Adult: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional tab/oral susp: Initially, 500 mg, followed by 500 mg 12 hourly or 250 mg 6-8 hourly as needed. Max: 1,250 mg on the 1st day, then 1,000 mg daily thereafter. As extended-release tab: Initially, 1,000 mg once daily, may be increased to 1,500 mg daily if needed for a limited period; then reduce to the usual Max dose of 1,000 mg daily. Use the lowest effective dose for the shortest possible duration based on individual patient treatment goals. Elderly: Use the lowest effective dose for the shortest possible duration.
Oral Acute gout
Adult: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional or effervescent tab/oral susp: Initially, 750 mg, followed by 250 mg 8 hourly until the attack subsides. As extended-release tab: Initially, 1,000-1,500 mg once daily, followed by 1,000 mg once daily until the attack subsides. Use the lowest effective dose for the shortest possible duration based on individual patient treatment goals. Elderly: Use the lowest effective dose for the shortest possible duration.
Oral Fever
Adult: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As 220 mg naproxen Na conventional tab/cap: Initially, 200-400 mg (220-440 mg naproxen Na) within the 1st hour, followed by 200 mg (220 mg naproxen Na) 8-12 hourly as needed. Max: 600 mg (660 mg naproxen Na) in a 24-hour period, or 400 mg (440 mg naproxen Na) in any 8- to 12-hour period. Use the lowest effective dose for the shortest possible duration based on individual patient treatment goals. Elderly: Use the lowest effective dose for the shortest possible duration. Child: ≥12 years As 220 mg naproxen Na conventional tab/cap: Same as adult dose.
Adult: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional tab/oral susp: 500-1,000 mg daily as a single or in 2 divided doses. As effervescent tab: Initially, 250 mg bid; adjusted to 500-1,000 mg daily in 2 divided doses. As delayed-release tab: 375 mg or 500 mg bid. As extended-release or sustained-release tab: 750 mg or 1,000 mg once daily. In patients who tolerate lower doses well, doses may be increased to 1,500 mg daily for a period of up to 6 months if required. Use the lowest effective dose for the shortest possible duration based on individual patient treatment goals. Elderly: Use the lowest effective dose for the shortest possible duration.
Oral Mild to moderate pain
Adult: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional tab/oral susp: Initially, 500 mg, followed by 500 mg 12 hourly or 250 mg 6-8 hourly as needed. Max: 1,250 mg on the 1st day, then 1,000 mg daily thereafter. Alternatively, as 220 mg naproxen Na conventional tab/cap: Initiate at 200-400 mg (220-440 mg naproxen Na) within the 1st hour, followed by 200 mg (220 mg naproxen Na) 8-12 hourly as needed. Max: 600 mg (660 mg naproxen Na) in a 24-hour period, or 400 mg (440 mg naproxen Na) in any 8- to 12-hour period. As extended-release tab: Initially, 1,000 mg once daily, may be increased to 1,500 mg daily if needed for a limited period; then reduce to the usual Max dose of 1,000 mg daily. Use the lowest effective dose for the shortest possible duration based on individual patient treatment goals. Elderly: Use the lowest effective dose for the shortest possible duration. Child: ≥12 years As 220 mg naproxen Na conventional tab/cap: Same as adult dose.
Oral Juvenile idiopathic arthritis
Child: ≥2 years Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional oral susp: 10 mg/kg daily in 2 divided doses at 12-hour intervals. Max: 1,000 mg daily.
Special Patient Group
Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis:
Patients with severe night-time pain or morning stiffness, pain as the predominant symptom in osteoarthritis, and who are switched to naproxen from high dose of another anti-rheumatic drug: Doses are expressed in terms of naproxen base (each 200 mg naproxen base is equivalent to 220 mg naproxen Na). As conventional tab: Loading dose of 750 mg or 1,000 mg daily is recommended for the acute phase.
Renal Impairment
Mild to moderate: Dosage reduction may be necessary.
CrCl (mL/min)
Dosage
<30
Contraindicated.
Hepatic Impairment
Mild to moderate: Dosage reduction may be necessary. Severe: Contraindicated.
Administration
Should be taken with food.
