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VIMOVO® (naproxen and esomeprazole magnesium) Tablets

The Smarter Naproxen Due to Added Gastroprotection

VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets 375 mg/20 mg and 500 mg/20 mg are a proprietary, single-tablet combination of the nonsteroidal anti-inflammatory drug (NSAID) naproxen and immediate-release esomeprazole, a stomach acid–reducing proton pump inhibitor (PPI). Naproxen has proven anti-inflammatory and analgesic properties, and esomeprazole magnesium reduces the stomach acid–secretion that can cause gastric ulceration. With the combination of naproxen and esomeprazole magnesium into a single product, VIMOVO decreases the risk of gastric gastrointestinal (GI) ulcers while reducing pain and inflammation from osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis.

INSIDE: Relief of pain and inflammation with NAPROXEN a medicine called a nonsteroidal anti-inflammatory drug, or NSAID.  OUTSIDE: A layer of protection called ESOMEPRAZOLE MAGNESIUM to decrease the possibility of getting gastric ulcers caused by NSAIDs.

Indications and Usage

VIMOVO (naproxen and esomeprazole magnesium) is a combination product that contains naproxen and esomeprazole. It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID‐associated gastric ulcers. VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.

LIMITATIONS OF USE
VIMOVO is not interchangeable with the individual components of naproxen and esomeprazole magnesium.

Important Safety Information

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), a component of VIMOVO, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
  • VIMOVO is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs, a component of VIMOVO, cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.


CONTRAINDICATIONS

  • VIMOVO is contraindicated in patients:
    • With known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or any component of the drug product, including omeprazole.
    • Who have a history of asthma, urticaria, or other allergic‐type reactions after taking aspirin or other NSAIDs. Fatal anaphylactic reactions to NSAIDs have been reported in such patients.
    • In the setting of coronary artery bypass graft (CABG) surgery.

WARNINGS AND PRECAUTIONS

  • Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. VIMOVO can be administered with low‐dose aspirin (≤325 mg/day) therapy. The concurrent use of aspirin and an NSAID, such as VIMOVO, increases the risk of serious GI events. As with all NSAIDs, concurrent administration of naproxen and aspirin is not generally recommended because of the increased risk of bleeding.
  • Elevation of one or more liver tests may occur during therapy with NSAIDs. VIMOVO should be discontinued immediately if clinical signs and symptoms consistent with liver disease develop. VIMOVO is not recommended in patients with severe hepatic insufficiency.
  • Hypertension can occur with NSAID treatment. Monitor blood pressure closely with VIMOVO treatment
  • Avoid use of VIMOVO in patients with severe heart failure unless benefits are expected to outweigh the risk.
  • Long-term administration of NSAIDs can result in renal papillary necrosis, other renal injury, and renal toxicity. Use VIMOVO with caution in patients at greatest risk of this reaction.
  • Anaphylactic reactions may occur in patients with or without known hypersensitivity to VIMOVO and in patients with aspirin-sensitive asthma.
  • VIMOVO can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens‐Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Discontinue use at first appearance of skin rash or any other sign of hypersensitivity.
  • Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
  • Discontinue VIMOVO if active and clinically significant bleeding from any source occurs.
  • In adults, symptomatic response to esomeprazole, a component of VIMOVO, does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
  • PPI use has been associated with acute interstitial nephritis, new onset or exacerbation of cutaneous or systemic lupus erythematosus, malabsorption of cyanocobalamin, hypomagnesemia, increased risk of diarrhea associated with Clostridium difficile infection, and increased risk for osteoporosis‐related fractures of the hip, wrist, or spine.
  • Avoid concomitant use of VIMOVO with:
    • Other naproxen-containing products or other non-aspirin NSAIDs.
    • Clopidogrel due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using esomeprazole consider alternative anti‐platelet therapy.
    • St. John’s Wort or rifampin due to the potential reduction in esomeprazole levels.
    • Methotrexate which may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.

Note: see full Prescribing Information for a list of clinically important drug interactions.

ADVERSE REACTIONS

The most commonly observed adverse events in clinical trials (experienced by >5% patients in the VIMOVO group) were gastritis and diarrhea.

USE IN SPECIFIC POPULATIONS

  • VIMOVO should not be used in pregnant or lactating women. Consider withdrawal of NSAIDs, including VIMOVO, in women who have difficulties conceiving or who are undergoing investigation of infertility.
  • Safety and efficacy of VIMOVO in pediatric patients has not been established.

For further information on VIMOVO, please see the Medication Guide and full Prescribing Information, including boxed warning, at www.VIMOVO.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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