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.
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 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.
top
