DRUG AND FORM TGA INDICATION CURRENT PBS LISTING LISTING REQUESTED any doctor who treats you that you are using esomeprazole and naproxen.Store at room temperature away from moisture heat and light.Back to Top What happens if I overdose on VIMOVO. The financing went in the pockets of the pharma executives.Lots of reps were dogs.Patients should be managed by symptomatic and supportive care following an NSAID overdose.There are no specific antidotes.Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding.Activated charcoal to g in adults to g kg in children and or osmotic cathartic may be indicated in patients seen within hours of ingestion with symptoms or following a large overdose.Forced diuresis alkalinization of urine or hemoperfusion may not be useful due to high protein binding.Overdosage of esomeprazole A single oral dose of esomeprazole at mg kg about times the human dose on a body surface area basis was lethal to rats.The major signs of acute toxicity were reduced motor activity changes in respiratory frequency tremor ataxia and intermittent clonic convulsions.The symptoms described in connection with deliberate esomeprazole overdose limited experience of doses in excess of mg day are transient.Single doses of mg of esomeprazole were uneventful.Reports of overdosage with omeprazole in humans may also be relevant.Doses ranged up to mg times the usual recommended clinical dose.Manifestations were variable but included confusion drowsiness blurred vision tachycardia nausea diaphoresis flushing headache dry mouth and other adverse reactions similar to those seen in normal clinical experience see omeprazole package insert Adverse Reactions.No specific antidote for esomeprazole is known.Since esomeprazole is extensively protein bound it is not expected to be removed by dialysis.In the event of overdosage treatment should be symptomatic and supportive.If overexposure occurs call the Poison Control Center at - Vimovo Description The active ingredients of Vimovo are naproxen which is a NSAID and esomeprazole magnesium which is a Proton Pump Inhibitor PPI. Clarithromycin used to treat infection.Quinolone antibiotic for infections such as ciprofloxacin or moxifloxacin.Diazepam celebrex even while taking Prilosec so my rheumy's trying me on this now.Questions.You're supposed to take it without food so the PPI will have time to work but this makes me super nervous since taking NSAIDs without food seems like a recipe for a world of stomach pain.Has anyone done this.
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific reaction hivesdifficulty breathingswelling of your face lips tongue or throat.Stop using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such aspale skin easy bruising unusual bleeding or any bleeding that will not stop;chest pain or heavy feeling pain spreading to the arm or shoulder nausea sweating general ill feeling;sudden numbness or weakness especially on one side of the body;sudden headache .Read All Potential Side Effects and See Pictures of Vimovo What are the precautions when taking naproxen and esomeprazole magnesium delayed release tablets Vimovo. You may need urgent medical attention.Serious side effects are rare.If nSAID and immediate-release esomeprazole magnesium a proton pump inhibitor PPI.VIMOVO modified-release tablets is indicated for the symptomatic treatment of osteoarthritis rheumatoid arthritis and ankylosing spondylitis in patients who are at risk for developing non-steroidal anti-inflammatory drug NSAID-associated gastric and or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.VIMOVO was co-developed by AstraZeneca and POZEN Inc.and approved by the US Food and Drug Administration on April While the Internet serves a global community the pharmaceutical industry is subject to country-specific regulatory considerations.This means that the registration status and approved product labels of VIMOVO may not be the same in different countries.Information on this site is derived from the Summary of Product Characteristics SPC for VIMOVO in the UK.Please refer to your local What happens if I miss a dose Vimovo.
Go tell the construction industry or the IT industry that they can't take enormous risk associated with drug development.I wish people like Dr.Pullen just said "thank you" rather than berate a drug company for marketing a drug that he doesn't feel is worth the cost.What I don't wonder is how much talent is required to be a critic.Or rather-the lack of talent.We all know what Vimovo is and what it does.If you don't like it don't prescribe it.If you think your patients will take pills a day at different times-prescribe this regiment.Keep in mind that assuming the patient survives the bleed from the ulcer-the hospitalization of gastric ulcer will cost more than a year supply of Vimovo.I wish Dr.Pullen would put his energy into constructive ideas rather than tearing down the work of others.If he did-He might not appear to be a shallow short-sighted pessimist.We have enough of those already.I used to use this argument but it really doesn't fly anymore especially when you are talking about Vimovo.Vimovo is a combination drug that I am sure works but so would many other regimens.Most doctors don't like to prescribe combination drugs.And your pills times a day is erroneous.As someone who has sold both proton pump inhibitors and NSAIDS I know there are many combinations on the market that would work and are much cheaper.Vimovo is breaking no new ground it's a hasty opportunistic attempt to come up with another product and not very successfully.Doctor Pullen leaves me in a state of wonder.I wonder how many advances in medicine Dr.Pullen is responsible for.
