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APO-NAPROXEN / ESOMEPRAZOLE 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: APO-NAPROXEN / ESOMEPRAZOLE (naproxen / esomeprazole modified release tablets) 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…
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. APO-NAPROXEN / ESOMEPRAZOLE (naproxen / esomeprazole modified release tablets) does not allow for administration of lower daily doses of naproxen or esomeprazole.
e. e. ≤40 mg/day) is more appropriate, alternate therapy should be considered. Since APO-NAPROXEN / ESOMEPRAZOLE is a combination product, carefully consider the implications of any dosing schedule on both components. 4 Geriatrics.
Pediatrics (<18 years):
APO-NAPROXEN / ESOMEPRAZOLE is not recommended for use in pediatric patients (see 2 CONTRAINDICATIONS).
Hepatic Insufficiency:
APO-NAPROXEN / ESOMEPRAZOLE is not recommended for use in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS and Hepatic/Biliary/Pancreatic).
Renal Insufficiency:
APO-NAPROXEN / ESOMEPRAZOLE is not recommended for use in patients with severe renal impairment or deteriorating renal disease (see 2 CONTRAINDICATIONS and Renal).
APO-NAPROXEN / ESOMEPRAZOLE Product Monograph Page 7 of 57 Genetic Polymorphism:
Dosage adjustment based on CYP 2C19 status is not necessary (see Endocrine and Metabolism). 4 Administration APO-NAPROXEN / ESOMEPRAZOLE must be swallowed whole with water, and not split, chewed or crushed. APO-NAPROXEN / ESOMEPRAZOLE 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 APO-NAPROXEN / ESOMEPRAZOLE should not be taken at the same time.
). 1 Adverse Reaction Overview Since APO-NAPROXEN / ESOMEPRAZOLE (naproxen / esomeprazole modified release tablets) 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 500/20 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).
). Use of APO-NAPROXEN / ESOMEPRAZOLE 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 ad verse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
APO-NAPROXEN / ESOMEPRAZOLE, as a NSAID, does NOT treat clinical disease or prevent its progression. 1 Pediatrics Pediatrics (<18 years of age): APO-NAPROXEN / ESOMEPRAZOLE 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 APO-NAPROXEN / ESOMEPRAZOLE (naproxen / esomeprazole modified release tablets) is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG).
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.
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) • patients with known hyperkalemia (see Fluid and Electrolyte Balance) • children and adolescents less than 18 years of age • co-administration with rilpivirine is contraindicated 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV) (See Cardiovascular).
Naproxen is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal.
and 7 WARNINGS AND PRECAUTIONS). Use of APO-NAPROXEN / ESOMEPRAZOLE 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 ad verse events (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS).
APO-NAPROXEN / ESOMEPRAZOLE, as a NSAID, does NOT treat clinical disease or prevent its progression. 1 Pediatrics Pediatrics (<18 years of age): APO-NAPROXEN / ESOMEPRAZOLE 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 APO-NAPROXEN / ESOMEPRAZOLE (naproxen / esomeprazole modified release tablets) is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG).
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.
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) • patients with known hyperkalemia (see Fluid and Electrolyte Balance) • children and adolescents less than 18 years of age • co-administration with rilpivirine is contraindicated
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.
4 Similar […]
This risk may occur as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
g. hypertension, hyperlipidemia, diabetes mellitus, and smoking. Use of NSAIDs such as naproxen, which is a component of APO-NAPROXEN / ESOMEPRAZOLE, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure (see Fluid and Electrolyte Balance).
APO-NAPROXEN / ESOMEPRAZOLE Product Monograph Page 6 of 57 Randomized clinical trials with naproxen / esomeprazole modified release tablets have not been designed to detect differences in cardiovascular events in a chronic setting.
Therefore, caution should be exercised when prescribing APO-NAPROXEN / ESOMEPRAZOLE. Risk of Gastrointestinal (GI) Adverse Events (see Gastrointestinal and 14 CLINICAL TRIALS). Use of NSAIDs such as naproxen, which is a component of APO-NAPROXEN / ESOMEPRAZOLE, is associated with an increased incidence of gastrointestinal adverse events (such as ulceration, bleeding, perforation and obstruction of the upper and lower gastrointestinal tract).
Risk in Pregnancy:
Caution should be exercised in prescribing NSAIDs such as naproxen, which is a component of APO-NAPROXEN / ESOMEPRAZOLE, during the first and second trimesters of pregnancy. Use of NSAIDs at approximately […]