confusing
abbreviations.
If a measuring device is not provided,
caregivers should use a medication dosing cup or
oral syringe.
In addition, caregivers must
understand the difference between teaspoon and
tablespoon.
They should understand the
abbreviations for tablespoons (Tbsp.) and
teaspoons (tsp.) and be able to identify them on
the measuring device.3
Nonpharmacologic Management of Cold
Symptoms
For infants younger than three months of age,
parents are advised to call their healthcare
provider at the first sign of illness. For older
infants and children, there are a variety of
nonpharmacologic measures that can be used to
alleviate the symptoms of a cold.
Infants and children suffering from cold
symptoms should be offered plenty of fluids.
Liquid can help loosen up congestion. Encourage
frequent feedings for young babies and offer
water between feedings or meals for older infants
or children.6,7
Saline nasal drops/spray (Ocean Spray, etc)
are recommended to loosen thick nasal mucus.
Suggest loosening nasal mucus with saline drops
More. . .
Copyright © 2011 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #270105: Page 3 of 6)
in infants (< 6 months old) before suctioning with
a rubber-bulb syringe.7,8 Use the bulb syringe to
irrigate the nasal passage with saline drops for
added efficacy. The bulb syringe should be
washed with soap and water between each use.
Moistening the air with either a humidifier or
vaporizer can also help relieve nasal congestion
and cough. Both humidifiers and vaporizers seem
to work equally well in relieving cold symptoms.
The main difference between the two is that
humidifiers release cool moisture into the air, and
vaporizers or steam vaporizers boil water and then
release warm moisture into the air.9,10
There are many types of humidifiers on the
market. An ultrasonic humidifier creates a cool
mist by means of ultrasonic sound vibrations. An
impeller, or “cool mist,” humidifier produces a
cool mist utilizing a high-speed rotating disk.
These two types of humidifiers seem to produce
the greatest dispersions of microorganisms and
minerals.9 An evaporative, or “wick,” humidifier
transmits moisture into the air invisibly by using a
fan to blow air through a moistened wick, filter, or
belt.9,10 A warm mist humidifier is a type of
steam vaporizer humidifier, which uses warm
water.10
Steam vaporizers create steam by heating
water with an electrical heating element or
electrodes. They are not expected to disperse
substantial amounts of minerals and are less likely
to harbor microorganisms since the water is boiled
to create steam. In addition, unlike humidifiers,
inhalants (e.g., menthol inhalants, etc) can be
added to vaporizers for added relief of cold
symptoms. If inhalants are used, parents should
be cautioned to keep them out-of-reach of
children.
In general, a cool mist humidifier is preferred
over a warm mist humidifier or steam vaporizer
because of the risk of accidental burns. But since
cool mist humidifiers don’t boil water, there is a
higher chance of spreading bacteria or mold and
minerals in the air. To minimize the dispersion of
minerals, consider using distilled water rather than
tap water with cool mist humidifiers. Besides
dispersing minerals in the air, using tap water can
also increase the development of crusty deposits
or scale in the humidifier itself. These deposits
can be a breeding ground for microorganisms.
Recommend using distilled water with ultrasonic
or impeller humidifiers. Avoid using bottled
waters labeled “spring,” “artesian,” or “mineral,”
since these types of bottled water have not been
treated to remove mineral content.9
To reduce the potential of bacterial growth, the
water in humidifiers and vaporizers should be
replaced daily and the machine should be cleaned
on a regular basis according to manufacturer
instructions. Use a humidifier or vaporizer only
when conditions require it. Keep indoor relative
humidity around 40% to 50% for optimal comfort.
Caution against keeping the environment too
humid. Excessive humidity can promote bacteria,
mold, and dust mite growth.9
Topical antitussives such as Vicks VapoRub
contain a combination of menthol, camphor, and
eucalyptus oil. (Vicks VapoRub ointment regular
scent [camphor 4.8%, eucalyptus oil 1.2%,
menthol 2.6%], Vicks VapoRub ointment lemon
scent [camphor 4.7%, eucalyptus oil 1.2%,
menthol 2.6%], Vicks VapoRub cream [camphor
5.2%, eucalyptus oil 1.2%, menthol 2.8%; not
available in Canada], and Vicks VapoSteam
[camphor 6.2%]).
Although there is the
perception of improvement in symptoms of cough
and congestion, evidence is lacking concerning its
beneficial effects.
