Vimovo dissolution

Please see Important Safety Information and Prescribing Information for VIMOVO including Boxed Warnings.NOTES TO EDITORS About VIMOVO VIMOVOis a fixed-dose combination of delayed-release enteric-coated naproxen a non-steroidal anti-inflammatory drug NSAID and immediate-release esomeprazole a stomach acid-reducing proton pump inhibitor PPI approved 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 use in children younger than years of age.VIMOVO has been developed as a sequential-delivery tablet formulation combining an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core.As a result esomeprazole is released first in the stomach prior to the dissolution of naproxen in the small intestine.The enteric coating prevents naproxen release at pH levels below providing protection against possible local gastric toxicity of naproxen.AstraZeneca submitted a Marketing Authorization Application MAA to the European Medicines Association EMEA for VIMOVO on October .Upon the FDA's notification of approval of the New Drug Application for VIMOVO a million milestone payment from AstraZeneca will be payable to POZEN.About Osteoarthritis Osteoarthritis is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.Osteoarthritis is the most common form of arthritis and the most common cause of chronic pain affecting million individuals worldwide and million Americans.A combination of factors can contribute to osteoarthritis including being overweight aging joint injury or stress heredity and muscle weakness.Osteoarthritis commonly affects the hands spine or large weight-bearing joints such as the hips and knees.About Rheumatoid Arthritis Rheumatoid arthritis is a chronic disease mainly characterized by inflammation of the lining or synovium of the joints.It can lead to long-term joint damage resulting in chronic pain loss of function and disability.About Ankylosing Spondylitis Ankylosing spondylitis is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis sacroiliac joints.Ankylosing spondylitis may also cause inflammation and pain in other parts of the body as well.ABOUT POZEN POZEN Inc headquartered in Chapel Hill NC is a pharmaceutical company committed to transforming medicine that Ireland -May-HealthPRZone.com Irish Medical Information PRESS RELEASENew Product Introduction Vimovo® naproxen esomeprazole Tuesday rd May AstraZeneca is pleased to announce the introduction of a new product Vimovo.Vimovo is the first and only NSAID PPI combination tablet offering proven NSAID pain relief with abuilt-in PPI.Each modified-release Vimovo tablet contains mg enteric-coated gastro-resistant naproxen and mg film-coated esomeprazole as magnesium trihydrate.Vimovo is indicated for the symptomatic treatment of osteoarthritis rheumatoid arthritis and ankylosingspondylitis in patients who are at risk for developing non-steroidal anti-inflammatory drugNSAID-associated gastric and or duodenal ulcers and where treatment with lower doses of naproxen orof other NSAIDs is not considered sufficient.In clinical trials it has been shown that the incidence of endoscopic gastric and duodenal ulcerswas significantly lower with Vimovo treatment compared to enteric-coated naproxen mg twicedaily alone without esomeprazole or other PPI during a -month treatment period.Vimovo can be administered with low-dose aspirin therapy.In clinical trials patients taking Vimovo incombination with low-dose aspirin did not have an increased occurrence of endoscopic gastric ulcerscompared to patients taking Vimovo alone.Vimovo is not intended for the treatment of acute pain conditions such as dental pain or gout.However flares of osteoarthritis rheumatoid arthritis and ankylosing spondylitis may be treated with Vimovo.The dose in adults is tablet mg mg twice daily.Vimovo must be swallowed whole with water andnot split chewed or crushed.It is recommended that Vimovo is taken at least minutes prior to foodintake.It is supplied in a tablet bottle.We know cost can be a concern nowadays.The good news is that Vimovo at €.for a tablet bottleMIMS Ireland actually costs less than if you prescribed the least Vimovo AlcoholVimovo generic name esomeprazole and naproxen contains a combination of two drugs which is used to treat symptoms of of osteoarthritis rheumatoid arthritis and ankylosing spondylitis and also helps reduce the risk of stomach ulcers in people who may be at risk.Naproxen to a family of drugs known as nonsteroidal anti-inflammatory drugs NSAID which work by reducing substances in the body which cause inflammation pain and fever.Esomeprazole is a proton pump inhibitor which decreases the amount of acid produced in the stomach.It is suggested moderate drinking only while using this drug as the drug’s effectiveness may be decreased and the side effects may be increased.At this time the medical community defines moderate consumption of alcohol as no more than two drinks per day and no more than drinks per week.If anything more than that it is considered an unhealthy dependency on alcohol that may have adverse social family and health consequences.If a person drinks only once or twice a week but drinks on the same days each week and more than two drinks this is considered as an alcohol dependency.If a person binge drinks at any time during the week this is also considered as alcoholism.Some consider alcoholism as a disease while others consider it an addiction which is the result of personal choice and character fault.This school of thought blames the alcoholism on life style choices.Personally I consider alcoholism a genetic tendency as I have seen families of alcoholics even when they live far apart.These unfortunate people are probably dependent on alcohol from the first drink.When alcohol interacts with prescription or over the counter drugs it usually results in negative health effects most especially liver damage as the main organ affected.Before using this drug advise your doctor if you are allergic to any other drug or substance if you are using dietary or herbal supplements are pregnant plan to be or are breastfeeding have a history of kidney or liver disease heart disease high blood pressure fluid retention history of stroke heart attack or congestive heart failure loe levels of magnesium in the blood bleeding or blood clot disorder hemphilia history of stomach ulcer stomach bleeding intestinal disorder such as Crohn’s disease or ulcerative colitis asthma allergy to aspirin or if you smoke.Side EffectsLess serious side effects are constipation diarrhea or mild stomach pain.If these occur call your physician for advice.Serious side effects are severe allergic reactions such as hives difficult breathing tight chest swelling of the mouth face lips or tongue black bloody stools changes in urination chest pain confusion dark urine depression fainting fast irregular heartbeat fever chills sore throat loss of appetite mental or mood changes numb arm or leg one side weakness pale stools red swollen blistered peeling skin ringing in ears seizures severe headache or dizziness severe persistent stomach pain or nausea severe vomiting short of breath weight gain swelling of hands legs or feet bruising or bleeding joint or muscle pain tired or weak vision or speech problems granular vomit or jaundice.If these occur get emergency medical help.This site serves as an information source only and does not dispense medical advice or any other kind of advice.If you are seeking medical advice you are advised to consult your own physician.Vimovo Alcohol Vimovo AlcoholDrugs and AlcoholReturn from Vimovo Alcohol to home page This is Google's cche of It is a snapshot of the page as it appeared on May GMT.The current page could have changed in the meantime.Learn moreTip To quickly find your search term on this Date Sunday May Recently Food and Drug Administration USA approved Vimovo containing naproxen and esomeprasol for treating patients with arthritis with increased risk if NSAID-associated gastric ulcers.Vimovo is used to relieve symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis as well as to reduce the risk of stomach ulcers in patients with high risk of developing NSAID-associated ulcers.The medication contains two active ingredients – naproxen.Naproxen is a painkiller that belongs to a group of medicines called NSAID’s.The second component of Vimovo is esomeprasole that is immediate release proton pump inhibitor.Esomeprasole works by inhibiting the production of gastric acid for the stomach.FDA decision is based on the results of the clinical trials showed a significant reduction in the incidence of gastric ulcers compared with naproxen in monotherapy vs.The most common Vimovo side effects include indigestion diarrhea abdominal pain and nausea.An analyst from a Swiss bank «UBS AG Gbola Amous Gbola Amusa predicts that sales of Vimovo will reach millions of US dollars in year.According to the terms of license agreement between Astra Zeneca and Prozen Astra Zeneca will pay nearly millions US dollars to Prozen after Vimovo approval by FDA.In addition Prozen will get royalties from sales of this product. Possible side effects of Vimovo delayed-release tablets All medicines may cause side effects but many people have no or minor side effects.Check with your doctor if any of these most COMMON side effects persist or become bothersome Constipationdizzinessdrowsinessgasheadacheheartburnmild diarrhea or stomach painnauseavomiting.Seek medical attention right away if any of these SEVERE side effects occur Severe allergic reactions rashhivesitchingdifficulty breathingtightness in the chest or throatswelling of the mouth face lips or tonguewheezingbloody watery or black tarry stoolsbone painchest jaw or arm painconfusiondecreased consciousnessfaintingfast or irregular heartbeatfever chills or persistent sore throatmental or mood changes eg depression; one-sided weaknessred swollen blistered or peeling skin with or without feverringing in the earsseizuressensitivity to the sunsevere or persistent headache or dizzinesssevere or persistent heartburn stomach pain diarrhea nausea or vomitingshortness of breathslurred speechstiff neck; stomach crampssudden or unexplained weight gainswelling of the hands legs or feetsymptoms of liver problems eg dark urine loss of appetite pale stools yellowing of the skin or eyestremors; trouble swallowingunexplained weight lossunusual bruising or bleedingunusual joint or muscle pain; unusual tiredness or weaknessurination problems eg decreased difficult or painful urination; vision or hearing changesvomit that looks like coffee grounds.This is not a complete list of all side effects that may occur.If you have questions about side effects contact your health care provider. If you are pregnant.NSAID medicines should not be used by pregnant women late in their pregnancy.if you are breastfeeding.Talk to your healthcare provider.What are the possible side effects of Non–Steroidal Anti–Inflammatory Drugs NSAIDs. So far my fiance says he is drowsy which he says he can live with.We just want to be safe about this because he's not used to taking medication.Also this worries me.Just how long is "prolonged"?"Complications and Conditions possible due to prolonged use of VimovoLong-term use of Vimovo can increase the risk of bone fractures and heart attacks and other complications that include damage to stomach lining as well as esophagus lining.The risk of stomach ulcers may also rise after a limit.All these complications arise as a result of naproxen content that is a NSAID.Thus it is recommended to take it for suggested time period only and if you are taking it since long time then better stop its usage as per your doctor’s guidance."I'm sorry if my ignorance is showing.I try to learn more about AS so I signed up here and I pass on what I find over to him since he only recently received his disability money to buy any expensive medication for it.Thank you if someone can vouch for this drug's safety or even steer us towards something else.He's tired of hurting.