Other effects of esomeprazole on the endocrine system were assessed using omeprazole fDA-.Need help identifying pills and medications. Not every pharma company is bad but AZ has been on a permanent Corporate blood pressure or heart problems aspirin cholestyramine Questran Questran Light Locholest Locholest Light Prevalite cyclosporine Gengraf Neoral Sandimmune or tacrolimus Prograf a water pill diuretic lithium carbonate methotrexate sodium Trexall blood thinner medicines including warfarin sodium Coumadin Jantoven dicumarol or a blood thinner that contains heparin an antidepressant medicine Ask your healthcare provider if you are not sure if your medicine is one that is listed above.Using VIMOVO with other medicines can cause serious side effects.VIMOVO may affect the way other medicines work and other medicines may affect how VIMOVO works.Know the medicines you take.Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.How should I take VIMOVO.
Therefore Vimovo should be used with caution in people with known high 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. And AstraZeneca is a fixed-dose combination of enteric-coated naproxen a pain-relieving non-steroidal anti-inflammatory drug nSAID.It works by reducing substances in the body that cause inflammation pain and fever.Vimovo is a proton pump inhibitor.It decreases the amount of acid produced in the stomach.The combination of Vimovo and naproxen is used to treat symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis. Biopharmaceutical company AstraZeneca Plc AZN Quote AZN.L Friday said a long-term when these events do occur.Most spontaneous reports of fatal GI events are in the geriatric population see Warnings and Precautions .Naproxen is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function care should be taken in dose selection and it may be useful to monitor renal function.Geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of NSAIDs see Warnings and Precautions ..Renal Insufficiency Naproxen-containing products including VIMOVO are not recommended for use in patients with advanced renal disease see Dosage and Administration and Warnings and Precautions ..There is no clinical data on overdosage with VIMOVO.Overdosage of naproxen Significant naproxen overdosage may be characterized by lethargy dizziness drowsiness epigastric pain abdominal discomfort heartburn indigestion nausea transient alterations in liver function hypoprothrombinemia renal dysfunction metabolic acidosis apnea disorientation or vomiting.Gastrointestinal bleeding can occur. Este medicamento é contraindicado para uso have caused you to have asthma wheeziness or an allergic reaction such as itchiness or skin rash urticaria.You are in the last months of pregnancy.You have severe problems with your liver kidney or heart.You have an ulcer in your stomach or gut.You have any bleeding disorder or serious and unexpected bleeding.Do not take VIMOVO if any of the above apply to you.If you are not sure talk to your doctor or pharmacist before taking VIMOVO.Take special care with VIMOVO You must not take VIMOVO and talk to your doctor straight away if any of the following happen to you before or while you are taking VIMOVO as this medicine may hide the symptoms of other disease You lose a lot of weight for no reason and have problems swallowing.You start to vomit food or blood.You pass black stools blood-stained faeces.If any of the above apply to you or you are not sure talk to your doctor or pharmacist before taking this medicine.Check with your doctor or pharmacist before taking this medicine if You have inflammation of your intestines Crohn’s disease or ulcerative colitis.You have any other problems with your liver or kidneys or if you are elderly.You are taking medicines such as corticosteroids taken by mouth warfarin Selective Serotonin Reuptake Inhibitors SSRIs acetylsalicylic acid aspirin or NSAIDs including COX-inhibitors see section Taking other medicines.If any of the above apply to you or you are not sure talk to your doctor or pharmacist before taking this medicine.If you have previously experienced stomach ulcer or bleeding you should let your doctor know.You will be asked to report any unusual symptoms from your stomach e.g.pain to your doctor.Medicines such as VIMOVO may be associated with a small increase in the risk of heart attack myocardial infarction or stroke.Any risk is more likely with high doses and long lasting treatment.
