No information provided.
The physician should read the “PRECAUTIONS”
section when considering the use of CARAFATE in pregnant or pediatric patients,
or patients of childbearing potential.
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 duodenal ulceration.
Episodes of hyperglycemia have been reported in diabetic
patients. Close monitoring of glycemia in diabetic patients treated with
sucralfate suspension is recommended. Adjustment of the anti-diabetic treatment
dose during the use of sucralfate suspension might be necessary.
Special Populations : Chronic Renal Failure And Dialysis
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 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.