Dexketoprofen

Dexketoprofen is used to treat short-term painful conditions such as muscular sprains and strains, period (menstrual) pain, and toothache.

NSAIDs

Dexketoprofen is the S(+)-enantiomer of Ketoprofen and is responsible for the analgesic and anti-inflammatory activity of Ketoprofen. The inactive R(-)-enantiomer does not contribute to the therapeutic properties of Ketoprofen but adds to the metabolic load. Dexketoprofen has been formulated as a trometamol salt. Its high solubility in water means a rapid absorption through the gut wall which results in a more rapid onset of action than Ketoprofen. Peak plasma concentrations are attained more quickly than other widely used analgesics with an onset of action of 30 minutes. Dexketoprofen trometamol, given as a tablet, is rapidly absorbed, with a time to maximum plasma concentration (tmax) of between 0.25 and 0.75 hours, whereas the tmax for the S-enantiomer after the racemic drug, administered as tablets or capsules prepared with the free acid, is between 0.5 and 3 hours. Peak plasma concentrations of 1.4 and 3.1 mg/L are reached after administration of Dexketoprofen trometamol 12.5 and 25 mg, respectively. From 70 to 80% of the administered dose is recovered in the urine during the first 12 hours, mainly as the acyl-glucuronoconjugated parent drug. No R(-)-Ketoprofen is found in the urine after administration of Dexketoprofen [S(+)-Ketoprofen], confirming the absence of bioinversion of the S(+)-enantiomer in humans. The anti-inflammatory potency of Dexketoprofen was always equivalent to that demonstrated by twice the dose of Ketoprofen.

Short-term treatment of mild to moderate pain including dysmenorrhoea BY MOUTH Adult: 12.5 mg every 4-6 hours, alternatively 25 mg every 8 hours; maximum 75 mg per day Elderly: 12.5 mg every 4-6 hours, alternatively 25 mg every 8 hours, initial max. 50 mg; maximum 75 mg daily

Any of the following drugs cannot be used at the same time while taking Dexketoprofen. Other non-steroidal anti-inflammatory drugs, anticoagulant medicines; lithium; methotrexate; hydantoins (a type of medicine used for epilepsy) or some antibiotics of sulphonamide type (e.g. sulfamethoxazole); medications used to treat high blood pressure (ACE inhibitors, diuretics and beta-blockers); pentoxifylline; zidovudine; cyclosporine or tacrolimus; some oral medicines for diabetes (sulphonylureas); thrombolytic medicines; probenecid; cardiac glycosides; mifepristone; and quinolone antibiotics.

CONTRA-INDICATIONS Active gastro-intestinal bleeding . active gastro-intestinal ulceration . history of gastrointestinal bleeding related to previous NSAID therapy . history of gastro-intestinal perforation related to previous NSAID therapy . history of recurrent gastro-intestinal haemorrhage (two or more distinct episodes) . history of recurrent gastro-intestinal ulceration (two or more distinct episodes) . severe heart failure CAUTIONS Allergic disorders . cardiac impairment (NSAIDs may impair renal function) . cerebrovascular disease . coagulation defects . connective-tissue disorders . Crohn’s disease (may be exacerbated) . elderly (risk of serious sideeffects and fatalities) . heart failure . ischaemic heart disease . peripheral arterial disease . risk factors for cardiovascular events . ulcerative colitis (may be exacerbated) . uncontrolled hypertension

Rare Alveolitis . aseptic meningitis (patients with connective-tissue disorders such as systemic lupus erythematosus may be especially susceptible) . hepatic damage . interstitial fibrosis associated with NSAIDs can lead to renal failure . pancreatitis . papillary necrosis associated with NSAIDs can lead to renal failure . pulmonary eosinophilia . Stevens-Johnson syndrome . toxic epidermal necrolysis . visual disturbances Frequency not known Angioedema . blood disorders . bronchospasm . colitis (induction of or exacerbation of) . Crohn’s disease (induction of or exacerbation of) . depression . diarrhoea . dizziness . drowsiness . fluid retention (rarely precipitating congestive heart failure) . gastro-intestinal bleeding . gastro-intestinal discomfort . gastro-intestinal disturbances . gastro-intestinal ulceration . haematuria . headache . hearing disturbances . hypersensitivity reactions . insomnia . nausea . nervousness . photosensitivity . raised blood pressure . rashes . renal failure (especially in patients with preexisting renal impairment) . tinnitus . vertigo

PREGNANCY Avoid unless the potential benefit outweighs the risk. Avoid during the third trimester (risk of closure of fetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of the newborn); onset of labour may be delayed and duration may be increased. BREAST FEEDING Use with caution during breast-feeding. Manufacturer advises avoid?no information available.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.