Naproxen Sodium + Esomeprazole Magnesium

Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.

General
: The combination of Naproxen and Esomeprazole tablet and NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided because of the cumulative risks of inducing serious NSAID-related adverse events. Naproxen and Esomeprazole tablet can be used with low dose acetylsalicylic acid. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Risk-factors to develop NSAID related gastro-intestinal complications include high age, concomitant use of anticoagulants, corticosteroids, other NSAIDs including low-dose acetylsalicylic acid, debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers and upper gastrointestinal bleeding. In patients with the conditions such as Inducible porphyries, Systemic lupus erythematosis and mixed connective tissue disease, Naproxen should only be used after a rigorous benefit-risk ratio. Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Older people
: Naproxen: Older people have an increased frequency of adverse reactions especially gastro-intestinal bleeding, and perforation, which may be fatal. The esomeprazole component of Naproxen and Esomeprazole tablet decreased the incidence of ulcers in older people.
Gastrointestinal effects
: Naproxen: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation with NSAIDs is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in older people. These patients should begin treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other drugs likely to increase gastrointestinal risk. Patients with a history of GI toxicity, particularly older people, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving NSAIDs with concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid. When GI bleeding or ulceration occurs in patients receiving Naproxen and Esomeprazole Tablet, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated. Esomeprazole: Dyspesia could still occur despite the addition of Esomperazole to the combination tablet. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter. Esomeprazole, as all acid-blocking medicines, might reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors of reduced vitamin B12 absorption on long-term therapy.
Cardiovascular and cerebrovascular effects
: Naproxen: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Naproxen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Renal effects
: Naproxen: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.