Generic Medicine Info
Indications and Dosage
Juvenile rheumatoid arthritis
Child: ≥6 yr 22-31 kg: 600 mg once daily; 32-54 kg: 900 mg once daily; ≥55 kg: 1,200 mg once daily.

Osteoarthritis, Rheumatoid arthritis
Adult: 1,200 mg once daily. Max: 1,800 mg or 26 mg/kg, whichever is lower, given in divided doses.
Special Patient Group
Patient w/ low body wt: Osteoarthritis; Rheumatoid arthritis: Initially, 600 mg once daily.
Renal Impairment
Osteoarthritis; Rheumatoid arthritis: Severe or on dialysis: Initially, 600 mg once daily, may be increased to 1,200 mg once daily if necessary.
Hypersensitivity. History of bronchospasm, asthma, urticaria, or other allergic-type reactions w/ NSAIDs; active GI bleeding, severe heart failure, recent MI. CABG surgery.
Special Precautions
Patient w/ history of peptic ulcer disease and/or GI bleeding, coagulopathy, HTN, oedema, known or risk factors for CV disease, on dialysis, DM, other forms of asthma. Smokers. Severe renal and hepatic impairment. Childn. Pregnancy and lactation.
Adverse Reactions
Significant: Drowsiness, dizziness, blurred vision, HTN, fluid retention, oedema, decreased platelet adhesion and aggregation, prolonged bleeding time, anaemia, increased risk of hyperkalaemia, photosensitivity reactions, renal papillary necrosis (long term use). Rarely, blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia).
Nervous: Headache, CNS inhibition (e.g. depression, sedation, confusion), sleep disturbance, sedation.
GI: Abdominal pain/distress, anorexia, constipation, diarrhoea, dyspepsia, flatulence, heartburn, nausea, vomiting.
Hepatic: Increased ALT/AST.
Genitourinary: Abnormal renal function, dysuria, urinary frequency.
Otic: Tinnitus.
Dermatologic: Pruritus, rash.
Potentially Fatal: Increased risk of CV thrombotic events (e.g. MI, heart failure, stroke); GI adverse events (e.g. inflammation, bleeding, ulceration and perforation of the stomach or intestines); anaphylactoid reactions (e.g. severe bronchospasm); serious skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Rarely, hepatic injury (e.g. fulminant hepatitis, hepatic necrosis, hepatic failure).
PO: 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 drowsiness, dizziness and blurred vision, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor BP, CBC, K levels, renal function, and LFT. Monitor signs and symptoms of GI bleeding.
Symptoms: Lethargy, drowsiness, nausea, vomiting, abdominal pain, GI bleeding, HTN, acute renal failure, resp depression, coma. Management: Symptomatic and supportive treatment. May consider emesis and/or activated charcoal admin.
Drug Interactions
Increased risk of renal toxicity w/ diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs). Increased risk of bleeding w/ anticoagulants, antiplatelets, SSRIs, serotonin norepinephrine reuptake inhibitors. Increased risk of hyperkalaemia w/ ACE inhibitors. May increase serum conc of lithium. May increase serum concentration and prolong the half-life of digoxin. May increase the risk of methotrexate and ciclosporin toxicity. Increased risk of myelosuppression, renal and GI toxicity w/ pemetrexed. May decrease antihypertensive effect of diuretics, ACE inhibitors, ARBs, β-blockers. May decrease natriuretic effect of furosemide.
Potentially Fatal: Increased risk of GI adverse events w/ oral corticosteroids, aspirin, anticoagulants, SSRIs.
Food Interaction
Increased risk of GI adverse events w/ alcohol.
Lab Interference
False positive result for benzodiazepines in urine immunoassay screening test.
Mechanism of Action: Oxaprozin is a propionic acid derivative NSAID w/ analgesic, and antipyretic properties. It inhibits the enzyme cyclooxygenase-1 and 2 (COX-1 and 2) resulting in the blockage of prostaglandin synthesis.
Absorption: Slowly but extensively absorbed from the GI tract. Time to peak plasma concentration: Approx 2-3 hr.
Distribution: Volume of distribution: 11-17 L/70 kg. Plasma protein binding: 99%, mainly to albumin.
Metabolism: Metabolised in the liver via oxidation and glucuronidation into ester and ether inactive glucuronide metabolites and active phenolic metabolite (small amount).
Excretion: Mainly via urine (5%, as unchanged drug; 65%, as metabolites); faeces (35%, as metabolites). Elimination half-life: 41-55 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Oxaprozin, CID=4614, https://pubchem.ncbi.nlm.nih.gov/compound/Oxaprozin (accessed on Jan. 22, 2020)

Store between 20-25°C. Protect from light.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE12 - oxaprozin ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Anon. Oxaprozin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/09/2017.

Buckingham R (ed). Oxaprozin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com/. Accessed 19/09/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Oxaprozin. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 19/09/2017.

Oxaprozin Tablet, Film Coated (PD-Rx Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/09/2017.

Disclaimer: This information is independently developed by MIMS based on Oxaprozin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
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