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
Prevacid Warnings, Precautions, Pregnancy, Nursing, Abuse - Lansoprazole
Prevacid Warnings, Precautions, Pregnancy, Nursing, Abuse - Lansoprazole
WARNINGS
CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL
CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE. IF PREGNANCY
OCCURS WHILE TAKING CLARITHROMYCIN, THE PATIENT SHOULD BE APPRISED OF
THE POTENTIAL HAZARD TO THE FETUS. (SEE WARNINGS
IN PRESCRIBING INFORMATION FOR CLARITHROMYCIN).
Pseudomembranous colitis
has been reported with nearly all antibacterial agents, including
clarithromycin and amoxicillin, and may range
in severity from mild to life
threatening. Therefore, it is important to consider this diagnosis
in patients who present
with diarrhea subsequent
to the administration of antibacterial
agents.
Treatment with antibacterial
agents alters the normal
flora of the colon and
may permit overgrowth
of clostridia. Studies indicate that a toxin produced by Clostridium
difficile is a primary cause
of “antibiotic-associated colitis”.
After the diagnosis
of pseudomembranous colitis
has been established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to discontinuation
of the drug alone. In
moderate to severe cases, consideration should be given to management
with fluids and electrolytes, protein
supplementation, and treatment
with an antibacterial drug clinically effective against Clostridium
difficile colitis.
Serious and occasionally fatal
hypersensitivity (anaphylactic) reactions have been reported in
patients on penicillin
therapy. These reactions are more apt to occur in individuals with
a history of penicillin
hypersensitivity and/or a history of sensitivity to multiple
allergens.
There have been well documented reports of individuals with a history
of penicillin hypersensitivity
reactions who have experienced severe hypersensitivity reactions
when treated with a cephalosporin. Before initiating therapy with
any penicillin, careful inquiry should be made concerning previous
hypersensitivity reactions to penicillins, cephalosporins, and other
allergens. If an allergic
reaction occurs, amoxicillin
should be discontinued and the appropriate
therapy instituted.
SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT
WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT,
INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS
INDICATED.
PRECAUTIONS
General
Symptomatic response
to therapy with lansoprazole
does not preclude the presence of gastric
malignancy.
Information for the Patient
Lansoprazole should be taken before eating.
For patients who have difficulty swallowing
capsules, lansoprazole
delayed-release capsules can be opened, and the intact granules
contained within can be sprinkled on one tablespoon
of applesauce and swallowed immediately. The granules should not
be chewed or crushed. The granules have also been shown in vitro
to remain intact when exposed to apple, cranberry, grape, orange,
pineapple, prune, tomato, and V-8® vegetable
juice and stored up to
30 minutes.
For patients who have a nasogastric
tube in place, lansoprazole
delayed-release capsules can be opened and the intact granules mixed
in 40 ml of apple juice and
injected through the
nasogastric tube
into the stomach. After administering the granules, the nasogastric
tube should be flushed
with additional apple juice
to clear the tube.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
In two 24-month carcinogenicity studies, Sprague-Dawley rats were
treated orally with doses of 5 to 150 mg/kg/day, about 1 to 40 times
the exposure on a body surface
(mg/m2) basis, of a 50 kg
person of average height
(1.46 m2 body surface
area) given the recommended human dose of 30 mg/day (22.2 mg/m2).
Lansoprazole produced dose-related gastric enterochromaffin-like
(ECL) cell hyperplasia
and ECL cell carcinoids
in both male and female
rats. It also increased the incidence
of intestinal metaplasia of the gastric
epithelium in both
sexes. In male
rats, lansoprazole produced a dose-related increase of testicular
interstitial cell
adenomas. The incidence
of these adenomas in rats receiving doses of 15 to 150 mg/kg/day
(4 to 40 times the recommended human
dose based on body surface
area) exceeded the low background incidence
(range = 1.4 to 10%) for this strain
of rat. Testicular interstitial
cell adenoma
also occurred in 1 of 30 rats treated with 50 mg/kg/day (13 times
the recommended human
dose based on body surface
area) in a 1-year toxicity study.
In a 24-month carcinogenicity study, CD-1 mice were treated orally
with doses of 15 to 600 mg/kg/day, 2 to 80 times the recommended
human dose based on body
surface area. Lansoprazole
produced as dose-related increased incidence of gastric
ECL cell hyperplasia. It
also produced an increased incidence of liver
tumors (hepatocellular adenoma
plus carcinoma). The tumor incidences in male
mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended
human dose
based on body surface
area) and female mice treated with 150 to 600 mg/kg/day (20 to 80
times the recommended human dose
based on body surface
area) exceeded the ranges of background incidences in historical
controls for this strain
of mice. Lansoprazole treatment produced adenoma
of rete testis
in male mice receiving
75 to 600 mg/kg/day (10 to 80 times the recommended human
dose based on the body
surface area).
Lansoprazole was not genotoxic
in the Ames test, the ex vivo rat hepatocyte
unscheduled DNA synthesis
(UDS) test, the in vivo mouse micronucleus
test or the rat
bone marrow
cell chromosomal aberration
test. It was positive
in in vitro human
lymphocyte chromosomal
aberration assays.
Lansoprazole oral doses
up to 150 mg/kg/day (40 times the recommended human dose
based on body surface
area) was found to have no effect
on fertility and reproductive
performance of male
and female rats.
Pregnancy, Teratogenic Effects, Pregnancy Category B
Lansoprazole: Teratology studies have been performed
in pregnant rats at oral
doses up to 150 mg/kg/day (40 times the recommended human dose
based on body surface
area) and pregnant
rabbits at oral doses up
to 30 mg/kg/day (16 times the recommended human
dose based on body surface
area) and have revealed no evidence
of impaired fertility or harm to the fetus due to lansoprazole.
There are, however, no adequate or 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.
Clarithromycin, Pregnancy Category C: See WARNINGS
and clarithromycin before using in pregnant
women.
Nursing Mothers
Lansoprazole or its metabolites are excreted in the milk
of rats. It is not known whether lansoprazole
is excreted in human milk.
Because many drugs are excreted in human
milk, because of the potential
for serious adverse reactions in nursing
infants from lansoprazole, and because of the potential
for tumorigenicity shown for lansoprazole
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.
Use in Women
Over 800 women were treated with lansoprazole. Ulcer healing
rates in females are similar to those in males. The incidence
rates of adverse events are also similar to those seen in males.
Use in Geriatric Patients
Ulcer healing rates
in elderly patients are similar to those in a younger age group.
The incidence rates
of adverse events and laboratory test
abnormalities are also similar to those seen in younger patients.
For elderly patients, dosage and administration
of lansoprazole
need not be altered for
a particular indication.
top
