Carafate

Product Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form:

NDC: 58914-170

Application: NDA019183

Effective: 20230608

INDICATIONS AND USAGE CARAFATE (sucralfate) Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

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.

CONTRAINDICATIONS CARAFATE Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.

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.

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.