No

Gastrointestinal Agent, Miscellaneous

Short-term management of duodenal ulcers

B

Clinical effects on the fetus: No data available; available evidence suggests safe use during pregnancy and breast-feeding

Breast-feeding/lactation: No data available. American Academy of Pediatrics has NO RECOMMENDATION.

Hypersensitivity to sucralfate or any component

Successful therapy with sucralfate should not be expected to alter the posthealing frequency of recurrence or the severity of duodenal ulceration; use with caution in patients with chronic renal failure who have an impaired excretion of absorbed aluminum. 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

1% to 10%: Gastrointestinal: Constipation

<1%: Dizziness, sleepiness, vertigo, insomnia, rash, pruritus, diarrhea, nausea, vomiting, gastric discomfort, indigestion, xerostomia, back pain

Toxicity is minimal, may cause constipation

Decreased effect: Digoxin, phenytoin (hydantoins), warfarin, ketoconazole, quinidine, ciprofloxacin, norfloxacin (quinolones), tetracycline, theophylline; because of the potential for sucralfate to alter the absorption of some drugs, separate administration (take other medications 2 hours before sucralfate) should be considered when alterations in bioavailability are believed to be critical

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 protects the lining against peptic acid, pepsin, and bile salts.

Onset of action: Paste formation and ulcer adhesion occur within 1-2 hours

Duration: At least 6 hours

Absorption: Oral: <5%

Distribution: Acts locally at ulcer sites; unbound in the GI tract to aluminum and sucrose octasulfate

Metabolism: Not metabolized

Elimination: Small absorbed amounts are excreted in urine as unchanged compounds

Oral:

Stomatitis: 2.5-5 mL (1 g/10 mL suspension), swish and spit or swish and swallow 4 times/day

Adults:

Stress ulcer prophylaxis: 1 g 4 times/day

Stress ulcer 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, the elderly may require 12 weeks

Maintenance: Prophylaxis: 1 g twice daily

Stomatitis: 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

Interferes with absorption of vitamin A, vitamin D, vitamin E, and vitamin K.

Oral: Tablet may be broken or dissolved in water before ingestion

May cause drowsiness, dizziness, or insomnia

None reported

No information available to require special precautions

No effects or complications reported

Take recommended dose before meals or on an empty stomach. Take any other medications at least 2 hours before taking sucralfate. Do not take antacids within 30 minutes of taking sucralfate. May cause constipation; increased exercise, increased dietary fiber, fruit or fluids, or mild stool softener may be helpful. If constipation or gastric distress persists, consult prescriber.

Monitor for constipation; administer other medications 2 hours before sucralfate

Suspension, oral: 1 g/10 mL (420 mL)

Tablet: 1 g

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.

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.

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.