Components:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 21.06.2022
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Naproxen and Esomeprazole Magnesium is a combination product that contains Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium). It is indicated 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. Naproxen and Esomeprazole Magnesium is not recommended for initial treatment of acute pain because the absorption of Naproxen (Naproxen and Esomeprazole Magnesium) is delayed compared to absorption from other Naproxen (Naproxen and Esomeprazole Magnesium)-containing products. Controlled studies do not extend beyond 6 months.
Naproxen and Esomeprazole Magnesium contains a combination of Naproxen and Esomeprazole Magnesium.
Naproxen (Naproxen and Esomeprazole Magnesium) is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause inflammation, pain, and fever. Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) is a proton pump inhibitor. It decreases the amount of acid produced in the stomach.
Naproxen and Esomeprazole Magnesium is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
The Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) is included in Naproxen and Esomeprazole Magnesium to help reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.
Use the lowest dose for the shortest duration consistent with individual patient treatment goals. Carefully consider the potential benefits and risks of Naproxen and Esomeprazole Magnesium and other treatment options before deciding to use Naproxen and Esomeprazole Magnesium. Naproxen and Esomeprazole Magnesium does not allow for administration of a lower daily dose of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium). If a dose of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered.
Rheumatoid Arthritis, Osteoarthritis And Ankylosing Spondylitis
The dosage is one tablet twice daily of Naproxen and Esomeprazole Magnesium 375 mg Naproxen (Naproxen and Esomeprazole Magnesium) and 20 mg of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) or 500 mg Naproxen (Naproxen and Esomeprazole Magnesium) and 20 mg of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium).
The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Naproxen and Esomeprazole Magnesium is to be taken at least 30 minutes before meals.
Geriatric Patients
Studies indicate that although total plasma concentration of Naproxen (Naproxen and Esomeprazole Magnesium) is unchanged, the unbound plasma fraction of Naproxen (Naproxen and Esomeprazole Magnesium) 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.
Patients With Moderate To Severe Renal Impairment
Naproxen (Naproxen and Esomeprazole Magnesium)-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance < 30 mL/min).
Hepatic Insufficiency
Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the Naproxen (Naproxen and Esomeprazole Magnesium) component of Naproxen and Esomeprazole Magnesium.
Naproxen and Esomeprazole Magnesium should be avoided in patients with severe hepatic impairment.
Pediatric Patients
The safety and efficacy of Naproxen and Esomeprazole Magnesium in children younger than 18 years has not been established. Naproxen and Esomeprazole Magnesium is therefore not recommended for use in children.
How supplied
Dosage Forms And Strengths
Naproxen and Esomeprazole Magnesium (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) magnesium) is an oval, yellow, delayed release tablets for oral administration containing either:
- 375 mg enteric coated Naproxen (Naproxen and Esomeprazole Magnesium) and 20 mg Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) (as magnesium trihydrate) tablets printed with 375/20 in black, or
- 500 mg enteric coated Naproxen (Naproxen and Esomeprazole Magnesium) and 20 mg Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) (as magnesium trihydrate) tablets printed with 500/20 in black.
Storage And Handling
Naproxen and Esomeprazole Magnesium 375 mg/20 mg tablets are oval, yellow film-coated tablets printed with 375/20 in black ink, supplied as:
NDC 75987-031-04 Bottles of 60 tablets
Naproxen and Esomeprazole Magnesium 500 mg/20 mg tablets are oval, yellow film-coated tablets printed with 500/20 in black ink, supplied as:
NDC 75987-030-04 Bottles of 60 tablets
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.
Distributed by: Horizon Pharma USA Inc., Lake Forest, IL 60045. For more information, go to www. Naproxen and Esomeprazole Magnesium.com or call 1-866-479-6742. Revised: May 2016
See also:
What is the most important information I should know about Naproxen and Esomeprazole Magnesium?
Known hypersensitivity to Naproxen (Naproxen and Esomeprazole Magnesium), Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium), substituted benzimidazoles or to any of the excipients of Naproxen and Esomeprazole Magnesium.
History of asthma, urticaria or allergic-type reactions induced by administration of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
Third trimester of pregnancy.
Severe hepatic impairment (eg, Childs-Pugh C).
Severe heart failure.
Severe renal impairment.
Active peptic ulceration.
Gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders.
Naproxen and Esomeprazole Magnesium must not be used concomitantly with atazanavir and nelfinavir.
Use Naproxen and Esomeprazole Magnesium as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Naproxen and Esomeprazole Magnesium comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen and Esomeprazole Magnesium refilled.
- Take Naproxen and Esomeprazole Magnesium by mouth at least 30 minutes before a meal unless your doctor tells you otherwise. Talk with your doctor or pharmacist if you have persistent stomach upset.
- Take Naproxen and Esomeprazole Magnesium with a full glass of water (8 oz [240 mL]).
