Vimovo - instructions for use, reviews, analogs and formulations (tablets 500 mg + 20 mg) of a medicament for the treatment of arthritis, arthrosis and the prevention of the risk of developing gastric ulcers in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Vimovo. There are reviews of visitors to the site - consumers of this medication, as well as opinions of specialists in the use of Vimovo in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Vimovo analogues with available structural analogues. Use for the treatment of arthrosis, arthritis and the prevention of concomitant risk of developing gastric and duodenal ulcers in adults, children, as well as during pregnancy and lactation.

Vimovo - a combined preparation containing a non-steroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor. Vimovo is formulated in the form of tablets with sequential delivery of substances: the shell contains immediate-release esomeprazole magnesium, and Naproxen in sustained release, coated with an enteric-coated membrane. As a result, esomeprazole is released in the stomach until naproxen is dissolved in the small intestine. The enteric membrane prevents the release of naproxen at pH below 5.5, providing protection against the possible negative effects of naproxen on the gastric mucosa.

Naproksen - NSAIDs, has an analgesic and antipyretic effect. The mechanism of action of the anion of naproxen, like other NSAIDs, is not fully understood, but may be associated with the suppression of prostaglandin synthetase.

Esomeprazole, the proton pump inhibitor, is the S-isomer of Omeprazole and reduces the secretion of hydrochloric acid in the stomach by specifically inhibiting the proton pump in the parietal cells of the stomach. S- and R-isomers of omeprazole have similar pharmacodynamic activity.

Esomeprazole is a weak base that transforms into an active form in a highly acidic environment of the secretory tubules of the parietal cells of the gastric mucosa and inhibits the proton pump, the enzyme H / K-ATPase, while inhibiting both basal and stimulated secretion of hydrochloric acid.

Patients treated with Vimovo had a lower incidence of NSAID side effects from the upper gastrointestinal tract compared with patients taking naproxen in enteric coated tablets (53.3% and 70.4%, respectively).

Patients who received Vimovo and low-dose Acetylsalicylic acid had a lower incidence of gastric and duodenal ulcers compared to patients who took acetylsalicylic acid with naproxen in enteric coated tablets (4% and 32.4%, respectively).

Vimovo was effective in patients aged 60 years and older - the incidence of gastric and duodenal ulcers was 3.3%, and in patients receiving naproxen in enteric coated tablets, 30.1%.

Patients who received Vimovo for 6 months had a lower incidence of dyspepsia symptoms compared with naproxen in enteric coated tablets.

Patients who received Vimovo were less likely to discontinue therapy because of side effects (7.9%) compared with patients receiving naproxen in enteric coated tablets (12.5%). The frequency of cessation of therapy due to side effects from the upper gastrointestinal tract was also lower with Vimovo therapy (4% and 12%, respectively). The average duration of Vimovo therapy was 152 days compared with 124 days of naproxen monotherapy.

In osteoarthritis of the knee joint, similar efficacy of Vimovo in a dose of 500 mg + 20 mg 2 times a day and celecoxib at a dose of 200 mg per day with admission for 12 weeks of therapy was noted. The frequency of cancellation of therapy due to the development of side effects was also similar.

Composition

Naproxen + Esomeprazole magnesium trihydrate + auxiliary substances.

Indications

• with the aim of alleviating symptoms in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in patients at risk of developing gastric and / or duodenal ulcers associated with NSAID administration.

Forms of release

Tablets coated with 500 mg + 20 mg.

Instructions for use and dosing regimen

The drug is prescribed by mouth, 1 tablet (500 mg / 20 mg) 2 times a day. It is recommended to take Vimovo at least 30 minutes before meals.

The tablet should be swallowed whole, washed down with water, not liquid, without breaking in half and not crushing.

In elderly patients, the risk of serious complications from unwanted reactions is increased.

