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Prevacid Side Effects, and Drug Interactions - Lansoprazole

SIDE EFFECTS

Worldwide, over 6100 patients have been treated with lansoprazole in Phase 2-3 clinical trials involving various dosages and duration of treatment. In general, lansoprazole treatment has been well tolerated in both short-term and long-term trials.

The following adverse events were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole treated patients and occurred at a greater rate in lansoprazole-treated patients than placebo-treated patients (see TABLE 17).

Body System/	Lansoprazole	Placebo
TABLE 17 Incidence of Possibly or Probably Treated-Related Averse Events in Short-term, Placebo-Controlled Studies
Adverse Event	(N=1457) %	(N=467) %
Body as a Whole
Abdominal Pain	1.8	1.3
Digestive System
Diarrhea	3.6	2.6
Nausea	1.4	1.3

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea is similar between patients who received placebo and patients who received lansoprazole 15 mg and 30 mg, but higher in the patients who received lansoprazole 60 mg patients (2.9, 1.4, 4.2, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

Additional Adverse Experiences Occurring in <1% of Patients or Subjects in Domestic and/or International Trials, or Occurring Since the Drug was Marked

Body as a Whole: Asthenia, candidiasis, chest pain (not otherwise specified), edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise.
Cardiovascular System: Angina, cerebrovascular accident, hypertension/hypotension, myocardial infarction, palpitations, shock (circulatory failure), vasodilation.
Digestive System: Melena, anorexia, bezoar, cardiospasm, cholelithiasis, constipation, dry mouth/thirst, dyspepsia, dysphagia, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastroenteritis, gastrointestinal hemorrhage, hematemesis, increased appetite, increased salivation, rectal hemorrhage, stomatitis, tenesmus, ulcerative colitis, vomiting.
Endocrine System: Diabetes mellitus, goiter, hyperglycemia/hypoglycemia.
Hematologic and Lymphatic System: Agranulocytosis, anemia, aplastic anemia, hemolysis, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura. (The majority of hematologic cases received were foreign-sourced and their relationship to lansoprazole was unclear.)
Metabolic and Nutritional Disorders: Gout, weight gain/loss.
Musculoskeletal System: Arthritis/arthralgia, musculoskeletal pain, myalgia.
Nervous System: Agitation, amnesia, anxiety, apathy, confusion, depression, dizziness/syncope, hallucinations, hemiplegia, hostility aggravated, libido decreased, nervousness, paresthesia, thinking abnormality.
Respiratory System: Asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, pneumonia, upper respiratory inflammation/infection.
Skin and Appendages: Acne, alopecia, pruritis, rash, urticaria.
Special Senses: Amblyopia, deafness, eye pain, visual field defect, speech disorder, otitis media, taste perversion, tinnitus.
Urogenital System: Abnormal menses, albuminuria, breast enlargement/gynecomastia, breast tenderness, glycosuria, hematuria, impotence, kidney calculus, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with lansoprazole plus amoxicillin and clarithromycin, and lansoprazole plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with lansoprazole, amoxicillin, or clarithromycin.

Triple Therapy: Lansoprazole/amoxicillin/clarithromycin: The most frequently reported adverse events for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse events between the 10- and 14-day triple therapy regimens. No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Lansoprazole/amoxicillin: The most frequently reported adverse events for patients who received lansoprazole tid plus amoxicillin tid dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with lansoprazole tid plus amoxicillin tid dual therapy than with lansoprazole alone.

For more information, see amoxicillin, ADVERSE REACTIONS and clarithromycin, ADVERSE REACTIONS.

Laboratory Values

The following changes in laboratory parameters were reported as adverse events.

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, eosinophilia, hyperlipemia, increased/decreased electrolytes, increased/decreased cholesterol, increased glucocorticoids, increased LDH, increase/decreased/abnormal platelets and increased gastrin levels. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (ALT) and SGPT (AST) were evaluated, 0.4% (1/250) placebo patients and 0.3% (2/795) lansoprazole patients had enzyme elevations greater than three times the upper limit of normal range at the first final treatment visit. None of these patients reported jaundice at any time during the study.

In clinical trials using combination therapy with lansoprazole plus amoxicillin and clarithromycin, and lansoprazole plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For more information on laboratory value changes, see amoxicillin,

SIDE EFFECTS

and clarithromycin,
SIDE EFFECTS
.

DRUG INTERACTIONS

Lansoprazole is metabolized through the cytochrome P₄₅₀ system, specifically through the CYP3A and CYP2C19 isozymes. Studies have shown that lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P₄₅₀ system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, clarithromycin, or terfenadine in healthy subjects. These compounds are metabolized through various cytochrome P₄₅₀ isozymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. When lansoprazole was administered concomitantly with theophylline (CYP1A2, CYP3A), a minor increase (10%) in the clearance of theophylline was seen. Because the small magnitude and the direction of the effect on theophylline clearance, this interaction is unlikely to be clinical concern. Nonetheless, individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood levels.

Lansoprazole has also been shown to have no clinically significant interaction with amoxicillin.

In a single-dose crossover study examining lansoprazole 30 mg and omeprazole 20 mg each administered alone and concomitantly with sucralfate 1 gram, absorption of the proton pump inhibitors was delayed and their bioavailability was reduced by 17% and 16%, respectively, when administered concomitantly with sucralfate. Therefore, proton pump inhibitors should be taken at least 30 minutes prior to sucralfate. In clinical trials, antacids were administered concomitantly with lansoprazole delayed-release capsules; this did not interfere with its effect.

Lansoprazole causes a profound and long lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that lansoprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, ampicillin esters, iron salts, digoxin).

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