PL Detail-Document

PL Detail-Document #290110
−This PL Detail-Document gives subscribers
additional insight related to the Recommendations published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
January 2013
Treatment of Canker Sores
Introduction
Aphthous ulcers, or canker sores, are a
common annoyance for patients. About one-third
of individuals will experience a canker sore in his
or her lifetime.1 There isn’t good evidence for
many of the treatments used for canker sores.
Most of the available data come from very small
clinical trials.2 This document reviews common
treatments for canker sores.
Background on Canker Sores
Canker sores generally occur in otherwise
healthy patients. They are noninfectious and their
cause is unclear.1,3 Canker sores tend to be
recurrent and to run in families. They can be
triggered by factors such as smoking, stress,
trauma, or vitamin and mineral deficiencies.
Medications such as beta-blockers, NSAIDs, and
antioxidants may also be associated with canker
sores.1
Onset of canker sores is more common during
the teen years than during adulthood.1,4 Ulcers
may have a prodromal phase, with tingling or
burning up to two days prior to ulcer appearance.1
In contrast to cold sores, canker sores occur on
the inside of the mouth on areas such as the
tongue or cheeks. The major problem with canker
sores is that they might cause difficulty eating or
drinking or performing oral hygeine.4,5 Canker
sores tend to heal naturally within one to two
weeks.6
There are different classifications of canker
sores, but the vast majority are considered minor
or simple (fewer, smaller, shorter healing time) as
opposed to major or complex (more, larger, longer
healing time).4,7 Treatment of canker sores is
directed at relieving pain, reducing duration of
ulcers, and reducing recurrence of ulcers.
In general, the evidence for canker sore
treatments is limited. However, the cost of most
canker sore treatments is relatively low, at around
$20 per course or less.2 Patients may provide
input on which treatments they feel are most
effective, and pick and choose based on that
experience.
Prescription Medications
Amlexanox 5% oral paste (Aphthasol),
available in the U.S., is an anti-inflammatory
agent.3 It’s the only prescription product FDAapproved for treating canker sores, and has the
best quality of evidence for efficacy compared
with other treatments.8 Amlexanox appears to
double a patient’s chances of being pain-free
and/or having ulcers healed at three days
compared with placebo.
It can also stop
development of a canker sore during the
prodromal phase in most instances.2 Amlexanox
should be applied to ulcers four times daily. Like
other treatments for canker sores, the best time to
apply is after eating and brushing the teeth.8
Topical corticosteroids have been shown to
reduce pain from canker sores in a number of
small clinical trials.1,2,9 Topical steroids may also
stop development of ulcers if used in the
prodromal phase.1
Compounded clobetasol
propionate 0.05% oral paste may be as effective
as
amlexanox.2,3
Other
corticosteroid
formulations that have been studied include
dexamethasone 0.5 mg/5 mL elixir (commercially
available) used as a mouth rinse three to four
times daily as well as a variety of other
compounded products. Triamcinolone (OraloneU.S., Oracort-Canada, generics) is commercially
available as a dental paste.
Systemic
corticosteroids may be useful for patients with
more severe or frequently recurring cases.1
Topical tetracycline regimens may be useful
for reducing pain and duration of ulcers.1,3
Formulations that have been studied include
various concentrations of tetracycline mouth
rinses applied four times daily and minocycline
0.2% mouth rinse applied four times daily.10 The
downside of topical antibiotics is that they might
increase the risk of thrush.11 Oral doxycycline
20 mg twice daily may reduce ulcer recurrence.12
More. . .
Copyright © 2013 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #290110: Page 2 of 3)
Sucralfate suspension has been studied in a
small number of patients with canker sores. It
may reduce pain and healing time of ulcers
through its effect as a protectant.13 Various
regimens are described including 5 to 10 mL
swished in the mouth four times daily, or a bit of
the suspension applied locally for about one
minute at a time, one or two times daily. Note
that when sucralfate tabs are used to prepare a
slurry, the tabs are not easily crushed. They
should be placed in about 10 mL of water per
tablet and allowed to dissolve, and then shaken to
disperse after about 15 to 20 minutes.14
The results from a number of small trials
suggest that chlorhexidine mouthwash used four
times daily can speed healing of canker sores.2
Magic mouthwash is an anecdotal remedy for
canker sores.2 This compounded product can
contain different ingredients depending on the
recipe used.
