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Medication Safety Issues
Sound-alike/look-alike issues:
Sucralfate may be confused with salsalate
Carafate® may be confused with Cafergot®
Pronunciation
(soo KRAL fate)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Short-term (?8 weeks) management of duodenal ulcers; maintenance therapy for duodenal ulcers
Use: Unlabeled/Investigational
Gastric ulcers; suspension may be used topically for treatment of stomatitis due to cancer chemotherapy and other causes of esophageal and gastric erosions; GERD, esophagitis; treatment of NSAID mucosal damage; prevention of stress ulcers; postsclerotherapy for esophageal variceal bleeding
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies. Sucralfate is only minimally absorbed following oral administration.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to sucralfate or any component of the formulation
Warnings/Precautions
Disease-related concerns:
• Duodenal ulceration: Because sucralfate acts locally at the ulcer, successful therapy with sucralfate should not be expected to alter the posthealing frequency of recurrence or the severity of duodenal ulceration.
• Renal impairment: Use with caution in patients with chronic renal failure; sucralfate is an aluminum complex, small amounts of aluminum are absorbed following oral administration. Excretion of aluminum may be decreased in patients with chronic renal failure.
Concurrent drug therapy issues:
• Altered absorption: Because of the potential for sucralfate to alter the absorption of some drugs, separate administration (take other medication 2 hours before sucralfate) should be considered when alterations in bioavailability are believed to be critical.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children.
Adverse Reactions
1% to 10%: Gastrointestinal: Constipation (2%)
<1%, postmarketing, and/or case reports: Back pain, bezoar formation, diarrhea, dizziness, flatulence, headache, gastric discomfort; hypersensitivity (urticaria, angioedema, facial swelling, laryngospasm, respiratory difficulty, rhinitis); indigestion, insomnia, nausea, pruritus, rash, sleepiness, vertigo, vomiting, xerostomia
Drug Interactions
Antifungal Agents (Azole Derivatives, Systemic): Sucralfate may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Miconazole. Risk C: Monitor therapy
Digoxin: Sucralfate may decrease the serum concentration of Digoxin. Specifically, sucralfate may decrease the absorption of digoxin. Management: Administer digoxin at least 2 hours before or at least 6 hours after sucralfate. Risk D: Consider therapy modification
Eltrombopag: Sucralfate may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any polyvalent cation (e.g., aluminum-containing products such as sucralfate) by at least 4 hours. Risk D: Consider therapy modification
Levothyroxine: Sucralfate may decrease the serum concentration of Levothyroxine. Risk C: Monitor therapy
Phosphate Supplements: Sucralfate may decrease the absorption of Phosphate Supplements. Risk D: Consider therapy modification
QuiNIDine: Sucralfate may decrease the serum concentration of QuiNIDine. Specifically, sucralfate may decrease the absorption of quinidine. Management: Administer quinidine at least 2 hours before or at least 6 hours after sucralfate. Risk D: Consider therapy modification
Quinolone Antibiotics: Sucralfate may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Tetracycline Derivatives: Sucralfate may decrease the absorption of Tetracycline Derivatives. Management: Administer the tetracycline derivative at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Sucralfate may diminish the anticoagulant effect of Vitamin K Antagonists. Sucralfate may decrease the serum concentration of Vitamin K Antagonists. Specifically, sucralfate may decrease the absorption of Vitamin K Antagonists. Management: Administer vitamin K antagonists at least 2 hours before or at least 6 hours after sucralfate. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Sucralfate may interfere with absorption of vitamin A, vitamin D, vitamin E, and vitamin K.
Storage
Suspension: Shake well. Store at 20°C to 25°C (68°F to 77°F); do not freeze.
Mechanism of Action
Forms a complex by binding with positively charged proteins in exudates, forming a viscous paste-like, adhesive substance. This selectively forms a protective coating that acts locally to protect the gastric lining against peptic acid, pepsin, and bile salts.
Pharmacodynamics/Kinetics
Onset of action: Paste formation and ulcer adhesion: 1-2 hours
Duration: Up to 6 hours
Absorption: Oral: <5%
Distribution: Acts locally at ulcer sites; unbound in GI tract to aluminum and sucrose octasulfate
Metabolism: None
Excretion: Urine (small amounts as unchanged compounds)
Dosage
Oral:
Children (unlabeled use): Doses of 40-80 mg/kg/day divided every 6 hours have been used
Stomatitis (unlabeled use): 5-10 mL (1 g/10 mL suspension), swish and spit or swish and swallow 4 times/day
Adults:
Stress ulcer (unlabeled use):
Prophylaxis: 1 g 4 times/day
Treatment: 1 g every 4 hours
Duodenal ulcer:
Treatment: 1 g 4 times/day on an empty stomach and at bedtime for 4-8 weeks, or alternatively 2 g twice daily; treatment is recommended for 4-8 weeks in adults
Maintenance: Prophylaxis: 1 g twice daily
Stomatitis (unlabeled use): 10 mL (1 g/10 mL suspension), swish and spit or swish and swallow 4 times/day
Dosage comment in renal impairment: Aluminum salt is minimally absorbed (<5%), however, may accumulate in renal failure
Administration: Oral
Tablet may be broken or dissolved in water before ingestion. Administer with water on an empty stomach.
