NFEN-IM

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, can be repeated 6 hr apart if necessary. Administer either by slow IM inj, by slow IV infusion over 10-30 min, or by slow IV bolus over no <15 sec. Total daily dose should not exceed 150 mg. Patient w/ mild to moderate hepatic (Child-Pugh score 5-9) impairment or mild renal (CrCl 50-80 mL/min) impairment Reduce dose to 50 mg total daily dose.

Hypersensitivity. Patients in whom substances w/ a similar action (eg, ASA & other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema; w/ active or suspected peptic ulcer/haemorrhage or history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding) or chronic dyspepsia; who have GI bleeding or other active bleeding or bleeding disorders; w/ history of GI bleeding or perforation, related to previous NSAIDs therapy; Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure; haemorrhagic diathesis & other coagulation disorders; moderate to severe renal impairment (CrCl <50 mL/min); severe hepatic impairment (Child-Pugh score 10-15). Neuraxial (intrathecal or epidural) administration. 3rd trimester of pregnancy & lactation.

Intended for short-term use; treatment must be limited to acute symptomatic period. Discontinue use at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. W/draw treatment when GI bleeding or ulceration occurs. Risk of GI bleeding, ulceration or perforation is higher w/ increased doses, in patients w/ history of ulcer, particularly if complicated w/ haemorrhage or perforation, & in the elderly. Monitor for digestive disturbances, especially GI bleeding, in patients w/ GI symptoms or history of GI disease. Can inhibit platelet aggregation & prolong bleeding time; increase plasma urea nitrogen & creatinine; cause transient small increases in some liver parameters, & significant increases in SGOT & SGPT; mask symptoms of infectious diseases. Associated w/ adverse effects on renal system which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome & acute renal failure. Discontinue therapy in case of relevant increase in liver parameters, SGOT & SGPT. Appropriate monitoring & advice are required for patients w/ history of HTN &/or mild to moderate CHF. May be associated w/ small increased risk of arterial thrombotic events (eg, MI or stroke) particularly at high doses & in long-term treatment. Caution in patients w/ history of allergic conditions; history of GI disease (ulcerative colitis or Crohn's disease); uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease; risk factors for CV disease eg, HTN, hyperlipidaemia, DM, smoking; hepatic &/or renal impairment; history of HTN &/or heart failure; patients receiving diuretic therapy or who could develop hypovolaemia; patients w/ history of cardiac disease, particularly previous episodes of heart failure; haematopoietic disorders, SLE or mixed connective tissue disease. Avoid concomitant use w/ other NSAIDs including COX-2 selective inhibitors. Caution in concomitant use w/ medications which could increase risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or antiplatelet agents (eg, aspirin); other coumarins or heparins. Contains ethanol; harmful to patients suffering from alcoholism. Minor or moderate influence on the ability to drive & use machines. May impair female fertility & is not recommended in women attempting to conceive. Consider w/drawal of treatment in women w/ difficulties conceiving or who are undergoing investigation of infertility. Not to be used during 1st & 2nd trimester of pregnancy unless clearly necessary. Not to be used in childn & adolescents. Increased frequency of adverse reactions especially GI bleeding & perforation in the elderly.

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

Risk of GI ulcers & bleeding may be increased w/ other NSAIDs, including high doses of salicylates (≥3 g/day). May enhance 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. May increase toxic effects of hydantoins & sulphonamides. May reduce effect of diuretics & other antihypertensives. May result in further deterioration of renal function w/ ACE inhibitors, AIIA or aminoglycosides in some patients w/ compromised renal function (eg, dehydrated patients or elderly w/ compromised renal function). Increased risk of bleeding w/ pentoxifylline; thrombolytics. Risk of increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. May decrease antihypertensive effect of β-blockers. May enhance nephrotoxicity w/ cyclosporin & tacrolimus. Increased risk of GI bleeding w/ antiplatelets & SSRIs. Plasma conc may be increased w/ probenecid. May increase plasma glycoside conc. May alter efficacy of mifepristone. Increased risk of developing convulsions w/ high doses of quinolones.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

Rx