- Swallow Naproxen and Esomeprazole Magnesium whole. Do not break, crush, chew, or dissolve before swallowing. Tell your doctor if you cannot swallow tablets whole. You may need a different medicine.
- If you also take antacids or cholestyramine, ask your doctor or pharmacist how to take them with Naproxen and Esomeprazole Magnesium.
- Continue to take Naproxen and Esomeprazole Magnesium even if you feel well. Do not miss any doses.
- If you miss a dose of Naproxen and Esomeprazole Magnesium, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Naproxen and Esomeprazole Magnesium.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: Reduction of the risk of NSAID-associated gastric ulcers in patients at risk of developing gastric ulcers who require an NSAID for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults.
Juvenile idiopathic arthritis: Reduction of the risk of NSAID-associated gastric ulcers in patients at risk of developing gastric ulcers who require an NSAID for the relief of signs and symptoms of juvenile idiopathic arthritis (JIA) in pediatric patients ≥12 years weighing ≥38 kg.
Limitations of use: Not recommended for the initial treatment of pain; controlled studies do not extend beyond 6 months.
See also:
What other drugs will affect Naproxen and Esomeprazole Magnesium?
Table 3: Clinically Significant Drug Interactions with Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) – Affecting Drugs Co-Administered with Naproxen and Esomeprazole Magnesium and Interactions with Diagnostics
Drugs That Interfere with Hemostatis | |
Clinical Impact: | Naproxen (Naproxen and Esomeprazole Magnesium)
|
Intervention: | Monitor patients with concomitant use of Naproxen and Esomeprazole Magnesium with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Clopidoarel: Avoid concomitant use of clopidogrel with Naproxen and Esomeprazole Magnesium. Consider use of alternative anti-platelet therapy. |
Aspirin | |
Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone. |
Intervention: | Concomitant use of Naproxen and Esomeprazole Magnesium and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Naproxen and Esomeprazole Magnesium is not a substitute for low dose asprin for cardiovascular protection. |
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |
Clinical Impact: |
|
Intervention: |
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Diuretics | |
Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriurectic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. |
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects. |
Antiretrovirals | |
Clinical Impact: | The effect of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) on antiretroviral drugs is variable.
|
Intervention: | Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Naproxen and Esomeprazole Magnesium. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information of specific drugs. |
Cilostazol | |
Clinical Impact: | Increased exposure of cilostazol and one of its active metabolities (3,4-dihydro-cilostazol) when coadministered with Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium), the racemate of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium). |
Intervention: | Consider reducing the dose of cilostazol to 50 mg twice daily. |
Digoxin | |
Clinical Impact: | Naproxen (Naproxen and Esomeprazole Magnesium)
|
Intervention: | Monitor digoxin concentrations during concomitant use of Naproxen and Esomeprazole Magnesium. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. |
Lithium | |
Clinical Impact: | NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. |
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium and lithium, monitor patients for signs of lithium toxicity. |
Methotrexate | |
Clinical Impact: | Naproxen (Naproxen and Esomeprazole Magnesium)
|
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium and methotrexate, monitor patients for methotrexate toxicity. A temporary withdrawal of Naproxen and Esomeprazole Magnesium may be considered in some patients receiving high-dose methotrexate. |
Cyclosporine | |
Clinical Impact: | Concomitant use of Naproxen (Naproxen and Esomeprazole Magnesium) and cyclosporine may increase cyclosporine’s nephrotoxicity. |
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium and cyclosporine, monitor patients for signs of worsening renal function. |
Tacrolimus | |
Clinical Impact: | Concomitant use of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) and tacrolimus may increase exposure of tacrolimus |
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium and tacrolimus, monitor tacrolimus whole blood concentrations. |
NSAIDs and Salicylates | |
Clinical Impact: | Concomitant use of Naproxen (Naproxen and Esomeprazole Magnesium) with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy. |
Intervention: | The concomitant use of Naproxen and Esomeprazole Magnesium with other NSAIDs or salicylates is not recommended. |
Pemetrexed | |
Clinical Impact: | Concomitant use of Naproxen and Esomeprazole Magnesium and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. |
Intervention: | During concomitant use of Naproxen and Esomeprazole Magnesium and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. |
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, mycophenoloate mofetil, ketoconazole) | |
Clinical Impact: | Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) can reduce the absorption of other drugs due to its effect on reducing intragastric acidity |
Intervention: | Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) and MMF. Use Naproxen and Esomeprazole Magnesium with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption. |
Interactions With Investigations of Neuroendocrine Tumors | |
Clinical Impact: | Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors. |
Intervention: | Temporarily stop Naproxen and Esomeprazole Magnesium treatment at least 14 days 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. |
Diazepam | |
Clinical Impact: | Increased exposure of diazepam. |
zIntervention: | Monitor patients for increased sedation and adjust the dose of diazepam as needed. |
Table 4: Clinically Significant Interactions with Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) --Affecting Co-Administered Drugs
CYP2C19 or CYP3A4 Inducers | |
Clinical Impact: | Decreased exposure of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) when used concomitantly with strong inducers. |
Intervention: | St. John’s Wort, rifampin: Avoid concomitant use with Naproxen and Esomeprazole Magnesium. |
Voriconazole | |
Clinical Impact: | Increased exposure of Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium). |
Intervention: | Dose adjustment of Naproxen and Esomeprazole Magnesium is not normally required. |
See also:
What are the possible side effects of Naproxen and Esomeprazole Magnesium?