Contraindications
Hypersensitivity to naproxen. History of asthma, nasal polyps, rhinitis, angioedema, urticaria or other allergic-type reactions after taking aspirin, ibuprofen, or other NSAIDs; active peptic ulcer or gastrointestinal bleeding, history of recurrent gastrointestinal ulceration or bleeding (≥2 distinct episodes of proven ulceration or bleeding), chronic dyspepsia, history of gastrointestinal bleeding or perforation related to previous NSAID use; severe heart failure, treatment of perioperative pain in the setting of CABG surgery. Severe renal (CrCl <30 mL/min) and hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with existing or previous history of asthma (without known aspirin sensitivity) or allergic disease; history of gastrointestinal disease (Crohn's disease, ulcerative colitis); SLE, mixed connective tissue disorders; uncontrolled hypertension, mild to moderate CHF, established ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, recent MI, risk factors for CV disease (e.g. hyperlipidaemia, diabetes mellitus, smoking); oedema, liver cirrhosis, dehydration, hypovolaemia, coagulation disorders. May mask fever and other signs of inflammation and infection. Different dose strengths and formulations are not interchangeable; refer to individual product guideline for detailed information. Patient receiving corticosteroids, anticoagulants, SSRIs, or antiplatelet agents. Mild to moderate renal and hepatic impairment. Children; elderly or debilitated patients. Pregnancy (1st-2nd trimester) and lactation.
Adverse Reactions
Significant: Acute interstitial nephritis, nephrotic syndrome, renal papillary necrosis, haematuria, proteinuria, renal failure; elevated transaminases, hyperkalaemia, fluid retention, oedema, new-onset or exacerbation of hypertension, decreased platelet aggregation, prolonged bleeding time, anaemia; increased risk of aseptic meningitis (particularly in patients with autoimmune disorders). Rarely, severe blood dyscrasias (e.g. aplastic anaemia, agranulocytosis, thrombocytopenia). Cardiac disorders: Palpitations. Ear and labyrinth disorders: Vertigo, tinnitus, hearing disturbances. Eye disorders: Visual disturbances, corneal opacity, papilloedema, papillitis. Gastrointestinal disorders: Nausea, vomiting, dyspepsia, constipation, diarrhoea, flatulence, abdominal pain or discomfort, epigastric distress, heartburn. General disorders and administration site conditions: Fatigue, pyrexia, malaise, thirst. Musculoskeletal and connective tissue disorders: Muscle weakness, myalgia, arthralgia. Nervous system disorders: Dizziness, headache, drowsiness, paraesthesia, convulsions, cognitive dysfunction. Psychiatric disorders: Depression, confusion, insomnia, dream abnormalities, irritability, sleep disorders, hallucinations. Reproductive system and breast disorders: Female infertility. Respiratory, thoracic and mediastinal disorders: Dyspnoea, eosinophilic pneumonitis, pulmonary oedema, asthma. Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, ecchymoses, purpura, sweating, alopecia. Vascular disorders: Hypertension, vasculitis. Potentially Fatal: Serious gastrointestinal inflammation, bleeding, ulceration, or perforation; serious CV thrombotic events (including MI and stroke), severe bronchospasm, severe anaphylactic reactions, drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity reactions. Rarely, severe hepatic reactions (e.g. fulminant hepatitis, hepatic failure or necrosis), serious skin reactions (e.g. Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis).
Parenteral/PO/Rectal: Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause dizziness, drowsiness, or blurred vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor CBC, chemistry profile (periodically during prolonged use), LFTs, renal function (e.g. serum BUN and creatinine, urine output), electrolytes, and blood pressure (at baseline and during treatment). Observe for signs or symptoms of allergic reaction, fluid retention, gastrointestinal ulceration, or bleeding (occult or gross blood loss). Perform periodic ophthalmic evaluation in patients who develop visual disturbances during long-term treatment.
Overdosage
Symptoms: Nausea, vomiting, indigestion, epigastric pain, headache, drowsiness, dizziness, gastrointestinal bleeding, liver damage, transient prolongation of prothrombin time. Rarely, diarrhoea, heartburn, tinnitus, disorientation, excitation, fainting, hypertension, acute renal failure, convulsions, respiratory depression, and coma. Management: Symptomatic and supportive treatment. Consider administration of activated charcoal or performing gastric lavage (in adults) within 1 hour of ingestion, or inducing emesis and/or use of osmotic cathartic (in symptomatic patients seen within 4 hours of ingestion). Ensure good urine output. Monitor liver and renal function. Observe the patient for at least 4 hours following ingestion. Administer IV diazepam for frequent or prolonged convulsions.
