Dalyx

Dexketoprofen trometamol

Symptomatic treatment of acute pain of moderate to severe intensity when oral administration is not appropriate eg, post-op pain, renal colic, & low back pain.

50 mg every 8-12 hr. May be repeated at 6 hr apart. Max: 150 mg daily. Moderate to severe post-op pain May be used in combination w/ opioid analgesics at the same recommended dose if indicated. Mild renal impairment (CrCl 50-80 mL/min) 50 mg daily. Mild to moderate hepatic impairment (Child-Pugh score 5-9) 50 mg daily. IM Administer 2 mL by slow inj deep into the muscle. IV infusion Administer infusion at 10-30 min. IV bolus Administer 2 mL in slow IV bolus not <15 sec.

Hypersensitivity to dexketoprofen trometamol, or to any other NSAID. Patients in whom substances w/ a similar action (eg, ASA & other NSAIDs) precipitate asthma attacks, bronchospasm, acute rhinitis, or nasal polyps, urticaria or angioneurotic oedema. History of GI bleeding or perforation related to previous NSAIDs therapy. Active or suspected peptic ulcer/GI haemorrhage or history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding) or chronic dyspepsia. Other active bleedings or bleeding disorders, Crohn's disease or ulcerative colitis, severe heart failure, history of bronchial asthma, haemorrhagic diathesis & other coagulation disorders, severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake). Neuraxial (intrathecal or epidural) administration due to its ethanol content. Moderate to severe renal dysfunction (CrCl <50 mL/min) & severely impaired hepatic function (Child-Pugh score 10-15). Pregnancy (3rd trimester) & lactation.

History of allergic conditions. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Avoid concomitant use w/ NSAIDs including COX-2 selective inhibitors. W/draw treatment when GI bleeding or ulceration occurs. History of ulcerative colitis or Crohn's disease. Monitor for digestive disturbances especially GI bleeding in patients w/ GI symptoms or history of GI disease. Consider combination therapy w/ protective agents (eg, misoprostol or PPIs) for patients requiring concomitant low dose ASA, or other drugs likely to increase GI risk. Concomitant use w/ medications which could increase risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or antiplatelet agents (eg, ASA); other coumarins or heparins. History of HTN &/or mild to moderate CHF. Risk of arterial thrombotic events particularly at high doses & in long term treatment. Patients w/ uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease; risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking). Increased risk of nephrotoxicity in patients receiving diuretic therapy or those who could develop hypovolaemia. Alcoholism. May affect ability to drive & use machines. Renal or hepatic impairment. May impair female fertility & is not recommended in women attempting to conceive. Pregnancy (2nd trimester). Elderly. Childn & adolescents.

Nausea, vomiting; inj site pain & reaction including inflammation, bruising or haemorrhage.

Increased risk of GI ulcers & bleeding w/ other NSAIDs including COX-2 selective inhibitors & high doses of salicylates (≥3 g/day); corticosteroids. May enhance the effects of anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparins. Increase blood lithium levels. Increased haematological toxicity of MTX. May reduce the effect of diuretics, ACE inhibitors, aminoglycosides & AIIA & may result in further deterioration of renal function. Increased risk of bleeding w/ pentoxyfylline & thrombolytics. Increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. Decrease antihypertensive effect of β-blockers. Enhanced nephrotoxicity w/ cyclosporin & tacrolimus. Increased risk of GI bleeding w/ antiplatelet agents & SSRIs. Increased plasma conc w/ probenecid. Increase plasma glycoside conc w/ cardiac glycosides. May alter the efficacy of mifepristone. Increased risk of developing convulsions w/ quinolones.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

Rx