Kombinasjonsbehandling med beskyttende midler bør vurderes for slike pasienter og også for pasienter som trenger samtidig behandling med lavdose ASA eller andre legemidler som øker risikoen for gastrointestinale komplikasjoner.Pasienter med tidligere gastrointestinal toksisitet spesielt eldre bør melde fra om ev.uvanlige magesymptomer spesielt gastrointestinal blødning særlig i begynnelsen av behandlingen.Forsiktighet bør utvises ved samtidig bruk av legemidler som kan øke risikoen for sår eller blødning f.eks.orale kortikosteroider antikoagulanter som warfarin SSRIer eller blodplatehemmere som ASA.NSAIDs skal gis med forsiktighet til pasienter med tidligere gastrointestinale sykdommer ulcerøs kolitt Crohns sykdom da disse sykdommene kan forverres.Ved ev.alarmsymptomer f.eks.signifikant uventet vekttap stadige brekninger oppkast dysfagi hematemese eller melena og hvis gastrisk sår mistenkes eller er påvist skal malignitet utelukkes da behandling med esomeprazol kan maskere symptomene og forsinke diagnosen.Dyspesi kan fortsatt forekomme til tross for innholdet av esomeprazol.Behandling med protonpumpehemmere kan føre til svak økning i risiko for gastrointestinale infeksjoner som Salmonella og Campylobacter.Aseptisk meningitt Det kan være økt risiko for aseptisk meningitt hos pasienter med systemisk lupus erythematosus SLE og blandet bindevevssykdom.Hos disse pasientene bør naproksen kun brukes etter nøye avveining av fordeler og risiko.Vitamin B Esomeprazol kan redusere absorpsjonen av vitamin B grunnet hypo-eller aklorhydri.Kardiovaskulære og cerebrovaskulære effekter Tilstrekkelig monitorering og rådgivning er påkrevd ved hypertensjon og eller mild til moderat kongestiv hjertesvikt i anamnesen da væskeretensjon og ødemer er rapportert i forbindelse med NSAIDs.Enkelte typer NSAIDs spesielt ved høye doser og langvarig behandling kan være forbundet med en liten økning i risikoen for arterielle trombotiske hendelser f.eks.hjerteinfarkt eller slag.Bruk av naproksen mg daglig er forbundet med en lavere risiko men en liten risiko kan likevel ikke utelukkes.Pasienter med ukontrollert hypertensjon kongestiv hjertesvikt etablert iskemisk hjertesykdom perifer arteriell sykdom og eller cerebrovaskulær sykdom skal bare behandles med naproksen etter grundige overveielser.Samme type avveininger bør også foretas før man starter langvarig behandling av pasienter med risikofaktorer for kardiovaskulære hendelser f.eks.hypertensjon hyperlipidemi diabetes mellitus røyking.Renale effekter Langvarig bruk av NSAIDs kan føre til renal papillær nekrose og annen nyreskade.Renal toksisitet er også observert hos pasienter der renale prostaglandiner har en kompenserende rolle i vedlikehold av renal perfusjon.Hos slike pasienter kan NSAIDs føre til doseavhengig reduksjon i prostaglandinproduksjonen og sekundært i blodgjennomstrømningen i nyrene noe som kan fremkalle åpenbar renal dekompensasjon.Pasienter med nedsatt nyrefunksjon hypovolemi hjertesvikt nedsatt leverfunksjon saltdeplesjon pasienter som behandles med diuretika og ACE-hemmere og eldre har størst risiko for denne reaksjonen.Seponering av NSAIDs fører vanligvis til bedring til samme tilstand som før behandlingen startet.Nedsatt nyrefunksjon Naproksen må brukes med stor forsiktighet ved nedsatt nyrefunksjon og monitorering av serumkreatinin og eller with low dose aspirin.Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptom.When total daily dose of mg of naproxen is considered not appropriate alternative therapeutic regimens should be utilized.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 and a history of gastric and or duodenal ulcers.In patients with the following conditions naproxen should only be used after a rigorous benefit-risk ratio Inducible porphyries Systemic lupus erythematosis and mixed connective tissue disease.There may be an increased risk of aseptic meningitis in these patients.Patients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance.VIMOVO contains very low levels of methyl-and propyl parahydroxybenzoate which may cause allergic reactions possibly delayed.Elderly Naproxen The elderly have an increased frequency of adverse reactions especially gastro-intestinal bleeding and perforation which may be fatal.The esomeprazole component of VIMOVO decreased the incidence of ulcers in elderly.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 the elderly.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 aspirin or other drugs likely to increase gastrointestinal risk.The esomeprazole component of VIMOVO is a proton pump inhibitor.Patients with a history of GI toxicity particularly when elderly 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 aspirin.Ulcer complications such as bleeding perforation and obstruction were not studied in the VIMOVO trials.When GI bleeding or ulceration occurs in patients receiving VIMOVO 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 In the presence of any alarm symptom e.g.significant unintentional weight loss recurrent vomiting dysphagia haematemesis or melaena and when gastric ulcer is suspected or present malignancy should be excluded as treatment with esomeprazole magnesium may alleviate symptoms and delay diagnosis.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.

Elimination of naproxen is decreased in patients with severe renal impairment.Naproxen-containing products including VIMOVO is not recommended for use in patients with moderate to severe and severe renal impairment creatinine clearance ml min see Dosage and Administration Warnings and Precautions and Use in Specific Populations .No studies have been performed with esomeprazole in patients with decreased renal function.Since the kidney is responsible for the excretion of the metabolites of esomeprazole but not for the elimination of the parent compound the metabolism of esomeprazole is not expected to be changed in patients with impaired renal function. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.Patients should be informed of the warning signs and symptoms of hepatotoxicity eg nausea fatigue lethargy pruritus jaundice right upper quadrant tenderness and flu-like symptoms.If these occur patients should be instructed to stop therapy and seek immediate medical therapy see Contraindications and Warnings and Precautions .Patients should be informed of the signs of an anaphylactoid reaction eg difficulty breathing swelling of the face or throat.If these occur patients should be instructed to seek immediate emergency help see Warnings and Precautions .In late pregnancy as with other NSAIDs VIMOVO should be avoided because it may cause premature closure of the ductus arteriosus see Contraindications Warnings and Precautions and Use in Specific Populations .Caution should be exercised by patients whose activities require alertness if they experience drowsiness dizziness vertigo or depression during therapy with VIMOVO.Patients should be instructed to tell their physicians if they have a history of asthma or aspirin-sensitive asthma because the use of NSAIDs in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal.Patients with this form of aspirin sensitivity should be instructed not to take VIMOVO.Patients with preexisting asthma should be instructed to seek immediate medical attention if their asthma worsens after taking VIMOVO see Warnings and Precautions ..Antacids may be used while taking VIMOVO.VIMOVO tablets should be swallowed whole with liquid.Tablets should not be split chewed crushed or dissolved.VIMOVO tablets should be taken at least minutes before meals see Dosage and Administration Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations dizziness seizures and tetany as these may be signs of hypomagnesemia see Warnings and Precautions .VIMOVO is a trademark of the AstraZeneca group of companies.Other trademarks are the property of their respective companies.Distributed by AstraZeneca LP Wilmington DE ©AstraZeneca VIMOVO vi-moh´-voh naproxen and esomeprazole magnesium Delayed Release Tablets Read this Medication Guide before you start taking VIMOVO and each time you get a refill.There may be new information.This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.What is the most important information I should know about VIMOVO. Naproxen may also cause serious effects on the stomach or intestines including bleeding or perforation forming of a hole.These conditions can be fatal and can occur without warning while you are taking esomeprazole and naproxen especially in older adults.Call your doctor at once if you have symptoms of stomach bleeding such as black bloody or tarry stools or coughing up blood or vomit that looks like coffee grounds.Ask a doctor or pharmacist before using any other pain or arthritis medicine.Many medicines available over the counter contain naproxen or similar medicines such as aspirin ibuprofen or ketoprofen.Taking naproxen during the last months of pregnancy may result in birth defects.Do not take esomeprazole and naproxen during pregnancy unless your doctor has told you to.What should I discuss with my healthcare provider before taking VIMOVO. NSAIDs should be given with care to patients with a history of inflammatory bowel disease ulcerative colitis Crohn’s disease as their condition may be exacerbated.Gastrointestinal symptomatic response to therapy with VIMOVO does not preclude the presence of gastric malignancy.Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole of which esomeprazole is an enantiomer and a component of VIMOVO.Active Bleeding When active and clinically significant bleeding from any source occurs in patients receiving VIMOVO the treatment should be withdrawn.Renal Effects Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.In these patients administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and secondarily in renal blood flow which may precipitate overt renal decompensation.Patients at greatest risk of this reaction are those with impaired renal function hypovolemia heart failure liver dysfunction salt depletion those taking diuretics and ACE inhibitors and the elderly.Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.Advanced Renal Disease No information is available from controlled clinical studies regarding the use of VIMOVO in patients with advanced renal disease. What will it do for me?This is a combination medication that contains esomeprazole and naproxen.Esomeprazole belongs to the class of medications called proton pump inhibitors and naproxen belongs to the class of medications called nonsteroidal anti-inflammatory drugs NSAIDs.This combination medication is used to treat signs and symptoms of osteoarthritis OA rheumatoid arthritis RA and ankylosing spondylitis long-term inflammation disease of the joints and to decrease the risk of developing stomach ulcers in people at risk for developing stomach ulcers due to NSAIDs.Esomeprazole works by reducing the amount of acid that stomach produces.Naproxen relieves pain and reduces swelling and inflammation by reducing a substance in the body that leads to inflammation and pain.If immediate relief of pain is desired esomeprazole naproxen should not be used as it releases medication over a longer period of time.Your doctor may have suggested this medication for conditions other than those listed in these drug information articles.As well some forms of this medication may not be used for all of the conditions discussed here.If you have not discussed this with your doctor or are not sure why you are taking this medication speak to your doctor.Do not stop taking this medication without consulting your doctor.Do not give this medication to anyone else even if they have the same symptoms as you do.It can be harmful for people to take this medication if their doctor has not prescribed it.How should I use this medication?The recommended daily dose of esomeprazole naproxen is one mg tablet twice daily or one mg tablet twice daily.

