Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Osteoarthritis; Dysmenorrhoea 600-900 mg/day in 2-3 divided doses, may be increased up to Max 1,200 mg/day, if necessary. Max: 400 mg/dose. Mild to moderate pain 600 mg/day 2-3 divided doses, may be increased up to 1,200 mg/day, if necessary. Max: 400 mg/dose.
Hypersensitivity to NSAIDs. Active or history of recurrent peptic ulcer/haemorrhage, history of gastrointestinal bleeding or perforation associated with previous NSAID therapy; cerebrovascular bleeding or other active bleedings, active Crohn's disease or ulcerative colitis; severe heart failure. Severe renal (GFR <30 mL/min) and hepatic impairment. Pregnancy (3rd trimester). Concomitant use with NSAIDs including COX2-selective inhibitors.
Special Precautions
Patient with allergic disorders, cardiac impairment, cerebrovascular disease, congestive heart failure; history of ulcerative colitis, Crohn's disease; haemorrhagic diathesis and other coagulation disorders, ischaemic heart disease, peripheral arterial disease, risk factors for CV events, uncontrolled hypertension, bronchial asthma, systemic lupus erythematosus, mixed connective tissue disease. Elderly. Mild to moderate renal and hepatic impairment. Pregnancy (1st and 2nd trimester) and lactation. Patient CounsellingThis drug may cause dizziness, fatigue, drowsiness, vertigo or visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal, hepatic and haematologic functions in patient receiving long-term therapy. Perform blood coagulation tests (e.g. INR, bleeding time) prior to treatment initiation in patient taking anticoagulants.
Adverse Reactions
Significant: Renal effects (e.g. glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome, acute renal failure), increased SGOT and SGPT. Ear and labyrinth disorders: Tinnitus. Eye disorders: Visual disturbances. Gastrointestinal disorders: Dyspepsia, abdominal pain, diarrhoea, nausea, vomiting. General disorders and administration site conditions: Fatigue. Immune system disorders: Allergic purpura, angioedema. Nervous system disorders: Drowsiness, headache, dizziness, vertigo, restlessness. Psychiatric disorders: Anxiety, insomnia. Respiratory, thoracic and mediastinal disorders: Rhinitis, bronchospasm. Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.
Potentially Fatal: Gastrointestinal bleeding, ulceration and perforation. Rarely, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Drug Interactions
May increase effect of anticoagulants (e.g. warfarin). May increase plasma levels thus increase risk of toxicity of methotrexate, lithium, digoxin, and phenytoin. May reduce antihypertensive effect of β-blockers. May increase risk of nephrotoxicity with immunosuppressants (e.g. ciclosporin, tacrolimus, sirolimus) and aminoglycoside antibiotics. Increased risk of gastrointestinal ulceration and bleeding with corticosteroids, antiplatelets and selective serotonin reupdate inhibitors. Reduced effect with CYP2C8 and CYP2C9 inducing agents (e.g. phenytoin, phenobarbital, rifampicin).
ATC Classification
M01AE14 - dexibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Disclaimer: This information is independently developed by CIMS based on dexibuprofen 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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