CARAFATE® (sucralfate) is indicated in:

• Short-term treatment (up to 8 weeks) of active duodenal ulcer. 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.
• Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.

Active Duodenal Ulcer. The recommended adult oral dosage for duodenal ulcer is 1 g four times per day 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.

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.

Maintenance Therapy: The recommended adult oral dosage is 1 g twice a day.

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)

CARAFATE (sucralfate) 1 g tablets are supplied in bottles of 100 (NDC 58914-171-10), 120 (NDC 58914-171-21), and 500 (NDC 58914-171-50). Light pink, scored, oblong tablets are embossed with CARAFATE on one side and 1712 on the other.

Axcan Scandipharm Inc. 22 Inverness Center, Parkway, Birmingham, AL 35242. www.axcan.com.
FDA Rev date: 4/26/2007

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