Vimovo (Naproxen and Esomeprazole Magnesium Delayed Release Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Vimovo

Ankylosing Spondylitis »

Ankylosing spondylitis facts

Ankylosing spondylitis belongs to a group of arthritis conditions which tend to cause chronic inflammation of the spine (spondyloarthropathies).
Ankylosing spondylitis affects males two to three times more commonly than females.
Ankylosing spondylitis is a cause of back pain in adolescents and young adults.
The tendency to develop ankylosing spondylitis is genetically inherited.
The HLA-B27 gene can be detected in the blood of most patients with ankylosing spondylitis.
Ankylosing spondylitis can also affect the eyes, heart, lungs, and occasionally the kidneys.
The optimal treatment of ankylosing spondylitis involves medications that reduce inflammation or suppress immunity, physical therapy, and exercise.

What is ankylosing spondylitis?

Ankylosing spondylitis is a form of chronic inflammat...

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VIMOVO®
(naproxen and esomeprazole magnesium)

Cardiovascular Risk

Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see WARNINGS AND PRECAUTIONS].
VIMOVO is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS].

Gastrointestinal Risk

NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

The active ingredients of VIMOVO are naproxen which is a NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI).

VIMOVO is available as an oval, yellow, multi-layer, delayed release tablet combining an enteric coated naproxen core and an immediate release esomeprazole magnesium layer surrounding the core. Each strength contains either 375 mg of naproxen and 20 mg of esomeprazole (present as 22.3 mg esomeprazole magnesium trihydrate) or 500 mg of naproxen and 20 mg of esomeprazole (present as 22.3 mg esomeprazole magnesium trihydrate) for oral administration. The inactive ingredients are carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate.

The chemical name for naproxen is (S)-6-methoxy-α-methyl2-naphthaleneacetic acid. Naproxen has the following structure:

Naproxen Structural Formula Illustration

Naproxen has a molecular weight of 230.26 and a molecular formula of C₁₄H₁₄O₃.

Naproxen is an odorless, white to off-white crystalline substance. It is lipid soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8.

The chemical name for esomeprazole is bis(5-methoxy-2[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. Its molecular formula is (C₁₇H₁₈N₃O₃S)₂Mg x 3 H₂O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:

Esomeprazole magnesium Structural Formula Illustration

The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water.

The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.

What are the precautions when taking naproxen and esomeprazole magnesium delayed release tablets (Vimovo)?

Before taking naproxen/esomeprazole, tell your doctor or pharmacist if you are allergic to either of them; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or to other proton-pump inhibitors such as omeprazole, pantoprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), kidney disease, liver disease, stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as congestive...

Read All Potential Precautions of Vimovo »

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.