Sucralfate

Indications

INDICATIONS AND USAGE Sucralfate tablets are 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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.

Contraindications

CONTRAINDICATIONS Sucralfate tablets are contraindicated in patients with known hypersensitivity reactions to the active substance or to any of the excipients.

Pregnancy

Pregnancy Teratogenic effects Teratogenicity studies have been performed in mice, rats, and rabbits at doses up to 50 times the human dose and have revealed no evidence of harm to the fetus due to sucralfate. There are, however, no adequate and well-controlled studies in pregnant women.

Storage and supply

HOW SUPPLIED Sucralfate 1 g tablets, USP are supplied in bottles of 100, and 500. White, oblong, bisected tablets debossed with "N'' and ''S1'' on one side. Bottles of 30...........NDC 68071-3478-3 Store at 20° to 25°C (68° to 77°F) . Manufacture by: Nostrum Laboratories, Inc. Kansas City, MO 64120 November 2019 Rx Only

Source: Sucralfate (Sucralfate) — US FDA prescribing information, 2025-01-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.