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, Stevens-Johnson syndrome & toxic epidermal necrolysis. 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.

Skudexa with alcohol

• Do not drink alcohol during treatment with Skudexa as it may increase the effect of the medication.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Tramadol is excreted into breast milk.
• The use of Skudexa is contraindicated in pregnancy as well as during breast-feeding.

Driving and using machines

Skudexa may affect your ability to drive and handle machines, due to the possibility of dizziness, blurred vision or drowsiness as side effects of treatment. This applies particularly when Skudexa is taken with medicines that affect mood and emotions, or alcohol.

If you are affected, do not drive or use machines until the symptoms wear off.

References:

https://www.medicines.org.uk/emc/product/8849/pil

https://www.medicines.ie/medicines/skudexa-75-mg-25-mg-film-coated-tablets-34646/patient-info

https://www.drugs.com/uk/skudexa-75-mg-25-mg-film-coated-tablets-leaflet.html

https://www.hpra.ie/HOMEPAGE/medicines/medicines-information

https://www.mims.com/philippines/drug/info/skudexa