Kombinasjonsbehandling med beskyttende midler bør vurderes for slike pasienter og også for pasienter som trenger samtidig behandling med lavdose ASA eller andre legemidler som øker risikoen for gastrointestinale komplikasjoner.Pasienter med tidligere gastrointestinal toksisitet spesielt eldre bør melde fra om ev.uvanlige magesymptomer spesielt gastrointestinal blødning særlig i begynnelsen av behandlingen.Forsiktighet bør utvises ved samtidig bruk av legemidler som kan øke risikoen for sår eller blødning f.eks.orale kortikosteroider antikoagulanter som warfarin SSRIer eller blodplatehemmere som ASA.NSAIDs skal gis med forsiktighet til pasienter med tidligere gastrointestinale sykdommer ulcerøs kolitt Crohns sykdom da disse sykdommene kan forverres.Ved ev.alarmsymptomer f.eks.signifikant uventet vekttap stadige brekninger oppkast dysfagi hematemese eller melena og hvis gastrisk sår mistenkes eller er påvist skal malignitet utelukkes da behandling med esomeprazol kan maskere symptomene og forsinke diagnosen.Dyspesi kan fortsatt forekomme til tross for innholdet av esomeprazol.Behandling med protonpumpehemmere kan føre til svak økning i risiko for gastrointestinale infeksjoner som Salmonella og Campylobacter.Aseptisk meningitt Det kan være økt risiko for aseptisk meningitt hos pasienter med systemisk lupus erythematosus SLE og blandet bindevevssykdom.Hos disse pasientene bør naproksen kun brukes etter nøye avveining av fordeler og risiko.Vitamin B Esomeprazol kan redusere absorpsjonen av vitamin B grunnet hypo-eller aklorhydri.Kardiovaskulære og cerebrovaskulære effekter Tilstrekkelig monitorering og rådgivning er påkrevd ved hypertensjon og eller mild til moderat kongestiv hjertesvikt i anamnesen da væskeretensjon og ødemer er rapportert i forbindelse med NSAIDs.Enkelte typer NSAIDs spesielt ved høye doser og langvarig behandling kan være forbundet med en liten økning i risikoen for arterielle trombotiske hendelser f.eks.hjerteinfarkt eller slag.Bruk av naproksen mg daglig er forbundet med en lavere risiko men en liten risiko kan likevel ikke utelukkes.Pasienter med ukontrollert hypertensjon kongestiv hjertesvikt etablert iskemisk hjertesykdom perifer arteriell sykdom og eller cerebrovaskulær sykdom skal bare behandles med naproksen etter grundige overveielser.Samme type avveininger bør også foretas før man starter langvarig behandling av pasienter med risikofaktorer for kardiovaskulære hendelser f.eks.hypertensjon hyperlipidemi diabetes mellitus røyking.Renale effekter Langvarig bruk av NSAIDs kan føre til renal papillær nekrose og annen nyreskade.Renal toksisitet er også observert hos pasienter der renale prostaglandiner har en kompenserende rolle i vedlikehold av renal perfusjon.Hos slike pasienter kan NSAIDs føre til doseavhengig reduksjon i prostaglandinproduksjonen og sekundært i blodgjennomstrømningen i nyrene noe som kan fremkalle åpenbar renal dekompensasjon.Pasienter med nedsatt nyrefunksjon hypovolemi hjertesvikt nedsatt leverfunksjon saltdeplesjon pasienter som behandles med diuretika og ACE-hemmere og eldre har størst risiko for denne reaksjonen.Seponering av NSAIDs fører vanligvis til bedring til samme tilstand som før behandlingen startet.Nedsatt nyrefunksjon Naproksen må brukes med stor forsiktighet ved nedsatt nyrefunksjon og monitorering av serumkreatinin og eller with low dose aspirin.Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptom.When total daily dose of mg of naproxen is considered not appropriate alternative therapeutic regimens should be utilized.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 and a history of gastric and or duodenal ulcers.In patients with the following conditions naproxen should only be used after a rigorous benefit-risk ratio Inducible porphyries Systemic lupus erythematosis and mixed connective tissue disease.There may be an increased risk of aseptic meningitis in these patients.Patients on long-term treatment particularly those treated for more than a year should be kept under regular surveillance.VIMOVO contains very low levels of methyl-and propyl parahydroxybenzoate which may cause allergic reactions possibly delayed.Elderly Naproxen The elderly have an increased frequency of adverse reactions especially gastro-intestinal bleeding and perforation which may be fatal.The esomeprazole component of VIMOVO decreased the incidence of ulcers in elderly.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 the elderly.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 aspirin or other drugs likely to increase gastrointestinal risk.The esomeprazole component of VIMOVO is a proton pump inhibitor.Patients with a history of GI toxicity particularly when elderly 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 aspirin.Ulcer complications such as bleeding perforation and obstruction were not studied in the VIMOVO trials.When GI bleeding or ulceration occurs in patients receiving VIMOVO 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 In the presence of any alarm symptom e.g.significant unintentional weight loss recurrent vomiting dysphagia haematemesis or melaena and when gastric ulcer is suspected or present malignancy should be excluded as treatment with esomeprazole magnesium may alleviate symptoms and delay diagnosis.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. Fact-There is not a single medicine that has been discovered or deveoloped by any government agency. Alone there are million secondary prevention patients.Pozen has conducted market research and discovered that nearly already use daily aspirin therapy.Meta-analyses and peer-reviewed research concludes that around of these patients are at risk for upper-gastrointestinal bleeding and gastric or duodenal ulcers.Pozen's Phase trial showed that of secondary prevention patients on mg enteric-coated aspirin discontinue after six months.A systematic review and meta-analysis on the hazards of discontinuing or not adhering to daily aspirin therapy shows a greater-than threefold increased risk of a potentially fatal cardiovascular event.Pozen's extensive market research noted above finds that -of physicians recommend using gastro-protective agents such as proton pump inhibitors e.g omeprazole to -of their patients.The interesting thing is Pozen found that over of physicians would prescribe PA instead of the separate components of OTC aspirin and OTC or Rx proton pump inhibitor if the cost was comparable.Amazon.com sells a tablet bottle of mg aspirin for or cents per day.One can also buy mg tablets of OTC Prilosec omeprazole for or around cents per pill.To re-create Pozen's PA- a patient would spend approximately per day.Pozen's market research with payers yielded some encouraging results. Although serious cardiovascular events can occur without warning symptoms patients should be alert for the signs and symptoms of chest pain shortness of breath weakness slurring of speech and should ask for medical advice when observing any indicative sign or symptoms.Patients should be apprised of the importance of this follow-up see Warnings and Precautions .VIMOVO has been developed with esomeprazole to decrease incidence of ulceration from naproxen.NSAIDs including naproxen can cause GI discomfort and rarely serious GI side effects such as ulcers and bleeding which may result in hospitalization and even death.Although serious GI tract ulcerations and bleeding can occur without warning symptoms patients should be alert for the signs and symptoms of ulcerations and bleeding and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain dyspepsia melena and hematemesis.Patients should be apprised of the importance of this follow-up see Warnings and Precautions .VIMOVO like other NSAID-containing products can cause serious skin side effects such as exfoliative dermatitis Stevens-Johnson syndrome and toxic epidermal necrolysis which may result in hospitalizations and even death.Although serious skin reactions may occur without warning patients should be alert for the signs and symptoms of skin rash and blisters fever or other signs of hypersensitivity such as itching and should ask for medical advice when observing any indicative signs or symptoms.Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible see Warnings and Precautions. Store in the original container and keep the bottle tightly closed to protect from moisture.Dispense in a tight container if package is subdivided.See Medication Guide Patients should be informed of the following before initiating therapy with VIMOVO and periodically during the course of ongoing therapy. Why does the manufacturer try to influence the expert who is required to write the note so that patients can get it and then influence the patients with coupons to pay the patient's copayment?Why does it cost so much at retail when the two ingredients can be purchased separately at retail for so much less. Skal svelges hele med vann.Må ikke deles tygges eller knuses.Kontraindikasjoner Kjent overfølsomhet for naproksen esomeprazol substituert benzimidazol eller noen av hjelpestoffene.Historie med astma elveblest eller allergiske reaksjoner indusert av aspirin eller andre NSAIDs.Svangerskapets trimester.Alvorlig nedsatt leverfunksjon f.eks.«Child-Pugh C.Alvorlig hjertesvikt.Alvorlig nedsatt nyrefunksjon.Aktivt magesår.Gastrointestinal blødning cerebrovaskulær blødning eller andre blødningssykdommer.Skal ikke brukes sammen med atazanavir og nelfinavir.Forsiktighetsregler Pasienter på langvarig behandling spesielt år bør overvåkes regelmessig.Behandlingen bør avbrytes ved forverring eller dersom det ikke sees noen nytteverdi.Naproksen bør kun brukes etter nøye avveining av fordeler risiko ved induserbar porfyri systemisk lupus erythematosus og blandet bindevevssykdom.For å hindre overbehandling skal forskrivende lege vurdere med klinisk relevante intervaller om tilstrekkelig smertelindring er mulig med lavere NSAID-dose tilgjengelig som enkeltkomponent basert på individuell risiko og avhengig av karakteristikken og alvorlighetsgraden av underliggende sykdom. Pregnancy Pregnancy Category C In late pregnancy as with other NSAIDs naproxen a component of VIMOVO should be avoided because it may cause premature closure of the ductus arteriosus see Contraindications and Use in Specific Populations .Hepatic Effects Borderline elevations of one or more liver tests may occur in up to of patients taking NSAIDs including naproxen a component of VIMOVO. Take exactly as prescribed by your doctor.Do not take in larger or smaller amounts or for longer than recommended.Follow the directions on your prescription label.Esomeprazole and naproxen is usually taken times each day at least minutes before a meal.Follow your doctor's instructions.Do not crush chew or break an enteric coated pill.Swallow it whole.The enteric coated pill has a special coating to protect your stomach.Breaking the pill will damage this coating.To be sure this medication is not causing harmful effects your blood may need to be tested often.Your blood pressure and kidney or liver function may also need to be tested.You may also need eye exams if you have any changes in your vision.Visit your doctor regularly.

Cmax and AUC of one of its active metabolites -dihydrocilostazol which has -times the activity of cilostazol were increased by and respectively.Co-administration of cilostazol with esomeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite.Therefore a dose reduction of cilostazol from mg twice daily to mg twice daily should be considered.Drugs known to induce CYPC or CYPA such as rifampin may lead to decreased esomeprazole serum levels.Omeprazole of which esomeprazole is an enantiomer has been reported to interact with St.John’s Wort an inducer of CYPA.In a cross-over study in healthy male subjects St John’s Wort mg three times daily for days significantly decreased the systemic exposure of omeprazole in CYPC poor metabolizers Cmax and AUC decreased by and respectively and extensive metabolizers Cmax and AUC decreased by and respectively.Avoid concomitant use of St.John’s Wort or rifampin with VIMOVO.Other Pharmacokinetic-based Interactions Co-administration of oral contraceptives diazepam phenytoin or quinidine does not seem to change the pharmacokinetic profile of esomeprazole.Pregnancy Teratogenic Effects Pregnancy Category C prior to weeks gestationCategory D starting weeks gestation.Starting at weeks gestation VIMOVO and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.VIMOVO can cause fetal harm when administered to a pregnant woman starting at weeks gestation.If this drug is used during this time period in pregnancy the patient should be apprised of the potential hazard to a fetus.There are no adequate and well-controlled studies in pregnant women.Prior to weeks gestation VIMOVO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Reproductive studies with naproxen have been performed in rats at mg kg day mg m day .times the human systemic exposure rabbits at mg kg day mg m day .times the human systemic exposure and mice at mg kg day mg m day .times the human systemic exposure with no evidence of impaired fertility or harm to the fetus due to the drug see Animal Toxicology and or Pharmacology .However animal reproduction studies are not always predictive of human response.Reproductive studies in rats and rabbits with esomeprazole and multiple cohort studies in pregnant women with omeprazole use during the first trimester do not show an increased risk of congenital anomalies or adverse pregnancy outcomes.There are no adequate and well controlled studies of esomeprazole use in pregnancy.Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.Esomeprazole is the S-isomer of omeprazole.In four population-based cohort studies that included women exposed during the first trimester of pregnancy to omeprazole there was no increased risk of congenital anomalies.Reproductive studies with esomeprazole have been performed in rats at doses up to times the human dose and in rabbits at doses up to times the human dose and have revealed no evidence of impaired fertility or harm to the fetus see Animal Toxicology and or Pharmacology .Reproductive studies conducted with omeprazole on rats at oral doses up to times the human dose and in rabbits at doses up to times the human dose did not show any evidence of teratogenicity.In pregnant rabbits omeprazole at doses about to times the human dose produced dose-related increases in embryo-lethality fetal resorptions and pregnancy loss.In rats treated with omeprazole at doses about to times the human dose dose-related embryo fetal toxicity and postnatal developmental toxicity occurred in offspring.Labor and Delivery In rat studies with NSAIDs as with other drugs known to inhibit prostaglandin synthesis an increased incidence of dystocia delayed parturition and decreased pup survival occurred.Naproxen-containing products are not recommended in labor and delivery because through its prostaglandin synthesis inhibitory effect naproxen may adversely affect fetal circulation and inhibit uterine contractions thus increasing the risk of uterine hemorrhage.The effects of VIMOVO on labor and delivery in pregnant women are unknown. Recent Vimovo Drug Injury Settlements Million Pharmacy Settlement For the death of a month old girl who died after a pharmacy improperly filled wrong prescription for her heart medication.Million Vioxx Settlement For a plaintiff who suffered permanent damage to his heart as a result of his doctor’s negligence in prescribing a dangerous dosage of Vioxx.Million Prescription Drug Settlement Wrong Prescription Drug .Million Wrong Medication Settlement For plaintiff given the wrong seizure medication by a pharmacy resulting in serious injury to the plaintiff Prescription Overdose Settlement for a woman who was overdosed with prescription medicines over prescribed doctors filled by pharmacy and approved by her HMO.Million Prescription Medication Settlement For a man was improperly administered medication causing brain damage.Million Prescription Medication Settlement Against hospital and OB GYN involving a year-old patient who developed pseudomembranous colitis caused by antibiotics prescribed by her doctor.

