CARAFATE Suspension Prescribing Information for Physicians

CARAFATE Suspension works locally with minimal absorption

How does CARAFATE work?

Although the mechanism of CARAFATE Suspension’s ability to accelerate healing of duodenal ulcer is not fully defined, it is thought that antiulcer activity is the result of formation of an ulcer-adherent complex that covers the ulcer site¹

H elps protect the ulcer site against further attack of acid, pepsin, and bile salts, as suggested by in vitro and human studies¹

E ncourages the formation of proteinaceous exudate at the ulcer site, as observed in human studies and with animal models of ulcer disease¹

A dsorbs bile salts, as observed in vitro¹

L eaves behind a sucralfate-albumin film, which acts as a barrier to the diffusion of hydrogen ions, as observed in vitro¹

CARAFATE Suspension dosage of 10 ml (1 g) four times daily was demonstrated to be superior in ulcer healing

CARAFATE Suspension healing rates for acute duodenal ulcer.

Data from a multicenter, double-blind, placebo-controlled study of 292 patients with duodenal ulcer. Patients were treated with 1 g (10 mL) of CARAFATE Suspension or placebo four times daily. Equivalence of sucralfate suspension to sucralfate tablets has not been demonstrated.¹

^*P=0.016.

^†P=0.001.

^ǂP=0.0001.

CARAFATE Suspension is a ready-to-use liquid

Recommended adult dosing for CARAFATE Suspension is 1 g (10 mL) four times per day¹
- CARAFATE Suspension should be administered on an empty stomach¹
- Antacids may be prescribed as needed for relief of pain but should not be taken within one-half hour before or after sucralfate¹
While healing with CARAFATE Suspension may occur during the first week or two, treatment should be continued for four to eight weeks unless healing has been demonstrated by x-ray or endoscopic examination¹

Write DAW (dispense as written) or the equivalent for your state, to ensure your patient gets CARAFATE Suspension.

IMPORTANT SAFETY INFORMATION

Contraindications

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

Warnings

Administer CARAFATE only by the oral route. Do not administer intravenously as fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration.

Precautions

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 treated with sucralfate suspension. Close monitoring of glycemia in diabetic patients is recommended and adjustment of the anti-diabetic treatment dose during treatment with sucralfate suspension may be necessary.

Special Populations

Patients with chronic renal failure or those receiving dialysis have impaired excretion of absorbed aluminum; aluminum accumulation and toxicity have been described in patients with renal impairment. Sucralfate should be used with caution in patients with chronic renal failure.
Safety and effectiveness in pediatric patients have not been established.
Dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range.

Drug Interactions

Subtherapeutic prothrombin times with concomitant warfarin and sucralfate therapy have been reported.
Because of its potential 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.

Adverse Reactions

The most common adverse reaction was constipation (2%).

INDICATIONS and USAGE

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

Please also see the full Prescribing Information for CARAFATE.