Some of the more common
ingredients are diphenhydramine, lidocaine, milk
of magnesia, and nystatin.
However, some
recipes include drugs that do have evidence of
benefit for canker sores, such as tetracyclines and
corticosteroids.15 Magic mouthwash is typically
used four times daily.
Nonprescription Medications
Topical anesthetics such as benzocaine
(Anbesol, Kank-A, Zilactin-B, etc), may help
reduce pain with canker sores.1 But remember to
avoid use of benzocaine in children under the age
of two years and advise keeping these products
out of their reach due to the risk of
methemoglobinemia.
Also avoid “caine”
anesthetics in patients with a history of allergic
reactions to them.
Canker Cover is another OTC product that
might help reduce discomfort. It has citrus oils
and menthol and forms a gel-like protective
patch over ulcers.5
Patients may try a number of other simple
remedies, although there is not good evidence for
their benefit in the treatment of canker sores.
Carbamide or hydrogen peroxide might help
debride or cleanse ulcers. These can be applied
directly to ulcers and allowed to remain for about
one minute at a time. Alternately, full-strength
solutions mixed with equal amounts of water or
commercially available formulations can be used
to rinse the mouth. Peroxides can be used up to
four times daily for up to seven days, but more
frequent or prolonged use might irritate the oral
mucosa.5
Salt water rinses (one to three teaspoons of
table salt in four to eight ounces [120 to 240 mL]
of water) or baking soda pastes may be tried to
reduce discomfort. OTC analgesics such as
acetaminophen or ibuprofen might also help
reduce pain with canker sores. Original Listerine
might help reduce healing time.5
Supplements
The use of vitamin B12 1000 mcg orally once
daily for prophylaxis of canker sores has been
studied. This regimen may reduce number,
duration, pain, and recurrence of canker sores.2,3
Propolis is a supplement that may have
antimicrobial and anti-inflammatory properties.
Propolis 500 mg orally once daily might also
reduce recurrences of canker sores.16
There are preliminary data that suggest aloe
vera or lavender oil applied topically to ulcers
might have some utility in reducing pain and
healing time.17,18
Non-Drug Strategies
Avoidance of certain kinds of food or
beverages (e.g., spicy, acidic, sharp) that cause
irritation to existing ulcers might help reduce
discomfort. Applying ice directly to ulcers for
about ten minutes at a time might help reduce pain
as well.5
Small studies suggest that avoiding toothpastes
with sodium lauryl sulfate might reduce
recurrence of canker sores, although data are
conflicting.1,2,6 Individuals prone to canker sores
may also benefit from preventing contact between
the inside of the mouth and sharp dental
appliances (e.g., braces, dentures), as well as
avoiding toothbrushes with very stiff bristles.
Conclusion
Amlexanox or topical corticosteroids appear to
be the best bets for reducing symptoms and
healing time of canker sores. Also consider
practical issues, such as patient preference and
convenience of application (e.g., a mouth rinse
instead of a paste for a patient with many ulcers)
when making recommendations for treatments for
canker sores.
To help maximize the benefits of topical
treatment for canker sores, counsel patients to
More. . .
Copyright © 2013 by Therapeutic Research Center
3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249
www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com
(PL Detail-Document #290110: Page 3 of 3)
avoid eating, drinking, and excessive speaking for
30 minutes after application.
In addition,
treatments should be started as soon as possible,
preferably during the prodromal phase.
7.
8.
Users of this PL Detail-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.
9.
10.
11.
12.
Project Leader in preparation of this PL DetailDocument:
Stacy A. Hester, R.Ph., BCPS,
Assistant Editor
13.
References
14.
1.
2.
3.
4.
5.
6.
Chavan M, Jain H, Diwan N, et al. Recurrent
aphthous stomatitis: a review. J Oral Pathol Med
2012;41:577-83.
Bailey J, McCarthy C, Smith RF. Clinical Inquiry.
What is the most effective way to treat recurrent
canker sores? J Fam Pract 2011;60:621-32.
