Skudexa

Tramadol HCl 75 mg, dexketoprofen 25 mg

Symptomatic short-term treatment of moderate to severe acute pain in adults whose pain is considered to require a combination of tramadol & dexketoprofen.

Adult 1 tab. Additional doses can be taken as needed w/ a min of 8 hr interval. Max: 3 tab daily. Elderly Initially 1 tab, additional doses can be taken as needed w/ a min of 8 hr interval. Max: 2 tab daily. Patient w/ mild to moderate hepatic impairment Start therapy at reduced number of doses. Max: 2 tab daily. Patient w/ mild renal impairment (CrCl 60-89 mL/min) 2 tab daily.

Should be taken on an empty stomach: Take 30 min before meals.

Hypersensitivity to tramadol, dexketoprofen, or NSAIDs. Post-op management in childn <18 yr following tonsillectomy &/or adenoidectomy. Pregnancy & lactation. Childn <12 yr. Tramadol HCl: Patients w/ epilepsy not adequately controlled by treatment. Severe resp depression. Acute intoxication w/ alcohol, hypnotics, analgesics, opioids or psychotropics. Concomitant use w/ MAOIs during therapy or w/in the last 14 days. Dexketoprofen: Patients in whom substances w/ a similar action (eg, ASA, or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema. Known photoallergic or phototoxic reactions during treatment w/ ketoprofen or fibrates. Patients w/ history of GI bleeding or perforation, related to previous NSAIDs therapy; active peptic ulcer/GI hemorrhage or any history of GI bleeding ulceration or perforation; chronic dyspepsia; other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; severe heart failure; haemorrhagic diathesis & other coagulation disorders; severe dehydration; treatment of peri-op pain in CABG surgery. Severe hepatic impairment (Child-Pugh C). Moderate to severe renal impairment (CrCl ≤59 mL/min).

Intended for short-term use only. Treatment must be strictly limited to the symptomatic period & in any case not >5 days. May impair ability to drive & use machines. Patients w/ hepatic or renal impairment. Should not be used in childn & adolescents. Elderly. Tramadol HCl: Use w/ particular caution in patients w/ addiction, head injury, shock, reduced level of consciousness of uncertain origin, resp centre or function disorders, increased intracranial pressure; opiate sensitivity; resp depression. Risk of convulsions; seizures; serotonin syndrome; sleep-related breathing disorders; reversible adrenal insufficiency. Tolerance, psychic & physical addiction may develop especially after long-term use. Poor CYP2D6 metaboliser or patient completely lacking CYP2D6; ultra-rapid CYP2D6 metaboliser. Concomitant use w/ CNS depressant drugs; sedatives eg, benzodiazepines or related drugs. Dexketoprofen: Discontinue at the 1st signs of severe hypersensitivity reactions. Risk of GI bleeding, ulceration or perforation; increased AST & ALT, serious liver injury (in rare cases); renal function deterioration, fluid retention & oedema; arterial thrombotic events; serious skin reactions (very rarely). Can inhibit platelet aggregation & prolong bleeding time. Patients w/ history of allergic reactions; CV diseases or risk factors for CV disease; congenital disorder of porphyrin metabolism (eg, acute intermittent porphyria); dehydration; directly after major surgery; patients w/ asthma combined w/ chronic rhinitis, chronic sinusitis, &/or nasal polyposis; haematopoietic disorders, SLE or mixed connective tissue disease. Avoid use in patients w/ varicella infection. Can mask symptoms of infection. May impair female fertility.

Dizziness; nausea, vomiting. Tramadol HCl: Headache, somnolence; constipation, dry mouth; hyperhidrosis; fatigue. Dexketoprofen: Abdominal pain, diarrhoea, dyspepsia.

Tramadol HCl: Life-threatening interactions on CNS, resp & CV function w/ MAOIs. Elevated INR w/ coumarin derivatives (eg, warfarin). Reduced analgesic effect of pure agonist in mixed agonists/antagonists opioid receptors (eg, buprenorphine, nalbuphine, pentazocine). Risk of convulsions w/ SSRIs, SNRIs, TCAs, antipsychotics & other seizure threshold-lowering medicinal product. Serotonin syndrome w/ serotonergic drugs. Increased risk of sedation, resp depression, coma & death w/ sedatives eg, benzodiazepines or related drugs. Potentiated CNS effects w/ other centrally depressants or alcohol. Reduced analgesic effect & shortened duration of action w/ carbamazepine (enzyme inducer). Increased dosing requirement w/ ondansetron. Possible inhibition of metabolism w/ CYP3A4 inhibitors (eg, ketoconazole, erythromycin). Dexketoprofen: Increased risk of GI ulcers & bleeding w/ other NSAIDs (including COX-2 inhibitors) including high doses of salicylates; corticosteroids. Enhanced effects of anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparins; pentoxyfilline; thombolytics. Increased blood levels of lithium. Increased haematological toxicity of methotrexate. Increased toxic effects of hydantoins (including phenytoin) & sulphonamides. Reduced effects of diuretics & antihypertensives. Risk of further renal deterioration w/ ACE inhibitors, AIIA or antibacterial aminoglycosides in patients w/ compromised renal function. Hyperkalaemia w/ K-sparing diuretics. Risk of increased red cell line toxicity w/ zidovudine. Increased hypoglycaemic effect of sulfonylureas. Decreased effects of β-blockers. Enhanced nephrotoxicity of cyclosporin & tacrolimus. Increased risk of GI bleeding w/ antiplatelet agents & SSRIs. Increased plasma conc w/ probenecid. Increased plasma conc of glycosides. May alter efficacy of mifepristone. Increased plasma urea nitrogen & creatinine w/ tenofovir. Increased risk of GI toxicity w/ deferasirox. Decreased elimination of pemetrexed.

Analgesics (Opioid) / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

N02AJ14 - tramadol and dexketoprofen ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

P₁S₁S₃