Vimovo

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-?-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:

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 25C and about 8 hours at 37C.

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


Vimovo Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, heartburn, diarrhea, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and tell your doctor immediately if any of these serious side effects occur: easy bruising/bleeding, lightheadedness/fainting, signs of a lung infection (such as fever, cough, trouble breathing), difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, change in amount of urine, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).

This drug may rarely cause serious (possibly fatal) liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, dark urine, unusual/extreme tiredness, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, unexplained fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 heart failure, history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), severe loss of body water (dehydration), low sodium blood levels, blood disorders (such as anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase the risk of stomach bleeding. Consult your doctor or pharmacist for more information.

Proton pump inhibitors (such as esomeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially stomach bleeding and kidney effects.

This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to the potential for harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breast-feeding.



Related Drugs Index: