Professional Documents
Culture Documents
Project Leaders in preparation of this PL Detail- 6. Tarascon Pharmacopoeia. 2009 Library Edition.
Document: Wan-Chih Tom, Pharm.D. (Original Ed. In Chief: Richard J. Hamilton. Jones &
Bartlett. Sudbury, MA:164.
November 2009 version); Stacy A. Hester, R.Ph., 7. Department of Pharmacy Services. Mount Sinai
BCPS, Assistant Editor (November 2014 update) Hospital. Toronto, Ontario MSG 1XS. October
2009.
References 8. Toronto Sunnybrook Regional Cancer Centre
Pharmacy. Toronto, Ontario M4N 3M5. October
1. The Erie St. Clair Palliative Care Management
2009.
Tool. January 2007.
9. Drug Information and Research Centre. Ontario
http://palliativecareswo.ca/PalliativeCareManagme
Pharmacist’s Association. October 2009.
nTool_v3.2.pdf. (Accessed October 14, 2014).
10. Randy Otterholt, DDS General Dentistry.
2. Anon. Slang terms and jargon can cause
http://www.drotterholt.com/magicmouthwash.html.
medication errors. Drugs & Therapy Bulletin.
(Accessed October 14, 2014).
Shands at the University of Florida.
11. Chan A, Ignoffo RJ. Survey of topical oral
November/December 2005. Volume 19, Number
solutions for the treatment of chemo-induced oral
10.
mucositis. J Oncol Pharm Pract 2005;11:139-43.
http://professionals.ufhealth.org/files/2011/11/1005-
12. Chapter 795 Pharmaceutical Compounding--
drugs-therapy-bulletin.pdf. (Accessed October 14,
Nonsterile Preparations. The United States
2014).
Pharmacopeia and The National Formulary (USP-
3. Bulletin Board of Oral Pathology. University at
NF).
Buffalo. 2007.
http://www.usp.org/sites/default/files/usp_pdf/EN/gc
4. North Carolina Board of Pharmacy.
795.pdf. (Accessed October 14, 2014).
http://www.ncbop.org/faqs/Pharmacist/faq_DukesM
agicMouthwash.htm. (Accessed October 14,
2014).
5. Hodgins C, Mosley M, Pola-Strowd M.
Recommendations for the diagnosis and
management of recurrent aphthous stomatitis.
2003. University of Texas at Austin, School of
Nursing.
QUESTION ANSWER
How can oral mucositis be Proper oral hygiene can help minimize severity of oral mucositis.1,2
prevented? Holding ice chips in the mouth, or cryotherapy, during treatment may help prevent mucositis in some
situations.1,3,12
Oral zinc supplements may be helpful in some patients.1
Rx palifermin (Kepivance) is FDA- and Health Canada-approved for prevention of oral mucositis in certain
oncology patients.1,2 It can reduce severity and duration of mucositis.5
What nondrug therapies Maintain proper oral hygiene, such as brushing the teeth with a soft-bristle toothbrush and flossing with gentle
can be recommended for irrigation using a water flosser on a low setting.1,5
patients with oral Avoid irritating foods or beverages (e.g., dry, salty, acidic, hard, hot).5
mucositis? Rinsing frequently, such as every four hours or between medicated mouth rinse doses, with a bland solution, such
as one teaspoon of table salt in 32 oz. (1 L) of water (to make 0.9% sodium chloride) with or without one to two
tablespoons of sodium bicarbonate, can be tried.1,2,5,12 This mixture can be used at room temperature or
refrigerated. The patient should rinse and swish then spit.2 (Note that experts suggest that patients who use well
water make their salt solution with bottled water instead.)
More. . .
Copyright © 2014 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 #301105: Page 2 of 5)
QUESTION ANSWER
What are some An OTC antacid liquid (e.g., Amphojel) or film-forming agent (e.g., Zilactin) can be tried.2
commercially available Rx oral protectants (e.g., Episil, Gelclair [alcohol-free], and MuGard-all U.S. only) may be more convenient than
treatments for oral OTC products.2 However, they can cost $100/week or more.5
mucositis? Commercial kits for compounding “magic mouthwash” are available in the U.S. These include:
o First-Mouthwash BLM (diphenhydramine, lidocaine, aluminum/magnesium hydroxide)
o First-BXN Mouthwash (diphenhydramine, lidocaine, nystatin)
o First-Duke’s Mouthwash (diphenhydramine, hydrocortisone, nystatin)
o First-Mary’s Mouthwash (diphenhydramine, hydrocortisone, nystatin, tetracycline)
Magic mouthwash kits might be easier to e-prescribe and bill for than compounded products. However, kits are
typically about three times more expensive than mixing the mouthwash from scratch using individual ingredients
(approximately $25 to $40 vs $5 to $15), and kits only come in specific combinations and concentrations.6
What are some common The logic behind “magic mouthwash” is to combine ingredients with different mechanisms of action.5 There are
ingredients of numerous magic mouthwash formulations. Most have at least three ingredients. Recipes may contain a
compounded “magic combination of an antibiotic (to reduce the bacterial flora around the lesion), antihistamine (for local anesthetic
mouthwash”? What is the effect), antifungal (to stop any fungal growth), steroid (to reduce inflammation), a local anesthetic/pain reliever, or
rationale for these? an antacid (to enhance coating of the ingredients on the mouth).7
Common ingredients of magic mouthwash recipes include viscous lidocaine, diphenhydramine, milk of magnesia,
kaolin with pectin, and aluminum/magnesium hydroxide.2
The most popular magic mouthwash formulation includes viscous lidocaine and diphenhydramine plus
aluminum/magnesium hydroxide to help ingredients coat the mouth.
