CONTRAINDICATIONS
There are no known contraindications to the use of sucralfate.
PRECAUTIONS
General
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 posthealing frequency or severity of duodenal ulceration.
Special Populations: Chronic Renal Failure and Dialysis Patients: When sucralfate is
administered orally, small amounts of aluminum are absorbed from the gastrointestinal tract.
Concomitant use of sucralfate with other products that contain aluminum, such as
aluminum-containing antacids, may increase the total body burden of aluminum. Patients with
normal renal function receiving the recommended doses of sucralfate and aluminum-containing
products adequately excrete aluminum in the urine. Patients with chronic renal failure or those
receiving dialysis have impaired excretion of absorbed aluminum. In addition, aluminum does not
cross dialysis membranes because it is bound to albumin and transferrin plasma proteins. Aluminum
accumulation and toxicity (aluminum osteodystrophy, osteomalacia, encephalopathy) have been
described in patients with renal impairment. Sucralfate should be used with caution in patients with
chronic renal failure.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Chronic oral toxicity studies of 24 months' duration were conducted in mice and rats at doses up to
1 g/kg (12 times the human dose). There was no evidence of drug-related tumorigenicity. A
reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of
fertility impairment. Mutagenicity studies were not conducted.
Pregnancy, Teratogenic Effects, Pregnancy Category B
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. Because animal reproduction
studies are not always predictive of human response, this drug should be used during pregnancy
only if clearly needed.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in
human milk, caution should be exercised when sucralfate is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.