While VIMOVO has been shown to significantly decrease the occurrence of gastric record with their own products and their stated goal to be the partner of choice for smaller companies.In of Vimovo’s million in global sales million came from the United States according to figures released by AstraZeneca.Plachetka says the U.S.number should have been higher given the million senior arthritic Americans at risk of aspirin-induced ulcers.Pozen’s first marketing partnership was with GlaxoSmithKline to sell Treximet and that relationship led Plachetka to realize the value of such arrangements.Pozen next selected AstraZeneca for Vimovo a drug struggling in the U.S.market.We think the problem is partially because of AstraZeneca’s corporate philosophy of pricing he said. John's Wort rifampin Rifater Rifamate Rimactane Rifadin a medicine for high been discovered or deveoloped by any government agency.
This includes prescription over-the-counter vitamin and herbal products.Do not start magnesium may increase the chance of a heart attack or stroke that can lead to death.This chance increases NSAID-containing medicines such as VIMOVO should never be used right before or after a heart surgery called a coronary artery bypass graft CABG.NSAID-containing medicines such as VIMOVO can cause ulcers and bleeding in the stomach and intestines at any time during treatment.Ulcers and bleeding The chance of a person getting an ulcer or bleeding increases with NSAID medicines should only be used What are Non-Steroidal Anti-Inflammatory Drugs NSAIDs. NSAIDs should be given with care to patients with a history of inflammatory bowel 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. Detailed View Safety Labeling Changes Approved By FDA Center for Drug more than one year may slightly increase your risk of fracture in the hip wrist or spine.Tell your doctor if you have osteoporosis or if you are taking corticosteroids which can increase the risk of osteoporosis.Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.This includes medicines that you buy without a presc ription including herbal medicines.This is because VIMOVO can affect the way some other medicines work.Also some other medicines can affect the way VIMOVO works.Do not take this medicine and tell your doctor or pharmacist if you are taking A medicine called atazanavir or nelfinavir used to treat HIV.Tell your doctor or pharmacist if you are taking any of the following medicines Acetylsalicylic acid aspirin.If you take low dose aspirin you can still take VIMOVO.Other NSAID medicines including COX-inhibitors.Certain drugs such as ketoconazole itraconazole posaconazole or voriconazole used to treat infections caused by a fungus.Erlotinib or another anticancer drug from the same class. Naproxen may also cause serious effects on the stomach or intestines 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 acompanhados de sachê com dessecante sílica gel.Número do registro no Ministério da Saúde Número e data do Registro Data da publicação global voltada para inovação com foco principal na descoberta desenvolvimento e na comercialização de medicamentos de prescrição nas seguintes linhas terapêuticas gastrointestinal cardiovascular neurológica respiratória e inflamatória oncológica reumatológica e doenças infecciosas.A By Jason Napodano CFAShares of Pozen POZN peaked in April and have been in a steady decline ever since.The sell-off was accelerated by sales figures in late October from Vimovo partner AstraZeneca AZN showing limited market acceptance for the combination mg naproxen and mg delayed-release esomeprazole product.AstraZeneca's financial results showed that Vimovo generated only million in sales in the third quarter and million for the first nine months of Sales of Vimovo totaled only million in the U.S.during the third quarter.AstraZeneca has turned its attention to international markets for Vimovo as it is clear the opportunity for Vimovo in the U.S.is limited.The single biggest question we receive from investors on Pozen is "If Vimovo is such a commercial failure in the U.S why should we expect any different from PA?" It's a valid question.Pozen designed Vimovo as a "safer NSAID" product for patients either taking daily naproxen or branded medications such as Pfizer's PFE Celebrex celecoxib.Similar to aspirin naproxen has nasty gastrointestinal side-effects and the Vimovo formulation which includes a delayed-release esomeprazole the active ingredient in AstraZeneca's Nexium protects the stomach from potential harm.
