Ketesse

Ketesse

dexketoprofen

Manufacturer:

A.Menarini

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Dexketoprofen trometamol
Indications/Uses
Symptomatic treatment of mild to moderate pain eg, dysmenorrhoea, musculoskeletal & dental pain.
Dosage/Direction for Use
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.
Administration
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).
Contraindications
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). Moderate to severe renal impairment (CrCl ≤59 mL/min). Severe hepatic impairment (Child-Pugh score 10-15). 3rd trimester of pregnancy. Lactation.
Special Precautions
Discontinue if GI bleeding or ulceration occurs; at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; in case of increased SGOT & SGPT. History of allergic conditions; ulcer; oesophagitis, gastritis &/or peptic ulcer; GI disease or toxicity; HTN &/or mild to moderate heart failure; cardiac disease. Glomerular & interstitial nephritis, renal papillary necrosis, nephrotic syndrome & acute renal failure. 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, dehydration, directly after major surgery; asthma combined w/ chronic rhinitis & sinusitis, &/or nasal polyposis. Patients 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. 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. Avoid in concomitant use w/ other NSAIDs including COX-2 selective inhibitors. Not recommended w/ other therapy interfering haemostasis eg, warfarin or other coumarins or heparins. Concomitant use w/ oral corticosteroids, anticoagulants eg, warfarin, SSRIs or anti-platelet agents eg, ASA. May affect ability to drive & use machines. Renal & hepatic impairment. May expose fetus to cardiopulmonary toxicity & renal impairment. May impair female fertility & not recommended in women attempting to conceive. Contraindicated during pregnancy (3rd trimester) & lactation. Childn & adolescents. Elderly.
Adverse Reactions
Nausea &/or vomiting, abdominal pain, diarrhoea, dyspepsia. SJS, TEN (Lyell's syndrome).
Drug Interactions
Increased risk of GI ulcers & bleeding w/ other NSAIDs including COX-2 selective inhibitors & high-dose salicylates (≥3 g daily). Enhanced effects of anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparins. Increased risk of GI ulceration or bleeding w/ corticosteroids. 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 glycosides 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.
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.
Presentation/Packing
Form
Ketesse FC tab 25 mg
Packing/Price
2 × 10's
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