Menarini-Von Heyden


Concise Prescribing Info
Tramadol HCl 75 mg, dexketoprofen 25 mg
Symptomatic short term treatment of moderate to severe acute pain in adults.
Dosage/Direction for Use
Adult 1 tab. Additional doses can be taken as needed w/ a min of 8 hr interval. Max total daily dose: 3 tab/day. Elderly Initially 1 tab. Additional doses can be taken as needed w/ a min of 8 hr interval. Max total daily dose: 2 tab/day. Mild to moderate hepatic impairment Start therapy at reduced doses. Max total daily dose: 2 tab. Mild renal impairment (CrCl 60-89 mL/min) Initially 2 tab daily.
May be taken with or without food: Swallow w/ sufficient amount of fluid (eg, 1 glass of water). May be taken at least 30 min before meals for faster effect.
Hypersensitivity to dexketoprofen, tramadol, or any other NSAID. Pregnancy & lactation. Dexketoprofen: Patients experiencing asthma attacks, bronchospasm, acute rhinitis, nasal polyps, urticaria or angioneurotic edema as similar w/ acetylsalicylic acid or other NSAIDs. Known photoallergic or phototoxic reactions during treatment w/ ketoprofen or fibrates. Patients w/ history or active peptic ulcer/GI haemorrhage or any history of GI bleeding ulceration or perforation related to previous NSAIDs therapy; chronic dyspepsia; other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; severe heart failure; moderate to severe renal dysfunction (CrCl <59 mL/min); severely impaired hepatic function (Child-Pugh C); haemorrhagic diathesis & other coagulation disorders; severe dehydration. Tramadol HCl: Acute intoxication w/ alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products. Patients receiving MAOIs, or who have taken w/in the last 14 days. Patients w/ epilepsy; severe resp depression.
Special Precautions
May affect ability to drive & use machines. Contraindicated in pregnancy & lactation. Dexketoprofen: History of allergic conditions. Avoid use w/ other NSAIDs including cyclooxygenase-2 selective inhibitors. W/draw treatment when GI bleeding or ulceration occurs. Identify any history of oesophagitis, gastritis &/or peptic ulcer prior to initiation of treatment; monitor patients w/ GI symptoms or history of GI disease. History of GI disease (eg, ulcerative colitis, Crohn's disease); GI toxicity particularly in elderly. Consider combination therapy w/ protective agents eg, misoprostol or proton pump inhibitors. Concomitant use w/ drug that increase risk of ulceration & bleeding eg, oral corticosteroids, anticoagulants eg, warfarin, SSRIs or anti-platelets eg, acetylsalicylic acid. Renal impairment. Increased risk of nephrotoxicity in patients receiving diuretic therapy or those who could develop hypovolaemia; ensure adequate fluid intake during treatment to prevent dehydration. Hepatic impairment; discontinue therapy in case of increase in liver parameters, AST, ALT, SGOT & SGPT. Appropriate monitoring for patients w/ history of HTN &/or mild to moderate CHF, cardiac disease, in particular those w/ previous episodes of heart failure. Small increase in the risk of arterial thrombotic events eg, MI or stroke particularly at high doses & in long term use. Uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial disease, &/or cerebrovascular disease. Not recommended in patients who are receiving other therapy that interferes w/ haemostasis eg, warfarin or other coumarins or heparins. Risk of exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; discontinue at the 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Patients w/ congenital disorder of porphyrin metabolism; dehydration; directly after major surgery; w/ asthma combined w/ chronic rhinitis, chronic sinusitis &/or nasal polyposis; suffering from haematopoietic disorders, SLE or mixed connective tissue disease.  Avoid in case of varicella. Childn & adolescents, elderly. Tramadol HCl: Addicted patients, patients w/ head injury, shock, reduced level of consciousness of uncertain origin, disorders of the resp centre or function, increased intracranial pressure; patients sensitive to opiates. Patients w/ resp depression, or if concomitant CNS depressant drugs are being administered, or if the recommended dosage is significantly exceeded. Increased risk of convulsions when doses exceed the recommended upper daily dose limit (400 mg); patients taking drugs that lower seizure threshold. Epilepsy. Tolerance, psychic & physical addiction may develop, especially after long-term use. Tendency to drug abuse or dependence. Concomitant use w/ sedatives eg, benzodiazepines or related drugs that may result to sedation, resp depression, coma & death. CYP2D6 deficiency. Extreme caution in childn for post-op pain relief & closely monitor for symptoms of opioid toxicity including resp depression. Not recommended for use in childn in whom resp function might be compromised including neuromuscular disorders, severe cardiac or resp conditions, upper resp or lung infections, multiple trauma or extensive surgical procedures. Na content.
Adverse Reactions
Dizziness; nausea, vomiting. Dexketoprofen: Abdominal pain, diarrhoea, dyspepsia; Stevens Johnson syndrome, toxic epidermal necrolysis. Tramadol HCl: Headache, somnolence; constipation, dry mouth; hyperhidrosis; fatigue.
Drug Interactions
Dexketoprofen: May increase the risk of GI ulcers & bleeding w/ other NSAIDs (including cyclooxygenase-2 selective inhibitors) including high doses of salicylates (≥3 g/day). May enhance effects of anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparin. Increased risk of GI ulceration or bleeding w/ corticosteroids. Increase blood levels of lithium. Increase haematological toxicity of methotrexate. Increase toxic effects of hydantoines. May reduce effects of diuretics & antihypertensive drugs. Increased risk of bleeding w/ pentoxyfilline & thrombolytics. Increased risk of red cell line toxicity w/ zidovudine. Increase hypoglycaemic effect of sulfonylureas. May decrease antihypertensive effect of β-blockers. May enhance nephrotoxicity w/ cyclosporin & tacrolimus. Increased risk of GI bleeding w/ anti-platelets & SSRIs. May increase plasma conc w/ probenecid. May increase plasma glycoside conc of cardiac glycosides. May alter efficacy of mifepristone. Increase risk of developing convulsions w/ quinolones. Increase plasma urea nitrogen & creatinine w/ tenofovir. Increase GI toxicity w/ deferasirox. Decrease elimination of pemetrexed. Tramadol: Concomitant use w/ MAOIs. Elevated INR w/ coumarin derivatives eg, warfarin. Analgesic effect may be  reduced w/ mixed agonists/antagonists opioid receptors eg, buprenorphine, nalbuphine, pentazocine. May induce convulsions w/ SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), TCAs, antipsychotics & other seizure threshold-lowering drugs. eg, bupropion, mirtazapine, tetrahydrocannabinol. May cause serotonin toxicity w/ serotonergic drugs eg, SSRIs, SNRIs, MAOIs, TCAs, mirtazapine. Increased risk of sedation, resp depression, coma & death w/ benzodiazepines. May potentiate CNS effects w/ alcohol & other central depressants. Reduced analgesic effect w/ carbamazepine. Increased requirement in post-op pain w/ ondansetron.
ATC Classification
N02AJ14 - tramadol and dexketoprofen ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Skudexa FC tab
1 × 15's
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