Menthol is the primary component of the
essential oil of peppermint.
Menthol is
responsible for the feeling of congestion relief.
Menthol binds to a receptor causing calcium ions
to flow into cells, and lowering the external
calcium concentrations.
This causes a
depolarization of the membrane, which is
perceived by the brain as increased airflow across
the nostrils. However, the opposite is true. In
studies using menthol in humans, nasal airflow
resistance is increased within one minute of
menthol application and this effect persists for
When used
more than three hours.11
inappropriately (e.g., in the nostrils) inhalation of
menthol can also cause aspiration, apnea,
laryngoconstriction, nausea, ataxia, and cardiac
and central nervous system (confusion, euphoria)
toxicity.11
Camphor was originally obtained from
distillation of the bark from the camphor tree.
Today, it is synthetically produced from
turpentine oil.12,13 The topical application of
camphor leads to a local sensation of heat and
anesthesia. In addition, it is responsible for the
pungent smell which leads to the perception of
efficacy, despite the lack of objective
improvement in airflow resistance.12-14 For more
More. . .
Copyright © 2011 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #270105: Page 4 of 6)
information regarding the efficacy and safety of
Vicks VapoRub in children, see our document,
Vicks VapoRub Safety and Children.
These topical rubs should be applied to the
neck and chest up to three times daily in children
two years of age and older. The product labeling
for Vicks products cautions against applying under
the nose or in the nostrils, and against use in
children less than two years of age, but these
warnings are often ignored. As a result there are
about 10,000 annual reports of camphor
exposures, some resulting in serious adverse
effects.13 While the majority of the cases involve
ingestion, a few are a result of inappropriate
topical or inhalation (microwave heated) use.12 If
a topical rub is used, dress children in loose
clothing covering the site of application to prevent
children from touching the application site and
prevent ingestion or eye irritation.
Keep these agents out of reach of children to
avoid accidental ingestion. There are a variety of
case reports of keratoconjunctivitis, mental status
changes, lipoid pneumonia, bronchospasm, severe
respiratory distress, hepatotoxicity, and type IV
allergic reactions following the inappropriate use
of Vicks VapoRub by the oral, dermal, or
inhalation routes.14
Another product, Vicks BabyRub is available in
the U.S. and Canada. However, it is a
nonmedicated product containing petrolatum,
aloe, rosemary (which contains a small amount of
camphor), and lavender. Because it is marketed
as a “nonmedicated” product, there are no studies
to support its efficacy in the relief of symptoms
due to cough and cold, and it is unlikely to
provide therapeutic benefit.
There is limited evidence to suggest that honey
is effective in relieving cough associated with the
common cold. In one study (n=150), children
between age two and 18 years, with upper
respiratory tract infections and nighttime cough,
were randomly assigned to receive artificially
honey-flavored
dextromethorphan
in
approximated typical OTC labeled dosages,
buckwheat honey, or no treatment.15 The no
treatment group was not blinded to their treatment
arm, whereas the honey and dextromethorphan
group were blinded. A single dose of either
honey-flavored dextromethorphan or honey was
given 30 minutes prior bedtime. Surveys were
given to parents to assess nighttime cough and
sleep difficulty at baseline and after treatment.
The results showed those who received honey had
a mean 1.89 point improvement as rated by their
parents compared with a 1.39 point change for
those receiving DM and a 0.92 point change for
those who had no treatment (p<0.001). The
severity of cough also improved 1.80 points with
honey, 1.30 points with dextromethorphan, and
1.11 points with no treatment (p<0.001). In
addition, patients who received honey had a better
night’s sleep compared to those who received
dextromethorphan or no treatment.15
The exact mechanisms of how honey helps
relieve cold symptoms are unclear. It is thought
that the antioxidant properties of honey may have
a role. Another theory is that the sweetness of
honey naturally causes reflex salivation and may
also induce secretion of airway mucus, which
soothes the pharynx and larynx and reduces
cough. It has also suggested that ingestion of
sweet substances can induce endogenous opioid
production. The interaction between the opioidresponsive sensory fibers and nerves may help to
produce the antitussive effects of sweet substances
via a central nervous system mechanism.15
For children older than 12 months of age,
honey, 30 minutes prior to bedtime, can be used
as an alternative to OTC cough medications for
nocturnal cough [Evidence Level B; lower quality
RCT].15 Do not recommend honey for infants
younger than 12 months of age due to the risk of
botulism.16 The approximate honey doses are half
a teaspoon for children between two to five years,
one teaspoon for children six to 11 years, and two
teaspoons for children 12 to 18 years.14
Conclusion
Acute upper respiratory tract infection, or the
common cold, is a common ailment in children.
