Sucralfate

What it is used for

Sucralfate oral suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.

How to take it

Active Duodenal Ulcer: The recommended adult oral dosage for duodenal ulcer is 1 gram (10 mL) four times per day. Sucralfate 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 sucralfate 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 Glenmark Pharmaceutical Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side effects, and when to stop

Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2,700 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

Dermatological: pruritus, rash

Nervous System: dizziness, insomnia, sleepiness, vertigo

Other: 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.

Who should not take it

Sucralfate 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 sucralfate oral suspension. Administer sucralfate oral suspension only by the oral route. Do not administer intravenously.

The physician should read the “PRECAUTIONS” section when considering the use of sucralfate oral suspension 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.

Episodes of hyperglycemia have been reported in diabetic patients. Close monitoring of glycemia in diabetic patients treated with sucralfate oral suspension is recommended. Adjustment of the anti-diabetic treatment dose during the use of sucralfate oral suspension might be necessary.