Baccaglini L, Lalla RV, Bruce AJ, et al. Urban
legends: recurrent aphthous stomatitis. Oral Dis
2011;17:755-70.
Brocklehurst P, Tickle M, Glenny AM, et al.
Systemic interventions for recurrent aphthous
stomatitis (mouth ulcers). Cochrane Database
Syst Rev 2012;(9):CD005411.
Albanese NP. Oral pain and discomfort. In:
Krinsky DL, Berardi RR, Ferreri SP, et al, Eds.
th
Handbook of Nonprescription Drugs. 17 ed.
Washington, DC:
American Pharmaceutical
Association, 2012.
Shim YJ, Choi JH, Ahn HJ, Kwon JS. Effect of
sodium lauryl sulfate on recurrent aphthous
15.
16.
17.
18.
stomatitis: a randomized controlled clinical trial.
Oral Dis 2012;18:655-60.
Liang MW, Neoh CY.
Oral aphthosis:
management gaps and recent advances. Ann
Acad Med Singapore 2012;41:463-70.
Product information for Aphthasol.
Access
Pharmaceuticals. Dallas, TX 75207. March 2004.
Liu C, Zhou Z, Liu G, et al. Efficacy and safety of
dexamethasone ointment on recurrent aphthous
ulceration. Am J Med 2012;125:292-301.
Gorsky M, Epstein JB, Rabenstein S, et al. Topical
minocycline and tetracycline rinses in treatment of
recurrent aphthous stomatitis: a randomized crossover study. Dermatol Online J 2007;13:1.
Mayo Clinic. Canker sore. March 24, 2012.
http://www.mayoclinic.com/health/cankersore/DS00354. (Accessed December 10, 2012).
Preshaw PM, Grainger P, Bradshaw MH, et al.
Subantimicrobial dose doxycycline in the treatment
of recurrent oral aphthous ulceration: a pilot study.
J Oral Pathol Med 2007;36:236-40.
Rattan J, Schneider M, Arber N, et al. Sucralfate
suspension as a treatment of recurrent aphthous
stomatitis. J Intern Med 1994;236:341-3.
Clinical Pharmacology [database online]. Tampa,
FL:
Gold
Standard,
Inc.;
2012.
http://www.clinicalpharmacology.com. (Accessed
December 11, 2012).
PL Detail-Document, Magic Mouthwash Recipes.
Pharmacist’s Letter/Prescriber’s Letter. November
2009.
Jellin JM, Gregory PJ, et al. Natural Medicines
Comprehensive
Database.
http://www.naturaldatabase.com.
(Accessed
December 7, 2012).
Babaee N, Zabihi E, Mohseni S, Moghadamnia AA.
Evaluation of the therapeutic effects of Aloe vera
gel on minor recurrent aphthous stomatitis. Dent
Res J (Isfahan) 2012;9:381-5.
Altaei DT. Topical lavender oil for the treatment of
recurrent aphthous ulceration.
Am J Dent
2012;25:39-43.
Cite this document as follows:
PL Detail-Document, Treatment of Canker Sores.
Letter/Prescriber’s Letter. January 2013.
Pharmacist’s
Evidence and Recommendations You Can Trust…
3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249
Copyright © 2013 by Therapeutic Research Center
Subscribers to the Letter can get PL Detail-Documents, like this one,
on any topic covered in any issue by going to www.PharmacistsLetter.com,
www.PrescribersLetter.com, or www.PharmacyTechniciansLetter.com
Detail-Document #251103
−This Detail-Document accompanies the related article published in−
PHARMACIST’S LETTER / PRESCRIBER’S LETTER
November 2009 ~ Volume 25 ~ Number 251103
Magic Mouthwash Recipes
Ingredients1-11,a-e
Amount
Diphenhydramine 12.5 mg/5 mL 240 mL
Hydrocortisone
60 mg
Nystatin powder
6 million
units
Tetracycline
1.5 g
Swish and spit 5 mL QID.
a.k.a. Mary’s Magic Potion
Ingredients1-11,a-e
Hydrocortisone
Nystatin
Diphenhydramine 12.5 mg/5 mL
a.k.a. Duke’s Magic Mouthwash4
Amount
60 mg
Suspension
30 mL OR
Powder
3 million
units
QS 240 mL
Distilled water
160 mL
Hydrocortisone
80 mg
Maalox
80 mL
Swish and spit 5 mL QID.
