A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Carafate Warnings, Precautions, Pregnancy, Nursing, Abuse - Sucralfate
Carafate Warnings, Precautions, Pregnancy, Nursing, Abuse - Sucralfate
WARNINGS
No Information Provided.
PRECAUTIONS
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.
Drug Interactions
See DRUG INTERACTIONS Section.
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
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 sulcralfate.
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.
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