Dietary Considerations
Take with water on an empty stomach.
Patient Education
Take recommended dose with water on an empty stomach, 1 hour before or 2 hours after meals. Take any other medications at least 2 hours before taking sucralfate. Do not take antacids (if prescribed) within 30 minutes of taking sucralfate. May cause constipation (increased exercise, fluids, fruit, or fiber may help). If constipation persists, consult prescriber for approved stool softener.
Geriatric Considerations
Caution should be used in the elderly due to reduced renal function. Patients with Clcr <30 mL/minute may be at risk for aluminum intoxication. Due to low side effect profile, this may be an agent of choice in the elderly with PUD.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness, dizziness, or insomnia
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Use caution is presence of renal failure. Assess potential for interactions with other pharmacological agents patient may be taking (eg, will affect absorption of concurrently administered drugs). Assess therapeutic effectiveness (reduction in clinical symptoms) and adverse reactions. Teach patient proper use (eg, timing of other medications), possible side effects (eg, constipation) and interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, oral: 1 g/10 mL (10 mL)
Carafate®: 1 g/10 mL (420 mL)
Tablet: 1 g
Carafate®: 1 g
Pricing: U.S. (www.drugstore.com)
Suspension (Carafate)
1 g/10 mL (420): $84.00
Tablets (Carafate)
1 g (30): $44.99
Tablets (Sucralfate)
1 g (90): $32.99
References
Algozzine GJ, Hill G, Scoggins WG, et al, “Sucralfate Bezoar,” N Engl J Med, 1983, 309(22):1387.
Allison RR, Vongtama V, Vaughan J, et al, “Symptomatic Acute Mucositis Can Be Minimized or Prophylaxed by the Combination of Sucralfate and Fluconazole,” Cancer Invest, 1995, 13(1):16-22.
Barker G, Loftus L, Cuddy P, et al, “The Effects of Sucralfate Suspension and Diphenhydramine Syrup Plus Kaolin-Pectin on Radiotherapy-Induced Mucositis,” Oral Surg Oral Med Oral Pathol, 1991, 71(3):288-93.
Collard HR, Saint S, and Matthay MA, “Prevention of Ventilator-Associated Pneumonia: An Evidence-Based Systematic Review,” Ann Intern Med, 2003, 138(6):494-501.
Cook D, Guyatt G, Marshall J, et al, “A Comparison of Sucralfate and Ranitidine for the Prevention of Upper Gastrointestinal Bleeding in Patients Requiring Mechanical Ventilation. Canadian Critical Care Trials Group,” N Engl J Med, 1998, 338(12):791-7.
Domingo JL, Gomez M, Llobet JM, et al, “Comparative Effects of Several Chelating Agents on the Toxicity, Distribution, and Excretion of Aluminum,” Hum Toxicol, 1988, 7(3):259-62.
Epstein JB and Wong FL, “The Efficacy of Sucralfate Suspension in the Prevention of Oral Mucositis Due to Radiation Therapy,” Int J Radiat Oncol Biol Phys, 1994, 28(3):693-8.
Gonzalez Sanchez JM, Serna Juan SA, Galindo Sacristan E, et al, “Aluminum Intoxication After Parenteral Sucralfate Administration,” Farmacia Clinica, 1994, 11:760-4.
Loprinzi CL, Ghosh C, Camoriano J, et al, “Phase III Controlled Evaluation of Sucralfate to Alleviate Stomatitis in Patients Receiving Fluorouracil-Based Chemotherapy,” J Clin Oncol, 1997, 15(3):1235-8.
Makkonen TA, Bostrom P, Vilja P, et al, “Sucralfate Mouth Washing in the Prevention of Radiation-Induced Mucositis: A Placebo-Controlled Double-Blind Randomized Study,” Int J Radiat Oncol Biol Phys, 1994, 30(1):177-82.
Overdahl MC and Wewers MD, “Acute Occlusion of a Mainstem Bronchus by a Rapidly Expanding Foreign Body,” Chest, 1994, 105(5):1600-2.
Robertson JA, Salusky IB, Goodman WG, et al, “Sucralfate, Intestinal Aluminum Absorption, and Aluminum Toxicity in a Patient on Dialysis,” Ann Intern Med, 1989, 111(2):179-81.
International Brand Names
Lexi-Comp.com
Last full review/revision July 2009
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