Drug Interactions
May reduce the therapeutic efficacy of antihypertensive agents (e.g. ACE inhibitors, β-blockers, angiotensin II receptor blockers) and diuretics (e.g. furosemide, thiazide diuretics). May increase the risk of renal impairment with ACE inhibitors or angiotensin II receptor blockers. Increased plasma levels and prolonged half-life with probenecid. May increase the plasma levels of lithium, methotrexate, and digoxin. May increase the nephrotoxic effects of ciclosporin and tacrolimus. May reduce the effect of mifepristone. May increase the risk of haematological toxicity with zidovudine. Concomitant use of antacids, colestyramine, and sucralfate may delay the absorption of naproxen. Potentially Fatal: Increased risk of gastrointestinal toxicity or bleeding when used concomitantly with other NSAIDs, corticosteroids, anticoagulants (e.g. warfarin), SSRIs, or antiplatelet agents (e.g. aspirin).
Food Interaction
Decreased rate but not the extent of absorption with food. Increased risk of gastrointestinal bleeding with alcohol.
Lab Interference
May interfere with 5-hydroxyindoleacetic acid urinary assays and some tests for 17-ketogenic steroids. May result in false-positive aldosterone/renin ratio (ARR).
Action
Description: Mechanism of Action: Naproxen, a propionic acid derivative, is an NSAID that has analgesic, anti-inflammatory and antipyretic properties. Its mechanism of action is not fully understood but may involve the reversible inhibition of cyclooxygenase-1 and 2 (COX-1 and 2) enzymes, which leads to decreased formation of prostaglandin precursors. Onset: Analgesic: 0.5-1 hour. Duration: Analgesic: <12 hours. Pharmacokinetics: Absorption: Readily and completely absorbed from the gastrointestinal tract. Naproxen Na is more rapidly absorbed as compared to naproxen. Decreased rate but not the extent of absorption with food. Bioavailability: 95%. Time to peak plasma concentrations: Conventional tab: 2-4 hours (naproxen); 1-2 hours (naproxen Na). Delayed-release tab: Approx 4-6 hours (fasted state); approx 12 hours (with food). Oral suspension: 1-4 hours. Distribution: Crosses the placenta; enters breast milk (small amounts). Volume of distribution: 0.16 L/kg. Plasma protein binding: >99%, mainly to albumin. Metabolism: Extensively metabolised in the liver by CYP1A2 and CYP2C9 isoenzymes to 6-O-desmethylnaproxen. Both naproxen and the desmethyl metabolite undergo further metabolism to their respective acylglucuronide conjugated metabolites. Excretion: Via urine (approx 95%, mainly as metabolites); faeces (≤3%). Elimination half-life: 12-17 hours.
Chemical Structure
Naproxen Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 156391, Naproxen. https://pubchem.ncbi.nlm.nih.gov/compound/Naproxen. Accessed Apr. 26, 2022.
Storage
Store between 15-30°C. Protect from light. Protect the oral susp from excessive heat.
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
References
Aleve Back and Muscle Pain Tablet (Bayer HealthCare LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2022.Aleve Easy Open Arthritis Capsule, Liquid Filled (Bayer HealthCare LLC.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/03/2022.Anon. Naproxen. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 14/03/2022.Anon. Naproxen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/03/2022.Buckingham R (ed). Naproxen. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/03/2022.Clinect NZ Pty Limited. Naprosyn SR Tablets data sheet 19 July 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 10/03/2022.Joint Formulary Committee. Naproxen. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/03/2022.Naprelan Tablet, Film Coated, Extended Release (Almatica Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2022.Naprosyn Suspension (Athena Bioscience, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2022.Naprosyn Tablet; EC-Naprosyn Tablet, Delayed Release; Anaprox DS Tablet (Canton Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/03/2022.Naproxen 50 mg/mL Oral Suspension (Thornton & Ross Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2022.Naproxen Tablets BP 250 mg (Milpharm Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2022.Stirlescent 250 mg Effervescent Tablets (Stirling Anglian Pharmaceuticals Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 10/03/2022.Synflex Tablets (DKSH Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/03/2022.
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