Although the common cold is a self-limiting
illness, its symptoms cause great discomfort in
children.
For infants younger than three months of age,
parents should call their healthcare provider at the
first sign of illness. Otherwise, in older infants or
children, cold symptoms can be managed by
nonpharmacologic measures.
Adequate fluid
intake is vital to prevent dehydration and to help
loosen congestion. In addition, saline nasal drops
and moistening air with a humidifier or vaporizer
can also help relieve nasal congestion. Instead of
OTC cough suppressants, honey can be tried to
relieve cough.
More. . .
Copyright © 2011 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #270105: Page 5 of 6)
The child should be seen by a healthcare
provider if the cold symptoms worsen
(temperature higher than 103°F [39.4°C] for one
day or higher than 100°F [37.8°C] for three days,
cough lasting for more than one week, thick green
nasal discharge for more than two weeks, yellow
eye discharge, ear or sinus pain) or if the child
appears to be dehydrated.7
Users of this document are cautioned to use their own
professional judgment and consult any other necessary
or appropriate sources prior to making clinical
judgments based on the content of this document. Our
editors have researched the information with input
from experts, government agencies, and national
organizations. Information and Internet links in this
article were current as of the date of publication.
Levels of Evidence
In accordance with the trend towards Evidence-Based
Medicine, we are citing the LEVEL OF EVIDENCE
for the statements we publish.
Level
A
B
C
D
Definition
High-quality randomized controlled trial (RCT)
High-quality meta-analysis (quantitative
systematic review)
Nonrandomized clinical trial
Nonquantitative systematic review
Lower quality RCT
Clinical cohort study
Case-control study
Historical control
Epidemiologic study
Consensus
Expert opinion
Anecdotal evidence
In vitro or animal study
3.
4.
5.
6.
7.
8.
9.
10.
11.
Adapted from Siwek J, et al. How to write an evidence-based
clinical review article. Am Fam Physician 2002;65:251-8.
Project Leaders in preparation of this DetailDocument: Wan-Chih Tom, Pharm.D. and Neeta
Bahal O’Mara, Pharm.D., BCPS
12.
13.
References
1.
2.
Anon. OTC cough and cold products: not for infants
and children under 2 years of age. January 17,
2008.
Food
and
Drug
Administration.
http://www.fda.gov/ForConsumers/ConsumerUpdat
es/ucm048682.htm.
(Accessed December 8,
2010).
Health Canada. Health Canada releases decision
on the labelling of cough and cold products for
14.
15.
children. December 18, 2008. Health Canada.
http://www.hc-sc.gc.ca/ahc-asc/media/advisoriesavis/_2008/2008_184-eng.php.
(Accessed
December 8, 2010).
FDA. Briefing information. Joint meeting of the
Nonprescription Drugs Advisory Committee and the
Pediatric Advisory Committee. October 18-19,
2007.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/20
07-4323b1-00-index.htm. (Accessed December 8,
2010).
Ryan T, Brewer M, Small L. Over-the-counter
cough and cold medication use in young children.
Pediatr Nurs 2008;34:174-80, 184.
CDC. Infant deaths associated with cough and cold
medications—two states, 2005.
MMWR Morb
Mortal Wkly Rep 2007;56(1):1-4.
Yin HS, Wolf MS, Dreyer BP, et al. Evaluation of
consistency in dosing directions and measuring
devices for pediatric nonprescription liquid
medications. JAMA 2010;304:2595-602.
Anon. Common cold in babies. October 8, 2010.
MayClinic.com.
http://www.mayoclinic.com/health/commoncold/PR00038. (Accessed December 8, 2010).
American Academy of Pediatrics. My child has a
virus, how can I help her feel better? August 12,
2010.
http://www.healthychildren.org/English/healthissues/conditions/ear-nose-throat/pages/Caring-fora-Child-with-a-Viral-Infection.aspx.
(Accessed
December 8, 2010).
U.S. Environmental Protection Agency. Indoor Air
Facts No. 8: Use and Care of Home Humidifiers.
September
30,
2010.
http://www.epa.gov/iaq/pubs/humidif.html.
