Dexibuprofen


Concise Prescribing Info
Indications/Uses
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 in 2-3 divided doses, may be increased up to Max 1,200 mg/day, if necessary. Max: 400 mg/dose.
Dosage Details
Oral
Osteoarthritis, Dysmenorrhoea
Adult: 600-900 mg daily in 2-3 divided doses, may be increased up to Max 1,200 mg daily if necessary. Max: 400 mg/dose.
Elderly: Use lowest effective dose.

Oral
Mild to moderate pain
Adult: 600 mg daily in 2-3 divided doses, may be increased up to Max 1,200 mg daily if necessary. Max: 400 mg/dose.
Elderly: Use lowest effective dose.
Renal Impairment
Mild to moderate: Dose reduction is recommended. Severe (GFR <30 mL/min): Contraindicated.
Hepatic Impairment
Mild to moderate: Dose reduction is recommended. Severe: Contraindicated.
Contraindications
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.
Adverse Reactions
Significant: Renal effects (e.g. glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome, acute renal failure), increase 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.
Patient Counseling Information
This drug may cause dizziness, fatigue, drowsiness, vertigo or visual disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
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.
Overdosage
Symptoms: Mild symptoms include abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nystagmus, tinnitus and ataxia. Rarely, moderate or severe symptoms such as gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress syndrome and transient episodes of apnoea (young children following large ingestions). Management: Symptomatic treatment. Small ingested amounts (<50 mg/kg) may be diluted water to reduce gastrointestinal upset. Consider emesis to empty stomach within 60 minutes of ingestion.
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).
Potentially Fatal: Increased risk of gastrointestinal bleeding, ulceration or perforation, and renal failure with NSAIDs including selective COX-2 inhibitors.
Food Interaction
Increased gastrointestinal adverse effects with alcohol.
Action
Description: Dexibuprofen is the S(+)-enantiomer of ibuprofen, a non-selective NSAID. Its mechanism of action may be due to inhibition of prostaglandin synthesis resulting to reduced pain, inflammation and fever.
Pharmacokinetics:
Absorption: Well-absorbed mainly from small intestine. Time to peak plasma concentration: Approx 2 hours.
Distribution: Plasma protein binding: Approx 99%.
Metabolism: Metabolised in the liver via hydroxylation and carboxylation to inactive metabolites.
Excretion: Via urine (90%) and faeces. Elimination half-life: 1.8-3.5 hours.
Chemical Structure

Chemical Structure Image
Dexibuprofen

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 39912, Dexibuprofen. https://pubchem.ncbi.nlm.nih.gov/compound/Dexibuprofen. Accessed Aug. 25, 2020.

ATC Classification
M01AE14 - dexibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
References
Buckingham R (ed). Dexibuprofen. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2020.

Dexibuprofen 300 mg Film-coated Tablets (Strides Pharma UK Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 05/08/2020.

Joint Formulary Committee. Dexibuprofen. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2020.

Disclaimer: This information is independently developed by MIMS 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 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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