Sucralfate

Trade Names:
Carafate
- Tablets 1 g
- Suspension 1 g/10 mL

Pharmacology

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Adheres to ulcer in acidic gastric juice, forming protective layer that serves as barrier against acid, bile salts, and enzymes present in stomach and duodenum.

Pharmacokinetics

Absorption

Sucralfate is minimally absorbed from the GI tract. Binding to the ulcer site has been shown for up to 6 h; approximately 30% of a dose is retained within the GI tract for at least 3 h.

Distribution

Approximately 95% of a dose remains in the GI tract, with only minute amounts being distributed into liver, kidneys, skeletal muscle, adipose tissue, and skin.

Elimination

Sucralfate is eliminated primarily in urine. Following reaction of sucralfate with hydrochloric acid, nonmetabolized sucrose sulfate is formed in the GI tract.

Duration

Duration of action of sucralfate depends on the time that the drug is in contact with the site because sucralfate exerts its effects directly at the site of the ulcer.

Indications and Usage

Short-term treatment of duodenal ulcer; maintenance therapy of duodenal ulcer (tablets only).

Unlabeled Uses

Treatment of gastric ulcers; reflux and peptic esophagitis; treatment of NSAID- or aspirin-induced GI symptoms and mucosal damage; prevention of stress ulcers and GI bleeding in critically ill patients; treatment of oral and esophageal ulcers caused by radiation, chemotherapy, and sclerotherapy; treatment of oral ulcerations and dysphagia in patients with epidermolysis bullosa.

Contraindications

Standard considerations.

Dosage and Administration

PO 1 g 4 times daily on empty stomach (1 h before meals and at bedtime) for 4 to 8 wk.

1 g twice daily.

Drug Interactions

May increase total body burden of aluminum.

Oral absorption and pharmacologic action of these agents may be reduced if given with sucralfate. Administer 2 h apart from sucralfate.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Dizziness; insomnia; vertigo; headache.

Dermatologic

Rash; pruritus.

GI

Constipation (2%); diarrhea; nausea; vomiting; dry mouth; indigestion; flatulence.

Miscellaneous

Back pain.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Chronic renal failure/dialysis

Small amounts of aluminum may be absorbed from sucralfate, and concomitant use of other aluminum-containing products may increase total body burden of aluminum. Aluminum is not removed by dialysis and excretion through kidneys is impaired in patients with chronic renal failure. Aluminum accumulation and toxicity (eg, aluminum osteodystrophy, osteomalacia, encephalopathy) have occurred.

Overdosage

Symptoms

Dyspepsia, abdominal pain, nausea, vomiting.

Patient Information

• Advise patient to take prescribed dose with a full glass of water, on empty stomach, at least 1 h before meals and at bedtime.
• Advise patient that initial treatment of ulcer requires taking prescribed dose 4 times daily, but that maintenance treatment is usually just 2 doses/day. Advise patient taking 2 doses/day to take first dose before breakfast and the second dose before bedtime.
• Advise patient using suspension to shake suspension well before measuring dose and to use a dosing cup or spoon to measure prescribed dose.
• Advise patient to continue to take as prescribed, even after ulcer symptoms have gone away, to ensure max healing of the ulcer.
• Advise patient that antacids can be used as needed for pain relief, but to take at least 30 min before or after the sucralfate.
• Advise patient to take other medications either 2 h before or after sucralfate to minimize effects on absorption.
• Advise patient that constipation is the most common side effect and that increasing fluid and fiber intake may prevent this problem from developing.
• Advise patient to notify health care provider if symptoms do not improve or appear to be getting worse, or if intolerable side effects (eg, constipation) develop.

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