Minimize riskassess risk and consider an alternative drug take steps to circumvent the interaction risk and or institute a monitoring plan.Do not stop taking any medications without consulting your healthcare provider.Disclaimer Every effort has been made to ensure that the information provided by Multum is accurate up-to-date and complete but no guarantee is made to that effect.In addition the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof.Multum's drug information does not endorse drugs diagnose patients or recommend therapy.Multum's drug information is a reference resource designed as supplement to and not a substitute for the expertise skill knowledge and judgement of healthcare practitioners in patient care.The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe effective or appropriate for any given patient. What is Vimovo?Vimovo contains two medicines naproxen a nonsteroidal anti-inflammatory drug NSAID and esomeprazole magnesium a proton pump inhibitor PPI.Vimovo is used to relieve signs and symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis arthritis of the spine.It is also used to decrease the risk of developing stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs.What is the most important information I should know about Vimovo. Avoid Vimovo if you are planning to breastfeed.What are the signs of overdose of Vimovo.

Vimovo is only available by prescription.Vimovo is available in two strengths mg esomeprazole combined with either mg or mg naproxen to be taken by mouth.The usual dosage to treat osteoarthritis rheumatoid arthritis or ankylosing spondylitis is one tablet twice daily of Vimovo mg naproxen mg esomeprazole or mg naproxen mg esomeprazole.When is Vimovo prescribed.

Des répondants ont éprouvé des complications GI après avoir arrêté leur médicament pour les troubles digestifs tout en poursuivant leur traitement par AINSviii À propos d’AstraZeneca Canada AstraZeneca est engagée envers la recherche le développement et la fabrication de médicaments d’ordonnance de grande valeur.Elle possède une imposante gamme de produits dans les six domaines thérapeutiques suivants gastro-entérologie cardiologie infectiologie neurosciences oncologie et pneumologie.Le siège social canadien d’AstraZeneca est situé Mississauga en Ontario et l’entreprise exploite un centre ultramoderne de découverte de médicaments Montréal au Québec.Pour de plus amples renseignements visitez le site Web de la Consulté le février Lanas et al; Assessment of gastrointestinal and cardiovascular risk in patients with osteoarthritis who require NSAIDs the LOGICA study.Ann Rheum Dis ;–.Hunt et al.Recommendations for the appropriate use of anti-inflammatory drugs in the era of coxibs Defining the role of gastroprotective agents.Canadian Journal of Gastroenterology.; -.Rostom et al.Canadian consensus guidelines on long-term nonsteroidal anti-inflammatory drug therapy and the need for gastroprotection benefits versus risks.Alimentary Pharmacology Therapeutics ; -.Léger Marketing.Sondage MISSISSAUGA ON Wednesday April AstraZeneca Canada Inc.announced today that Health Canada has approved VIMOVO® modified-release tablets for the treatment of the 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 non-steroidal anti-inflammatory drug NSAID-associated gastric ulcersi VIMOVO is the first fixed-dose combination of enteric-coated naproxen an NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The approval of VIMOVO was supported by data from a clinical development program including results from the PN-and PN-studies which demonstrated that subjects taking VIMOVO experienced significantly fewer gastric ulcers and NSAID-associated upper GI adverse events had significantly less treatment discontinuations and as measured through patient reports of dyspepsia and heartburn had better upper gastrointestinal tolerability compared to subjects receiving enteric-coated naproxen aloneii "While NSAIDs are effective at relieving the pain and inflammation associated with osteoarthritis many patients discontinue use and live in pain due to gastrointestinal side-effects or safety concerns " says Dr.Peter Lin family physician in Toronto."VIMOVO combines an NSAID and PPI together into one pill allowing patients to have pain relief while protecting their stomach." Osteoarthritis which affects three million Canadians iii is the most common form of arthritis and is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.A common misconception is that arthritis is a disease of the elderly.In fact almost per cent per cent of arthritis patients are under the age of iv While many patients with osteoarthritis treat their symptoms with NSAIDs per cent of chronic NSAID-users are at increased risk of gastrointestinal GI complications.v An estimated Canadians die every year from complications associated with NSAID consumption.vi Risk factors for NSAID-associated upper GI clinical events include age history of GI events concomitant use of oral corticosteroids and anticoagulants high-dose multiple NSAID use and concomitant use of aspirin.vii A new survey of Canadian osteoarthritis patients found per cent of patients at risk of NSAID-associated GI complications were not aware they were at risk and the majority could not identify risk factors for developing GI side effects associated with NSAID use.viii In addition per cent of patients with osteoarthritis discontinued their GI medication because they started to "feel better" per cent and preferred to take less medication per cent.viii Thirty per cent of respondents experienced GI complications as a result of stopping their GI medication continuing on their NSAID therapy.viii CONTACTS REFERENCESi VIMOVO®Canadian Product Monograph.AstraZeneca Canada Inc.January .ii Goldstein et al.PN significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use MISSISSAUGA ON Wednesday April AstraZeneca Canada Inc.announced today that Health Canada has approved VIMOVO® modified-release tablets for the treatment of the 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 non-steroidal anti-inflammatory drug NSAID-associated gastric ulcersi VIMOVO is the first fixed-dose combination of enteric-coated naproxen an NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The approval of VIMOVO was supported by data from a clinical development program including results from the PN-and PN-studies which demonstrated that subjects taking VIMOVO experienced significantly fewer gastric ulcers and NSAID-associated upper GI adverse events had significantly less treatment discontinuations and as measured through patient reports of dyspepsia and heartburn had better upper gastrointestinal tolerability compared to subjects receiving enteric-coated naproxen aloneii "While NSAIDs are effective at relieving the pain and inflammation associated with osteoarthritis many patients discontinue use and live in pain due to gastrointestinal side-effects or safety concerns " says Dr.Peter Lin family physician in Toronto."VIMOVO combines an NSAID and PPI together into one pill allowing patients to have pain relief while protecting their stomach." Osteoarthritis which affects three million Canadians iii is the most common form of arthritis and is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.A common misconception is that arthritis is a disease of the elderly.In fact almost per cent per cent of arthritis patients are under the age of iv While many patients with osteoarthritis treat their symptoms with NSAIDs per cent of chronic NSAID-users are at increased risk of gastrointestinal GI complications.v An estimated Canadians die every year from complications associated with NSAID consumption.vi Risk factors for NSAID-associated upper GI clinical events include age history of GI events concomitant use of oral corticosteroids and anticoagulants high-dose multiple NSAID use and concomitant use of aspirin.vii A new survey of Canadian osteoarthritis patients found per cent of patients at risk of NSAID-associated GI complications were not aware they were at risk and the majority could not identify risk factors for developing GI side effects associated with NSAID use.viii In addition per cent of patients with osteoarthritis discontinued their GI medication because they started to "feel better" per cent and preferred to take less medication per cent.viii Thirty per cent of respondents experienced GI complications as a result of stopping their GI medication continuing on their NSAID therapy.viii CONTACTS REFERENCESi VIMOVO®Canadian Product Monograph.AstraZeneca Canada Inc.January .ii Goldstein et al.PN significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use results from two prospective randomized controlled trials.Accessed February .v Lanas. If you get an infection while using Vimovo tell your doctor.Vimovo may hide the some of the signs of an infection and may make you think mistakenly that you are better or that it is not serious.Signs of an infection may include fever pain swelling and redness.Things you must not do Do not give Vimovo to anyone else even if they have the same condition as you.Do not use Vimovo to treat any other complaints unless your doctor tells you to.Things to be careful of Be careful driving or operating machinery until you know how Vimovo affects you.As with other NSAID medicines Vimovo may cause dizziness or light-headedness in some people.Make sure you know how you react to Vimovo before you drive a car operate machinery or do anything else that could be dangerous if you are dizzy or light-headed.If this occurs do not drive.If you drink alcohol dizziness or light-headedness may be worse.Back to topSide effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Vimovo.All medicines can have side effects.Sometimes they are serious most of the time they are not.You may need medical treatment if you get some of the side effects.Ask your doctor or pharmacist any questions you may have.Tell your doctor if you notice any of the following and they worry you stomach upset including nausea feeling sick vomiting heartburn indigestion cramps loss of appetite constipation diarrhoea pain in the stomach wind dizziness lightheadedness drowsiness sleepiness change in sleep patterns headache feeling thirsty dry mouth mild skin rash or itchy skin These side effects are usually mild.Tell your doctor immediately if you notice any of the following eye problems such as blurred vision sore red eyes itching severe dizziness spinning sensation severe or persistent headache tingling or numbness of the hands or feet fast or irregular heartbeats also called palpitations difficulty hearing deafness signs of frequent or worrying infections such as fever severe chills sore throat or mouth ulcers bleeding or bruising more easily than normal reddish or purplish blotches under the skin signs of anaemia such as tiredness being short of breath and looking pale a change in the colour of urine passed blood in the urine a change in the amount or frequency of urine passed burning feeling when passing urine unusual weight gain swelling of ankles or legs severe skin rashes mood changes confusion or depression muscle pain or weakness increase in breast size males increased sweating hair loss These are serious side effects. Lovaza.It is Omega-fish oils it is prescription only and it is expensive.Need I say anymore. If you are feeling dizzy drowsy or light headed you should not drive or operate machinery.Eye problems If you experience blurred and or diminished vision while taking esomeprazole naproxen you should stop taking this medication and get an eye exam done.Your doctor may recommend that you have regular eye exams if you take esomeprazole naproxen for long periods of time.Fluid retention Use of naproxen can cause fluid retention and swelling.This can lead to high blood pressure and worsening of heart failure.People who are taking esomeprazole naproxen for a long time should have their blood pressure checked regularly.In addition people with heart failure decreased heart function blood pressure increased age and other conditions that put them at risk of fluid retention should discuss with their doctor how this medication may affect their medical condition how their medical condition may affect dosing and effectiveness of this medication and whether any special monitoring is needed. Side-effects A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.Once a medicine has been licensed information on the medicine's effects both intended and unintended is continuously recorded and updated.Some side-effects may be serious while others may only be a mild inconvenience.Everyone's reaction to a medicine is different.It is difficult to predict which side-effects you will have from taking a particular medicine or whether you will have any side-effects at all.The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.Very common More than in people who take Vimovo indigestion seek medical advice if you develop indigestion Common More than in people who take Vimovo constipation diarrhoea feeling dizzy flatulence gastritis seek medical advice if you develop gastritis headaches jointpain nausea seek medical advice if you develop nausea oedema oesophagitis raised blood pressure skin rash or rashes stop taking Vimovo and seek immediate medical advice if you develop a rash stomachpain seek medical advice if you develop stomachpain stomachulcers some cases of stomachulcers may be fatal taste changes vomiting seek immediate medical advice if you vomit repeatedly Uncommon More than in people who take Vimovo abnormal laboratory test results asthma belching breathing difficulties bronchospasm changes in appetite depression dermatitis difficulty sleeping dry mouth fainting or brief loss of consciousness feeling anxious fever fracture of the hip wrist or spine this may happen if Vimovo is taken at high doses for a long period of time gastrointestinal bleeding some cases of gastrointestinal bleeding may be fatal heart problems increased sweating infections inflammation of the mouth itching musclepain or tenderness palpitations paraesthesiae tinnitus tiredness urticaria vertigo weakness Rare More than in people who take Vimovo blood problems confusion faster heart rate fluid retention gastrointestinal problems seek medical advice if you develop gastrointestinal problems hair loss heart attack hypersensitivity or allergic reactions seek medical advice if you develop any symptoms of hypersensitivity or allergy to Vimovo inflammation of the tongue kidney problems menstrual problems - seek medical advice if you get heavy bleeding metabolic problems proteinuria rectal bleeding seek medical advice if you get bleeding from the rectum sleepiness strange dreams tremors unexplained or unexpected bruising vomitingblood seek medical advice if you vomit blood The frequency of these side-effects is unknown eye or eyesight problems seek medical advice if you develop any problems with your vision low levels of magnesium in the blood seek medical advice if you develop symptoms such as tiredness involuntarymuscle contractions delirium convulsions dizziness or irregular heart rate may affect the results for certain tests meningitis or meningitis-like symptoms reduced fertility stroke thromboembolism vitamin B levels reduced worsening of the problem that Vimovo is being used to treat - seek medical advice if you experience worsening of your condition The following side effects have been reported in people who have had medicines similar to Vimovo.The frequency of these side-effects in people who take Vimovo is not known increased bleeding or prolonged bleeding times seek medical advice if you bleed for an unusually long time jaundice liver problems some liver problems may be fatal melaena seek medical advice if you get melaena or notice blood in your stools skin problems such as exfoliative dermatitis toxic epidermal necrolysis and Stevens Johnson Syndrome some of these skin problems may be fatal worsening of colitis worsening of Crohn's disease If you feel unwell or if you have concerns about a side-effect you will need to seek advice.If you feel very ill get medical help straight away.Contact your prescriber pharmacist nurse or call NHS Direct on Manufacturer AstraZeneca Distributor AstraZeneca Contents Naproxen mg esomeprazole as Mg trihydrate mg Indications Symptomatic relief in the treatment of RA OA ankylosing spondylitis in patients at risk of developing NSAID-associated gastric or duodenal ulcers.Click to view Vimovo detailed prescribing infomation Dosage Adult tab bid.Click to view Vimovo detailed prescribing infomation Administration Should be taken on an empty stomach.Take at least min before meals.

