Fatal complications, including
pulmonary and cerebral emboli have occurred with inappropriate intravenous
administration of CARAFATE Oral Suspension. Administer CARAFATE Oral Suspension
only by the oral route. Do not administer intravenously.
The physician should read the
“ PRECAUTIONS ” section when considering the use of CARAFATE Oral
Suspension in pregnant or pediatric patients, or patients of childbearing
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
Episodes of hyperglycemia have
been reported in diabetic patients. Close monitoring of glycemia in diabetic
patients treated with CARAFATE Oral Suspension is recommended. Adjustment of
the anti-diabetic treatment dose during the use of CARAFATE Oral Suspension
might be necessary.
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, 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 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.
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.
Safety and effectiveness in pediatric patients have not
Clinical studies of CARAFATE Oral Suspension did not
include sufficient numbers of subjects aged 65 and over to determine whether
they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the elderly and
younger patients. 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 DOSAGE AND ADMINISTRATION).
This drug is known to be substantially excreted by the kidney, and the risk of
toxic reactions to this drug may be greater in patients with impaired renal
function (See PRECAUTIONS Special Populations: Chronic Renal
Failure and Dialysis Patients). Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection, and it
may be useful to monitor renal function.