A. Menarini


Zuellig Pharma
Concise Prescribing Info
Dexketoprofen trometamol
FC tab/granules for oral soln: Symptomatic treatment of mild to moderate pain eg, musculoskeletal pain, dysmenorrhoea, dental pain. Soln for inj: Symptomatic treatment of acute moderate to severe pain when PO is inappropriate eg, post-op & low back pain, renal colic.
Dosage/Direction for Use
FC tab Adult 12.5 mg every 4-6 hr. Total daily dose: Not to exceed 75 mg. Elderly, mild to moderate hepatic & mild renal impairment Total daily dose: 50 mg. Granules for oral soln Adult 25 mg every 8 hr. Total daily dose: Not to exceed 75 mg. Elderly, mild to moderate hepatic & mild renal impairment Total daily dose: 50 mg. Soln for inj Adult 50 mg every 8-12 hr, may be repeated 6 hr apart. Total daily dose: 150 mg. Elderly, mild to moderate hepatic & mild renal impairment Total daily dose: 50 mg.
Should be taken on an empty stomach: Take 30 min before meals, especially for quick relief of acute pain.
Hypersensitivity to dexketoprofen or any other NSAID. Patients in whom aspirin or other NSAIDs precipitate attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic oedema. Active or suspected GI ulcer or history of GI ulcer or chronic dyspepsia, GI bleeding or other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure. Haemorrhagic diathesis & other coagulation disorders or patients receiving anticoagulant therapy. Moderate to severe renal dysfunction. Severe hepatic impairment. Pregnancy & lactation. Granules for oral soln/soln for inj: Photoallergic or phototoxic reactions during ketoprofen or fibrates treatment, chronic dyspepsia, severe dehydration. Soln for inj: Neuraxial (intrathecal or epidural) administration.
Special Precautions
Hypersensitivity. Discontinue use if GI bleeding or ulceration occurs. GI symptoms & history of GI disease; risk factors associated w/ PUD eg, alcoholism, smoking. Cardiac impairment & other conditions predisposing to fluid retention; hematopoietic disorders, SLE or mixed connective tissue disease. Masked symptoms of infectious disease. Diuretic therapy & risk of developing hypovolaemia. Not intended for long-term use. Concomitant use w/ corticosteroids. Renal or hepatic impairment. Not to be used during pregnancy & lactation. Not to be used in childn. Elderly or debilitated patients. Granules for oral soln: Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Soln for inj: Alcoholism.
Adverse Reactions
Nausea &/or vomiting. FC tab/granules for oral soln: Abdominal pain, diarrhoea, dyspepsia. Soln for inj: Inj site pain & reaction ie, inflammation, bruising or haemorrhage.
Drug Interactions
Increased risk of GI ulcers & bleeding w/ other NSAIDs including high-dose salicylates (≥3 g daily). Increased haemorrhagic effect of oral anticoagulants. Increased risk of haemorrhage w/ heparins. Increased blood lithium levels. Increased haematological toxicity of methotrexate at high dose (≥15 mg wkly). Increased toxic effects of hydantoins & sulphonamides. Granules for oral soln/soln for inj: Reduced effect of diuretics, ACE inhibitors, antibacterial aminoglycosides & angiotensin II receptor antagonists. Hyperkalaemia w/ K-sparing diuretics. Increased risk of bleeding w/ pentoxifylline, thrombolytics. Risk of increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. Decreased β-blockers antihypertensive effect. Enhanced nephrotoxicity of cyclosporin & tacrolimus. Increased plasma conc by probenecid. Increased plasma cardiac glycosides conc. Altered efficacy of mifepristone. Increased risk of convulsions w/ quinolones.
ATC Classification
M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Ketesse FC tab 25 mg
Ketesse granules for oral soln 25 mg
10 × 1's;2 × 1's;20 × 1's;4 × 1's
Ketesse soln for inj 50 mg/2 mL
10 × 1's;20 × 1's
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