Significant unintentional weight loss recurrent vomiting dysphagia haematemesis melaena and pregnancy due to possible harm to the unborn baby and interference with normal labor delivery.Naproxen passes into breast milk.It is unknown if esomeprazole passes into breast milk.Consult your doctor before breast-feeding.Drug interactions The effects of some drugs can change if you take other drugs or herbal products at the same time.This can increase your risk for serious side effects or may cause your medications not to work correctly.These drug interactions are possible but do not always occur.Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care be sure to tell your doctor and pharmacist about all the products you use including prescription drugs nonprescription drugs and herbal products before starting treatment with this product.While using this product do not start stop or change the dosage of any other medicines you are using without your doctor's approval.Some products that may interact with this drug include aliskiren ACE Inhibitors such as lisinopril angiotensin II receptor blockers such as valsartan losartan corticosteroids such as prednisone lithium methotrexate especially high-dose treatment pemetrexed probenecid rifampin St John's wort.This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding.Examples include anti-platelet drugs such as clopidogrel "blood thinners" such as dabigatran enoxaparin warfarin among others.Some products need stomach acid so that the body can absorb them properly.These include atazanavir digoxin erlotinib nelfinavir rilpivirine certain azole antifungals itraconazole ketoconazole posaconazole among others.Esomeprazole decreases stomach acid so it may change how well these other products work.Before using esomeprazole consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.Do not take other products containing naproxen or proton pump inhibitors such as omeprazole.Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers fever reducers aspirin NSAIDs such as celecoxib or ibuprofen.These drugs are similar to the naproxen in this product and may increase your risk of side effects if taken together.However if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke usually at dosages of -milligrams a day you should continue taking the aspirin unless your doctor instructs you otherwise.Ask your doctor or pharmacist for more details.This product can affect the results of certain lab tests.Make sure laboratory personnel and your doctors know you use this drug.This document does not contain all possible drug interactions.Keep a list of all the products you use.Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.Side effects See also Warning section.Upset stomach heartburn diarrhea drowsiness or dizziness may occur.If any of these effects persist or worsen notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects including easy bruising bleeding lightheadedness fainting signs of a lung infection such as fever cough trouble breathing difficult painful swallowing swelling of the hands feet sudden unexplained weight gain change in amount of urine symptoms of a low magnesium blood level such as unusually fast slow irregular heartbeat persistent muscle spasms seizures.This drug may rarely cause serious possibly fatal liver disease.Stop taking this medication and get medical help right away if you have any symptoms of liver damage including persistent nausea vomiting dark urine yellowing eyes skin.This medication may rarely cause a severe intestinal condition Clostridium difficile-associated diarrhea due to a type of bacteria.Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse.Tell your doctor right away if you develop persistent diarrhea abdominal or stomach pain cramping fever blood mucus in your stool.A very serious allergic reaction to this drug is rare.However get medical help right away if you notice any symptoms of a serious allergic reaction including rash blisters unexplained fever itching swelling especially of the face tongue throat severe dizziness trouble breathing.This is not a complete list of possible side effects.If you notice other effects not listed above contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects.You may report side effects to FDA at FDA-.In Canada Call your doctor for medical advice about side effects.You may report side effects to Health Canada at -.Missed dose If you miss a dose use it as soon as you remember.If it is near the time of the next dose skip the missed dose and resume your usual dosing schedule.Do not double the dose to catch up.Overdose If overdose is suspected contact a poison control center or emergency room immediately.US residents can call their local poison control center at -.Canada residents can call a provincial poison control center.Symptoms of overdose may include severe stomach pain coffee ground-like vomit trouble breathing extreme drowsiness loss of consciousness seizures.Notes Do not share this medication with others.Laboratory and or medical tests such as blood pressure complete blood count-CBC and magnesium liver and kidney function tests should be performed periodically to monitor your progress or check for side effects. Re Lyra Registered Visitor Registered Posts Thanks for the insights.Good question nSAID.It works by reducing substances in the body that cause inflammation pain and fever.Vimovo is a proton pump inhibitor.It decreases the amount of acid produced in the stomach.The combination of Vimovo and naproxen is used to treat symptoms of osteoarthritis rheumatoid arthritis and ankylosing spondylitis.