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U.S. Department of Health and Human Services


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Prevpac (lansoprazole 30 mg/amoxicillin 500 mg/clarithromycin 500 mg) April 2009

Label approved 04/01/2009 is not available on Drugs@FDA


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • A history of allergic reaction to any of the penicillins is a contraindication.
  • Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin,
    erythromycin, or any of the macrolide antibiotics.


  • Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving clarithromycin therapy.
  • Information for Patients
    • Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
  • Laboratory Tests/Amoxicillin subsection added
  • Drug Interactions subsection added and first paragraph:
    • No drug interaction studies have been conducted specifically with PREVPAC...
  • Drug Interactions/Clarithromycin subsection paragraph 4-7 added: (& last paragraph deleted)
    • Simultaneous oral administration of clarithromycin tablets and zidovudine to HIV infected adult...
    • Simultaneous administration of clarithromycin...
    • Concomitant administration of fluconazole 200 mg daily...
    • Concomitant administration of clarithromycin and ritonavir...
  • Drug Interaction/Carcinogenesis, Mutagenesis, Impairment of Fertility revised 5th paragraph
    • ...however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay...
  • Use in Geriatric Patients, three new paragraphs
    • An analysis of clinical studies of amoxicillin was conducted...
    • This drug is known to be substantially excreted by the kidney...
    • In a steady-state study in which healthy elderly subjects...


  • Incidence in Clinical Trials subsection, the fifth paragraph adds
    • Digestive System- gastrointestinal moniliasis
    • Metabolic and Nutritional Disorders- avitaminosis
    • Musculoskeletal System- ptosis
    • Nervous System- dementia
    • Respiratory System- lung fibrosis
    • Special Senses- amblyopia, blepharitis, cataract, eye disorder, glaucoma, retinal disorder
    • Urogenital System- urinary retention