Side-effects A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.Once a medicine has been licensed information on the medicine's effects both intended and unintended is continuously recorded and updated.Some side-effects may be serious while others may only be a mild inconvenience.Everyone's reaction to a medicine is different.It is difficult to predict which side-effects you will have from taking a particular medicine or whether you will have any side-effects at all.The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.Very common More than in people who take Vimovo indigestion seek medical advice if you develop indigestion Common More than in people who take Vimovo constipation diarrhoea feeling dizzy flatulence gastritis seek medical advice if you develop gastritis headaches jointpain nausea seek medical advice if you develop nausea oedema oesophagitis raised blood pressure skin rash or rashes stop taking Vimovo and seek immediate medical advice if you develop a rash stomachpain seek medical advice if you develop stomachpain stomachulcers some cases of stomachulcers may be fatal taste changes vomiting seek immediate medical advice if you vomit repeatedly Uncommon More than in people who take Vimovo abnormal laboratory test results asthma belching breathing difficulties bronchospasm changes in appetite depression dermatitis difficulty sleeping dry mouth fainting or brief loss of consciousness feeling anxious fever fracture of the hip wrist or spine this may happen if Vimovo is taken at high doses for a long period of time gastrointestinal bleeding some cases of gastrointestinal bleeding may be fatal heart problems increased sweating infections inflammation of the mouth itching musclepain or tenderness palpitations paraesthesiae tinnitus tiredness urticaria vertigo weakness Rare More than in people who take Vimovo blood problems confusion faster heart rate fluid retention gastrointestinal problems seek medical advice if you develop gastrointestinal problems hair loss heart attack hypersensitivity or allergic reactions seek medical advice if you develop any symptoms of hypersensitivity or allergy to Vimovo inflammation of the tongue kidney problems menstrual problems - seek medical advice if you get heavy bleeding metabolic problems proteinuria rectal bleeding seek medical advice if you get bleeding from the rectum sleepiness strange dreams tremors unexplained or unexpected bruising vomitingblood seek medical advice if you vomit blood The frequency of these side-effects is unknown eye or eyesight problems seek medical advice if you develop any problems with your vision low levels of magnesium in the blood seek medical advice if you develop symptoms such as tiredness involuntarymuscle contractions delirium convulsions dizziness or irregular heart rate may affect the results for certain tests meningitis or meningitis-like symptoms reduced fertility stroke thromboembolism vitamin B levels reduced worsening of the problem that Vimovo is being used to treat - seek medical advice if you experience worsening of your condition The following side effects have been reported in people who have had medicines similar to Vimovo.The frequency of these side-effects in people who take Vimovo is not known increased bleeding or prolonged bleeding times seek medical advice if you bleed for an unusually long time jaundice liver problems some liver problems may be fatal melaena seek medical advice if you get melaena or notice blood in your stools skin problems such as exfoliative dermatitis toxic epidermal necrolysis and Stevens Johnson Syndrome some of these skin problems may be fatal worsening of colitis worsening of Crohn's disease If you feel unwell or if you have concerns about a side-effect you will need to seek advice.If you feel very ill get medical help straight away.Contact your prescriber pharmacist nurse or call NHS Direct on Manufacturer AstraZeneca Distributor AstraZeneca Contents Naproxen mg esomeprazole as Mg trihydrate mg Indications Symptomatic relief in the treatment of RA OA ankylosing spondylitis in patients at risk of developing NSAID-associated gastric or duodenal ulcers.Click to view Vimovo detailed prescribing infomation Dosage Adult tab bid.Click to view Vimovo detailed prescribing infomation Administration Should be taken on an empty stomach.Take at least min before meals.

Do not change the dosage without the doctor’s consent.The usual dosage is one tablet twice daily of either of the strengths mentioned before.Swallow the tablet whole and take it half an hour before meals.Buy Vimovo From North Drug Store You can buy Vimovo online from North Drug Store as we are a registered and recognized online prescription service.When you buy from us we assure you of low price How does this medication work.

