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U.S. Department of Health and Human Services

Safety

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Prevacid NapraPAC 500 (lansoprazole delayed-release 15 mg capsules and naproxen 500 mg tablets kit October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

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

CONTRAINDICATIONS

WARNINGS

  • GI Effects - Risk of Ulceration, Bleeding, and Perforation
  • Renal Effects
    • ...In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation...
  • Advanced Renal Disease
    • ...If Naprosyn therapy must be initiated, close monitoring of the patient’s renal function is advisable.
  • Anaphylactoid Reactions
  • Skin Reactions
    • NSAIDs, including Naprosyn,...

PRECAUTIONS

  • General
    • Naprosyn
      • ...it is recommended that ophthalmic studies be carried out if any change or disturbance in vision occurs.
      • Hepatic Effects
      • Preexisting Asthma
  • Drug Interactions - Naprosyn
    • Antacids and Sucralfate
      • Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.
    • Aspirin
      • ...however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.
    • Cholestyramine
      • As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen.
    • Methotrexate
    • Selective Serotonin Reuptake Inhibitors (SSRIs)
  • Drug Interactions - Prevacid
  • Geriatric Use
    • Naprosyn

ADVERSE REACTIONS

  • Naprosyn
    • Initial Paragraph
    • The following are additional adverse experiences reported in less than 1% of patients taking naproxen during clinical trials and through postmarketing reports...
      • Cardiovascular
      • GI
      • Hepatobiliary
      • Nervous System
      • Respiratory
      • Dermatologic
      • Special Senses
      • Urogenital
      • Reproduction (female)
  • Prevacid
    • ...Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated the safety profile was similar...
  • Laboratory Values (in patients who received Prevacid and laboratory results reported as adverse events)
    • blood potassium increased
    • blood urea increased
    • crystal urine present
    • eosinophilia
    • hemoglobin decreased
    • positive fecal occult

MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

NSAID Medications that Need a Prescription:

  • Flector (added)
  • Vicoprofen

PREVACID NapraPAC

  • Can I take other medicines with Prevacid NapraPAC?
    • Atazanavir (added)

CONTRAINDICATIONS

Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS –Preexisting Asthma).

WARNINGS

GI Effects - Risk of Ulceration, Bleeding, and Perforation:

NSAIDs, including Naprosyn, can cause serious GI adverse events including inflammation...

These serious adverse events can occur at any time, with or without warning symptoms in patients treated with NSAIDs...

...Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.

...For high risk patients, alternate therapies that do not involve NSAIDs should be considered.

Epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper GI bleeding. In two studies, concurrent use of an NSAID or aspirin potentiated the risk of bleeding (see PRECAUTIONS: Drug Interactions). Although these studies focused on upper GI bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated.

NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.

Anaphylactoid Reactions

As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to Naprosyn and/or Prevacid. Naprosyn should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs (see CONTRAINDICATIONS and PRECAUTIONS, Preexisting Asthma).

...Anaphylactoid reactions, like anaphylaxis, may have a fatal outcome.

 

For current Medication Guide contact Takeda Pharmaceuticals at 1-877-226-4589.

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