Carafate 1 g/1
Sucralfate · TABLET · Allergan, Inc.
Carafate is a tablet containing sucralfate at 1 g/1, taken oral. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- Carafate
- Generic Name
- Sucralfate
- NDC Code (Product)
58914-171- Manufacturer
- Allergan, Inc.
- Strength
- 1 g/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA018333
- Drug Class
- Aluminum Complex [EPC]
- Marketing Start
- 10/30/1981
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.
Dosage & Administration
DOS A GE AN D A DMINIS T RAT I ON Acti v e Duodenal Ulcer : The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. CARAFATE Oral Suspension should be administered on an empty stomach. Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after CARAFATE Oral Suspension. 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. Elderly : In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (See PRECAUTIONS , Geriatric Use ). Call your doctor for medical advice about side effects. You may report side effects to AbbVie, Inc at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Contraindications
CONTRAINDICATIONS CARAFATE Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.
Drug Interactions
Drug Intera c tions 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 cases studied to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing the concomitant medication 2 hours before sucralfate eliminated the interaction. Due to CARAFATE Oral Suspension’s potential to alter the absorption of some drugs, CARAFATE Oral Suspension should be administered separately from other drugs when alterat…
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 th…
Frequently Asked Questions
What is Carafate used for?
Carafate contains Sucralfate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Carafate a controlled substance?
Carafate is not classified as a controlled substance by the DEA.
What is the generic name for Carafate?
The generic name for Carafate is Sucralfate. There are 11 other brand versions of Sucralfate.
What is the NDC code for Carafate 1 g/1?
The NDC (National Drug Code) for Carafate 1 g/1 is 58914-171, listed by Allergan, Inc..