Naproxen is absorbed from the gastrointestinal tract with an in vivo bioavailability of Steady-state levels of naproxen are reached in to days.Esomeprazole Following administration of Vimovo twice daily esomeprazole is rapidly absorbed with peak plasma concentration reached within on average .to hours following the morning and evening dose on both the first day of administration and at steady state.The peak plasma concentrations of esomeprazole are higher at steady state compared to on first day of dosing of Vimovo.Figure represents the pharmacokinetics of naproxen and esomeprazole following administration of Vimovo mg mg.Figure Mean plasma concentrations of naproxen and esomeprazole following single dose administration of Vimovo mg mg Food effect Administration of Vimovo together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs tmax by hours and decreases peak plasma concentration Cmax by about Administration of Vimovo together with high-fat food in healthy volunteers delays tmax of esomeprazole by hour and significantly reduces the extent of absorption resulting in and reductions of area under the plasma concentration versus time curve AUC and peak plasma concentration Cmax respectively.Administration of Vimovo minutes before high-fat food intake in healthy volunteers does not affect the extent of absorption of naproxen but delays the absorption by about hours and decreases peak plasma concentration Cmax by about but has no significant effect on the rate or extent of esomeprazole absorption compared to administration under fasted conditions see Dosage and Administration Administration of Vimovo minutes before high-fat food intake in healthy volunteers has no effect on the rate and extent of naproxen absorption; however increases the esomeprazole AUC by and Cmax by compared to administration under fasted conditions.This increase in esomeprazole Cmax does not raise a safety issue since the approved dosing regimen of esomeprazole at mg QD would result in higher Cmax see Dosage and Administration Therefore Vimovo should be taken at least minutes before the meal.Distribution Naproxen Naproxen has a volume of distribution of L kg.At therapeutic levels naproxen is greater than albumin-bound.At doses of naproxen greater than mg day there is less than proportional increase in plasma levels due to an increase in clearance caused by saturation of plasma protein binding at higher doses average trough Css .and mg L with and mg daily doses of naproxen respectively.The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately of maximum naproxen concentration in plasma see Use in Specific Populations .Esomeprazole The apparent volume of distribution at steady state in healthy subjects is approximately L.Esomeprazole is plasma protein bound.Metabolism Naproxen Naproxen is extensively metabolized in the liver by the cytochrome P system CYP CYPC and CYPA to desmethyl naproxen.Neither the parent drug nor the metabolites induce metabolizing enzymes.Both naproxen and desmethyl naproxen are further metabolized to their respective acylglucuronide conjugated metabolites.Consistent with the half-life of naproxen the area under the plasma concentration time curve increases with repeated dosing of Vimovo twice daily.Esomeprazole Esomeprazole is extensively metabolized in the liver by the CYP enzyme system.The major part of the metabolism of esomeprazole is dependent on the polymorphic CYPC responsible for the formation of the hydroxyl-and desmethyl metabolites of esomeprazole.The remaining part is dependent on another specific isoform CYPA responsible for the formation of esomeprazole sulphone the main metabolite in plasma.The major metabolites of esomeprazole have no effect on gastric acid secretion.The area under the plasma esomeprazole concentration-time curve increases with repeated administration of Vimovo.This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration.An increased absorption of esomeprazole with repeated administration of Vimovo probably also contributes to the time-and dose-dependency.Excretion Naproxen Following administration of Vimovo twice daily the mean elimination half-life for naproxen is approximately hours following the evening dose with no change with repeated dosing.The clearance of naproxen is mL min kg.Approximately of the naproxen from any dose is excreted in the urine primarily as naproxen desmethyl naproxen or their conjugates to Small amounts or less of the administered dose are excreted in the feces.In patients with renal failure metabolites may accumulate see Warnings and Precautions Esomeprazole Following administration of Vimovo twice daily the mean elimination half-life of esomeprazole is approximately hour following both the morning and evening dose on day with a slightly longer elimination half-life at steady state -.hours.Almost of an oral dose of esomeprazole is excreted as metabolites in the urine the remainder in the feces.Less than of the parent drug is found in the urine.Concomitant Use with Clopidogrel Results from a crossover study in healthy subjects have shown a pharmacokinetic interaction between clopidogrel mg loading dose mg daily maintenance dose and esomeprazole mg p.o.once daily when co-administered for days. The major part of the metabolism of esomeprazole is dependent on the polymorphic CYPC responsible for the formation of the hydroxyl-and desmethyl metabolites of esomeprazole.The remaining part is dependent on another specific isoform CYPA responsible for the formation of esomeprazole sulphone the main metabolite in plasma.The major metabolites of esomeprazole have no effect on gastric acid secretion.The area under the plasma esomeprazole concentration-time curve increases with repeated administration of VIMOVO.This increase is dose-dependent and results in a non-linear dose-AUC relationship after repeated administration.An increased absorption of esomeprazole with repeated administration of VIMOVO probably also contributes to the time-and dose-dependency.Excretion Naproxen Following administration of VIMOVO twice daily the mean elimination half-life for naproxen is approximately hours following the evening dose with no change with repeated dosing.The clearance of naproxen is mL min kg.Approximately of the naproxen from any dose is excreted in the urine primarily as naproxen desmethyl naproxen or their conjugates to Small amounts or less of the administered dose are excreted in the feces.In patients with renal failure metabolites may accumulate see Warnings and Precautions ..Esomeprazole Following administration of VIMOVO twice daily the mean elimination half-life of esomeprazole is approximately hour following both the morning and evening dose on day with a slightly longer elimination half-life at steady state -.hours.Almost of an oral dose of esomeprazole is excreted as metabolites in the urine the remainder in the feces.Less than of the parent drug is found in the urine. Skal svelges hele med vann.Må ikke deles tygges eller knuses.Kontraindikasjoner Kjent overfølsomhet for naproksen esomeprazol substituert benzimidazol eller noen av hjelpestoffene.Historie med astma elveblest eller allergiske reaksjoner indusert av aspirin eller andre NSAIDs.Svangerskapets trimester.Alvorlig nedsatt leverfunksjon f.eks.«Child-Pugh C.Alvorlig hjertesvikt.Alvorlig nedsatt nyrefunksjon.Aktivt magesår.Gastrointestinal blødning cerebrovaskulær blødning eller andre blødningssykdommer.Skal ikke brukes sammen med atazanavir og nelfinavir.Forsiktighetsregler Pasienter på langvarig behandling spesielt år bør overvåkes regelmessig.Behandlingen bør avbrytes ved forverring eller dersom det ikke sees noen nytteverdi.Naproksen bør kun brukes etter nøye avveining av fordeler risiko ved induserbar porfyri systemisk lupus erythematosus og blandet bindevevssykdom.For å hindre overbehandling skal forskrivende lege vurdere med klinisk relevante intervaller om tilstrekkelig smertelindring er mulig med lavere NSAID-dose tilgjengelig som enkeltkomponent basert på individuell risiko og avhengig av karakteristikken og alvorlighetsgraden av underliggende sykdom. This diarrhea may be caused by an infection Clostridium difficile in your intestines.Call your healthcare provider right away if you have watery stool stomach pain and fever that does not go away. These laboratory abnormalities may progress may remain essentially unchanged or may be transient with continued therapy.The SGPT ALT test is probably the most sensitive indicator of liver dysfunction. If it's so easy why do they need a note from a doctor to get. Serum chromogranin A CgA levels increase secondary to drug-induced decreases in gastric acidity.The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high.If serial tests are performed e.g.for monitoring the same commercial laboratory should be used for testing as reference ranges between tests may vary see Pharmacodynamics .Hypomagnesemia Hypomagnesemia symptomatic and asymptomatic has been reported rarely in patients treated with PPIs for at least three months in most cases after a year of therapy.Serious adverse events include tetany arrhythmias and seizures.In most patients treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia e.g diuretics health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.see Adverse Reactions. Controlled studies do not extend beyond months.Carefully consider the potential benefits and risks of VIMOVO and other treatment options before deciding to use VIMOVO.Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.VIMOVO does not allow for administration of a lower daily dose of esomeprazole.If a dose of esomeprazole lower than a total daily dose of mg is more appropriate a different treatment should be considered.Rheumatoid Arthritis Osteoarthritis and Ankylosing Spondylitis The dosage is one tablet twice daily of VIMOVO mg naproxen and mg of esomeprazole or mg naproxen and mg of esomeprazole.The tablets are to be swallowed whole with liquid.Do not split chew crush or dissolve the tablet.VIMOVO is to be taken at least minutes before meals.Geriatric Patients Studies indicate that although total plasma concentration of naproxen is unchanged the unbound plasma fraction of naproxen is increased in the elderly.Use caution when high doses are required and some adjustment of dosage may be required in elderly patients.As with other drugs used in the elderly use the lowest effective dose see Use in Specific Populations and Clinical Pharmacology .Patients With Moderate to Severe Renal Impairment Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment creatinine clearance mL min see Warnings and Precautions .and Use in Specific Populations .Hepatic Insufficiency Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of VIMOVO.VIMOVO should be avoided in patients with severe hepatic impairment see Warnings and Precautions Use in Specific Populations and Clinical Pharmacology .Pediatric Patients The safety and efficacy of VIMOVO in children younger than years has not been established.VIMOVO is therefore not recommended for use in children.Oval yellow delayed release tablets for oral administration containing either mg enteric coated naproxen and mg esomeprazole as magnesium trihydrate tablets printed with in black or mg enteric coated naproxen and mg esomeprazole as magnesium trihydrate tablets printed with in black.VIMOVO is contraindicated in patients with known hypersensitivity to naproxen esomeprazole magnesium substituted benzimidazoles or to any of the excipients.VIMOVO is contraindicated in patients who have experienced asthma urticaria or allergic-type reactions after taking aspirin or other NSAIDs.Severe rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients see Warnings and Precautions. VIMOVO should be avoided in patients with severe hepatic impairment see Dosage and Administration Use in Specific Populations and Clinical Pharmacology .Hematological Effects Anemia is sometimes seen in patients receiving NSAIDs.This may be due to fluid retention occult or gross GI blood loss or an incompletely described effect upon erythropoiesis.Patients on long-term treatment with NSAIDs should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.Unlike aspirin their effect on platelet function is quantitatively less of shorter duration and reversible.Patients receiving VIMOVO who may be adversely affected by alterations in platelet function such as those with coagulation disorders or patients receiving anticoagulants or antiplatelets should be carefully monitored.Pre-existing Asthma Patients with asthma may have aspirin-sensitive asthma.The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal.Since cross reactivity including bronchospasm between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients VIMOVO should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with pre-existing asthma.Concomitant NSAID Use VIMOVO contains naproxen as one of its active ingredients.It should not be used with other naproxen-containing products since they all circulate in the plasma as the naproxen anion.The concomitant use of VIMOVO with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions. Masking of Inflammation and Fever The pharmacological activity of VIMOVO in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious noninflammatory painful conditions.Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms physicians should monitor for signs or symptoms of GI bleeding.Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically.If clinical signs and symptoms consistent with liver or renal disease develop systemic manifestations occur eg eosinophilia rash etc.or if abnormal liver tests persist or worsen VIMOVO should be discontinued.Patients with initial hemoglobin values of g or less who are to receive long-term therapy should have hemoglobin values determined periodically.Serum chromogranin A CgA levels increase secondary to drug-induced decreases in gastric acidity.The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors.Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high.If serial tests are performed e.g.for monitoring the same commercial laboratory should be used for testing as reference ranges between tests may vary see Pharmacodynamics .Hypomagnesemia Hypomagnesemia symptomatic and asymptomatic has been reported rarely in patients treated with PPIs for at least three months in most cases after a year of therapy.Serious adverse events include tetany arrhythmias and seizures.In most patients treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia e.g diuretics health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.see Adverse Reactions Concomitant use of St John's Wort or Rifampin with VIMOVO Drugs that induce CYPC or CYPA such as St John’s Wort or rifampin can substantially decrease esomeprazole concentrations.Avoid concomitant use of VIMOVO with St John’s Wort or rifampin see Drug Interactions .Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The adverse reactions reported below are specific to the clinical trials with VIMOVO.See also the full prescribing information for naproxen and esomeprazole magnesium products.The safety of VIMOVO was evaluated in clinical studies involving patients aged to years and ranging from -months.Patients received either mg mg of VIMOVO twice daily n mg of enteric-coated naproxen twice daily n or placebo n.The average number of VIMOVO doses taken over months was +.The table below lists all adverse reactions regardless of causality occurring in of patients receiving VIMOVO from two clinical studies Study and Study Both of these studies were randomized multi-center double-blind parallel studies.The majority of patients were female white The majority of patients were -years of age Approximately one quarter were on low-dose aspirin.Table Adverse Reactions occurring in patients Study and Study endoscopic studies Preferred term sorted by SOC VIMOVO mg mg twice daily n EC-Naproxen mg twice daily n Gastrointestinal Disorders Gastritis Erosive Dyspepsia Gastritis Diarrhea Gastric Ulcer Abdominal Pain Upper Nausea Hiatus Hernia Abdominal Distension Flatulence Esophagitis Constipation Abdominal pain Erosive Duodenitis Abdominal pain lower Duodenitis Gastritis hemorrhagic Gastroesophageal reflux disease Duodenal ulcer Erosive esophagitis Infections and infestations Upper respiratory tract infection Bronchitis Urinary tract infection Sinusitis Nasopharyngitis Musculoskeletal and connective tissue disorders Arthralgia Nervous system disorders Headache Dysgeusia Respiratory thoracic and mediastinal disorders Cough In Study and Study patients taking VIMOVO had fewer premature discontinuations due to adverse reactions compared to patients taking enteric-coated naproxen alone The most common reasons for discontinuations due to adverse events in the VIMOVO treatment group were upper abdominal pain n duodenal ulcer n and erosive gastritis n.Among patients receiving enteric-coated naproxen the most common reasons for discontinuations due to adverse events were duodenal ulcer n dyspepsia n and upper abdominal pain n.The proportion of patients discontinuing treatment due to any upper gastrointestinal adverse events including duodenal ulcers in patients treated with VIMOVO was compared to for patients taking enteric-coated naproxen.The table below lists all adverse reactions regardless of causality occurring in of patients from clinical studies conducted in patients with osteoarthritis of the knee Study and Study Table Adverse Reactions occurring in patients Study and Study Preferred term sorted by SOC VIMOVO mg mg twice daily n Placebo n Gastrointestinal Disorders Dyspepsia Diarrhea Abdominal Pain Upper Constipation Nausea Nervous System Disorders Dizziness Headache General disorders and administration site conditions Peripheral edema Respiratory thoracic and mediastinal disorders Cough Infections and infestations Sinusitis The percentage of subjects who withdrew from the VIMOVO treatment group in these studies due to treatment-emergent adverse events was There were no preferred terms in which more than of subjects withdrew from any treatment group.The long-term safety of VIMOVO was evaluated in an open-label clinical trial of patients of which patients received mg mg of VIMOVO for months.There were no differences in frequency or types of adverse reactions seen in the long-term safety study compared to shorter-term treatment in the randomized controlled studies.Postmarketing Experience Naproxen The following adverse reactions have been identified during post-approval use of naproxen.Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.These reports are listed below by body system Body as a Whole anaphylactoid reactions angioneurotic edema menstrual disorders pyrexia chills and fever Cardiovascular congestive heart failure vasculitis hypertension pulmonary edema Gastrointestinal gastrointestinal bleeding and or perforation hematemesis pancreatitis vomiting colitis exacerbation of inflammatory bowel disease ulcerative colitis Crohn’s disease nonpeptic gastrointestinal ulceration ulcerative stomatitis esophagitis peptic ulceration Hepatobiliary jaundice abnormal liver function tests hepatitis some cases have been fatal Hemic and Lymphatic eosinophilia leukopenia melena thrombocytopenia agranulocytosis granulocytopenia hemolytic anemia aplastic anemia Metabolic and Nutritional hyperglycemia hypoglycemia Nervous System inability to concentrate depression dream abnormalities insomnia malaise myalgia muscle weakness aseptic meningitis cognitive dysfunction convulsions Respiratory eosinophilic pneumonitis asthma Dermatologic alopecia urticaria skin rashes toxic epidermal necrolysis erythema multiforme erythema nodosum fixed drug eruption lichen planus pustular reaction systemic lupus erythematoses bullous reactions including Stevens-Johnson syndrome photosensitive dermatitis photosensitivity reactions including rare cases resembling porphyria cutanea tarda pseudoporphyria or epidermolysis bullosa.If skin fragility blistering or other symptoms suggestive of pseudoporphyria occur treatment should be discontinued and the patient monitored.Special Senses hearing impairment corneal opacity papillitis retrobulbar optic neuritis papilledema Urogenital glomerular nephritis hematuria hyperkalemia interstitial nephritis nephrotic syndrome renal disease renal failure renal papillary necrosis raised serum creatinine Reproduction female infertility Esomeprazole The following adverse reactions have been identified during post-approval use of esomeprazole.Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.These reports are listed below by body system Blood and Lymphatic agranulocytosis pancytopeniaEye blurred visionGastrointestinal pancreatitisstomatitisHepatobiliary hepatic failure hepatitis with or without jaundiceImmune System anaphylactic reaction shockInfections and Infestations GI candidiasisMetabolism and Nutritional Disorders hypomagnesemia Musculoskeletal and Connective Tissue muscular weakness myalgia; Nervous System hepatic encephalopathy taste disturbancePsychiatric aggression agitation depression hallucinationRenal and Urinary interstitial nephritisReproductive System and Breast gynecomastiaRespiratory Thoracic and Mediastinal bronchospasmSkin and Subcutaneous Tissue alopecia erythema multiforme hyperhidrosis photosensitivity Stevens-Johnson syndrome toxic epidermal necrolysis some fatal.Several studies conducted with VIMOVO have shown no interaction between the two components naproxen and esomeprazole.ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors.This interaction should be given consideration in patients taking VIMOVO concomitantly with ACE-inhibitors.Aspirin VIMOVO can be administered with low-dose aspirin ≤ mg day therapy.The concurrent use of aspirin and VIMOVO may increase the risk of serious adverse events see Warnings and Precautions Adverse Reactions and Clinical Studies When naproxen is administered with doses of aspirin gram day its protein binding is reduced.The clinical significance of this interaction is not known.However as with other NSAIDs concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.Cholestyramine As with other NSAIDs concomitant administration of cholestyramine can delay the absorption of naproxen.Cyclosporin As with all NSAIDs caution is advised when cyclosporin is co-administered because of the increased risk of nephrotoxicity.Tacrolimus Concomitant administration of esomeprazole a component of VIMOVO and tacrolimus may increase the serum levels of tacrolimus.Diuretics Clinical studies as well as postmarketing observations have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients.This response has been attributed to inhibition of renal prostaglandin synthesis.During concomitant therapy with NSAIDs the patient should be observed closely both for signs of renal failure as well as to monitor to assure diuretic efficacy see Warnings and Precautions Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.The mean minimum lithium concentration increased and the renal clearance was decreased by approximately These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID.Thus when NSAIDs and lithium are administered concurrently subjects should be observed carefully for signs of lithium toxicity.Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.NSAIDs have been reported to reduce the tubular secretion of methotrexate in an animal model.This may indicate that they could enhance the toxicity of methotrexate.Caution should be used when NSAIDs are administered concomitantly with methotrexate.Anticoagulants Naproxen decreases platelet aggregation and may prolong bleeding time.In addition because warfarin and NSAIDs are highly protein bound the free fraction of warfarin and naproxen may increase substantially in some patients.Concomitant use of VIMOVO and anticoagulants such as warfarin dicumarol and heparin may result in increased risk of bleeding complications.The effects of warfarin and NSAIDs on GI bleeding are synergistic such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.Post-marketing reports of changes in prothrombin measures have been reported among patients on concomitant warfarin and esomeprazole therapy.Increases in INR and prothrombin time may lead to abnormal bleeding and even death.Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.Selective Serotonin Reuptake Inhibitors SSRIs There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors SSRIs are combined with NSAIDs including COX-selective inhibitors.Caution should be used when NSAIDs are administered concomitantly with SSRIs see Warnings and Precautions .Other Information Concerning Drug Interactions Naproxen is highly bound to plasma albuminit thus has a theoretical potential for interaction with other albumin-bound drugs such as sulphonylureas hydantoins and other NSAIDs.Patients simultaneously receiving VIMOVO and a hydantoin sulphonamide or sulphonylurea should be observed for adjustment of dose if required.Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other beta-blockers.Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.Interactions With Investigations of Neuroendocrine Tumors Drug-induced decrease in gastric acidity results in enterochromaffin-like cell hyperplasia and increased Chromogranin A levels which may interfere with investigations for neuroendocrine tumors see Warnings and Precautions and Pharmacodynamics Drug Laboratory Test Interaction Naproxen may decrease platelet aggregation and prolong bleeding time.This effect should be kept in mind when bleeding times are determined.The administration of naproxen may result in increased urinary values for -ketogenic steroids because of an interaction between the drug and or its metabolites with m-di-nitrobenzene used in this assay.Although hydroxy-corticosteroid measurements Porter-Silber test do not appear to be artifactually altered it is suggested that therapy with naproxen be temporarily discontinued hours before adrenal function tests are performed if the Porter-Silber test is to be used.Naproxen may interfere with some urinary assays of -hydroxy indoleacetic acid HIAA.Interactions Related to Absorption Esomeprazole inhibits gastric acid secretion.Therefore esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability eg ketoconazole iron salts and digoxin.Concomitant treatment with omeprazole mg daily and digoxin in healthy subjects increased the bioavailability of digoxin by in two subjects.Esomeprazole is an enantiomer of omeprazole.Coadministration of digoxin with esomeprazole is expected to increase the systemic exposure of digoxin.Therefore patients may need to be monitored for increases in digoxin toxicity when digoxin is taken concomitantly with esomeprazole.Antiretroviral Agents Concomitant use of atazanavir and nelfinavir with proton pump inhibitors such as esomeprazole is not recommended.Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.Omeprazole the racemate of esomeprazole has been reported to interact with some antiretroviral drugs.The clinical importance and the mechanisms behind these interactions are not always known.Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug.Other possible interaction mechanisms are via CYPC. Des répondants ont éprouvé des complications GI après avoir arrêté leur médicament pour les troubles digestifs tout en poursuivant leur traitement par AINSviii À propos d’AstraZeneca Canada AstraZeneca est engagée envers la recherche le développement et la fabrication de médicaments d’ordonnance de grande valeur.Elle possède une imposante gamme de produits dans les six domaines thérapeutiques suivants gastro-entérologie cardiologie infectiologie neurosciences oncologie et pneumologie.Le siège social canadien d’AstraZeneca est situé Mississauga en Ontario et l’entreprise exploite un centre ultramoderne de découverte de médicaments Montréal au Québec.Pour de plus amples renseignements visitez le site Web de la Consulté le février Lanas et al; Assessment of gastrointestinal and cardiovascular risk in patients with osteoarthritis who require NSAIDs the LOGICA study.Ann Rheum Dis ;–.Hunt et al.Recommendations for the appropriate use of anti-inflammatory drugs in the era of coxibs Defining the role of gastroprotective agents.Canadian Journal of Gastroenterology.; -.Rostom et al.Canadian consensus guidelines on long-term nonsteroidal anti-inflammatory drug therapy and the need for gastroprotection benefits versus risks.Alimentary Pharmacology Therapeutics ; -.Léger Marketing.Sondage MISSISSAUGA ON Wednesday April AstraZeneca Canada Inc.announced today that Health Canada has approved VIMOVO® modified-release tablets for the treatment of the 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 non-steroidal anti-inflammatory drug NSAID-associated gastric ulcersi VIMOVO is the first fixed-dose combination of enteric-coated naproxen an NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The approval of VIMOVO was supported by data from a clinical development program including results from the PN-and PN-studies which demonstrated that subjects taking VIMOVO experienced significantly fewer gastric ulcers and NSAID-associated upper GI adverse events had significantly less treatment discontinuations and as measured through patient reports of dyspepsia and heartburn had better upper gastrointestinal tolerability compared to subjects receiving enteric-coated naproxen aloneii "While NSAIDs are effective at relieving the pain and inflammation associated with osteoarthritis many patients discontinue use and live in pain due to gastrointestinal side-effects or safety concerns " says Dr.Peter Lin family physician in Toronto."VIMOVO combines an NSAID and PPI together into one pill allowing patients to have pain relief while protecting their stomach." Osteoarthritis which affects three million Canadians iii is the most common form of arthritis and is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.A common misconception is that arthritis is a disease of the elderly.In fact almost per cent per cent of arthritis patients are under the age of iv While many patients with osteoarthritis treat their symptoms with NSAIDs per cent of chronic NSAID-users are at increased risk of gastrointestinal GI complications.v An estimated Canadians die every year from complications associated with NSAID consumption.vi Risk factors for NSAID-associated upper GI clinical events include age history of GI events concomitant use of oral corticosteroids and anticoagulants high-dose multiple NSAID use and concomitant use of aspirin.vii A new survey of Canadian osteoarthritis patients found per cent of patients at risk of NSAID-associated GI complications were not aware they were at risk and the majority could not identify risk factors for developing GI side effects associated with NSAID use.viii In addition per cent of patients with osteoarthritis discontinued their GI medication because they started to "feel better" per cent and preferred to take less medication per cent.viii Thirty per cent of respondents experienced GI complications as a result of stopping their GI medication continuing on their NSAID therapy.viii CONTACTS REFERENCESi VIMOVO®Canadian Product Monograph.AstraZeneca Canada Inc.January .ii Goldstein et al.PN significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use MISSISSAUGA ON Wednesday April AstraZeneca Canada Inc.announced today that Health Canada has approved VIMOVO® modified-release tablets for the treatment of the 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 non-steroidal anti-inflammatory drug NSAID-associated gastric ulcersi VIMOVO is the first fixed-dose combination of enteric-coated naproxen an NSAID and immediate-release esomeprazole a proton pump inhibitor PPI.The approval of VIMOVO was supported by data from a clinical development program including results from the PN-and PN-studies which demonstrated that subjects taking VIMOVO experienced significantly fewer gastric ulcers and NSAID-associated upper GI adverse events had significantly less treatment discontinuations and as measured through patient reports of dyspepsia and heartburn had better upper gastrointestinal tolerability compared to subjects receiving enteric-coated naproxen aloneii "While NSAIDs are effective at relieving the pain and inflammation associated with osteoarthritis many patients discontinue use and live in pain due to gastrointestinal side-effects or safety concerns " says Dr.Peter Lin family physician in Toronto."VIMOVO combines an NSAID and PPI together into one pill allowing patients to have pain relief while protecting their stomach." Osteoarthritis which affects three million Canadians iii is the most common form of arthritis and is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.A common misconception is that arthritis is a disease of the elderly.In fact almost per cent per cent of arthritis patients are under the age of iv While many patients with osteoarthritis treat their symptoms with NSAIDs per cent of chronic NSAID-users are at increased risk of gastrointestinal GI complications.v An estimated Canadians die every year from complications associated with NSAID consumption.vi Risk factors for NSAID-associated upper GI clinical events include age history of GI events concomitant use of oral corticosteroids and anticoagulants high-dose multiple NSAID use and concomitant use of aspirin.vii A new survey of Canadian osteoarthritis patients found per cent of patients at risk of NSAID-associated GI complications were not aware they were at risk and the majority could not identify risk factors for developing GI side effects associated with NSAID use.viii In addition per cent of patients with osteoarthritis discontinued their GI medication because they started to "feel better" per cent and preferred to take less medication per cent.viii Thirty per cent of respondents experienced GI complications as a result of stopping their GI medication continuing on their NSAID therapy.viii CONTACTS REFERENCESi VIMOVO®Canadian Product Monograph.AstraZeneca Canada Inc.January .ii Goldstein et al.PN significantly reduces the incidence of gastric ulcers compared with enteric-coated naproxen in patients requiring chronic NSAID therapy regardless of low-dose aspirin use results from two prospective randomized controlled trials.Accessed February .v Lanas. Use Medication name Generic name Naproxen esomeprazole OralPronunciation na-PROX-en ES-oh-MEP-ra-zoleBrand names Vimovo Warning The naproxen in this combination medication may rarely cause blood clots to form causing a heart attack or stroke.The risk may be greater if you have heart disease or increased risk for heart disease for example due to smoking family history of heart disease or conditions such as high blood pressure or diabetes or with longer use.This drug should not be taken right before or after heart bypass surgery CABG.Also this drug may infrequently cause serious rarely fatal bleeding from the stomach or intestines.This can occur without warning symptoms and at any time during treatment.The risk of bleeding is greater in older adults.Esomeprazole decreases the risk of bleeding.Stop taking this medication and get medical help right away if you notice any of the following rare but very serious side effects chest jaw left arm pain severe dizziness weakness on one side of the body vision changes slurred speech black stools persistent stomach abdominal pain vomit that looks like coffee grounds.See also Precautions section.Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.Uses This medication is used to treat the signs and symptoms of rheumatoid arthritis osteoarthritis and ankylosing spondylitis when there is a high risk for stomach bleeding ulcer.This product contains medications esomeprazole and naproxen.This product should not be used to relieve sudden pain.The naproxen starts to work slower than other naproxen products because of a special coating delayed-release.If you are treating a chronic condition such as arthritis ask your doctor about non-drug treatments and or using other medications to treat your pain.See also Warning section.Naproxen is a nonsteroidal anti-inflammatory drug NSAID.It reduces pain swelling and joint stiffness.

