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
Prilosec Warnings, Precautions, Pregnancy, Nursing, Abuse - Omeprazole
Prilosec Warnings, Precautions, Pregnancy, Nursing, Abuse - Omeprazole
WARNINGS
PRECAUTIONS
General: Symptomatic response
to therapy with omeprazole does not preclude the presence of gastric
malignancy.
Atrophic gastritis
has been noted occasionally in gastric
corpus biopsies from
patients treated long-term with omeprazole.
Information for the Patient: Omeprazole delayed-release
capsules should be taken before eating. Patients should be cautioned
that the omeprazole
delayed-release capsule
should not be opened, chewed or crushed, and should be swallowed
whole.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
In two 24-month carcinogenicity studies in rats, omeprazole
at daily doses of 1.7, 3.4, 13.8, 44.0 and 140.8 mg/kg/day (approximately
4 to 352 times the human
dose, based on a patient
weight of 50 kg
and a human dose
of 20 mg) produced gastric
ECL cell carcinoids in
a dose-related manner in both male
and female rats; the
incidence of this
effect was markedly higher
in female rats, which
had higher blood levels
of omeprazole. Gastric carcinoids seldom occur in the untreated
rat. In addition, ECL cell
hyperplasia was
present in all treated groups of both sexes. In
one of these studies, female rats were treated with 13.8 mg
omeprazole/kg/day (approximately 35 times the human
dose) for one year, then followed for an additional year without
the drug. No carcinoids were seen in these rats. An
increased incidence of treatment-related ECL cell
hyperplasia was
observed at the end of one
year (94% treated vs 10% controls). By the second year the difference
between treated and control
rats was much smaller (46% vs 26%) but still showed more hyperplasia
in the treated group. An
unusual primary malignant
tumor in the stomach
was seen in one rat (2%).
No similar tumor was seen
in male or female rats
treated for two years. For this strain
of rat no similar tumor
has been noted historically, but a finding involving only one tumor
is difficult to interpret. A 78-week mouse
carcinogenicity study of omeprazole did not wshow
increased tumor occurrence,
but the study was not conclusive.
Omeprazole was not mutagenic in an in vitro Ames Salmonella
typhimurium assay, an in vitro mouse
lymphoma cell
assay and an in vivo rat liver
DNA damage assay. A mouse
micronucleus test
at 625 and 6250 times the human
dose gave a borderline
result, as did an in vivo bone marrow chromosome
aberration test.
A second mouse micronucleus
study at 2000 times the human
dose, but with different (suboptimal) sampling
times, was negative.
In a rat fertility and
general reproductive
performance test,
omeprazole in a dose range
of 13.8 to 138.0 mg/kg/day (approximately 35 to 345 times the human
dose) was not toxic or
deleterious to the
reproductive performance
of parental animals.
Pregnancy Category C: Teratology studies conducted
in pregnant rats at doses up to 138 mg/kg/day (approximately 345
times the human dose) and in pregnant
rabbits at doses up to 69 mg/kg/day (approximately 172 times the
human dose) did not disclose
any evidence for a
teratogenic potential of omeprazole.
In rabbits, omeprazole
in a dose range
of 6.9 to 69.1 mg/kg/day (approximately 17 to 172 times the human
dose) produced dose-related increases in embryo-lethality, fetal
resorptions and pregnancy disruptions. In
rats, dose-related embryo/fetal toxicity and postnatal
developmental
toxicity were observed in offspring resulting from parents treated
with omeprazole 13.8
to 138.0 mg/kg/day (approximately 35 to 345 times the human
dose). There are no adequate or well-controlled studies in pregnant
women. Sporadic reports have been received of congenital
abnormalities occurring in infants born to women who have received
omeprazole during
pregnancy. Omeprazole should be used during pregnancy only if the
potential benefit
justifies the potential
risk to the fetus.
Nursing Mothers: It is not known whether omeprazole
is excreted in human milk.
In rats, omeprazole
administration
during late gestation and lactation
at doses of 13.8 to 138 mg/kg/day (35 to 345 times the human
dose) resulted in decreased weight
gain in pups. Because many
drugs are excreted in human
milk, because of the potential
for serious adverse reactions in nursing
infants from omeprazole, and because of the potential for tumorigenicity
shown for omeprazole
in rat carcinogenicity studies,
a decision should be made whether to discontinue nursing
or to discontinue the drug, taking into account the importance of
the drug to the mother.
Pediatric Use: Safety and effectiveness
in children have not been established.
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