SUCRALFATE SUSPENSION 1 g/10 mL

R_X Only

Sucralfate Suspension contains sucralfate and sucralfate is an α-D-glucopyranoside β-D-fructo-furanosyl-, octakis-(hydrogen sulfate), aluminum complex.

Sucralfate Suspension for oral administration contains 1 g of sucralfate per 10 mL. 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 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:

1. Studies in human subjects and with animal models of ulcer disease have shown that sucralfate forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
2. In vitro, a sucralfate-albumin film provides a barrier to diffusion of hydrogen ions.
3. In human subjects sucralfate given in doses recommended for ulcer therapy inhibits pepsin activity in gastric juice by 32%.
4. In vitro, sucralfate absorbs bile salts.

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.

Sucralfate Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

There are no known contraindications to the use of sucralfate.

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.

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 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 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.

NDC 54868-5299-1
Ten (10) 10 mL oral liquid unit dose cups per tray.
Ten (10) trays per shipper.

NDC 54868-5299-0
Ten (10) 10 mL oral liquid unit dose cups per tray.
Three (3) trays per shipper.

SHAKE WELL BEFORE USING

Distributed by:
Axcan Scandipharm Inc.
Birmingham, AL 35242 USA

Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK       74146

LI 770
Rev. 11/07

NDC 54868-5299-0

image of package label

SUCRALFATE
Suspension
1 g/10 mL

Delivers 10 mL
Shake Well

Store between 20°-25°C (68°-77°F)