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MYLAN-NAPROXEN/ESOMEPRAZOLE MR is a brand name for Naproxen, supplied as a tablet (immediate and delayed-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MYLAN-NAPROXEN / ESOMEPRAZOLE MR (naproxen/esomeprazole) is indicated for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and to decrease the risk of developing gastric ulcers in patients at risk for developing non-steroidal anti- inflammatory…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. MYLAN-NAPROXEN / ESOMEPRAZOLE MR (naproxen/esomeprazole) does not allow for administration of lower daily doses of naproxen or esomeprazole.
e. e. ≤40mg/day) is more appropriate, alternate therapy should be considered. Since MYLAN-NAPROXEN / ESOMEPRAZOLE MR is a combination product, carefully consider the implications of any dosing schedule on both components. 4 Geriatrics.
MYLAN-NAPROXEN / ESOMEPRAZOLE MR (Naproxen / Esomeprazole Modified Release Tablets) Page 7 of 65 Pediatrics (<18 years): MYLAN-NAPROXEN / ESOMEPRAZOLE MR is not recommended for use in pediatric patients (see 2 CONTRAINDICATIONS).
Hepatic Insufficiency:
MYLAN-NAPROXEN / ESOMEPRAZOLE MR is not recommended for use in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
Renal Insufficiency:
MYLAN-NAPROXEN / ESOMEPRAZOLE MR is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see 2 CONTRAINDICATIONS and Renal).
Genetic Polymorphism:
Dosage adjustment based on CYP 2C19 status is not necessary (see Endocrine and Metabolism). 4 Administration MYLAN-NAPROXEN / ESOMEPRAZOLE MR must be swallowed whole with water, and not split, chewed or crushed. MYLAN-NAPROXEN / ESOMEPRAZOLE MR should be taken at least 30 minutes before meals.
5 Missed Dose The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of MYLAN-NAPROXEN / ESOMEPRAZOLE MR should not be taken at the same time.
). 1 Adverse Reaction Overview Since MYLAN-NAPROXEN / ESOMEPRAZOLE MR (naproxen/esomeprazole) contains both naproxen and esomeprazole, the same pattern of undesirable effects reported for these individual substances may occur. The most common adverse reactions seen with naproxen are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe.
Fatalities have occurred particularly in the elderly. Other common adverse reactions include dyspepsia, stomach pain, nausea and vomiting. Common reactions seen with esomeprazole in clinical trials include headache, diarrhea, flatulence, abdominal pain, nausea, vomiting and dizziness, which are thought to be causally related.
The most commonly reported adverse reactions with naproxen/esomeprazole modified release tablets are erosive gastritis, dyspepsia and gastritis. No new safety findings were identified during naproxen/esomeprazole modified release tablets treatment compared to the established safety profile for the individual substances.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Adverse event data is provided from controlled studies using naproxen/esomeprazole modified release tablets, involving 2317 patients ranging in duration from 3-12 months.
Patients received either 500 mg / 20 mg of naproxen/esomeprazole modified release tablets twice daily (n=1157), 500 mg of enteric- coated (EC) naproxen twice daily (n=426), 200 mg of celecoxib once daily (n=488), or placebo (n=246).
1 Special Populations 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ................................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration............................................................................................................ 5 Missed Dose ...............................................................................................................
7 5 OVERDOSAGE............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 8 7 WARNINGS AND PRECAUTIONS ..................................................................................
and 7 WARNINGS AND PRECAUTIONS). Use of MYLAN-NAPROXEN / ESOMEPRAZOLE MR should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
MYLAN-NAPROXEN / ESOMEPRAZOLE MR, as a NSAID, does NOT treat clinical disease or prevent its progression. MYLAN-NAPROXEN / ESOMEPRAZOLE MR, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
1 Pediatrics Pediatrics (<18 years of age): MYLAN-NAPROXEN / ESOMEPRAZOLE MR should not be used in children or adolescents under 18 years of age. The safety and efficacy of naproxen/esomeprazole modified release tablets in this population has not been established.
4 Geriatrics). 2 CONTRAINDICATIONS MYLAN-NAPROXEN / ESOMEPRAZOLE MR (naproxen/esomeprazole) is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although naproxen/esomeprazole modified release tablets has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections and sternal wound complications.
e. complete or partial syndrome of ASA-intolerance - rhinosinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactoid reactions have occurred in such individuals. Individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse reaction.
The potential for cross-reactivity between different NSAIDs must be kept in mind (see Anaphylactoid Reactions). 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored) (see Renal).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Naproxen in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
All adverse reactions, regardless of causality, occurring in ≥2% of patients from two 6-month randomized, double-blind, parallel-group controlled clinical studies (Study 301 and 302) conducted in patients at risk of developing NSAID-associated ulcers compared to EC-naproxen are presented in the below table.
4%). 9% vs. 5% respectively). 7%, n=3). 2% (n=5). 001). Adverse reaction data for naproxen/esomeprazole modified release tablets, regardless of causality, occurring in ≥2 % of patients, and greater than placebo from two 3-month randomized double-blind, placebo-controlled clinical studies conducted in patients with osteoarthritis of the knee are presented below.
3 General […]
1 Special Populations .................................................................................................. 1 Pregnant Women ..................................................................................................
2 Breast-feeding ....................................................................................................... 3 Pediatrics ...............................................................................................................
4 Geriatrics ............................................................................................................... 20 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................. 5 Post-Market Adverse Reactions..............................................................................
25 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview ....................................................................................
3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 32 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .......................................................................................... 2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................
34 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 38 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 38 PART II: SCIENTIFIC INFORMATION ......................................................................................
39 13 PHARMACEUTICAL INFORMATION ........................................................................... 39 14 CLINICAL TRIALS .......................................................................................................
1 Clinical Trials by Indication .................................................................................. 40 Treatment of Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) and Decreasing Risk of Gastric Ulcers in Patients at Risk of Developing NSAID- associated Gastric Ulcers ..................................................................................................
2 Comparative Bioavailability Studies .................................................................... 47 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 51 17 SUPPORTING PRODUCT MONOGRAPHS […]
• patients with known hyperkalemia (see Fluid and Electrolyte Balance) • children and adolescents less than 18 years of age • co-administration with rilpivirine is contraindicated.