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Sucralfate

Pronunciation

(soo KRAL fate)

Index Terms

  • Aluminum Sucrose Sulfate, Basic

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

Carafate: 1 g/10 mL (420 mL) [contains fd&c red #40, methylparaben; cherry flavor]

Tablet, Oral:

Carafate: 1 g [scored; contains fd&c blue #1 aluminum lake]

Generic: 1 g

Brand Names: U.S.

  • Carafate

Pharmacologic Category

  • Gastrointestinal Agent, Miscellaneous

Pharmacology

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.

Absorption

Oral: Minimal from GI tract

Distribution

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

Metabolism

None

Excretion

Primarily urine (small amounts of sulfated disaccharide)

Onset of Action

Paste formation and ulcer adhesion: 1 to 2 hours; acid neutralizing capacity: ~14 to 16 mEq/1 g dose of sucralfate

Use: Labeled Indications

Duodenal ulcer: Short-term (≤8 weeks) treatment of active duodenal ulcers; maintenance therapy for duodenal ulcers (tablets only)

Contraindications

Hypersensitivity to sucralfate or any component of the formulation

Dosing: Adult

Duodenal ulcer: Oral:

Active duodenal ulcer: Suspension, tablet: Initial: 1 g 4 times daily for 4 to 8 weeks

Maintenance therapy: Tablet: 1 g twice daily

Dosing: Geriatric

Refer to adult dosing. Use with caution; initiate at low end of dosage range.

Dosing: Pediatric

Esophagitis (off-label use): Oral: Limited data available: (Arguelles-Martin 1989)

Infants ≥3 months of age and Children <6 years of age: 500 mg 4 times daily.

Children ≥6 years of age and Adolescents: 1,000 mg 4 times daily.

Peptic ulcer, adjunct therapy (off-label use): Infants, Children, and Adolescents (limited data available): Oral: 40 to 80 mg/kg/day divided every 6 hours (maximum: 1,000 mg/dose) (Kliegman 2016; Nelson 1996)

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling. Aluminum salt is minimally absorbed; however, may accumulate in renal impairment; use with caution in patients with chronic renal failure or on dialysis.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling.

Extemporaneously Prepared

Note: Commercial oral suspension is available (100 mg/mL).

A 66.67 mg/mL oral suspension may be made with tablets. Add eight 1 g tablets to a 120 mL glass bottle. Add 40 mL of SWFI and allow tablets to dissolve (~2 minutes). Add 40 mL of sorbitol 70% solution and shake well. In a separate container, dissolve 2 flavor packets (Vari-Flavors; Ross Laboratories) with 10 mL of water, and swirl until dissolved then add to drug mixture. Add SWFI to make 120 mL. Label "shake well" and "refrigerate". Use within 2 weeks.

Ferraro JM. Sucralfate suspension for mouth ulcers. Drug Intell Clin Pharm. 1985;19(6):480.3839180

Administration

Administer on an empty stomach. Shake suspension well before use. Do not administer antacids within 30 minutes of administration of sucralfate.

Dietary Considerations

Take with water on an empty stomach.

Storage

Suspension: Store at 20°C to 25°C (68°F to 77°F); do not freeze.

Tablet: Store at 15°C to 30°C (59°F to 86°F).

Drug Interactions

Cholic Acid: Sucralfate may decrease the absorption of Cholic Acid. Consider therapy modification

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. Consider therapy modification

Dolutegravir: Sucralfate may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after sucralfate. Consider therapy modification

Eltrombopag: Sucralfate may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of sucralfate. Consider therapy modification

Furosemide: Sucralfate may decrease the serum concentration of Furosemide. Sucralfate may impair the absorption of furosemide. Management: Avoid concomitant oral administration of furosemide and sucralfate. Separate administration by at least 2 hours. Does not apply to parenterally administered furosemide. Consider therapy modification

Ketoconazole (Systemic): Sucralfate may decrease the serum concentration of Ketoconazole (Systemic). Monitor therapy

Levothyroxine: Sucralfate may decrease the serum concentration of Levothyroxine. Monitor therapy

Multivitamins/Fluoride (with ADE): May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum may be increased. Sucralfate may decrease the serum concentration of Multivitamins/Fluoride (with ADE). More specifically, sucralfate may impair the absorption of fluoride. Management: Avoid administration of aluminum-containing products, such as sucralfate, within at least 1-2 hours of fluoride administration. In patients with severe renal dysfunction, consider avoiding this combination altogether. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Avoid combination

Phosphate Supplements: Sucralfate may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Administering oral phosphate supplements at least 1 hour before or 2 hours after administration of sucralfate may reduce the significance of the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. 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. Consider therapy modification

Quinolones: Sucralfate may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after the sucralfate dose. Greater separation of doses may further lessen the risk for a significant interaction. Exceptions: LevoFLOXacin (Oral Inhalation). Consider therapy modification

Sulpiride: Sucralfate may decrease the serum concentration of Sulpiride. Management: Separate administration of sucralfate and sulpiride by at least 2 hours in order to minimize the impact of sucralfate on sulpiride absorption. Consider therapy modification

Tetracyclines: Sucralfate may decrease the absorption of Tetracyclines. Management: Administer the tetracycline derivative at least 2 hours prior to sucralfate in order to minimize the impact of this interaction. Consider therapy modification

Vitamin D Analogs: May increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Avoid combination

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. Consider therapy modification

Adverse Reactions

1% to 10%: Gastrointestinal: Constipation (2%)

<1% (Limited to important or life-threatening): Anaphylaxis, bezoar formation; hypersensitivity (urticaria, angioedema, facial swelling, laryngospasm, respiratory difficulty, rhinitis)

Warnings/Precautions

Disease-related concerns:

• Diabetes: Hyperglycemia has been reported with sucralfate suspension in patients with diabetes; monitor glycemia closely; adjustment of antidiabetic treatment may be necessary.

• 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 or on dialysis, increasing the risk of aluminum accumulation and toxicity (eg, aluminum osteodystrophy, osteomalacia, and encephalopathy).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Tablets: Use with caution in patients with conditions that may impair swallowing (eg, recent or prolonged intubation, tracheostomy, dysphagia, history of aspiration) or other conditions that may alter gag/cough reflexes, or diminish oropharyngeal coordination or motility; aspiration with accompanying respiratory complications has been reported.

Other warnings/precautions:

• Administration: Administer sucralfate by oral route only; fatal complications, including cerebral and pulmonary emboli, have been reported with inadvertent IV administration of sucralfate.

Monitoring Parameters

Blood glucose levels (in diabetic patients receiving oral suspension).

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Sucralfate is only minimally absorbed following oral administration. Based on available data, use of sucralfate does not appear to increase the risk of adverse fetal events when used during the first trimester (Mahadevan, 2006).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience constipation. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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