CARAFATE SUMMARY
CARAFATE Tablets contain sucralfate and sucralfate is an (alpha)-D-glucopyranoside, ß-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
CARAFATE® (sucralfate) is indicated in:
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Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with 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.
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Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
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NEWS HIGHLIGHTS
Published Studies Related to Carafate (Sucralfate)
Topical sucralfate treatment of anal fistulotomy wounds: a randomized placebo-controlled trial. [2011.06]
BACKGROUND: Sucralfate is a cytoprotective agent which adheres to mucoproteins and forms a protective barrier at wound sites. In oral form it is a common ulcer medication, and as a topical preparation it has been used to treat a wide variety of wounds. OBJECTIVE: The present study was designed to evaluate the effectiveness and safety of topical sucralfate in wound healing after anal fistulotomy... CONCLUSIONS: The results of this study add support to the evidence that topical sucralfate is a safe and effective method for promoting mucosal healing and for providing analgesia during wound treatment. Patients undergoing anal fistulotomy can benefit from the use of topical application of sucralfate.
Topical sucralfate in post-adenotonsillectomy analgesia in children: a double-blind randomized clinical trial. [2009.09]
OBJECTIVES: Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures in pediatric otolaryngology. Despite its relative simplicity, pain is the main cause of morbidity in the postoperative period. We determined the effect of topical sucralfate on reduction of oropharyngeal pain in children submitted to adenotonsillectomy. Secondary outcomes were otalgia, analgesic use, type of diet, secondary bleeding, vomiting, fever, and weight loss... CONCLUSION: We found beneficial effect of use of sucralfate in reduction of oropharyngeal pain in the postoperative period of adenotonsillectomy. However, topical sucralfate does not have a potent effect to the point of being utilized as a single analgesic treatment. Because it is simple, safe, tolerated, and low-cost, it is an important tool as adjuvant treatment of post-tonsillectomy pain.
Anti-inflammatory Effects of Rebamipide According to Helicobacter pylori Status in Patients with Chronic Erosive Gastritis: A Randomized Sucralfate-Controlled Multicenter Trial in China-STARS Study. [2008.11]
The aim of the study was to investigate the effects of rebamipide on symptom, histology, endogenous prostaglandin, and mucosal oxygen free radicals in chronic erosive gastritis (CEG) patients by using sucralfate as a control. The trial also examined whether Helicobacter pylori infection would affect rebamipide-induced protection...
Anti-inflammatory Effects of Rebamipide According to Helicobacter pylori Status in Patients with Chronic Erosive Gastritis: A Randomized Sucralfate-Controlled Multicenter Trial in China-STARS Study. [2008.02.21]
The aim of the study was to investigate the effects of rebamipide on symptom, histology, endogenous prostaglandin, and mucosal oxygen free radicals in chronic erosive gastritis (CEG) patients by using sucralfate as a control. The trial also examined whether Helicobacter pylori infection would affect rebamipide-induced protection...
Efficacy of sucralfate in the postoperative management of uvulopalatopharyngoplasty: a double-blind, randomized, controlled study. [2006.10]
OBJECTIVE: To evaluate the effectiveness of sucralfate in influencing throat pain, otalgia, analgesic requirement, bleeding, mucosal recovery, and incidence of postoperative bleeding in patients undergoing uvulopalatopharyngoplasty... CONCLUSIONS: Although sucralfate therapy may not provide complete analgesia after uvulopalatopharyngoplasty, it may reduce the amount of analgesic required, thus preventing dose-related adverse effects from the analgesic agent. It can also significantly reduce the total number of days needed to return to normal daily activities (P=.41).
Clinical Trials Related to Carafate (Sucralfate)
A Study to Evaluate the Efficacy of Teprenone On Chinese Patients With Chronic Non-Atrophic Erosive Gastritis [Recruiting]
Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrogen Chloride (HCl) for the Treatment of Radiation-Induced Mucositis [Recruiting]
Radiation treatment is very effective for treating cancers of the head and neck, however,
during the course of treatment, it is common for patients to experience soreness of their
mouth and throat due to the radiation. When radiation causes inflammation of the inside of
the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to
prevent and treat mucositis, but none of these have been shown to be superior to another.
This study is being conducted to see if using a combination of magic mouthwash and
sucralfate is better than using a single mouthwash called benzydamine at decreasing the
burden of mucositis.
A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia [Completed]
Objective of this study was to determine incidence, risk factors, etiological micro-organisms
and their antimicrobial susceptibility pattern and outcome of VAP; and to study effect of
ranitidine vs. sucralfate, used for stress ulcer prophylaxis, on gastric colonization and on
occurrence of VAP.
Methods: Design: Prospective randomized study. Setting: ICUs of Medicine Department and
Anesthesiology Department, Maulana Azad Medical College and Lok Nayak Hospital, University of
Delhi, New Delhi. Patients: 50 patients of age more than 12 years, who had been on ventilator
for more than 48 hrs. Intervention: Endotracheal Aspirate and blood sample of all patients
were cultured to determine micro-organisms causing VAP and their antimicrobial susceptibility
pattern. Patients were divided into 2 groups on random basis. The first group was given
ranitidine for stress ulcer prophylaxis while the second was given sucralfate. Thereafter,
difference in gastric colonization (on basis of quantitative culture of nasogastric aspirate)
and on occurrence of VAP in both the groups was compared.
Study Hypothesis: Study was designed to create data about Ventilator associated pneumonia in
developing countries like India. This data is crucial for providing information for deciding
future guidelines for treatment of and prevention of Ventilator associated pneumonia. Further
to test the hypothesis that H2 blockers, by virtue of raising gastric Ph, increase gastric
colonization by pathogenic organism and increase incidence of Ventilator associated
pneumonia; patients were divided into two groups on random basis, as described above.
Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit [Recruiting]
Although stress ulcer is a complication that can cause mortality and morbidity in critical
patients, there is still lack of consensus about its prophylaxis. There is also few data
available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer
sucralfate (a mucosal protective agent) for the sake of less associated nosocomial
pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for
stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and
the tablets are soluble for the use of tube feeding. Our previous study showed that there
was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and
sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence
of nosocomial pneumonia was also similar.
We will enroll those patients that have received intracranial surgery and admitted to
neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7
days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg
qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the
following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test,
NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We
define the end point as overt bleeding, death or transfer out of ICU. We will compare the
prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis [Recruiting]
Although stress ulcer is a complication that can cause significant mortality and morbidity
in critical patients with risk factors, there is still lack of consensus about its
prophylaxis. There are also few data available from Taiwan. H2 blockers are commonly used
due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less
association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have
good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form
of proton pump inhibitor that was approved by FDA. There are some reports about its
application for treatment of peptic ulcer bleeding. It also has good acid suppression effect
in patients under critical care. We expect that intravenous pantoprazole will have a role in
stress ulcer prophylaxis.
We will enroll those patients that have received major abdominal surgery and admitted to
surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days
within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv
bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will
monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool
character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic
examination will be performed. We define the end point as overt bleeding, death or transfer
out of ICU. We will compare the prevalence of UGI bleeding and ventilator associated
pneumonia in these 2 groups
Reports of Suspected Carafate (Sucralfate) Side Effects
Gastrooesophageal Reflux Disease (5),
Vomiting (5),
Nausea (5),
OFF Label USE (4),
Feeling Abnormal (4),
Headache (3),
Foreign Body (3),
Treatment Noncompliance (2),
Abdominal Pain Upper (2),
Malaise (2), more >>
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Page last updated: 2011-12-09
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