Sucralfate () is only minimally absorbed from the gastrointestinal tract. The small amounts of the sulfated disaccharide that are absorbed are excreted primarily in the urine.
Although the mechanism of Sucralfate () ’s ability to accelerate healing of duodenal ulcers remains to be fully defined, it is known that it exerts its effect through a local, rather than systemic, action. The following observations also appear pertinent:
These observations suggest that Sucralfate () ’s antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attack by acid, pepsin, and bile salts. There are approximately 14 to 16 mEq of acid-neutralizing capacity per 1-g dose of Sucralfate () .
In a multicenter, double-blind, placebo-controlled study of Sucralfate () Suspension, a dosage regimen of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.
Equivalence of Sucralfate () suspension to Sucralfate () tablets has not been demonstrated.
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Sucralfate () can result in complete healing of the ulcer, a successful course of treatment with Sucralfate () should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
Clinical studies of Sucralfate () Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See )
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. (See ) Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse reactions to Sucralfate () tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with Sucralfate () , adverse effects were reported in 129 (4.7%).
Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system:
Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting
Dermatological: pruritus, rash
Nervous System: dizziness, insomnia, sleepiness, vertigo
Other: back pain, headache
Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Sucralfate () tablets. Similar events were reported with Sucralfate () suspension. However, a causal relationship has not been established.
Bezoars have been reported in patients treated with Sucralfate () . The majority of patients had underlying medical conditions that may predispose to bezoar formation (such as delayed gastric emptying) or were receiving concomitant enteral tube feedings.
Inadvertent injection of insoluble Sucralfate () and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate () is not intended for intravenous administration.
Due to limited experience in humans with overdosage of Sucralfate () , no specific treatment recommendations can be given. Acute oral studies in animals, however, using doses up to 12 g/kg body weight, could not find a lethal dose. Sucralfate () is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing Sucralfate () overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Sucralfate () Suspension 1 g/10 mL is a pink suspension supplied in unit dose cups of 10 mL packaged in trays of 10, NDC 0121-0747-10.
SHAKE WELL BEFORE USING.
AVOID FREEZING.
Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