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforations
- Hepatotoxicity
- Hypertension
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic Reactions
- Serious Skin Reactions
- Hematologic Toxicity
- Active Bleeding
- Acute Interstitial Nephritis
- Cyanocobalamin (vitamin B-12) Deficiency
- Clostridium difficile Associated Diarrhea
- Bone Fracture
- Hypomagnesemia
Clinical Trials Experience
Clinical Trials Experience With Naproxen and Esomeprazole Magnesium
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 Naproxen and Esomeprazole Magnesium.
The safety of Naproxen and Esomeprazole Magnesium was evaluated in clinical studies involving 2317 patients (aged 27 to 90 years) and ranging from 3 to 12 months. Patients received either 500 mg/20 mg of Naproxen and Esomeprazole Magnesium twice daily (n=1157), 500 mg of enteric-coated Naproxen (Naproxen and Esomeprazole Magnesium) twice daily (n=426), or placebo (n=246). The average number of Naproxen and Esomeprazole Magnesium doses taken over 12 months was 696+44.
The table below lists all adverse reactions, regardless of causality, occurring in > 2% of patients receiving Naproxen and Esomeprazole Magnesium and higher in the Naproxen and Esomeprazole Magnesium group than control from two clinical studies (Study 1 and Study 2). Both of these studies were randomized, multi-center, double-blind, parallel studies. The majority of patients were female (67%), white (86%). The majority of patients were 50-69 years of age (83%). Approximately one quarter were on low-dose aspirin.
Table 1: Adverse Reactions* in Study 1 and Study 2 (endoscopic studies)
Preferred term | Naproxen and Esomeprazole Magnesium 500mg/20 mg twice daily (n=428)% | EC-Naproxen (Naproxen and Esomeprazole Magnesium) 500 mg twice daily (n=426)% |
Gastritis | 17 | 14 |
Diarrhea | 6 | 5 |
Upper respiratory tract infection | 5 | 4 |
Flatulence | 4 | 3 |
Headache | 3 | 1 |
Urinary tract infection | 2 | 1 |
Dysgeusia | 2 | 1 |
*reported in > 2% of patients and higher in the Naproxen and Esomeprazole Magnesium group than control |
In Study 1 and Study 2, patients taking Naproxen and Esomeprazole Magnesium had fewer premature discontinuations due to adverse reactions compared to patients taking enteric-coated Naproxen (Naproxen and Esomeprazole Magnesium) alone (7.9% vs. 12.5% respectively). The most common reasons for discontinuations due to adverse events in the Naproxen and Esomeprazole Magnesium treatment group were upper abdominal pain (1.2%, n=5), duodenal ulcer (0.7%, n=3) and erosive gastritis (0.7%, n=3). Among patients receiving enteric-coated Naproxen (Naproxen and Esomeprazole Magnesium), the most common reasons for discontinuations due to adverse events were duodenal ulcer 5.4% (n=23), dyspepsia 2.8% (n=12) and upper abdominal pain 1.2% (n=5). The proportion of patients discontinuing treatment due to any upper gastrointestinal adverse events (including duodenal ulcers) in patients treated with Naproxen and Esomeprazole Magnesium was 4% compared to 12% for patients taking enteric
Each modified-release tablet contains enteric-coated (gastro-resistant) Naproxen (Naproxen and Esomeprazole Magnesium) 500 mg and film-coated Esomeprazole (Naproxen (Naproxen and Esomeprazole Magnesium) and Esomeprazole Magnesium) 20 mg (as magnesium trihydrate 22.3 mg).
Naproxen and Esomeprazole Magnesium contains very low, nonpreserving levels of methyl parahydroxybenzoate 0.02 mg and propyl parahydroxybenzoate 0.01 mg.
It also contains the following excipients: Tablet Core: Croscarmellose sodium, magnesium stearate, povidone K90, anhydrous colloidal silica. Coating: Carnauba wax, glycerol monostearate 40-55, hypromellose, yellow iron oxide (E172), macrogol 8000, methacrylic acid-ethyl acrylate copolymer (1:1), methyl parahydroxybenzoate (E218*), polydextrose, polysorbate 80, propyl parahydroxybenzoate (E216*), sodium lauryl sulfate, titanium dioxide (E171), triethyl citrate. Printing Ink: Hypromellose, black iron oxide (E172), propylene glycol.
*These preservatives are present in a film-coating mixture and will carry through into the finished product at very low, nonfunctional levels.