How effective is magic There is a lack of controlled studies to evaluate the efficacy of the many different magic mouthwash recipes.
mouthwash? Whether one recipe is more effective than another is unknown.8,12
The 2004 guidelines for the treatment of oral mucositis suggest that magic mouthwashes (with various
combinations of viscous lidocaine, benzocaine, milk of magnesia, kaolin-pectin, chlorhexidine, or
diphenhydramine) are no better than normal saline solution in pain relief.9 In addition, a Cochrane review found
magic mouthwash (containing lidocaine, diphenhydramine, and aluminum hydroxide) to be ineffective in
shortening the healing time of oral mucositis related to cancer therapies.10 There is also concern about the
absorption of anesthetics such as lidocaine when used on damaged mucosa.9
Although frequently used as an ingredient of magic mouthwash, nystatin has not been shown to be effective in
treating oral fungal infection associated with mucositis.7 It is also suggested that the high sugar content of nystatin
suspension may feed the fungus.8
Continued Corticosteroids have not been studied adequately to be recommended as an ingredient of magic mouthwash, and
More. . .
Copyright © 2014 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 #301105: Page 3 of 5)
QUESTION ANSWER
continued there’s concern that long-term use may lead to oral candidiasis.
How effective is magic Despite the lack of evidence that magic mouthwashes work in decreasing the pain associated with
mouthwash? chemotherapy/radiation-induced mucositis, canker sores, or other oral pain conditions, many patients and
prescribers continue to use them. There is a need to standardize the ingredients used to compound magic
mouthwash in order to fully evaluate efficacy.
Where can I find recipes We have a number of different recipes in our PL Chart, Magic Mouthwash Recipes.
for magic mouthwash? Most formulations are used every four to six hours with instructions to hold in the mouth for one to two minutes
then spit out or swallow. (Those with lidocaine should be spit out.)12 Patients should be instructed not to eat or
drink for 30 minutes after use.7
Focal application should be used when possible, instead of widespread topical administration.2
What are some tips for When compounding these mixtures, try to avoid using elixir formulations as the alcohol content can cause
compounding magic stinging. Consider injectable or bulk powder formulations, crushed tablets, or opened capsules if needed.
mouthwash? In some cases injectable formulations are used in place of elixirs. 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 the
place of Maalox. Canadian Kaopectate formulation does not contain bismuth.
The combination of lidocaine and sucralfate in magic mouthwash may not be compatible in some recipes. Some
clinicians report the formation of a thick gel when the two ingredients are mixed.
Prior to dispensing magic mouthwash, pharmacists should verify the formula and patient allergies. Patients should
be counseled regarding the proper use of magic mouthwash (e.g., to shake well before use, hold in mouth for a
minute or two, whether to swallow or not, etc).
What are some tips for Billing for magic mouthwash is not straightforward and varies among different pharmacies. There is no single
billing compounded magic NDC number that can be used to bill for magic mouthwash mixed from individual ingredients. In addition, some
mouthwash products? of the ingredients used in the magic mouthwash are OTC products, which may not be covered by some insurances.
Some pharmacists are left with the option of billing for a single prescription ingredient used for the compound and
for the full bottle used since billing a partial bottle is not allowed by insurance companies. Some pharmacists have
the patient pay cash. In some cases, the dispensing software allows the pharmacist to enter each ingredient used
and the cost of each ingredient for billing. In other cases, pharmacists may choose to bill each ingredient
separately as separate prescriptions.
The magic mouthwash compounding kits each come with a single unique NDC number accounting for all the
Continued ingredients, which can make billing less complicated in some cases. It may be easier to compound with these kits
More. . .
