HIGHLIGHT
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, musculoskeletal pain, dysmenorrhoea, dental pain.
Dosage/Direction for Use
Adult 12.5 mg every 4-6 hr or 25 mg every 8 hr. Total daily dose: Not to exceed 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. Patients in whom ASA or other NSAIDs precipitate attacks of asthma, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic oedema. History of GI bleeding or perforation, related to previous NSAIDs therapy. Active peptic ulcer/GI haemorrhage or history of GI bleeding, ulceration or perforation; chronic dyspepsia; who have 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). Known photoallergic or phototoxic reactions during treatment w/ ketoprofen or fibrates. Moderate to severe renal dysfunction (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. History of allergic conditions; ulcer; GI toxicity; cardiac disease. Patients w/ uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial &/or cerebrovascular disease; risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking); asthma combined w/ chronic rhinitis & sinusitis, &/or nasal polyposis. Patients suffering from haematopoietic disorders, SLE or mixed connective tissue disease. Patients requiring concomitant low dose ASA; receiving diuretic therapy. Avoid use in case of varicella; if suspected w/ dengue fever. Masked symptoms of infectious diseases. Monitor for digestive disturbances, especially GI bleeding in patients w/ GI symptoms or history of GI disease. 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 haemostasia eg, warfarin or other coumarins or heparins. Combination therapy w/ protective agents eg, misoprostol or PPIs. 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 impair female fertility & not recommended in women attempting to conceive. Not to be given during 1st & 2nd trimester of pregnancy. 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 high-dose salicylates (≥3 g daily). Enhanced effects of oral anticoagulants. Increased risk of haemorrhage w/ heparins. Increased risk of GI ulceration or bleeding w/ corticosteroids. Increased blood lithium levels. Increased haematological toxicity of MTX at high dose (≥15 mg/wk). Increased toxic effects of hydantoins & sulphonamides. Reduced effect of diuretics, ACE inhibitors, antibacterial aminoglycosides & angiotensin II receptor antagonists.. 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 risk of GI bleeding w/ antiplatelet agents & SSRIs. Increased plasma conc by probenecid. Increased plasma cardiac glycosides conc. Altered efficacy of mifepristone. Increased risk of 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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