Side effect

• increased activity of liver enzymes;
• increased bleeding time;
• increased serum creatinine;
• palpitation;
• arrhythmia;
• congestive heart failure;
• myocardial infarction;
• tachycardia;
• increased blood pressure;
• a decrease in blood pressure;
• vasculitis;
• agranulocytosis, aplastic anemia, eosinophilia, granulocytopenia, hemolytic anemia, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia;
• dizziness;
• drowsiness;
• headache;
• pre-fainting condition;
• vertigo;
• cognitive dysfunction;
• coma;
• convulsions;
• decreased concentration of attention;
• optic neuritis;
• paresthesia;
• fainting;
• tremor;
• depression;
• insomnia;
• excitation;
• anxiety;
• confusion of consciousness;
• unusual dreams;
• hallucinations;
• nervousness;
• impaired vision;
• blurred vision;
• conjunctivitis;
• corneal opacity;
• edema of the optic disc;
• tinnitus;
• hearing impairment;
• dyspnea;
• bronchial asthma;
• bronchospasm;
• eosinophilic pneumonitis;
• pneumonia;
• pulmonary edema;
• respiratory depression;
• dyspepsia;
• abdominal pain;
• nausea, vomiting;
• diarrhea, constipation;
• heartburn;
• peptic ulcers;
• stomatitis;
• dry mouth;
• esophagitis;
• gastritis;
• glossitis;
• eructation;
• flatulence;
• stomach ulcers and duodenal ulcers;
• gastrointestinal bleeding and perforation;
• melena;
• bloody vomiting;
• pancreatitis;
• exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• non-peptic ulcer of the gastrointestinal tract;
• rectal bleeding;
• ulcerative stomatitis;
• cholestasis;
• hepatitis;
• jaundice;
• liver failure;
• glomerulonephritis;
• hematuria;
• interstitial nephritis;
• nephrotic syndrome;
• oliguria / polyuria;
• proteinuria;
• kidney failure;
• itching;
• bruise;
• purpura;
• skin rash;
• alopecia;
• exanthema;
• hives;
• toxic epidermal necrolysis;
• erythema multiforme;
• erythema nodosum;
• persistent drug erythema;
• red flat lichen;
• systemic lupus erythematosus;
• Stevens-Johnson syndrome;
• photosensitive dermatitis;
• photosensitivity reaction;
• exfoliative dermatitis;
• angioedema;
• muscle weakness;
• myalgia;
• a violation of appetite;
• fluid retention;
• change in body weight (associated with swelling / fluid retention);
• diverticulitis;
• aseptic meningitis;
• anaphylactic reactions;
• anaphylactoid reactions;
• hypersensitivity reactions;
• infertility;
• violation of the menstrual cycle;
• fatigue;
• edema;
• sweating;
• thirst;
• asthenia;
• malaise;
• fever.

Contraindications

• a history of bronchial asthma, urticaria and allergic reactions with acetylsalicylic acid and other NSAIDs (complete or incomplete combination of intolerance to acetylsalicylic acid, rhinosinusitis, urticaria / angioedema, polyposis of the nasal mucosa and bronchial asthma);
• severe hepatic insufficiency (class C in Child-Pugh) or active liver disease;
• renal failure of severe degree (QC less than 30 ml / min);
• severe uncontrolled heart failure;
• confirmed hyperkalemia;
• peptic ulcer of the stomach or duodenum in the phase of exacerbation;
• Gastrointestinal bleeding, cerebral hemorrhage or other bleeding;
• inflammatory bowel disease in the phase of exacerbation (ulcerative colitis, Crohn's disease);
• state after coronary artery bypass grafting;
• simultaneous reception with atazanavir and nelfinavir;
• 3 trimester of pregnancy;
• the period of breastfeeding;
• children and adolescents under 18 years of age (efficacy and safety of use not studied);
• hypersensitivity to the components of the drug;
• hypersensitivity to other substituted benzimidazoles.

Application in pregnancy and lactation

Vimovo is contraindicated in pregnancy and lactation.

