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APO-NAPROXEN EC is a brand name for Naproxen, supplied as a tablet (enteric-coated). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-NAPROXEN (naproxen) is indicated for: • The treatment of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. • The relief of minor aches and pains in muscles, bones and joints, mild to moderate pain accompanied by inflammation in musculoskeletal injuries (sprains and…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 5 of 53 2 CONTRAINDICATIONS APO-NAPROXEN is contraindicated in: • the peri-operative setting of coronary artery bypass graft surgery (CABG). Although naproxen 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.
• the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus and prolonged parturition • women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants • severe uncontrolled heart failure • patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
In addition, patients on 1500 mg/day need to be followed closely for the development of any adverse events. During long–term administration, the dose of APO-NAPROXEN may be adjusted up or down depending on the clinical response of the patient.
A lower dose may suffice for long–term administration. Patients with rheumatoid arthritis or osteoarthritis maintained on a dose of 750 or 1000 mg/day in divided doses can be switched to a once daily dose of APO-NAPROXEN SR 750 mg. The single daily dose of APO-NAPROXEN SR should not be exceeded and can be administered in the morning or evening.
Analgesia / Musculoskeletal Injuries The recommended dose for naproxen is 250 mg three times a day or 375 mg twice a day. This may be increased to 500 mg twice a day if needed. The lowest effective dose should be used. Dysmenorrhea The recommended starting dose for naproxen is two 250 mg tablets (or one 500 mg tablet), followed by one 250 mg tablet every 6 to 8 hours, as required.
The total daily dose should not exceed 5 tablets (1250 mg). Alternatively, one 500 mg tablet given twice daily may be used.
Pediatrics (< 18 years of age):
Health Canada has not authorized an indication for pediatric use.
See 2 CONTRAINDICATIONS Geriatrics (>65 years of age):
In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary. 4 Geriatrics Renal impairment: A lower dose should be considered in patients with mild and moderate renal impairment.
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 2 CONTRAINDICATIONS APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 9 of 53 Hepatic impairment: A lower dose should be considered in patients with mild and moderate hepatic impairment.
1 Pregnant Women 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 .....................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................. 6 4 DOSAGE AND ADMINISTRATION ..................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................. 5 Missed Dose .................................................................................................................
9 5 OVERDOSAGE ................................................................................................................. 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 10 7 WARNINGS AND PRECAUTIONS ....................................................................................
1 Pregnant Women 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 .....................................................................................................
5
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.
APO-NAPROXEN is contraindicated in severe liver impairment or active liver disease. 4 Administration APO-NAPROXEN, APO-NAPROXEN SR and APO-NAPROXEN EC tablets should be swallowed whole. 5 Missed Dose If a dose is missed, the patient should take it as soon as it is recognized.
If it is almost time for the next dose, skip the missed dose and continue with the next scheduled dose. The patient should be instructed not take 2 doses at the same time. 5 OVERDOSAGE Frequently observed signs and symptoms of overdose are drowsiness, dizziness, disorientation, heartburn, indigestion, epigastric pain, abdominal discomfort, nausea, vomiting, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis and apnea.
A few patients have experienced convulsions, but it is not clear whether or not these were naproxen related. Gastrointestinal bleeding may occur. Hypertension, acute renal failure, respiratory depression and coma may occur after the ingestion of NSAIDs but are rare.
Anaphylactoid reactions have been repeated with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following NSAIDs overdose. There are no specific antidotes.
g. activated charcoal) may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, haemodialysis, or haemoperfusion may not be useful due to high protein binding.
For management of a suspected drug overdose, contact your regional poison control centre. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 10 of 53 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1: Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Tablets, 125 mg, 250 mg, 375 mg and 500 mg Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and methylcellulose.
The 250 and the 500 mg tablets also contain D&C yellow #10 and FD&C yellow #6; the 375 mg tablets contain only FD&C yellow #6; the 125 mg tablets contain D&C yellow #10 and FD&C blue #2. Sustained-Release Tablets, 750 mg D&C yellow #10, FD&C yellow #6, hydroxypropyl methylcellulose and magnesium stearate.
Enteric-coated Tablets, 250 mg, 375 mg and 500 mg Colloidal silicon dioxide, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, methacrylic acid copolymer, methylcellulose, polyethylene glycol, talc, titanium dioxide and triethyl citrate.
Description APO-NAPROXEN is available as:
Tablets: APO-NAPROXEN 125 mg tablets: Each pale green, oval, biconvex tablet engraved “APO-125” on one side, contains 125 mg naproxen. Available in bottles of 100 and 500 tablets.
APO-NAPROXEN 250 mg tablets:
Each yellow, oval, biconvex tablet engraved “APO-250” on one side contains 250 mg naproxen. Available in bottles of 100 and 1000 tablets. APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 11 of 53 APO-NAPROXEN 375 mg tablets: Each peach-coloured, capsule- shaped, biconvex tablet, scored and engraved “APO 375” on one side, contains 375 mg naproxen.
Available in bottles of 100 and 500 tablets.
APO-NAPROXEN 500 mg tablets:
Each yellow, capsule-shaped, biconvex tablet, scored and engraved “APO 500” on one side, contains 500 mg naproxen. Available in bottles of 100 and 500 tablets.
Sustained-Release Tablets:
APO-NAPROXEN SR 750 mg tablets: Each peach, capsule-shaped, biconvex tablet, engraved “APO-750” on one side, contains 750 mg of naproxen. Available in bottles of 100 and 500 and unit dose packages of 100 (10 x 10).
Enteric-Coated Tablets:
APO-NAPROXEN EC 250 mg tablets: Each white, round, biconvex, enteric-coated tablet, engraved “APO” on one side, and “250” on the other side, contains 250 mg of naproxen. Available in bottles of 100 and 500 […]
1 Special Populations .................................................................................................... 1 Pregnant Women .......................................................................................................
2 Breast-feeding ............................................................................................................ 3 Pediatrics ....................................................................................................................
4 Geriatrics .................................................................................................................... 20 APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 3 of 53 8 ADVERSE REACTIONS ....................................................................................................
1 Adverse Reaction Overview ....................................................................................... 2 Clinical Trial Adverse Drug Reactions......................................................................... 3 Less Common Clinical Trial Adverse Reactions ..........................................................
5 Post-Market Adverse Reactions ................................................................................. 23 9 DRUG INTERACTIONS ....................................................................................................
3 Drug- Behavioural Interactions .................................................................................. 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions .............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................. 31 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 32 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
34 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 34 PART II: SCIENTIFIC INFORMATION ......................................................................................
35 13 PHARMACEUTICAL INFORMATION ................................................................................ 35 14 CLINICAL TRIALS ............................................................................................................
2 Comparative Bioavailability Studies........................................................................... 35 15 MICROBIOLOGY ............................................................................................................
40 16 NON-CLINICAL TOXICOLOGY ......................................................................................... 40 17 SUPPORTING PRODUCT MONOGRAPHS ........................................................................ 43 PATIENT MEDICATION INFORMATION .................................................................................
44 APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) Page 4 of 53 PART I: HEALTH PROFESSIONAL […]