Sucralfate Information
Sucralfate (Sucralfate)
Sucralfate (Sucralfate) Description
Sucralfate (Sucralfate) Suspension contains Sucralfate (Sucralfate) and Sucralfate (Sucralfate) is an D-glucopyranoside βD-fructo-furanosyl-, octakis-(hydrogen sulfate), aluminum complex.
Sucralfate (Sucralfate) Suspension for oral administration contains 1 g of Sucralfate (Sucralfate) per 10 mL. Sucralfate (Sucralfate) Suspension also contains: colloidal silicon dioxide NF, FD&C Red #40, flavor, glycerin USP, methyl-cellulose USP, methylparaben NF, microcrystalline cellulose NF, purified water USP, simethicone USP, and sorbitol solution USP.
Therapeutic category: antiulcer.
Sucralfate (Sucralfate) Clinical Pharmacology
Sucralfate (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 (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 (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 (Sucralfate) .
Sucralfate (Sucralfate) Clinical Trials
In a multicenter, double-blind, placebo-controlled study of Sucralfate (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 (Sucralfate) suspension to Sucralfate (Sucralfate) tablets has not been demonstrated.
Sucralfate (Sucralfate) Indications And Usage
Sucralfate (Sucralfate) Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Sucralfate (Sucralfate) Contraindications
There are no known contraindications to the use of Sucralfate (Sucralfate) .
Sucralfate (Sucralfate) Precautions
Duodenal ulcer is a chronic, recurrent disease. While short-term treatment with Sucralfate (Sucralfate) can result in complete healing of the ulcer a successful course of treatment with Sucralfate (Sucralfate) should not be expected to alter the posthealing frequency or severity of duodenal ulceration.
Clinical studies of Sucralfate (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.
Sucralfate (Sucralfate) Adverse Reactions
Adverse reactions to Sucralfate (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 (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:
Postmarketing reports of hypersensitivity reactions, including urticaria (hives), angioedema, respiratory difficulty, rhinitis, laryngospasm, and facial swelling have been reported in patients receiving Sucralfate (Sucralfate) tablets. Similar events were reported with Sucralfate (Sucralfate) suspension. However, a causal relationship has not been established.
Bezoars have been reported in patients treated with Sucralfate (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 (Sucralfate) and its insoluble excipients has led to fatal complications, including pulmonary and cerebral emboli. Sucralfate (Sucralfate) is intended for intravenous administration.
Sucralfate (Sucralfate) Overdosage
Due to limited experience in humans with overdosage of Sucralfate (Sucralfate) , no specific treatment recommen-dations 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 (Sucralfate) is only minimally absorbed from the gastrointestinal tract. Risks associated with acute overdosage should, therefore, be minimal. In rare reports describing Sucralfate (Sucralfate) overdose, most patients remained asymptomatic. Those few reports where adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Sucralfate (Sucralfate) Dosage And Administration
The recommended adult oral dosage for duodenal ulcer is 1 g (10 mL/2 teaspoonfuls) four times per day. Sucralfate (Sucralfate) should be administered on an empty stomach.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after Sucralfate (Sucralfate) .
While healing with Sucralfate (Sucralfate) may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination.
Sucralfate (Sucralfate) How Supplied
Sucralfate (Sucralfate) Suspension 1 g/10 mL is a pink suspension.
NDC 54868-5299-1Ten (10) 10 mL oral liquid unit dose cups per tray.Ten (10) trays per shipper.
NDC 54868-5299-0Ten (10) 10 mL oral liquid unit dose cups per tray.Three (3) trays per shipper.
Sucralfate (Sucralfate)
Sucralfate (Sucralfate) Principal Display Panel - Ml Cup Label
NDC 54868-5299-0
Delivers 10 mLShake Well
Store between 20°-25°C (68°-77°F)