Use in children

Contraindicated in children and adolescents under the age of 18 years (efficacy and safety of use not studied).

special instructions

Elderly patients

Naproxen. In elderly patients, there was an increased incidence of adverse reactions with NSAIDs, in particular gastrointestinal bleeding, ulcerative lesions, and perforation of the gastrointestinal tract, which could lead to the death of the patient.During clinical trials of the Vimovo drug in elderly patients, there was no increase in the incidence of gastric and duodenal ulcer compared with patients younger than 60; The risk of ulcers was reduced in this population of elderly patients. However, complications of ulcers, such as bleeding, perforation and gastrointestinal obstruction, have not been studied in these studies by Vimovo.

Effect on the digestive tract

Naproxen. Gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract, which can lead to the death of the patient, was observed with all NSAIDs at any time during treatment, with or without symptoms, with or without serious gastrointestinal disease. The composition of the drug Vimovo includes esomeprazole to reduce the incidence of gastrointestinal side effects of naproxen, including ulceration. Despite the fact that Vimovo significantly reduces the incidence of stomach ulcers compared to one naproxen, the development of ulcers and accompanying complications is still possible.

The risk of developing gastrointestinal bleeding, ulceration and perforation of the gastrointestinal tract with the use of NSAIDs increases with an increase in the dose of naproxen in patients with a history of peptic ulcer disease,if the ulcer is complicated by bleeding or perforation, and in elderly patients. Such patients should be prescribed therapy, starting with the lowest dose. Patients with a history of gastrointestinal adverse reactions; especially elderly patients, should report any unusual symptoms in the abdominal cavity (especially, gastrointestinal bleeding) and, especially, at the beginning of treatment. Caution should be taken to prescribe NSAIDs to patients already taking medications that may increase the risk of developing ulcers or bleeding, such as oral corticosteroids, anticoagulants, for example, warfarin, selective serotonin reuptake inhibitors or antithrombotic drugs such as acetylsalicylic acid.

With the development of gastrointestinal bleeding or ulceration, the use of Vimovo must be stopped.

Caution should be used to prescribe NSAIDs for patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) due to possible exacerbation of the disease.

Esomeprazole. With the development of any alarming symptom (for example, significant, unintended weight loss, recurrent vomiting, dysphagia,blood vomiting or melena) and the presence of an assumption or confidence in the development of a stomach ulcer, it is necessary to exclude malignant neoplasm, t. esomeprazole magnesium can relieve symptoms and delay the diagnosis. Therapy with proton pump inhibitors may slightly increase the risk of GI infection by microorganisms such as Salmonella (Salmonella) and Campylobacter.

Influence on the cardiovascular system and cerebral circulation

Naproxen. As with any NSAID, it is necessary to monitor patients with arterial hypertension and / or chronic heart failure in history, because therapy with NSAIDs is accompanied by fluid retention and edema development.

Patients with uncontrolled hypertension, chronic heart failure, ischemic heart disease, peripheral arterial disease and / or cerebral circulation disorder should be prescribed naproxen only after a thorough examination. The same examination should be performed before long-term therapy of patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes, smoking).

According to the results of clinical and epidemiological studies, therapy with naproxen (1000 mg per day) may be associated with a lower risk of developing arterial thrombosis than selective inhibitors of COX-2, but this small risk can not be ruled out. In general, the data do not confirm a cardioprotective effect.

Influence on the kidneys

Naproxen. Long-term use of NSAIDs led to the development of medullary necrosis of the kidney and other kidney lesions. Toxicity to the kidneys was also observed in patients in whom renal prostaglandins played a compensatory role in maintaining renal perfusion. In these patients, the use of NSAIDs can lead to a dose-dependent reduction in the synthesis of prostaglandins, and secondly - to a decrease in renal blood flow, which can accelerate the development of renal failure with clinical manifestations. The greatest risk of such a reaction is present in patients with impaired renal function, hypovolemia, heart failure, liver failure, excessive removal of sodium chloride from the body, in patients receiving diuretics and ACE inhibitors, and in elderly patients.After the abolition of therapy with NSAIDs, the condition of patients is usually restored to the level before the start of treatment.

