Adult Dosing
Prophylaxis for Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis induced gastric ulcer
Notes:- Use lowest effective dose for shortest effective duration
- Administer dose at least 30 mins before meals
- Avoid splitting chewing crushing or dissolving the formulation
Pediatric Dosing
- Safety and effectiveness in pediatric patients has not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
- <30 mL /min: Avoid use
- Hemodialysis: Dose adjustments not defined
Hepatic Dose Adjustment
- Child-Pugh Class A/B: Use with caution; decrease naproxen dose
- Child-Pugh Class C: Avoid use
See Supplemental Patient Information
- Increased risk of serious, fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, are associated with NSAID component of this combination drug. Patients with known CV disease or risk factors for CV disease are at greater risk [US Black Box Warning]
- In patients treated with an NSAID use the lowest effective dose for the shortest duration possible for minimizing the potential risk for an adverse CV/GI event. Remain alert for occurrence of such events, even in the absence of previous CV/GI symptoms. On suspection of serious GI adverse event initiate additional evaluation and therapy. Consider suspending therapy until a serious GI adverse event is ruled out. Consider alternate therapies that do not involve NSAIDs for high risk patients. Concomitant use of an NSAID, COX-2 inhibitor, or aspirin with this therapy may potentiate the risk of bleeding
- Increased incidence of MI and stroke are associated in patients treated for management of pain in the first 10-14 days following CABG surgery [US Black Box Warning]
- Onset of new hypertension or worsening of preexisting hypertension may occur which in turn may lead to increased risk of CV events
- Impaired responses to thiazides or loop diuretics are associated with NSAID component of this combination drug
- Closely monitor blood pressure during the initiation of treatment and throughout the course of therapy
- NSAID component of this combination drug is associated with fluid retention, edema, and peripheral edema
- Serious, fatal GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine are associated with NSAID component. Ulceration and associated complications may occur with this therapy
- Serious adverse events may occur at any time, with or without warning symptoms, in patients treated with NSAID component. Upper GI ulcers, gross bleeding, or perforation may occur. Patients having history of peptic ulcer disease and/or GI bleeding using NSAIDs have a >10-fold increased risk of developing a GI bleed compared to patients with neither of these risk factors. Concurrent use of oral corticosteroids/anticoagulants/antiplatelets (including low-dose aspirin), longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status are the other risk factors associated with increased risk for GI bleeding
- Atrophic gastritis is associated with omeprazole component of this drug on long term therapy
- Withdraw therapy on occurrence of active and clinically significant bleeding from any source in patients receiving this combination drug
- Renal papillary necrosis and other renal injury are associated with NSAID component of this combination drug. Renal toxicity may also occur in patients in whom renal prostaglandin plays a compensatory role in the maintenance of renal perfusion; precipitation of overt renal decompensation may occur in such patients. Patients with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics and ACE inhibitors, and the elderly are more susceptible for development of this manifestations
- Therapy with this combination drug is not recommended in patients with advanced renal disease. If therapy with this drug is initiated, closely monitor patient’s renal function
- Patients without known prior exposure to either component of this combination drug are susceptible for development of anaphylactoid reactions. Avoid administration to patients with the aspirin triad. Asthmatic patients experiencing rhinitis with or without nasal polyps, or those exhibiting severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs are susceptible for development of this symptom. Immediately undertake emergency help on development of anaphylactoid reaction. Anaphylactoid reactions, like anaphylaxis, may be fatal
- Serious, fatal skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations and discontinue use of the drug at the first appearance of skin rash or any other sign of hypersensitivity
- Premature closure of the ductus arteriosus may occur
- Elevations of one or more liver tests may occur. Severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes may occur. Evaluate patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred for evidence of the development of more severe hepatic reaction. Discontinue therapy on development of clinical signs and symptoms consistent with liver disease or on occurrence of systemic manifestations. Exercise caution on requiring higher doses and some adjustment of dosage may be essential in patients. with chronic alcoholic liver disease and probably other diseases with decreased or abnormal plasma proteins. This drug is not recommended in patients with severe hepatic impairment