a.k.a. Weisman’s Philadelphia Mouthwash
Diphenhydramine 12.5 mg/5 mL
Hydrocortisone
Nystatin suspension
Tetracycline
Diphenhydramine 12.5 mg/5 mL
Nystatin suspension
Maalox
Water
Diphenhydramine 12.5 mg/5 mL
Hydrocortisone
Nystatin suspension
Tetracycline
100 mL
0.02 g
4.8 mL
200 mg
Diphenhydramine 12.5 mg/5 mL
Prednisone 5 mg/5 mL
Nystatin suspension
1 part
1 part
1 part
Nystatin Susp. 100,000 U/mL
Lidocaine Viscous 2%
Distilled Water
Crystal Light-Raspberry with
Aspartame crystals8
83.3 mL
83.3 mL
83.3 mL
0.47 g
1 part
1 part
1 part
1 part
Diphenhydramine 12.5 mg/5 mL 1 part
Viscous lidocaine 2%
1 part
Maalox
1 part
Swish and swallow 5 mL no more than Q4H.
OR For radiation oncology mucositis; palliative
care:
Swish, hold, and spit or swallow 30 mL Q2H.1
Diphenhydramine 12.5 mg/5 mL
240 mL
120 mg
Hydrocortisone powder
(wet with 1% CMCf to dissolve)
Nystatin Suspension
60 mL
Tetracycline 125 mg/5 mL
120 mL
(capsule dissolved in flavored
syrup)
CMCf 1%
QS 480 mL
Swish and swallow 10 mL TID.
Diphenhydramine 12.5 mg/5 mL
Mylanta or Maalox
Sucralfate
Swish and spit or swallow 5 mL
meals and PRN.6
30 mL
60 mL
4g
TID before
180 mL
0.072 g
36 mL
0.75 g
Cherry flavored Kool-Aid mixed
100 mL
with 2000 mL distilled water
(sugar-free)
Viscous lidocaine 2%
100 mL
Nystatin suspension
100 mL
Swish and spit or swallow 15 mL QID. OR
For radiation oncology mucositis; palliative
care:
Swish, hold, and spit or swallow 30 mL Q4H.1
a.k.a. Koolstat
More. . .
Copyright © 2009 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 #251103: Page 2 of 3)
Ingredients1-11,a-e
Amount
Hydrocortisone 100 mg/2 mL
12 mL
(Solu-Cortef)
Nystatin suspension
7.2 mL
Tetracycline 125 mg/5 mL
12 mL
(capsule dissolved in syrup)
Diphenhydramine 12.5 mg /5 mL 150 mL
Swish and swallow 10 mL QID.
Viscous lidocaine 2%
Hydrocortisone 100 mg/2 mL
(Solu-Cortef)
Nystatin suspension
Mouth rinse
Do not swallow.
250 mL
1g
150 mL
QS 500 mL
Diphenhydramine 12.5 mg /5 mL
Dexamethasone 4 mg/mL injection
Nystatin suspension
Distilled water QS to 200 mL8
Swish and Spit 5 mL QID.
120 mL
0.56 mL
40 mL
Viscous lidocaine 2%
Cherry flavored Kool-Aid mixed
with 1500 mL of sterile water for
irrigation (sugar-free)
2000 mL
QS
3400 mL
Diphenhydramine 12.5 mg/5 mL
Prednisone 5 mg/5 mL
Nystatin suspension
1 part
1 part
1 part
Viscous lidocaine 2%
80 mL
Mylanta
80 mL
Diphenhydramine 12.5 mg/5 mL
80 mL
Nystatin suspension
80 mL
Prednisolone 15 mg/5 mL
80 mL
Distilled water
80 mL
Swish, gargle, and spit 5 mL to 10 mL Q6H
PRN.