Use in patients with renal insufficiency

Because naproxen is more (95%) excreted by renal excretion by glomerular filtration, with greater caution should be given to patients with renal insufficiency, and it is recommended that serum creatinine and / or CC levels be monitored in these patients. It is not recommended to appoint Vimovo to patients with baseline CK less than 30 ml / min. Hemodialysis does not reduce the plasma concentration of naproxen due to high binding to plasma proteins. Certain patients, especially those with impaired renal blood flow as a result of a decrease in the volume of intercellular fluid, cirrhosis of the liver, limited salt intake, chronic heart failure and pre-existing kidney disease, should assess kidney function before and during Vimovo. Some elderly patients with suspected renal dysfunction, as well as patients receiving diuretics, may also fall into this category. To prevent possible excessive cumulation of naproxen metabolites in these patients,should reduce the daily dose of the drug.

Influence on the hemopoietic system

Naproxen. It is necessary to prescribe with caution the drugs containing naproxen, patients with coagulation disorders or receiving therapy, affecting hemostasis. The risk of bleeding in such patients with a high risk of bleeding or receiving complete anticoagulant therapy (for example, dicumarol derivatives) increases with the concomitant use of drugs containing naproxen. Naproxenum reduces platelet aggregation and lengthens the time of bleeding. This should be considered when determining bleeding time.

With the development of active or clinically significant bleeding in any area in patients taking Vimovo, therapy should be discontinued.

Dermatological effects

Naproxen. Very rarely in the application of NSAIDs, serious skin reactions developed, some of which led to the death of patients, incl. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The greatest risk of such reactions exists at the beginning of therapy, and in most cases the onset of development of such reactions occurs in the first month of treatment.At the first signs of skin rash, lesions of the mucous membranes or other symptoms of hypersensitivity, it is necessary to stop taking Vimovo.

Influence on visual function

When there are visual disorders when taking Vimovo, consultation of an ophthalmologist is recommended.

Anaphylactic (anaphylactoid) reactions

Naproxen. Hypersensitivity reactions can develop in patients predisposed to them. Anaphylactic (anaphylactoid) reactions can develop in patients with or without hypersensitivity, or with or without hypersensitivity to acetylsalicylic acid, other NSAIDs, or preparations containing naproxen. These reactions can develop in patients with angioneurotic edema, bronchospasm (eg, bronchial asthma), rhinitis and polyposis rhinosinusopathy in history.

Patients with bronchial asthma

Naproxen. The use of acetylsalicylic acid in patients with Aspirin asthma was accompanied by the development of severe bronchospasm, which can lead to the death of the patient. Because in patients with hypersensitivity to acetylsalicylic acid, cross reactivity, including bronchospasm,between acetylsalicylic acid and other NSAIDs, it is not recommended to prescribe Vimovo to patients with such hypersensitivity to acetylsalicylic acid and with caution to prescribe to patients with bronchial asthma.

Inflammation

Naproxen. Antipyretic and anti-inflammatory properties of naproxen can reduce fever and other signs of inflammation, thereby reducing their significance as diagnostic symptoms.

Combinations with other medicinal products

Naproxen. It is not recommended to use naproxen simultaneously with NSAIDs (except acetylsalicylic acid), including selective inhibitors of COX-2, due to the cumulative risk of developing serious adverse events associated with NSAIDs.

General instructions

If the daily dose of naproxen 1000 mg is not acceptable, then alternative therapies should be used.

For patients receiving long-term therapy (especially more than 1 year), it is necessary to conduct constant monitoring.

Impact on the ability to drive vehicles and manage mechanisms

Due to the fact that during therapy with the drug Vimovo can be observed dizziness, visual impairment and drowsiness,Care should be taken when driving vehicles and other mechanisms.

Drug Interactions

Unrecommended combinations

Antiretroviral drugs. It is shown that omeprazole, and its racemate - esomeprazole, interact with some antiretroviral drugs. The clinical significance and mechanisms of this interaction are not completely clear. An increase in the pH of the stomach during the administration of omeprazole may alter the absorption of the antiretroviral drug. Other possible mechanisms of interaction are mediated by the CYP2C19 isoenzyme. With the use of some antiretroviral drugs, such as atazanavir and nelfinavir, concomitantly with omeprazole, the concentrations of these drugs in serum were reduced. In this regard, it is not recommended to take omeprazole simultaneously with such drugs as atazanavir and nelfinavir. When omeprazole was used concomitantly with other antiretroviral drugs, such as saquinavir, there was an increase in serum concentrations of serum. Concentrations of some other antiretroviral drugs in serum did not change with concomitant use with omeprazole.Due to the similar pharmacodynamic and pharmacokinetic properties of omeprazole and esomeprazole, the use of esomeprazole is concomitant with antiretroviral drugs such as atazanavir and nelfinavir.

