Generic Medicine Info
Should be taken with food.
Hypersensitivity. Patient with active or history of recurrent peptic ulcer, history of gastrointestinal bleeding or perforation related to previous NSAID therapy, chronic dyspepsia, severe heart failure, history of asthma, bronchospasm, nasal polyps, rhinitis, angioedema, or urticaria associated with aspirin or NSAID therapy. Treatment of peri-operative pain in the setting of CABG surgery. Renal (CrCl <30 mL/min) and severe hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with or a history of bronchial asthma, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), mild to moderate heart failure, fluid retention, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, coagulation disorders, risk factors for CV events (e.g. hyperlipidaemia, diabetes mellitus, smoking), cirrhosis, chronic alcoholic liver disease, dehydration, hypovolaemia. Debilitated patients. Mild to moderate renal and hepatic impairment. Elderly. Pregnancy (1st-2nd trimester) and lactation. Patient Counselling This drug may cause dizziness, drowsiness or blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor CBC, chemistry profile, renal and liver function. Blood pressure should be monitored during initiation of treatment and throughout the course of therapy.
Adverse Reactions
Significant: Aggravated asthma, bronchospasm, hypertension, hyperkalaemia, fluid retention, anaemia, increased ALT/AST. Blood and lymphatic system disorders: Haemolysis, purpura, agranulocytosis, leucopenia, neutropenia, thrombocytopenia. Cardiac disorders: Palpitation. Ear and labyrinth disorders: Tinnitus, hearing disturbances. Eye disorders: Visual disturbances, corneal opacity. Gastrointestinal disorders: Nausea, vomiting, constipation, abdominal pain, heartburn, diarrhoea, flatulence, dyspepsia, stomatitis. General disorders and administration site conditions: Fatigue, malaise, pyrexia, diaphoresis. Hepatobiliary disorders: Jaundice, abnormal liver function. Musculoskeletal and connective tissue disorders: Myalgia, muscle weakness. Nervous system disorders: Headache, vertigo, paraesthesia. Psychiatric disorders: Insomnia, depression, confusion, hallucination, disorientation, dream abnormality. Renal and urinary disorders: Cystitis. Respiratory, thoracic and mediastinal disorders: Dyspnoea, asthma, eosinophilic pneumonitis, pulmonary oedema. Skin and subcutaneous tissue disorders: Pruritus, urticaria, rash, ecchymoses, alopecia, photosensitivity reaction. Vascular disorders: Vasculitis.
Potentially Fatal: Gastrointestinal obstruction, inflammation, bleeding, ulceration or perforation;, CV thrombotic events including MI and stroke, anaphylactic reactions. Rarely, fulminant hepatitis, hepatic necrosis, hepatic failure, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis,
C D in 3rd trimester or near delivery.
Drug Interactions
May increase the risk of bleeding with other NSAIDs or salicylates (e.g. aspirin), anticoagulants (e.g. warfarin), corticosteroids, SSRI. May decrease efficacy of antihypertensive agents (e.g. β-blockers, ACE inhibitors, angiotensin II receptor antagonists). Increased risk of nephrotoxicity of ciclosporin or tacrolimus. May increase risk of haematological toxicity with zidovudine. Reduced natriuretic effects of diuretics (e.g. furosemide, thiazide diuretics). Increased plasma concentration and prolonged half-life with probenecid. May increase serum levels of lithium, digoxin, and methotrexate. May decrease the effects of mifepristone. Increased risk of myelosuppression, renal and gastrointestinal toxicity of pemetrexed. Delayed absorption rate with antacid, colestyramine, and sucralfate.
ATC Classification
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
G02CC02 - naproxen ; Belongs to the class of antiinflammatory products for vaginal administration used in the treatment and prevention of inflammation.
M02AA12 - naproxen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Disclaimer: This information is independently developed by CIMS based on naproxen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 © 2021 CIMS. All rights reserved. Powered by
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