Criteria for Outpatient Use Guidelines

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[Developed, October 2000 (formerly a component of Anti-Ulcer Therapy criteria); Revised, November 2001; October 2002; November 2003; December 2005; June 2009; September 2009]

Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*].

1.* Dosage

Adults
Sucralfate is FDA-approved to prevent and treat duodenal ulcers. The maximum daily dose for sucralfate when prescribed as acute therapy to treat duodenal ulcers is 4 grams per day. Dosage regimens exceeding this maximum recommended value will be reviewed. Maintenance sucralfate dosages for duodenal ulcer should not exceed 2 grams per day. Dosage regimens exceeding this maximum recommended value will be reviewed.

While sucralfate has been utilized off-label for managing oral chemotherapy- and radiotherapy-induced mucositis in cancer patients, recent clinical trials have not documented significant clinical benefit with sucralfate compared to placebo. Sucralfate has also been used anecdotally to manage oral mucosal problems in palliative care patients, but trials are lacking that demonstrate statistically significant benefit and use may induce nausea in patients already subject to this adverse experience.

Pediatrics
Sucralfate safety and efficacy have not been established in the pediatric population.

2. Duration of Therapy

Clinical studies document a maximum treatment duration of 56 days (eight weeks) for anti-ulcer therapy in the treatment of acute duodenal ulcer. The Texas Vendor Drug Program limits reimbursement for sucralfate to 62 days per calendar year at the maximum daily acute treatment dose. This treatment duration has been allotted to allow a 31 day supply per prescription. Treatment regimens at acute dosage levels lasting longer than 62 days will be reviewed.

Maintenance therapy at the recommended daily maintenance dose may be continued indefinitely based on patient need.

References

1. Drug facts and comparisons. Facts and Comparisons 4.0 [database online]. St. Louis, MO: Wolters
   Kluwer Health, Inc.; 2009. Available at: http://online.factsandcomparisons.com. Accessed May
   29th, 2009.
2. Klasko RK (Ed): DRUGDEX® System (electronic version). Thomson Micromedex, Greenwood Village, CO, USA. Available at: http://www.thomsonhc.com . Accessed May 29th, 2009.
3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2009. Available at: http://www.clinicalpharmacology.com. Accessed May 29th, 2009.
4. Soll AH. Pharmacology of antiulcer medications. In: UpToDate, Rose BD (ed), UpToDate, Waltham, MA, 2009. Accessed May 29th, 2009.
5. Cappell MS. Gastric and duodenal ulcers during pregnancy. Gastroenterol Clin N Am. 2003;32:263-308.
6. Hui WM, Lam SK, Lok AS, Ng MM, Lai CL. Maintenance therapy for duodenal ulcer: a randomized controlled comparison of seven forms of treatment. Am J Med. 1992;92:265-74.
7. Archimandritis A, Charitopoulos N, Diamantis T, et al. Comparison of sucralfate and ranitidine twice daily in duodenal ulcer treatment: a multicenter randomized double-blind study. J Clin Gastroenterol. 1991;13:380-3.
8. Drugs for treatment of peptic ulcers. Med Lett Drugs Ther. 1997;39:1-4.
9. McCarthy DM. Sucralfate. N Engl J Med. 1991;3251017-25.
10. Worthington HV, Clarkson JE, Eden TOB. Interventions for treating oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2007;(4):CD000978.
11. Saadeh CE. Chemotherapy- and radiotherapy-induced oral mucositis: review of preventive strategies and treatment. Pharmacotherapy. 2005;25(4):540-554.
12. Barker G, Loftus L, Cuddy P, Barker B. The effects of sucralfate suspension and diphenhydramine syrup plus kaolin-pectin on radiotherapy-induced mucositis. Oral Surg Oral Med Oral Pathol. 1991;71:288-93.
13. Goldstein NE, Genden E, Morrison S. Palliative care for patients with head and neck cancer. “I would like a quick return to a normal lifestyle”. JAMA. 2008;299(15):1818-25.

Prepared by: Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.