Use with caution

Acetylsalicylic acid. Vimovo can be taken concomitantly with acetylsalicylic acid in a low dose (≤325 mg / day). In clinical trials, the frequency of development of gastric ulcers did not increase in patients taking Vimove in combination with low-dose acetylsalicylic acid in comparison with patients receiving only Vimovo. However, concomitant use of acetylsalicylic acid and Vimovo may increase the risk of serious side effects.

With the simultaneous use of naproxen with acetylsalicylic acid in high doses, its binding to plasma proteins is reduced, but without affecting the clearance of free naproxen. The clinical significance of this interaction is unknown.

Diuretics. Clinical studies, as well as postmarketing observation, have shown that in some patients, NSAIDs can reduce the natriuretic effect of Furosemide and thiazide diuretics.This is due to the suppression of prostaglandin synthesis in the kidneys. When using diuretics with NSAIDs, carefully monitor the signs of renal failure, and monitor the effectiveness of diuretic therapy.

Selective serotonin reuptake inhibitors. According to epidemiological studies a correlation between use of psychotropic drugs affecting the reuptake of serotonin and development of bleeding from the upper GI tract. Therefore, caution should be taken to prescribe NSAIDs, including selective COX-2 inhibitors, along with selective serotonin reuptake inhibitors.

Corticosteroids. With simultaneous use of corticosteroids with NSAIDs, including selective COX-2 inhibitors, increases the risk of gastrointestinal bleeding. Caution should be given to NSAIDs simultaneously with corticosteroids.

ACE inhibitors. NSAIDs can reduce the antihypertensive effect of ACE inhibitors. This interaction should be considered when prescribing NSAIDs simultaneously with ACE inhibitors.

Lithium preparations. NSAIDs increase the concentration of lithium in the blood plasma and reduce the kidney clearance of lithium.The average Cmin of lithium rises by 15%, and the renal clearance is reduced by 20%. These effects were due to the inhibition of prostaglandin synthesis in the kidneys under the influence of NSAIDs. Therefore, with the simultaneous use of NSAIDs and lithium preparations, you should closely monitor the signs of lithium toxicity.

Methotrexate. NSAIDs competitively inhibit Methotrexate cumulation and decrease the secretion of methotrexate in the renal tubules on animal models. This may indicate a possible increase in toxicity of methotrexate when used concomitantly with NSAIDs. In this regard, caution should be exercised in the combined use of NSAIDs and methotrexate.

Derivatives of sulfonylureas, hydantoin. Naproxen binds to a high degree with blood plasma albumin, therefore it is theoretically possible to interact with other albumin binding drugs, such as sulfonylurea derivatives and hydantoin. Patients receiving simultaneously naproxen and hydantoin derivatives, sulfonamide or sulfonylureas, if necessary, should adjust the dose of the drug.

Warfarin. NSAIDs can enhance the effect of oral anticoagulants (eg, Warfarin and acenocoumarol) and heparin.With the simultaneous use of esomeprazole at a dose of 40 mg with warfarin, despite a slight increase in Cmin in the plasma of the less potent R-isomer of warfarin, the coagulation time remained within the allowable range. However, post-marketing surveillance revealed cases of clinically significant increases in MHO when concomitant with warfarin. Therefore, it is recommended to carefully monitor the initiation and completion of therapy with warfarin or other coumarin derivatives.

Beta-blockers. Naproxen and other NSAIDs can reduce the antihypertensive effect of Propranolol and other beta-blockers.

Ciclosporin / tacrolimus. Due to the increased risk of nephrotoxicity, caution should be exercised when taking cyclosporine or tacrolimus simultaneously with any NSAID.

