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Carafate
Overview
What is Carafate?
CARAFATE Tablets contain sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex.
Tablets for oral administration contain 1 g of sucralfate.
Also contain: D & C Red #30 Lake, FD&C Blue #1 Lake, magnesium stearate, microcrystalline cellulose, and starch. Therapeutic category: antiulcer.
What does Carafate look like?
What are the available doses of Carafate?
Sorry No records found.
What should I talk to my health care provider before I take Carafate?
Sorry No records found
How should I use Carafate?
CARAFATE (sucralfate) is indicated in:
Active Duodenal Ulcer.
Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate.
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.
What interacts with Carafate?
Sorry No Records found
What are the warnings of Carafate?
Sorry No Records found
What are the precautions of Carafate?
Sorry No Records found
What are the side effects of Carafate?
Sorry No records found
What should I look out for while using Carafate?
Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.
What might happen if I take too much Carafate?
Due to limited experience in humans with overdosage of sucralfate, no specific treatment recommendations can be given. Acute oral toxicity 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.
How should I store and handle Carafate?
Store at 25°C (77°F); excursions permitted to 15-30°C (5986°F) [see USP Controlled Room Temperature]. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. CARAFATE (sucralfate) 1g tablets are supplied in bottles of 100 (NDC 58914-171-10). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other. Rx Only Prescribing Information rev. November 2016 Distributed by:Allergan USA, Inc.Irvine, CA 92612 © 2016 Allergan. All rights reserved. CARAFATE® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate.
Clinical Information
Chemical Structure
No Image foundClinical 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:
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.
Non-Clinical Toxicology
Carafate is contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.Some studies have shown that simultaneous sucralfate administration in healthy volunteers reduced the extent of absorption (bioavailability) of single doses of the following: cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline. Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported in spontaneous and published case reports. However, two clinical studies have demonstrated no change in either serum warfarin concentration or prothrombin time with the addition of sucralfate to chronic warfarin therapy.
The mechanism of these interactions appears to be nonsystemic in nature, presumably resulting from sucralfate binding to the concomitant agent in the gastrointestinal tract. In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Because of the potential of CARAFATE to alter the absorption of some drugs, CARAFATE should be administered separately from other drugs when alterations in bioavailability are felt to be critical. In these cases, patients should be monitored appropriately.
The physician should read the " PRECAUTIONS " section when considering the use of this drug in pregnant or pediatric patients, or patients of childbearing potential.
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 post healing frequency or severity of duodenal ulceration.
Isolated reports of sucralfate tablet aspiration with accompanying respiratory complications have been received. Therefore, sucralfate tablets should be used with caution by patients who have known conditions that may impair swallowing, such as recent or prolonged intubation, tracheostomy, prior history of aspiration, dysphagia, or any other conditions that may alter gag and cough reflexes, or diminish oropharyngeal coordination or motility.
Adverse reactions to sucralfate in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate tablets, 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:
Dermatological:
Nervous System:
Other:
Post-marketing:
Cases of anaphylactic reactions, bronchospasm, laryngeal edema, edema of the mouth, Pharyngeal edema, respiratory tract edema and swelling of the face have been reported with an unknown oral formulation of sucralfate.
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 intended for intravenous administration.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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