Copyright © 2014 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 #301105: Page 4 of 5)
QUESTION ANSWER
continued than having to measure and mix each individual ingredient. These compounding kits have also gone through
What are some tips for stability testing and have specified stability duration for an expiration date. Lastly, these mouthwashes have added
billing compounded magic flavors and may be better tasting than mouthwashes compounded from scratch. Check insurance coverage before
mouthwash products? assembling the kit. Medicare and Medicaid coverage may be spotty because these are compounding kits, not
approved drug products. However, some managed plans may still cover the kits.
Prescribers should specify mouthwash kits by brand name or specify the magic mouthwash formula.
What beyond-use date Beyond-use dates of these mixtures can vary depending on the ingredients and their individual expiration dates. In
should be assigned to general, per USP standards, if a mixture contains water and is a mucosal liquid, the beyond-use date should not be
compounded magic longer than 30 days (room temperature).7,11 Oral mixtures containing water should have an expiration not longer
mouthwash products? than two weeks (refrigerated).11
How should pain from Start with topical anesthetics such as topical lidocaine, 0.5% doxepin mouth rinse, or diphenhydramine mouth
oral mucositis be rinse.1,2
managed? Keep in mind most magic mouthwash recipes contain a topical anesthetic.
If topical anesthetics don’t provide relief, consider opioids such as an alcohol-free morphine solution to swish and
swallow, transdermal fentanyl, PCA morphine, etc.1,2,5
What treatments for oral Avoid sucralfate or chlorhexidine, because they aren’t likely to help.1,3,4
mucositis should actually Also avoid alcohol-based mouth rinses, which can increase pain.12
be avoided? Avoid using hydrogen peroxide solutions (e.g., 3% hydrogen peroxide diluted 1:1 with water or normal saline) for
more than two days. These may help remove oral debris, but longer periods of use can slow healing.2
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.
More. . .
Copyright © 2014 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 #301105: Page 5 of 5)
Project Leader in preparation of this PL Detail- 7. Chan A, Ignoffo RJ. Survey of topical oral solutions
Document: Stacy A. Hester, R.Ph., BCPS, for the treatment of chemo-induced oral mucositis. J
Oncol Pharm Pract 2005;11:139-43.
Assistant Editor 8. Dodd MJ, Dibble SL, Miaskowski C, et al.
Randomized clinical trial of the effectiveness of 3
References commonly used mouthwashes to treat
1. Lalla RV, Bowen J, Barasch A, et al. MASCC/ISOO chemotherapy-induced mucositis. Oral Surg Oral
clinical practice guidelines for the management of Med Oral Pathol Oral Radiol Endod 2000;90:39-47.
mucositis secondary to cancer therapy. Cancer 9. Rubenstein EB, Peterson DE, Schubert M, et al.
2014;120:1453-61. Clinical practice guidelines for the prevention and
2. NCI. Oral mucositis. treatment of cancer therapy-induced oral and
http://www.cancer.gov/cancertopics/pdq/supportivec gastrointestinal mucositis. Cancer 2004;100(9
are/oralcomplications/HealthProfessional/page5. Suppl):2026-46.
(Accessed October 8, 2014). 10. Clarkson JE, Worthington HV, Eden OB.
3. Worthington HV, Clarkson JE, Bryan G, et al. Interventions for treating oral mucositis for patients
Interventions for preventing oral mucositis for with cancer receiving treatment. Cochrane Database
patients with cancer receiving treatment (Review). Syst Rev 2007;(2):CD001973.
Cochrane Database Syst Rev 2011;(4):CD000978. 11. <795> Pharmaceutical Compounding--Nonsterile
4. Clarkson JE, Worthington HV, Furness S, et al. Preparations. The United States Pharmacopeia and
Interventions for treating oral mucositis for patients The National Formulary (USP-NF).
with cancer receiving treatment. Cochrane Database http://www.usp.org/sites/default/files/usp_pdf/EN/gc7
Syst Rev 2010;(4):CD001973. 95.pdf. (Accessed October 9, 2014).
5. Negrin RS, Bedard J, Toljanic JA. Oral toxicity 12. Bensinger W, Schubert M, Ang K, et al. NCCN task
associated with chemotherapy. Last updated force report: prevention and management of
September 12, 2014. In UpToDate, Basow DS (ed), mucositis in cancer care. January 2008.
UpToDate, Waltham, MA 02013. http://www.nccn.org/JNCCN/PDF/mucositis_2008.pd
6. Cutis Pharmaceuticals. f. (Accessed October 10, 2014).
http://www.cutispharma.com. (Accessed October 9,
2014).
Cite this document as follows: PL Detail-Document, Prevention and Treatment of Oral Mucositis. Pharmacist’s
Letter/Prescriber’s Letter. November 2014.