Dexketoprofen


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Mild to moderate pain 12.5 mg 4-6 hourly or 25 mg 8 hourly. Max: 75 mg daily. IV/IM Moderate to severe acute pain 50 mg 8-12 hourly given via slow IV bolus inj over not less than 15 seconds, or infused over 10-30 minutes, or via slow deep IM inj. Dosage may be repeated 6 hours apart if necessary. Max: 150 mg total daily dose. Switch to oral treatment as soon as possible.
Dosage Details
Oral
Mild to moderate pain
Adult: 12.5 mg 4-6 hourly or 25 mg 8 hourly. Max: 75 mg daily.
Elderly: Initiate at the lower end of the dosage range with total dose not exceeding 50 mg daily. Dose may be increased to that recommended for general population only if well tolerated.

Parenteral
Moderate to severe acute pain
Adult: 50 mg 8-12 hourly via slow IV bolus inj over not less than 15 seconds, or infused over 10-30 minutes, or via slow deep IM inj. Dosage may be repeated 6 hours apart if necessary. Max: 150 mg total daily dose. Switch to oral treatment as soon as possible.
Renal Impairment
CrCl (mL/min)
Dosage
60-89
Initially, 50 mg total daily dose.
≤59
Contraindicated.
Hepatic Impairment
Mild to moderate: Initially, 50 mg total daily dose. Severe: Contraindicated.
Administration
Should be taken on an empty stomach. Take 30 min before meals, especially for quick relief of acute pain.
Reconstitution
Granules for oral solution: Dissolve the contents of 1 sachet in a glass of water. Solution for IV infusion: Dilute contents of 1 ampoule labelled as containing 50 mg with 30-100 mL of normal saline, glucose or Ringer lactate solution.
Incompatibility
Incompatible with dopamine, hydroxyzine, pentazocine, pethidine, promethazine.
Contraindications
Hypersensitivity to dexketoprofen, aspirin, or other NSAIDs. History of bronchial asthma or asthma attacks, bronchospasm, angioneurotic oedema, urticaria, acute rhinitis or nasal polyps that were precipitated or caused by aspirin or other NSAIDs; active, suspected, or recurrent peptic ulcer and gastrointestinal haemorrhage, other active bleeding or bleeding disorders, haemorrhagic diathesis and other coagulation disorders; any history of gastrointestinal bleeding, ulceration, or perforation, including related to previous NSAIDs treatment; chronic dyspepsia, Crohn’s disease, ulcerative colitis, severe heart failure, severe dehydration (caused by diarrhoea, vomiting, insufficient fluid intake), varicella infection, history of CABG; known phototoxic or photoallergic reactions during therapy with ketoprofen or fibrates. Moderate to severe renal (CrCl ≤59 mL/min) impairment. Severe hepatic (Child-Pugh score 10-15) impairment. Pregnancy (3rd trimester) and lactation.
Special Precautions
Patient with history of gastrointestinal disease, toxicity, or symptoms; uncontrolled hypertension, CHF, ischaemic heart disease, mild to moderate heart failure, history of cardiac disease, risk factors for CV events (e.g. diabetes mellitus, hyperlipidaemia, smoking), peripheral arterial disease, cerebrovascular disease; congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria), SLE, mixed connective tissue disease, haematopoietic disorders, dehydration, hypovolaemia; asthma combined with chronic rhinitis, chronic sinusitis or nasal polyposis; history of allergic conditions; history of major surgery. Not indicated for long term use. Mild renal (CrCl 60-89 mL/min) and mild to moderate hepatic impairment. Elderly. Pregnancy (1st-2nd trimester).
Adverse Reactions
Significant: Renal effects (e.g. deteriorated renal function, fluid retention, oedema, increased BUN or creatinine), hepatic effects (e.g. significantly elevated AST/ALT), increased risk of MI or stroke (high doses), exacerbated colitis or Crohn’s disease, inhibited platelet aggregation, prolonged bleeding time, masked symptoms of infection.
Blood and lymphatic system disorders: Anaemia.
Cardiac disorders: Palpitation.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, dry mouth, gastritis, constipation, flatulence, haematemesis.
General disorders and administration site conditions: Fatigue, asthenia, malaise, pyrexia, inj site reactions (e.g. pain, inflammation, haemorrhage, bruising).
Musculoskeletal and connective tissue disorder: Rigor.
Nervous system disorders: Headache, dizziness, aseptic meningitis, vertigo.
Psychiatric disorders: Insomnia, anxiety, somnolence.
Reproductive system and breast disorders: Impaired female fertility.
Skin and subcutaneous tissue disorders: Rash, pruritus, dermatitis, increased sweating.
Vascular disorders: Flushing, hypotension.
Potentially Fatal: Gastrointestinal bleeding, ulceration, or perforation; asthma attacks or bronchospasm. Rarely, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, anaphylactic shock.
Patient Counseling Information
This drug may cause dizziness, drowsiness, or visual disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood counts, renal and hepatic function regularly; signs of gastrointestinal bleeding and hypersensitivity reactions.
Overdosage
Symptoms: Anorexia, nausea, vomiting, abdominal pain, headache, dizziness, vertigo, somnolence, and disorientation. Management: Symptomatic treatment. Administer activated charcoal within 1 hour of ingesting more than 5 mg/kg. May be removed by dialysis.
Drug Interactions
May increase the risk of toxicity of lithium, methotrexate, hydantoins and sulfonamides. May reduce the effects of diuretics and antihypertensive agents. May enhance the nephrotoxic effects with ciclosporin, tacrolimus, diuretics, ACE inhibitors, angiotensin II receptor antagonist, antibacterial aminoglycosides. Increased risk of red cell line toxicity with zidovudine; bleeding with pentoxifylline and thrombolytics. Increased plasma concentrations with probenecid. May increase the hypoglycaemic effects of sulfonylureas. May decrease the elimination of pemetrexed. May elevate plasma levels of cardiac glycosides.
Potentially Fatal: Increased risk of gastrointestinal bleeding and ulceration with other NSAIDs (including cyclooxygenase-2 inhibitors), aspirin, anticoagulants (e.g. warfarin, heparin), corticosteroids, SSRI, antiplatelet agents.
Food Interaction
Rate of absorption may be delayed by food.
Action
Description: Dexketoprofen, the S-(+) enantiomer of ketoprofen, is a propionic acid derivative with analgesic, anti-inflammatory, and antipyretic properties. It is an NSAID that reduces prostaglandin synthesis by inhibiting the cyclooxygenase pathway.
Onset: Analgesic effect: 30 minutes.
Duration: Analgesic effect: 4-6 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed from the gastrointestinal tract. Delayed rate of absorption with food. Time to peak plasma concentration: Tab: 30 (range: 15-60) minutes; Granules for oral solution: 15-20 minutes; Oral solution: 15 (range: 10-40) minutes; IM inj: 20 (range: 10-45) minutes.
Distribution: Volume of distribution: <0.25 L/kg.
Excretion: Via urine. Elimination half-life: 1-2.7 hours.
Chemical Structure