If you reside outside the jurisdiction of British Columbia Canada and a problem arises with our pharmacy you can contact the College of Pharmacists at B.C.to report your concern.Search alphabetically for prescription medication brand medication or generic medication online.Buy Vimovo and or Generic Alternative Drug Name Drug Names Related Vimovo Product Description When you order Vimovo from onlinepharmaciescanada.com you have peace of mind as we protect your privacy with a secure ordering process.The Vimovo medication you purchase is manufactured by Astra Zeneca and is coming from a CIPA certified and Pharmacy Checker verified online pharmacy.Naproxen Esomeprazole Magnesium is the generic alternative to Vimovo.Vimovo can be found in dosages such as Vimovo mg and Vimovo mg In almost years of facilitating online ordering for prescription or OTC medication Online Pharmacies Canada has never had a counterfeit product complaint for vimovo as our association randomly tests our drug suppliers and we physically visit inspect and ensure our international dispensing pharmacies are Pharmacy Checker approved.We make sure that when you buy Vimovo online you are ordering high quality safe and affordable prescription medication.Place your order and buy Vimovo today at onlinepharmaciescanada.com a global leader of Canadian based online pharmacies and a trusted online Canadian pharmacy since We offer a low price guarantee price match when you order Vimovo online against any competing CIPA certified online pharmacy website.Our service is of top quality and we always verify your prescription with your doctor i.e an initial fax copy of your prescription followed by you mailing your original prescription us.Your GuaranteeYou can shop with confidence at Online Pharmacies Canada because we enforce strict policies and procedures to safeguard Vimovo naproxen + esomeprazole is a very varied medication.It has been recently approved by FDA and can be used to treat arthritis and spondylitis.It is also indicated for osteoarthritis.The drug doesn’t fight against these disease at all but mostly against the symptoms.As if it wasn’t enough Vimovo is also used to prevent the gastric ulcer therefore it is a multifunctional drug.Besides it is also recommended when small doses of naproxen or other similar medications are not enough to ameliorate the patients’ state of health.The product is manufactured by AstraZeneca in a tight collaboration with POZEN Inc.and represents a combination of fixed doses of enteric naproxen and esomeprazole.AdministrationVimovo naproxen + esomeprazole may be very efficient but it is not always the best solution for the patients.The patient will carefully have to analyze all the other alternatives too.Each medication has both advantages and disadvantages.Carry this discussion with the specialist doctor and according to how severe the problem is you can make a decision.If for example the dose of esomeprazole you are recommended is smaller than what Vimovo naproxen + esomeprazole can provide then perhaps you should consider an alternative instead.The pills must be taken whole.Whether you use water or not never break them into pieces.Also keep in mind to take them at least half an hour before having a meal.The pills come in two different doses with mg and mg of naproxen.ContraindicationsVimovo naproxen + esomeprazole is not indicated in the people who are allergic to esomeprazole naproxen or any other components of the drug.Besides there is a list of disorders that exclude it from a treatment.No matter how small the connection may seem asthma is one of them.If you have ever been through a treatment for asthma you can forget about this one.The same goes for urticaria or any NSAID hypersensitivity.The allergy can be so problematic that in some cases it may be fatal.Vimovo naproxen + esomeprazole may present multiple risks to pregnant women if administered within the first weeks of the pregnancy.After this optimal period of time the fetus is risk free.Side effectsThe frequency and intensity of the side effects mostly depend on the sensitivity of each organism.Almost of the patients end up with gastritis or abdominal pains.At the other end of the rope less than encounter duodenal ulcer or esophagitis.Diarrhea nausea and constipation are among the less harmful adverse reactions of Vimovo naproxen + esomeprazole.views Article Vimovo mg-mg hr Tab Drug Name NAPROXEN ESOMEPRAZOLE ORAL Other Brand Names Vimovo Uses This medication is used to treat the signs and symptoms of rheumatoid arthritis osteoarthritis and ankylosing spondylitis when there is a high risk for stomach bleeding ulcer.This product contains medications esomeprazole and naproxen.This product should not be used to relieve sudden pain.The naproxen starts to work slower than other naproxen products because of a special coating delayed-release.Naproxen is a nonsteroidal anti-inflammatory drug NSAID.It reduces pain swelling and joint stiffness.Naproxen can cause stomach ulcers especially in patients with a history of stomach ulcers.Esomeprazole is a proton pump inhibitor PPI that blocks acid production in the stomach.This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.Posts on vimovo im taking lortab somas predisone and vimoxo can i take all those together A couple of months ago I was diagnosed with Fibromyalgia.I've been on Savella mg for Six months I woke up with sore and swolen fingers both hands.Doctors tested or arthriti.Six months ago I woke up with sore and swolen fingers both hands.Doctors tested for art.hi I was a front seat passenger of a vehicle which was involved in an accident.The hospital.I am a yr old female who has been having problems with pain.I have been having a lot o.I was just diaged a few days ago as "acutely infected" and suspect I've had Lyme for yrs-ha.Just wondering what if anything people take for headache.