(Accessed December 8, 2010).
Anon. Home health: humidifiers vs. vaporizers.
2002.
http://www.essortment.com/lifestyle/differencebaby
_sixo.htm. (Accessed December 8, 2010).
Gardiner P. Peppermint (Mentha piperita). The
Longwood Herbal Task Force. May 2000. The
Center for Holistic Pediatric Education and
Research.
http://www.longwoodherbal.org/peppermint/pepper
mint.pdf. (Accessed December 8, 2010).
Love JN, Sammon M, Smereck J. Are one or two
dangerous? Camphor exposure in toddlers. J
Emerg Med 2004;27:49-54.
Manoguerra AS, Erdman AR, Wax PM, et al.
Camphor poisoning: an evidence-based practice
guideline for out-of-hospital management. Clin
Toxicol (Phila) 2006;44:357-70.
Abanses JC, Arima S, Rubin BK. Vicks VapoRub
induces mucin secretion, decreases ciliary beat
frequency, and increases tracheal mucus transport
in the ferret trachea. Chest 2009;135:143-8.
Paul IM, Beiler J, McMonagle A, et al. Effect of
honey, dextromethorphan, and no treatment on
nocturnal cough and sleep quality for coughing
children and their parents. Arch Pediatr Adolesc
Med 2007;161:1140-6.
More. . .
Copyright © 2011 by Therapeutic Research Center
Pharmacist’s Letter / Prescriber’s Letter ~ P.O. Box 8190, Stockton, CA 95208 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.pharmacistsletter.com ~ www.prescribersletter.com
(Detail-Document #270105: Page 6 of 6)
16. Jellin JM, Gregory PJ, et al. Natural Medicines
Comprehensive
Database.
http://www.naturaldatabase.com.
(Accessed
December 8, 2010).
17. Shehab N, Schaefer MK, Kegler SR, Budnitz DS.
Adverse effects from cough and cold medications
after a market withdrawal of products labeled for
infants. Pediatrics 2010;126:1100-7.
Cite this Detail-Document as follows: OTC cough and cold medication: keeping children safe. Pharmacist’s
Letter/Prescriber’s Letter 2011;27(1):270105.
Evidence and Advice You Can Trust…
3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright © 2011 by Therapeutic Research Center
Subscribers to Pharmacist’s Letter and Prescriber’s Letter can get Detail-Documents, like this one, on any
topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com
Cautions with Pediatric Cough and Cold Products
A number of nonprescription infant cough and cold products were voluntarily taken off the
market by some manufacturers in 2007. These products were used to treat cold symptoms like a
runny or stuffy nose, sneezing, or cough in very young children. The products removed were
those containing combinations of antihistamines (i.e., diphenhydramine, brompheniramine,
chlorpheniramine), decongestants (i.e., pseudoephedrine, phenylephrine), and cough
suppressants (dextromethorphan). Cough and cold products for older children are still available,
but may have a warning on their labels not to use them in younger children.
There is concern that these ingredients may not be safe in children younger than 6 years old.
There have been many reports of accidental overdose with the use of these drugs. A few
children have died after using them. Also, there is no good proof that cough/cold medicines
work in young children, so any minor benefits from use of these products may not be worth the
possible risks.
What Should I Do Now?
•
•
•
•
•
•
Do not use any cough/cold medicine in children under the age of 6 years old unless
you first check with your healthcare practitioner.
Do not use antihistamine products to make a child sleepy.
Do not give your young child medicine that’s supposed to be used in older children or
adults.
Read and follow the directions on medicine bottles carefully. Be sure to read the
“Drug Facts” on the label and note the ingredients and warnings.
Do not use two products at the same time that contain the same ingredients.
When giving a child any medicine, use a calibrated dosing cup, dropper, or dosing
syringe to make sure you measure the right dose. Do not use a spoon from your
kitchen.
Other Ways to Keep Your Infant Comfortable
•
•
•
Have your child drink plenty of fluids so they don’t become dehydrated.
Single-ingredient pain/fever relievers like acetaminophen (e.g., Tylenol) or ibuprofen
(e.g., Advil) are still okay to use and can help make your child more comfortable.
These medicines come in drops for infants, liquid (elixir) for toddlers, and chewable
tablets for older children. The infant drops are more concentrated than the liquid elixir
for toddlers. Do not switch back and forth between different products or you may give
your child too much or too little medicine.
