A. Menarini


Zuellig Pharma
Concise Prescribing Info
Dexketoprofen 25 mg, tramadol HCl 75 mg
Symptomatic short-term treatment of moderate to severe acute pain in adult patients.
Dosage/Direction for Use
Adult 1 tab daily for not >5 days, additional doses can be taken as needed w/ min of 8 hr interval. Total dose: Not to exceed 3 tab daily. Elderly Initially 1 tab daily, additional doses can be taken as needed w/ min of 8 hr interval. Total dose: Not to exceed 2 tab daily. Mild to moderate hepatic dysfunction Start therapy at reduced doses. Total dose: Not to exceed 2 tab daily. Mild renal impairment (CrCl 60-89 mL/min) Total dose: Reduce to 2 tab daily.
Should be taken on an empty stomach: Take at least 30 min before meals for faster effect. Swallow w/ sufficient amount of fluid.
Hypersensitivity to dexketoprofen, tramadol or any other NSAID. Pregnancy & lactation. Dexketoprofen: Precipitated attacks of asthma, bronchospasm, acute rhinitis, causing nasal polyps, urticaria or angioneurotic oedema w/ acetylsalicylic acid or other NSAIDs. Photoallergic or phototoxic reactions w/ ketoprofen or fibrates. 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; haemorrhagic diathesis & other coagulation disorders; severe dehydration. Moderate to severe renal dysfunction (CrCl ≤59 mL/min); severe hepatic impairment (Child Pugh C). Tramadol HCl: Patients w/ epilepsy not adequately controlled by treatment. Severe resp depression. Acute intoxication w/ alcohol, hypnotics, analgesics, opioids or psychotropic medicinal products. Concomitant use w/ MAOIs during therapy or discontinuation w/in last 14 days. Post-op pain in childn <18 yr after removal of tonsils &/or adenoids. Adolescents 12-18 yr w/ obesity or conditions increasing serious breathing problems eg, obstructive sleep apnea or severe lung disease.
Special Precautions
May affect ability to drive & use machines. Not to be used in severe hepatic & moderate to severe renal dysfunction. May impair female fertility. Not recommended in women of childbearing potential. Not to be used during pregnancy & lactation. Not to be used in childn & adolescents. Elderly >75 yr. Dexketoprofen: Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Avoid use in patients w/ varicella infection. History of allergic conditions. Increased risk of GI bleeding, ulceration or perforation, history of GI disease; increased risk of nephrotoxicity; history of cardiac disease, uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial & cerebrovascular disease; congenital disorder of porphyrin metabolism eg, acute intermittent porphyria; dehydration; directly after major surgery; asthma in combination w/ chronic rhinitis, sinusitis &/or nasal polyposis; haematopoietic disorders, SLE or mixed connective tissue disease. May mask symptoms of infectious diseases. Ensure adequate fluid intake during therapy. Avoid concomitant use w/ other NSAIDs including COX-2 selective inhibitors. Concomitant use w/ oral corticosteroids, anticoagulants, SSRIs or antiplatelets; diuretics. Tramadol HCl: Addicted patients, patients w/ head injury, shock, reduced level of consciousness of uncertain origin, resp centre or function disorders or increased intracranial pressure; opiate sensitivity; risk for resp depression including patients w/ substantially decreased resp reserve, hypoxia, hypercapnia or pre-existing resp depression. Increased risk of convulsions, seizures. Tolerance, psychic & physical addiction may develop during long-term use. CYP2D6 ultra rapid metabolisers. Concomitant use of sedatives eg, benzodiazepines or related drugs. Not recommended in childn w/ compromised resp function. Post-op pain relief in childn.
Adverse Reactions
Dizziness; nausea, vomiting. Dexketoprofen: Abdominal pain, diarrhoea, dyspepsia. Tramadol HCl: Headache, somnolence; constipation, dry mouth; hyperhidrosis; fatigue.
Drug Interactions
Dexketoprofen: Increased risk of GI ulceration & bleeding w/ other NSAIDs, corticosteroids, antiplatelets, SSRIs. Enhanced effects of anticoagulants. Increased risk of haemorrhage w/ heparins. Increased blood lithium levels. Increased haematological toxicity of methotrexate. Increased toxic effects of hydantoins, sulphonamides. Reduced effect of diuretics & antihypertensives. Hyperkalaemia w/ K-sparing diuretics. Increased risk of bleeding w/ pentoxifylline, thrombolytics. Risk of increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. Decrease antihypertensive effect of β-blockers. Enhanced nephrotoxicity w/ cyclosporin, tacrolimus. Increased plasma conc w/ probenecid. Increase plasma glycoside 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. Tramadol HCl: Not to be used w/ MAOIs or discontinuation w/in last 14 days. Elevated INR w/ coumarin derivatives. Reduced analgesic effect w/ mixed agonists/antagonists opioid receptors eg, buprenorphine, nalbuphine, pentazocine. Induced convulsions w/ SSRIs, SNRIs, TCAs, antipsychotics, other seizure threshold-lowering medicinal products. Serotonin toxicity w/ serotonergic drugs. Additive CNS depressant effect w/ sedatives. Potentiated CNS effects w/ other centrally-depressant medicinal products or alcohol. Reduced analgesic effect w/ carbamazepine. Increased dosing requirement w/ ondansetron. Inhibited metabolism w/ CYP3A4 inhibitors eg, ketoconazole, erythromycin.
ATC Classification
N02AJ14 - tramadol and dexketoprofen ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
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