Ketesse

FC tab: Symptomatic treatment of mild to moderate pain eg, dysmenorrhoea, musculoskeletal & dental pain. Soln for inj: Symptomatic treatment of moderate to severe acute pain, when oral administration is not appropriate eg, post-op, renal colic & low back pain.

FC tab Adult 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max daily dose: 75 mg. Elderly, mild to moderate hepatic & mild renal impairment (CrCl 60-89 mL/min) Total daily dose: 50 mg. Soln for inj Administer as slow IM inj, slow IV infusion over 10-30 min, or slow IV bolus over no <15 sec. Adult 50 mg every 8-12 hr, may be repeated 6 hr apart. Max daily dose: 150 mg. Elderly w/ mild renal impairment, mild to moderate hepatic impairment (Child-Pugh score 5-9), mild renal impairment (CrCl 60-89 mL/min) Total daily dose: 50 mg.

FC tab: Should be taken on an empty stomach. Take at least 30 min before meals. Swallow whole w/ sufficient amount of fluid (eg, a glass of water).

Hypersensitivity to dexketoprofen trometamol or any other NSAIDs. Photoallergy or phototoxic reactions during treatment w/ ketoprofen or fibrates. Patients in whom ASA or other NSAIDs precipitate attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic oedema. Patients w/ history of GI bleeding or perforation, related to previous NSAID therapy; active peptic ulcer/GI haemorrhage or history of GI bleeding, ulceration or perforation; chronic dyspepsia; other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; severe heart failure; haemorrhagic diathesis & other coagulation disorders; severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake); dengue fever. Moderate to severe renal impairment (CrCl ≤59 mL/min). Severe hepatic impairment (Child-Pugh score 10-15). Pregnancy (3rd trimester) & lactation. Soln for inj: Neuraxial (intrathecal or epidural) administration.

Severe acute hypersensitivity reactions (anaphylactic shock); serious skin reactions eg, exfoliative dermatitis, SJS & TEN. Discontinue treatment at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; in case of increased liver parameters eg, SGOT & SGPT. W/draw treatment if GI bleeding or ulceration occurs. Avoid use in case of varicella; if suspected w/ dengue fever or platelet level abnormalities from other causes. History of allergic conditions; ulcer; oesophagitis, gastritis &/or peptic ulcer; GI disease (ulcerative colitis, Crohn's disease) or toxicity; HTN &/or mild to moderate CHF; cardiac disease. Glomerular & interstitial nephritis, renal papillary necrosis, nephrotic syndrome & acute renal failure. Increased risk of arterial thrombotic events eg, MI or stroke w/ high doses or long-term use. Patients receiving diuretics or those who develop hypovolaemia; w/ uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial &/or cerebrovascular disease; risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking); congenital porphyrin metabolism disorder (eg, acute intermittent porphyria), dehydration, directly after major surgery; asthma combined w/ chronic rhinitis & sinusitis, &/or nasal polyposis; suffering from haematopoietic disorders, SLE or mixed connective tissue disease. Monitor for digestive disturbances, especially GI bleeding in patients w/ GI symptoms or history of GI disease; patients receiving therapy that interferes w/ haemostasis eg, warfarin or other coumarins or heparins. Consider therapy w/ protective agents eg, misoprostol or PPIs in patients w/ GI disease or those requiring low dose of ASA or other drugs increasing GI risk. Ensure adequate fluid intake. Regularly check hepatic & renal function, blood count. Monitor symptoms of underlying infections. Avoid concomitant use w/ other NSAIDs including COX-2 selective inhibitors. Concomitant use w/ oral corticosteroids, anticoagulants eg, warfarin, SSRIs or anti-platelet agents eg, ASA. May impair ability to drive & use machines. Renal & hepatic impairment. May impair female fertility & not recommended in women attempting to conceive. 1st & 2nd trimester of pregnancy. Childn & adolescents. Elderly. Soln for inj: Contains ethanol. Patients suffering from alcoholism; w/ epilepsy.

Nausea &/or vomiting. SJS, TEN (Lyell's syndrome). FC tab: Abdominal pain, diarrhoea, dyspepsia. Soln for inj: Inj site pain & reaction including inflammation, bruising or haemorrhage.

Increased risk of GI ulcers & bleeding w/ other NSAIDs including COX-2 selective inhibitors & high-dose salicylates (≥3 g daily); corticosteroids. Enhanced effects of anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparins. Increased blood lithium levels. Increased haematological toxicity of MTX. Increased toxic effects of hydantoins & sulphonamides. Reduced effect of diuretics, ACE inhibitors, AIIA & antibacterial aminoglycosides. Increased risk of bleeding w/ pentoxifylline; thrombolytics. Risk of increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. Decreased antihypertensive effect of β-blockers. Enhanced nephrotoxicity of cyclosporin & tacrolimus. Increased risk of GI bleeding w/ antiplatelet agents & SSRIs. Increased plasma conc w/ probenecid. Increased plasma cardiac glycoside conc. Altered efficacy of mifepristone. Increased risk of developing convulsions w/ quinolones. Increased plasma urea nitrogen & creatinine w/ tenofovir. Increased risk of GI toxicity w/ deferasirox. Decreased pemetrexed elimination.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.

D