Carafate
Generic: SUCRALFATE
Basic Information
Manufacturer
Allergan, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
0fb67b1c-b4c0-46f2-8a81-df1510e006aa
Indications & Usage
INDICATIONS AND USAGE CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Warnings
WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of CARAFATE Oral Suspension.
Administer CARAFATE Oral Suspension only by the oral route.
Do not administer intravenously.
Administer CARAFATE Oral Suspension only by the oral route.
Do not administer intravenously.
Adverse Reactions
ADV E RSE R EACTI O NS 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 Derm a tolog i cal: pruritus, rash Ner v ous S y s tem: dizziness, insomnia, sleepiness, vertigo Oth e r: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.
Cases of hyperglycemia have been reported with 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.
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 Derm a tolog i cal: pruritus, rash Ner v ous S y s tem: dizziness, insomnia, sleepiness, vertigo Oth e r: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of sucralfate oral suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria.
Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate.
Cases of hyperglycemia have been reported with 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.