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Pronunciation:

(soo KRAL fate)

U.S. Brand Names:

Carafate®

Synonyms:

Aluminum Sucrose Sulfate, Basic

Generic Available:

Yes

Canadian Brand Names:

Apo-Sucralate®; Novo-Sucralate; Nu-Sucralate; PMS-Sucralate; Sulcrate®; Sulcrate® Suspension Plus

Use:

Short-term management of duodenal ulcers; maintenance of 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:

Pregnancy Implications:

No data available; available evidence suggests safe use during pregnancy.

Lactation:

Enters breast milk/compatible

Contraindications:

Hypersensitivity to sucralfate or any component of the formulation

Warnings/Precautions:

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

Adverse Reactions:

1% to 10%: Gastrointestinal: Constipation

<1%: Back pain, bezoar formation, diarrhea, dizziness, gastric discomfort; hypersensitivity (pruritus, urticaria, angioedema); indigestion, insomnia, nausea, pruritus, rash, sleepiness, vertigo, vomiting, xerostomia

Overdosage/Toxicology:

Toxicity is minimal, may cause constipation

Drug Interactions:

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

Note: When given with aluminum-containing antacids, may increase serum/body aluminum concentrations (see Warnings/Precautions)

Ethanol/Nutrition/Herb Interactions:

Food: Sucralfate may interfere with absorption of vitamin A, vitamin D, vitamin E, and vitamin K.

Stability:

Suspension: Shake well. Refrigeration is not necessary; 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 protects the 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: Dose not established, doses of 40-80 mg/kg/day divided every 6 hours have been used

Stomatitis (unlabeled use): 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 (unlabeled use): 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:

Tablet may be broken or dissolved in water before ingestion. Administer with water on an empty stomach.

Dietary Considerations:

Administer 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.

Nursing Implications:

Monitor for constipation; administer other medications 2 hours before sucralfate

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

Dosage Forms:

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

Carafate®: 1 g/10 mL (420 mL)

Tablet (Carafate®): 1 g

International Brand Names:

Alsucral® (CO, CZ, FI, SG); Alusulin® (HU); Ancrusal® (PL); Andapsin® (SE); Antepsin® (AR, BD, BR, DK, FI, GB, IE, IT, NO, TR); Apo-Sucralate® (CA); Benofat® (ID); Calfate® (PT); Carafate® (AU, NZ); Citogel® (IT); Crafilm® (IT); Dip® (CO, EC); Escudo® (IT); Gastalfet® (BD); Gastrocol® (CL); Gastrofait® (JO, KW, LB, RO); Gastrogel® (CH, IT); Hexagastron® (DK); Inpepsa® (ID); Ipagastril® (IT); Kéal® (FR, LU); Mulcatel® (CL); Neciblok® (ID); Netunal® (AR); Novo-Sucralate (CA); Nu-Sucralate (CA); Peptiliz® (TR); PMS-Sucralate (CA); Sucrabest® (DE, LU); Sucrafen® (TH); Sucrager® (IT); Sucralan® (AT, PL, RO); Sucralate® (IL); Sucralbene® (AT); Sucralfat® (BG); Sucralfate® (GB, PL); Sucralfat Genericon® (AT); Sucralfato Denver® (AR); Sucralfato Ecar® (CO); Sucralfato Merck® (IT, PT); Sucralfato Pliva® (IT); Sucralfato Teva® (IT); Sucralfat-ratiopharm® (DE); Sucralfin® (IT); Sucralmax® (AR); Sucralstad® (AT); Sucral® (TH); Sucralum® (PT); Sucramal® (CY, EC, EG, IT, JO, KW, LB, MA, MT, SY); Sucramed® (AT); Sucraphil® (DE, RO); Sucrassyl® (HN, SV); Sucrate Gel® (TH); Sucrate® (IT, RU); Sugar® (IT); Sugast® (IT); Sulcran® (CL); Sulcrate® (CA); Sulcrate® Suspension Plus (CA); Suratio® (PL); Suril® (IT); Ulcar® (FR); Ulcefate® (TH); Ulcerlmin® (JP); Ulcermin® (PT); Ulcertec® (SG); Ulcetab® (ZA); Ulcogant® (AT, BE, CH, CR, CZ, DE, DO, GT, HN, HU, LU, NL, PA, PL, SV); Ulcon® (EC); Ulcrafate® (TH); Ulcrast® (IT); Ulcumaag® (ID); Ulcyte® (AU); Ulgastran® (PL); Ulsafate® (ID); Ulsanic® (HK, ID, IL, TH, ZA); Ulsidex® (ID); Urbal® (ES); Venter® (CZ, HU, PL, RO, RU, SI); Zenodian® (IT)

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.

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