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PRO-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: PRO-NAPROXEN EC (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. 2 CONTRAINDICATIONS PRO-NAPROXEN EC Page 5 of 47 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. Naproxen enteric-coated tablets has not been studied in subjects under the age of 18. 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. PRO-NAPROXEN EC is not recommended for initial treatment of acute pain because absorption of naproxen is delayed by the enteric coating compared to other naproxen-containing products (see 10 CLINICAL PHARMACOLOGY).
The maximum recommended daily dose is 1000 mg of naproxen. e. 250 or 375 mg doses twice daily) is more appropriate, an alternative product should be considered*. *Naproxen (enteric coated tablets) 250 & 375 mg are not currently marketed by PRO DOC LTÉE in Canada.
PRO-NAPROXEN EC Page 9 of 47 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 - 8 hours, as required. The total daily dose should not exceed five 250 mg* tablets (1250 mg).
Alternatively, one 500 mg tablet given twice daily may be used. *Naproxen (enteric coated tablets) 250 mg is not currently marketed by PRO DOC LTÉE in Canada. PRO-NAPROXEN EC is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed by the enteric coating compared to other naproxen- containing products (see 10 CLINICAL PHARMACOLOGY).
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.
1 Pregnant Women 03/2023 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 ................................................................. 6 4 DOSAGE AND ADMINISTRATION ..................................................................................... 1 Dosing considerations ....................................................................................................
2 Recommended Dose and Dosage Adjustment .............................................................. 4 Administration ...............................................................................................................
5 Missed Dose ................................................................................................................... 9 5 OVERDOSAGE .................................................................................................................
1 Pregnant Women 03/2023 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
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.
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 Hepatic impairment:
A lower dose should be considered in patients with mild and moderate hepatic impairment. PRO-NAPROXEN EC is contraindicated in severe liver impairment or active liver disease. 4 Administration PRO-NAPROXEN EC tablet should be swallowed whole with food or milk.
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 PRO-NAPROXEN EC Page 10 of 47 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. 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 500 mg Enteric-Coated Tablets Chromateric White Deb 5018 WE, Colloidal Silicon Dioxide, Croscarmellose Sodium (Ac- Di-Sol), Dri Klear 042, Eudragit L30D, Magnesium Stearate, Povidone and Sodium Lauryl Sulphate PRO-NAPROXEN EC (naproxen) is available as: PRO-NAPROXEN Enteric-Coated Tablets: 500 mg White, capsule shaped, enteric coated tablet, printed in black on one side with “N” and “500” on the other side.
Available in bottles of 100. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX PRO-NAPROXEN EC Page 11 of 47 General Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population.
To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.
For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. PRO-NAPROXEN EC is NOT recommended for use with other NSAIDs, with the exception of low- dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
See
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..................................... 10 7 WARNINGS AND PRECAUTIONS ..................................................................................... 1 Special Populations ......................................................................................................
1 Pregnant Women ......................................................................................................... 2 Breast-feeding ..............................................................................................................
3 Pediatrics ...................................................................................................................... 4 Geriatrics ......................................................................................................................
19 8 ADVERSE REACTIONS ..................................................................................................... 1 Adverse Reaction Overview .........................................................................................
2 Clinical Trial Adverse Reactions ................................................................................... 3 Less Common Clinical Trial Adverse Reactions ............................................................ 5 Post-Market Adverse Reactions...................................................................................
21 9 DRUG INTERACTIONS ..................................................................................................... 3 Drug-Behavioural Interactions .....................................................................................
4 Drug-Drug Interactions ................................................................................................ 5 Drug-Food Interactions.................................................................................................
6 Drug-Herb Interactions ................................................................................................ 7 Drug-Laboratory Interactions ......................................................................................
30 10 CLINICAL PHARMACOLOGY............................................................................................. 1 Mechanism of Action ...................................................................................................
2 Pharmacodynamics ...................................................................................................... 3 Pharmacokinetics .........................................................................................................
31 11 STORAGE, STABILITY AND DISPOSAL ............................................................................... 33 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................
33 PART II: SCIENTIFIC INFORMATION........................................................................................ 34 13 PHARMACEUTICAL INFORMATION ...............................................................................
34 14 CLINICAL TRIALS ........................................................................................................... 3 Comparative Bioavailability Studies ............................................................................
35 15 MICROBIOLOGY ........................................................................................................... 36 16 NON-CLINICAL TOXICOLOGY ........................................................................................
36 17 SUPPORTING PRODUCT MONOGRAPH ......................................................................... 39 PATIENT MEDICATION INFORMATION................................................................................... 40 PRO-NAPROXEN EC Page 4 of 47 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS PRO-NAPROXEN EC […]