- Anemia associated with NSAID component of this combination drug may occur. Monitor hemoglobin or hematocrit if patients exhibit any signs or symptoms of anemia. Inhibition of platelet aggregation and prolongation of bleeding time may occur in some patients. Carefully monitor patients with coagulation disorders or patients receiving anticoagulants or antiplatelets along with this combination drug
- Avoid administration of this combination drug in patients with forms of aspirin sensitivity
- Avoid concomitant use with other naproxen-containing products. Avoid the concomitant use of this combination drug with any dose of a non-aspirin NSAID for avoiding the potential for increased risk of adverse reactions
- This combination drug should not be substituted for corticosteroids or for treating corticosteroid insufficiency
- PPI therapy including esomeprazole/naproxen may increase risk of Clostridium difficile associated diarrhea, particularly in hospitalized patients
- Avoid concomitant use of esomeprazole with clopidogrel
- Increased risks for osteoporosis-related fractures of the hip, wrist, or spine are associated with proton pump inhibitor component of this combination drug. Manage patients at risk for osteoporosis-related fractures according to the established treatment guidelines. Provide adequate supplementation of vitamin D and calcium
- Masking of inflammation and fever may occur during course of therapy with this combination drug
- Periodically perform CBC and a chemistry profiles in patients on prolong therapy. Discontinue therapy on development of clinical signs and symptoms consistent with liver or renal disease as systemic manifestations may occur; discontinuation of therapy is also essential on persistent abnormal liver tests or worsening of LFTs. Periodically determine hemoglobin values in patients with initial hemoglobin values of
10 g who are to receive long-term therapy - Hypomagnesemia may occur in patients. Magnesium replacement and discontinuation of therapy may require in most patients. Consider monitoring of magnesium levels prior to initiation of therapy and periodically in patients expected to be on prolonged treatment and taking digoxin or drugs inducing hypomagnesemia simultaneously
- Use of PPIs with high dose methotrexate may increase and prolong serum levels of methotrexate and its metabolite leading to methotrexate toxicities. Temporary withdrawal of the PPI must be considered in patients who are on high-dose of methotrexate
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Cardiovascular disease
- CHF
- Hypertension
- Fluid retention
- Heart failure
- History of ulcer disease or GI bleeding
- Pre-existing asthma
- Coagulation disorders
- Dehydration
- Sodium restriction
- History of inflammatory bowel disease
- Prolong use
- Higher dose
- Hypomagnesemia
- Smokers
- Changes in smoking habits
- Use of alcohol
- Debilitated patients
- Geriatrics
Supplemental Patient Information
- Inform patients about the signs and/or symptoms of serious CV/GI events and the measures to take on occurrence of these events
Pregnancy Category:C
Breastfeeding: Limited literature indicates that maternal doses of esomeprazole with 20 mg/day produce low levels in milk and are not be expected to cause any adverse effects in breastfed infants. Low levels of naproxen are excreted in breastmilk and adverse effects in breastfed infants are uncommon. Prefer other agents while nursing a newborn or preterm infant as naproxen exhibits long half-life and serious adverse reactions are reported in breastfed neonates. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 13 June 2011). As per the manufacturer's data avoid using this drug in nursing mothers due to presence of naproxen component.
US Trade Name(s)
US Availability
esomeprazole/naproxen (generic)
Vimovo (esomeprazole/naproxen)
Canadian Trade Name(s)
Canadian Availability
Vimovo (esomeprazole/naproxen)
UK Trade Name(s)
UK Availability
Vimovo (esomeprazole/naproxen)
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Vimovo 375-20 MG TBEC [Bottle] (ASTRAZENECA LP)
60 mg = $109.99
180 mg = $305.97 - Vimovo 500-20 MG TBEC [Bottle] (ASTRAZENECA LP)
60 mg = $109.99
180 mg = $309.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Vimovo 375/20 Enteric Coated Tablet
Ingredient(s): Esomeprazole mixture with Naproxen
Imprint: 375;20
Color(s): Yellow
Shape: Oval
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): carnauba wax / silicon dioxide / croscarmellose sodium / ferric oxide yellow / glyceryl monostearate / hypromellose / magnesium stearate / methacrylic acid / methylparaben / polysorbate 80 / polyethylene glycol / povidone / propylene glycol / propylparaben / titanium dioxide / triethyl citrate / ferrosoferric oxide / polydextrose
Drug Label Author:
AstraZeneca LP
DEA Schedule:
Non-Scheduled
Drug Name: Vimovo 500/20 (naproxen 500 MG / esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Tablet
Ingredient(s): Esomeprazole mixture with Naproxen
Imprint: 500;20
Color(s): Yellow
Shape: Oval
Size (mm): 18.00
Score: 1
Inactive Ingredient(s): carnauba wax / silicon dioxide / croscarmellose sodium / ferric oxide yellow / glyceryl monostearate / hypromellose / magnesium stearate / methacrylic acid / methylparaben / polysorbate 80 / polyethylene glycol / povidone / propylene glycol / propylparaben / titanium dioxide / triethyl citrate / ferrosoferric oxide / polydextrose
Drug Label Author:
AstraZeneca LP
DEA Schedule:
Non-Scheduled