Chemical Structure Image
Dexketoprofen_01

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 667550, Dexketoprofen. https://pubchem.ncbi.nlm.nih.gov/compound/Dexketoprofen. Accessed Sept. 24, 2020.

Storage
Store below 30°C. Protect from light.
ATC Classification
M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Dexketoprofen. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/08/2020.

Buckingham R (ed). Ketoprofen. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/08/2020.

Enantyum 12.5 mg and 25 mg Film-Coated Tablets (Menarini International O.L.S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 10/08/2020.

Enantyum 25 mg Granules for Oral Solution (Menarini International Operations Luxembourg S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 10/08/2020.

Enantyum 50 mg/2 mL Solution for Injection/Infusion (Menarini International O.L.S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 10/08/2020.

Joint Formulary Committee. Dexketoprofen. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/08/2020.

Keral 25 mg Oral Solution in Sachet (Menarini International O.L.S.A.). MHRA. https://products.mhra.gov.uk/. Accessed 10/08/2020.

Ketesse 25 mg Film-Coated Tablets (A. Menarini Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 10/08/2020.

Ketesse 25 mg/mL Solution for Injection or Concentrate for Solution for Infusion (A. Menarini Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 10/08/2020.

Ketesse Granules for Oral Solution (A. Menarini Singapore Pte. Ltd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 10/08/2020.

Disclaimer: This information is independently developed by MIMS based on Dexketoprofen 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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