CONTRAINDICATIONS
Lansoprazole is contraindicated in patients with known hypersensitivity to any component of the
formulation.
Lansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity
to any component of the formulation.
Amoxicillin is contraindicated in patients with a known hypersensitivity to any penicillin. (Please
refer to full prescribing information for amoxicillin before prescribing.)
Clarithromycin is contraindicated in patients with a known hypersensitivity to any macrolide
antibiotic, and in patients receiving terfenadine therapy who have preexisting cardiac abnormalities
or electrolyte disturbances. (Please refer to clarithromycin before prescribing.)
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.