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JAMP NAPROXEN is a brand name for Naproxen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: JAMP 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. JAMP Naproxen (Naproxen Tablets) Page 5 of 47 2 CONTRAINDICATIONS JAMP 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 JAMP Naproxen may be adjusted up or down depending on the clinical response of the patient.
A lower dose may suffice for long–term administration. 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 Hepatic impairment:
A lower dose should be considered in patients with mild and moderate hepatic impairment. JAMP Naproxen is contraindicated in severe liver impairment or active liver disease. 4 Administration JAMP Naproxen tablets should be swallowed whole.
Use of JAMP Naproxen 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 JAMP Naproxen, as a NSAID, does NOT treat clinical disease or prevent its progression.
JAMP Naproxen, 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): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of naproxen in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 4 Geriatrics. JAMP Naproxen (Naproxen Tablets) Page 5 of 47 2 CONTRAINDICATIONS JAMP 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.
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.
and 7 WARNINGS AND PRECAUTIONS. Use of JAMP Naproxen 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 JAMP Naproxen, as a NSAID, does NOT treat clinical disease or prevent its progression. JAMP Naproxen, 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): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of naproxen in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669). 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, 250 mg, 375 mg and 500 mg Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No.
10 aluminum lake (250 mg & 500 mg), FD&C yellow no. 6 (375 mg), FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate. JAMP Naproxen (Naproxen Tablets) Page 10 of 47 Description JAMP Naproxen is available as: JAMP Naproxen 250 mg tablets: Yellow, oval biconvex tablet engraved “N-250” on one side and “JP” on other side, contains 250 mg of naproxen.
Available in bottles of 100 and 500 tablets, and blister pack of 100 tablets.
JAMP Naproxen 375 mg tablets:
Peach coloured, capsule shaped, biconvex tablet scored and engraved “N” and “375” on either side of score line on one side and “JP” on other side, contains 375 mg of naproxen. Available in bottles of 100 and 500 tablets, and blister pack of 100 tablets.
JAMP Naproxen 500 mg tablets:
Yellow, capsule-shaped, biconvex tablet, scored and engraved “N” and “500” on either side of scoreline on one side and “JP” on other side, contains 500 mg of naproxen. Available in bottles of 100 and 500 tablets, and blister pack of 100 tablets.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 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.
JAMP Naproxen 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.
4 Drug-Drug Interactions, Acetylsalicylic acid (ASA) or other NSAIDs JAMP Naproxen (naproxen) should not be used concomitantly with the related drug naproxen sodium since they both circulate in plasma as the naproxen anion. Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY JAMP Naproxen (Naproxen Tablets) Page 11 of 47 Cardiovascular JAMP Naproxen […]
The potential for cross-reactivity between different NSAIDs must be kept in mind. See 7 WARNINGS AND PRECAUTIONS, Sensitivity / Resistance, Anaphylactoid Reactions • active gastric/duodenal/peptic ulcer, active GI bleeding. 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 7 WARNINGS AND PRECAUTIONS, Renal • known hyperkalemia. See 7 WARNINGS AND PRECAUTIONS, Renal, Fluid and Electrolyte Balance • children and adolescents less than 18 years of age since naproxen has not been studied in subjects under the age of 18.
JAMP Naproxen (Naproxen Tablets) Page 6 of 47 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): JAMP Naproxen is a non-steroidal anti-inflammatory drug (NSAID).
Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Caution should be exercised in prescribing JAMP Naproxen to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and / or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and / or amaurosis fugax) and / or congestive heart failure (NYHA II-IV).
Use of NSAIDs, such as JAMP Naproxen, 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. Randomized clinical trials with naproxen have not been designed to detect differences in cardiovascular events in a chronic setting.
Therefore, caution should be exercised when prescribing JAMP Naproxen.
See 7 WARNINGS AND PRECAUTIONS • Risk of Gastrointestinal (GI) Adverse Events:
Use of NSAIDs, such as JAMP Naproxen, is associated with an increased incidence of gastrointestinal adverse events (such as ulceration, bleeding, perforation and obstruction of the upper and lower gastrointestinal tract).
See 7 WARNINGS AND PRECAUTIONS:
Gastrointestinal • Risk in Pregnancy: Caution should be exercised in prescribing JAMP Naproxen during the first and second trimesters of pregnancy. 1 Pregnant Women). JAMP Naproxen is contraindicated for use during the third trimester because of risk of premature closure of the ductus arteriosus and uterine inertia (prolonged parturition).
1 Dosing Considerations • Use of JAMP Naproxen should be limited to the lowest effective dose for the shortest possible duration of treatment. See 1 INDICATIONS. • For all indications, treatment must be initiated with the lowest dose.
Other 250 mg naproxen formulations are available for the 250 mg tablet starting […]