Preparations, the absorption of which depends on the pH of the stomach. Reducing the acidity of gastric juice with esomeprazole may increase or decrease absorption of drugs if the absorption mechanism of these drugs depends on the acidity of the gastric juice. As well as with the use of other drugs that suppress the secretion of hydrochloric acid, or antacid agents,treatment with esomeprazole may lead to a decrease in the absorption of Ketoconazole or itraconazole, as well as an increase in absorption of digoxin. The joint administration of omeprazole at a dose of 20 mg once a day and Digoxin increases the bioavailability of digoxin by 10% (the bioavailability of digoxin was increased by up to 30% in 20% of patients).

Drug interaction with other drugs

Studies of the combined use of esomeprazole and naproxen (nonselective NSAIDs) or rofecoxib (selective COX-2 inhibitor) have not revealed a clinically significant interaction.

As with other NSAIDs, the concomitant use of colestyramine may inhibit naproxen absorption.

Esomeprazole inhibits CYP2C19, the main isoenzyme involved in the metabolism of esomeprazole. Esomeprazole is also metabolized by the enzyme CYP3A4. There are the following data concerning CYP2C19-, CYP3A4-mediated interaction:

• joint use of esomeprazole at a dose of 30 mg lowers the clearance of diazepam, substrate CYP2C19 by 45% (it is unlikely that this interaction has clinical significance).
• the simultaneous use of esomeprazole at a dose of 40 mg by 13% increases the Cmin of phenytoin in plasma in patients with epilepsy.
• the combined use of esomeprazole and the combined inhibitor CYP2C19 and CYP3A4, such as voriconazole, can almost double the concentration of esomeprazole;
• joint use of esomeprazole and inhibitor CYP3A4, clarithromycin (500 mg twice a day), 2 times increases the AUC of esomeprazole.

You do not need to change the dose of esomeprazole in these cases.

Drugs that induce isoenzymes CYP2C19 and CYP3A4, such as rifampicin and preparations of St. John's wort, when combined with esomeprazole may lead to a decrease in plasma esomeprazole concentration by accelerating the metabolism of esomeprazole.

Impact on laboratory performance

Naproxen can reduce platelet aggregation and prolong bleeding time. This should be remembered in determining the time of bleeding.

Naproxen can increase the levels of 17-ketosteroids in urine when determined by interaction of the drug and / or its metabolites with m-dinitrobenzene used in this assay. Although the measurements of 17-hydroxycorticosteroids (Porter-Silber test) were not changed, naproxen therapy was temporarily suspended for 72 hours before the adrenal gland tests were performed, if the Porter-Silber test was used.

Naproxen can enter into interactions with certain substances used in the analysis of urine for 5-hydroxyindoleacetic acid.

Analogues of the drug Vimovo

Vimovo does not have structural analogs for the active substance.

Analogues on the curative effect (remedies for the treatment of rheumatoid arthritis):

• Azathioprine;
• Actasulide;
• Amelotex;
• Arava;
• Arkoxy;
• Arthrosylen;
• Arthrotheca;
• Aertal;
• Wobenzym;
• Voltaren;
• Decortin;
• Dexazone;
• Dexalgin;
• Dexamethasone;
• Derinat;
• Diklak;
• Diqlovit;
• Dicloran;
• Dicloran plus;
• Diclofenac;
• Dimexide;
• Diprospan;
• Dolgit;
• Donalgin;
• Ibuprofen;
• Indomethacin;
• Ketonal;
• Ketoprofen;
• Xsefokam;
• MabThera;
• Meloksikam;
• Movalis;
• Nyz;
• Naklofen;
• Nalgezin;
• Nalgezin forte;
• Naproxen;
• Neurodiclavitis;
• Nimesulide;
• Panavir;
• Polyoxidonium;
• Polcortolone;
• Prednisolone;
• Sulfasalazine;
• Tilcotyl;
• Feloran;
• Flamax;
• Celebrex;
• Cyclosporin;
• Cycloferon;
• Endoxane.

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