For congestion, keep your child upright, or try gentle nasal suctioning, saline nose
drops, or a room humidifier.
When to Call Your Doctor
You should call your doctor if your child:
• is under 3 months old.
• has had a fever for more than 24 hours if your child is under 2 years.
• has ear pain or a severe sore throat.
• has symptoms that don’t improve within 10 to 14 days.
Prepared for the subscribers of
Pharmacist’s Letter / Prescriber’s Letter to give to their patients.
Copyright © 2008 by Therapeutic Research Center
www.pharmacistsletter.com ~ www.prescribersletter.com
Precauciones que se deben tomar cuando se usan productos
pediátricos para la tos y el resfrío
En el año 2007 algunos fabricantes retiraron del mercado, en forma voluntaria, algunos
productos para bebés de venta sin receta que se usaban para la tos y el resfrío. Estos productos
se utilizaban para tratar los síntomas del resfriado como la congestión o el goteo nasal, los
estornudos, o la tos en los niños muy pequeños. Los productos que se retiraron del mercado
fueron los que contenían combinaciones de antihistamínicos (por ejemplo, difenhidramina,
bromfeniramina, clorfeniramina), descongestionantes (por ejemplo, pseudoefedrina, fenilefrina)
y antitusígenos (dextrometorfano). Todavía hay productos disponibles para la tos y el resfrío
para usar en niños mayores, pero estos productos pueden tener la advertencia en sus etiquetas de
no usar en niños más pequeños.
Existe la preocupación de que estos ingredientes pueden no ser seguros en niños menores de 6
años de edad. Ha habido muchos informes de sobredosis accidental con el uso de estos
medicamentos. Algunos niños han muerto después de tomarlos. Además, no hay pruebas que
indiquen que los medicamentos para la tos/resfrío funcionan en los niños pequeños, por lo que es
posible que el beneficio de su uso no justifique los posibles riesgos.
¿Qué debo hacer ahora?
•
No utilice medicinas para la tos y el resfrío en niños menores de 6 años de edad sin antes
consultar a su profesional de la salud.
•
No utilice productos antihistamínicos para hacer que su niño duerma.
•
No le dé a su niño pequeño medicamentos destinados para niños mayores o para adultos.
•
Lea y siga cuidadosamente las instrucciones en los frascos de las medicinas. Asegúrese
de leer en la etiqueta la información acerca de los ingredientes y las instrucciones para su
uso y fíjese cuáles son las advertencias.
•
No use al mismo tiempo dos productos que contienen los mismos ingredientes.
•
Al dar a un niño cualquier medicamento, use una tacita de dosificación, un gotero o una
jeringa dosificadora calibrada para asegurarse de darle la dosis correcta. No utilice una
cuchara de cocina.
Otras maneras para mantener a su bebé cómodo
•
Haga que su hijo beba gran cantidad de líquidos para que no se deshidrate.
•
Para que su niño esté más cómodo puede utilizar medicamentos para bajar la fiebre y
calmar el dolor que contienen sólo un ingrediente ya sea acetaminofeno (Tylenol) o
ibuprofeno (Advil). Estos medicamentos vienen en forma de gotas para los bebés, jarabe
(elixir) para los niños y tabletas masticables para los niños mayores. Las gotas para
bebés son más concentradas que el elixir líquido para los niños. No alterne entre dos
productos distintos ya que podría darle a su hijo demasiado o muy poco medicamento.
Prepared for the subscribers of
Pharmacist’s Letter / Prescriber’s Letter to give to their patients.
Copyright © 2010 by Therapeutic Research Center
www.pharmacistsletter.com ~ www.prescribersletter.com
•
Para aliviar la congestión, mantenga a su hijo en posición vertical, o trate de aspirar la
nariz suavemente, o use una solución salina de gotas nasales, o bien use un humidificador
de ambiente.
Cuando debe llamar al médico
Usted debe llamar a su médico si su hijo:
•
Tiene menos de 3 meses de edad.
•
Es menor de 2 años de edad y ha tenido fiebre por más de 24 horas.
•
Tiene dolor de oído o dolor de garganta severo.
•
Tiene síntomas que no han mejorado en 10 o 14 días.
Prepared for the subscribers of
Pharmacist’s Letter / Prescriber’s Letter to give to their patients.
Copyright © 2010 by Therapeutic Research Center
www.pharmacistsletter.com ~ www.prescribersletter.com