We do not sell drugs.This site contains prices only for information purposes to help you buy drugs cheaply.You should consult a doctor about the dosage before using this medicine.

Vimovo oral

07.09.2013, admin

Naproxen has the following structure Naproxen has a molecular weight of and second quarter Pozen has been very good vimovo oral at signing commercialization partnerships.The those listed in this Medication Guide.Do not use VIMOVO for a condition ... Read more... »

Vimovo 500 20mg tablets

29.08.2013, admin

Why should a third high degree of its protein binding.Activated charcoal to g in adults to g kg in children and or osmotic without warning while you are taking esomeprazole and naproxen especially rest of the drugs there are thousands helped ... Read more... »

What is vimovo good for

28.08.2013, admin

Active ingredients naproxen and esomeprazole magnesium Inactive ingredients carnauba wax colloidal silicon dioxide croscarmellose sodium iron oxide yellow glyceryl monostearate hypromellose iron oxide black magnesium stearate methacrylic acid ... Read more... »

Is vimovo safe

27.08.2013, admin

Are breastfeeding or plan to breastfeed.VIMOVO can pass into your milk and you are bleeding from the rectum back passage have black severe renal impairment creatinine clearance ml min see Dosage and Administration Warnings and Precautions and Use ... Read more... »

Vimovo and ibuprofen

24.08.2013, admin

Avoid much of a certain drug.Check the label to see if a medicine contains naproxen complications of presumed noninfectious noninflammatory painful conditions.Laboratory Tests Because serious GI tract clinical development program vimovo and ... Read more... »

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