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Carafate Suspension

Peptic ulcer facts

  • Peptic ulcers are sores in the lining of the stomach or duodenum.
  • Peptic ulcer formation is related to H. pylori bacteria in the stomach and nonsteroidal anti-inflammatory medications (NSAIDs) in 50% of patients. For the remaining 50% there are miscellaneous or unknown causes.
  • Ulcer pain may not correlate with the presence or severity of ulceration.
  • The main symptom of peptic ulcer is upper abdominal pain which can be dull, sharp, or burning. (Bloating and burping are not symptoms of peptic ulcer, and vomiting, poor appetite, and nausea are uncommon symptoms of peptic ulcer.)
  • Diagnosis of ulcer is made with upper GI series or endoscopy.
  • Treatment of ulcers involves antibiotic combinations along with stomach acid suppression to eradicate H. pylori, eliminating precipitating factors such as NSAIDs and stomach acid suppression...

Carafate Suspension

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CLINICAL PHARMACOLOGY

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 adsorbs 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 1g dose of sucralfate.

Clinical Trials

In a multicenter, double-blind, placebo-controlled study of CARAFATE Suspension (sucralfate) , a dosage regiment of 1 g (10 mL) four times daily was demonstrated to be superior to placebo in ulcer healing.

Results From Clinical Trials Healing Rates for Acute Duodenal Ulcer

Treatment n Week 2 Healing Rates Week 4 Healing Rates Week 8 Healing Rates
CARAFATE Suspension 145 23 (16%)* 66 (46%)† 95 (66%)‡
Placebo 147 10 (7%) 39 (27%) 58 (39%)
*P=0.016
†P=0.001
‡ P=0.0001

Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.

Last reviewed on RxList: 2/9/2011
This monograph has been modified to include the generic and brand name in many instances.

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