Skudexa

Skudexa

tramadol + dexketoprofen

Manufacturer:

A. Menarini

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Tramadol 75 mg, dexketoprofen 25 mg
Indications/Uses
Symptomatic short term treatment of moderate to severe acute pain in adult.
Dosage/Direction for Use
Adult 1 tab. Additional doses can be taken as needed in 8 hr interval. Max: 3 tab/day. Elderly Initially 1 tab, additional doses can be taken as needed every 8 hr interval. Max: 2 tab daily.
Administration
Should be taken on an empty stomach: Take 30 min before meals for faster effect.
Contraindications
Hypersensitivity to dexketoprofen, tramadol or to any other NDSAID. Pregnancy & lactation. Dexketoprofen: Patients in whom substances w/ similar action (eg, acetylsalicylic acid or other NSAIDs) precipitate asthma attacks, bronchospasm, acute rhinitis or nasal polyps, urticaria or angioneurotic edema; photoallergic or phototoxic reactions w/ ketoprofen or fibrates; active peptic ulcer/GI haemorrhage or any history of GI bleeding ulceration of perforation; GI bleeding of 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; haemorrhagic diathesis or other coagulation disorders; severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). Tramadol: Acute intoxication w/ alcohol, hypnotics, analgesics, opioids or psychotropics; patients receiving MAOIs or who have taken w/in 14 days; inadequately controlled epilepsy; severe resp depression.
Special Precautions
May affect ability to drive or operate machinery. Childn & adolescents. Dexketoprofen: History of allergic conditions. Avoid concomitant use w/ other NSAIDs including COX-2 selective inhibitors. W/draw treatment if GI bleeding or ulceration occurs; risk of GI bleeding, ulceration or perforation; history of ulcer, oesophagitis, gastritis &/or peptic ulcer; history of GI disease (ulcerative colitis, Crohn's disease); increase risk of ulceration or bleeding w/ concomitant intake of oral corticosteroids, anticoagulants eg, warfarin, SSRIs or anti-platelet agents eg, ASA. Renal impairment; patients receiving diuretic therapy or those who could develop hypovolemia; ensure adequate fluid intake; glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome & acute renal failure. Patients w/ impaired hepatic functions; may be associated w/ small increase in the risk of arterial thrombotic event (eg, MI or stroke); patients w/ risk factors for CV disease (eg, HTN, hyperlipidemia, DM, smoking); patients receiving other therapy that interferes w/ haemostasis eg, warfarin, other coumarins or heparins. Exfoliative dermatitis, SJS & TEN. Elderly. Patients w/ congenital disorder of porphyrin metabolism (eg, acute intermittent porphyria), dehydration, directly after major surgery; asthma combined w/ chronic rhinitis, sinusitis &/or nasal polyposis; haematopoietic disorders, SLE or mixed connective tissue disease. Tramadol: Addicted patients, patients w/ head injury, shock, reduced level of consciousness of uncertain origin, disorders of the resp centre/function or increased intracranial pressure; patients sensitive to opiates; possibility of resp depression; convulsions; may increase risk of seizure.
Adverse Reactions
Drug Interactions
Dexketoprofen: Synergism w/ other NSAIDs (including COX-2 selective inhibitors); may enhanced effects of anticoagulants; increased risk of hemorrhage w/ heparins; increase blood lithium levels; increased hematological toxicity w/ methotrexate; increased toxic effects w/ hydantoines (including phenytoin) & sulphonamides. May reduce effects of diuretics & antihypertensive drugs; increased risk of bleeding w/ pentoxyfilline; increased risk of red cell line toxicity w/ zidovudine; increased hypoglycemic effect of sulfonylureas. β-blockers, cyclosporine & tacrolimus, thrombolytics, antiplatelets & SSRIs, probenecid, cardiac glycosides, mifepristone, quinolone antibiotics, tenofovir, pemetrexed. Tramadol: MAOIs; elevated INR w/ warfarin; mixed agonists/antagonists opioid receptors (eg, buprenorphine, nalbuphine, pentazocine). SSNRIs, SNRIs, TCA, antipsychotics & other seizure threshold lowering product (eg, bupropion, mirtazapine, tetrahydrocannabinol). May potentiate CNS effects w/ alcohol; cimetidine; carbamazepine; ondansetron; ketoconazole & erythromycin.
MIMS Class
Analgesics (Opioid) / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
N02AJ14 - tramadol and dexketoprofen ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Presentation/Packing
Form
Skudexa 75 mg/25 mg FC tab
Packing/Price
20's (P63/film-coated tab);2's (P63/film-coated tab)
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