May be swallowed if esophageal
involvement.10
Viscous lidocaine 2%
150 mL
Diphenhydramine 12.5 mg/5 mL
20 mL
Hydrocortisone (Solu-Cortef)
100 mg
Tetracycline
2 grams
Nystatin suspension
20 mL
Swish, hold, and swallow 15 to 30 mL Q4-6H.1
a.k.a. Mile’s Solution
Ingredients1-11,a-e
Amount
Viscous lidocaine 2%
30 mL
Maalox
60 mL
Diphenhydramine 12.5 mg/5 mL
30 mL
Carafate 1 g/10 mL
40 mL
Swish, gargle, and spit 5 mL to 10 mL Q6H
PRN. May swallow if esophageal involvement.10
Dexamethasone 0.5 mg/5 mL
100 mL
Diphenhydramine 12.5 mg/5 mL
100mL
Nystatin suspension
60 mL
Tetracycline
1500 mg
Swish, gargle, and spit 5 mL to 10 mL Q6H
PRN. May swallow if esophageal
involvement.10
a. Elixirs containing alcohol can cause stinging.
Consider using injectable or powder
formulation, crushing tablets, or opening
capsules in place of elixir formulation to
avoid stinging.
b. Some U.S. clinicians have found the new
formulation of Kaopectate (i.e., containing
bismuth) to solidify over a short period of
time when mixed with other ingredients. U.S.
clinicians should consider this potential
problem if utilizing recipes which use
Kaopectate in place of Maalox. Canadian
Kaopectate formulation does not contain
bismuth.
c. Nystatin has not been shown to be effective in
treating oral fungal infection associated with
oral mucositis.11
d. The use of corticosteroids, such as
hydrocortisone or dexamethasone, has not
been adequately studied to recommend its
inclusion in magic mouthwash.11
e. According to USP standards, mixtures
containing water should have an expiration
not longer than two weeks.12
f. CMC=Carboxymethylcellulose.
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.
More. . .
Copyright © 2009 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 #251103: Page 3 of 3)
Project Leader in preparation of this DetailDocument: Wan-Chih Tom, Pharm.D.
References
1.
2.
3.
4.
5.
The Erie St. Clair Palliative Care Management
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January
2007.
http://www.ccacont.ca/Upload/esc/General/Palliative_Care_Manag
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(Accessed October 11,
2009).
Anon.
Slang terms and jargon can cause
medication errors. Drugs & Therapy Bulletin.
Shands
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the
University
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November/December 2005. Volume 19, Number
10.
http://www.shands.org/professionals/drugInfo/bullet
ins/1005.pdf. (Accessed October 11, 2009).
Bulletin Board of Oral Pathology. University at
Buffalo. 2007.
North
Carolina
Board
of
Pharmacy.
http://www.ncbop.org/faqs/Pharmacist/faq_DukesM
agicMouthwash.htm.
(Accessed October 11,
2009).
Hodgins C, Mosley M, Pola-Strowd M.
Recommendations
for the
diagnosis
and
management of recurrent aphthous stomatitis.
Cite this Detail-Document as follows:
2009;25(11):251103.
2003. University of Texas at Austin, School of
Nursing.
6. Tarascon Pharmacopoeia. 2009 Library Edition.
Ed. In Chief: Richard J. Hamilton. Jones &
Bartlett. Sudbury, MA:164.
7. Department of Pharmacy Services. Mount Sinai
Hospital. Toronto, Ontario MSG 1XS. October
2009.
8. Toronto Sunnybrook Regional Cancer Centre
Pharmacy. Toronto, Ontario M4N 3M5. October
2009.
9. Drug Information and Research Centre. Ontario
Pharmacist’s Association. October 2009.
10. Randy Otterholt, DDS General Dentistry.
http://www.drotterholt.com/magicmouthwash.html.
(Accessed October 11, 2009).
11. Chan A, Ignoffo RJ.
Survey of topical oral
solutions for the treatment of chemo-induced oral
mucositis. J Oncol Pharm Pract 2005;11:139-43.
12. Chapter 795 Pharmaceutical Compounding-Nonsterile Preparations.
The United States
Pharmacopeia and The National Formulary (USPNF).
http://www.usp.org/pdf/EN/USPNF/generalChapter
795_PF354.pdf. (Accessed October 11, 2009).
Magic mouthwash recipes.
Pharmacist’s Letter/Prescriber’s Letter
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 © 2009 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