Generic Medicine Info
Indications and Dosage
Intramuscular, Intravenous
Moderate to severe acute pain
Adult: For short-term treatment (≤2 days): 50 mg 8-12 hourly via slow IV inj over at least 15 seconds or IV infusion over 10-30 minutes, or via deep IM inj. Doses may be repeated with a minimum interval of 6 hours if needed. Max: 150 mg daily. Switch to oral treatment when possible.

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 dosing range with total dose not exceeding 50 mg daily. May increase dose within usual adult dose range if tolerated.
Renal Impairment
CrCl (mL/min) Dosage
≤59 Contraindicated.
60-89 Initiate at the lower end of the dosing range. Max initial dose: 50 mg daily.

CrCl (mL/min) Dosage
≤59 Contraindicated.
60-89 50 mg total daily dose.
Hepatic Impairment
Mild to moderate: Initiate at the lower end of the dosing range. Max initial dose: 50 mg daily. Severe: Contraindicated.

Mild to moderate: 50 mg total daily dose. Severe: Contraindicated.
Should be taken on an empty stomach. Take 30 min before meals, especially for quick relief of acute pain.
Solution for IV infusion: Dilute the contents of the 2 mL amp (labelled as containing 50 mg) with 30-100 mL of NaCl 0.9%, dextrose 5% in water, or Lactated Ringer's solution.
Syringe: May be precipitated with solutions of dopamine, promethazine, pentazocine, pethidine or hydroxyzine. Diluted solution for infusion: Incompatible with promethazine or pentazocine.
Hypersensitivity to dexketoprofen, or any other NSAIDs. History of asthma attacks, bronchospasm, angioneurotic oedema, acute rhinitis, nasal polyps, urticaria, or other allergic-type reaction after taking aspirin or other NSAIDs; known photoallergic or phototoxic reactions during therapy with ketoprofen or fibrates; active or suspected peptic ulcer or haemorrhage, history of gastrointestinal bleeding, ulceration, or perforation, including cases related to previous NSAID therapy; other active bleedings or bleeding disorders, haemorrhagic diathesis and other coagulation disorders, chronic dyspepsia, Crohn's disease or ulcerative colitis, varicella infection, severe heart failure; severe dehydration due to vomiting, diarrhoea or insufficient fluid intake. Moderate to severe renal (CrCl ≤59 mL/min) and severe hepatic (Child-Pugh score 10-15) impairment. Pregnancy (3rd trimester) and lactation.
Special Precautions
Patient with history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease) or toxicity; history of hypertension, uncontrolled hypertension; mild to moderate heart failure; ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, risk factors for CV disease (e.g. hyperlipidaemia, diabetes mellitus, smoking), haematopoietic disorders, SLE, mixed connective tissue disease, congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria); asthma combined with chronic rhinitis, chronic sinusitis and/or nasal polyposis. Patient who underwent major surgery. Dehydrated and debilitated patients. May mask signs and symptoms of infections. Not recommended for treatment of perioperative pain in the setting of CABG. Not intended 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: Glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome, acute renal failure; increased ALT or AST; risk for arterial thrombotic events (e.g. MI or stroke); risk for asthma attacks or bronchospasm; fluid retention, oedema, decreased platelet adhesion and aggregation, prolonged bleeding time, new-onset or worsening of hypertension. Rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock).
Cardiac disorders: Palpitations.
Ear and labyrinth disorders: Vertigo.
Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, vomiting, dyspepsia, gastritis, constipation, flatulence, dry mouth.
General disorders and administration site conditions: Fatigue, asthenia, rigors, malaise; inj site reaction (e.g. pain, inflammation, haemorrhage, bruising).
Nervous system disorders: Headache, dizziness, somnolence.
Psychiatric disorders: Insomnia, anxiety.
Skin and subcutaneous tissue disorders: Rash.
Vascular disorders: Flushing.
Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation. Very rarely, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
IM/IV/Parenteral/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 dizziness, visual disturbances or drowsiness, if affected, do not drive or operate machinery.
Monitoring Parameters
Monitor CBC, occult blood loss, hepatic (periodically) and renal function; blood pressure.
Symptoms: Anorexia, abdominal pain, vomiting, headache, somnolence, vertigo, disorientation. Management: Symptomatic treatment. Administer activated charcoal if more than 5 mg/kg has been ingested within an hour. May perform dialysis.
Drug Interactions
Increases plasma concentrations of lithium, methotrexate and cardiac glycosides. May increase the toxic effects of hydantoins and sulfonamides. May decrease the effect of diuretics and antihypertensive drugs (e.g. β-blockers). Increased risk of bleeding with pentoxifylline and thrombolytics. Risk of increased red cell line toxicity with zidovudine. May increase the hypoglycaemic effect of sulfonylureas. May enhance the nephrotoxic effect with ACE inhibitors, ciclosporin and tacrolimus. Probenecid may increase the plasma concentrations of dexketoprofen. May alter the efficacy of mifepristone. May increase the risk of developing convulsions with quinolone antibiotics. Concomitant use with tenofovir may result in increased plasma urea nitrogen and creatinine. May increase the risk of gastrointestinal toxicity with deferasirox. Dexketoprofen may decrease pemetrexed elimination. Increased risk of hyperkalaemia with K-sparing diuretics.
Potentially Fatal: Increased risk of gastrointestinal ulcers and bleeding with other NSAIDs (including COX-2 selective inhibitors), corticosteroids, SSRIs, anticoagulants (e.g. warfarin, heparin), and antiplatelet agents (e.g. aspirin).
Food Interaction
Delayed absorption with food. May enhance the adverse effects with alcohol.
Lab Interference
May result in false-positive aldosterone/renin ratio (ARR).
Mechanism of Action: Dexketoprofen, the S-(+) enantiomer of ketoprofen, is an analgesic, anti-inflammatory and antipyretic agent. It reduces the synthesis of prostaglandin by inhibiting cyclooxygenase pathway which also affects other inflammation mediators (e.g. kinins), causing further increase in anti-inflammatory activity.
Duration: Oral: 4-6 hours. IM or IV: Approx 8 hours.
Absorption: Rapidly absorbed from the gastrointestinal tract. Delayed absorption with food. Time to peak plasma concentration: 15-60 minutes (tab); 15-20 minutes (granules for oral solution); 10-45 minutes (IM).
Distribution: Volume of distribution: <0.25 L/kg. Plasma protein binding: 99%.
Metabolism: Metabolised in the liver via glucuronidation.
Excretion: Via urine (primarily as metabolites). Elimination half-life: 1-2.7 hours.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 667550, Dexketoprofen. Accessed Apr. 27, 2023.

Store below 30°C. Protect from light.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
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Keral 25 mg Oral Solution in Sachet (Menarini International O.L.S.A.). MHRA. Accessed 13/03/2023.

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Ketesse 25 mg Granules for Oral Solution (A. Menarini Singapore Pte. Ltd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. Accessed 13/03/2023.

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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 © 2024 MIMS. All rights reserved. Powered by
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