Ketesse

Ketesse

dexketoprofen

Manufacturer:

A. Menarini

Distributor:

Zuellig
Concise Prescribing Info
Contents
Dexketoprofen (trometamol)
Indications/Uses
Tab: Treatment of pain of mild to moderate intensity like musculo-skeletal pain, dysmenorrheal & dental pain. Inj: Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate eg, post-op pain, renal colic & low back pain.
Dosage/Direction for Use
Tab 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max daily dose: 75 mg. IV/IM inj Adult 50 mg every 8-12 hr, may be repeated 6 hr apart. Max daily dose: 150 mg. Liver disease & renal dysfunction Total daily dose: 50 mg.
Administration
Should be taken on an empty stomach: Take 30 min before meals, especially for quick relief of acute pain.
Contraindications
Hypersensitivity or to eg, aspirin & any other NSAIDs. History of stroke (CVA), heart attack (MI), CABG, uncontrolled HTN, CHF NYHA II-IV; precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic edema; active or suspected peptic ulcer/haemorrhage or history of recurrent peptic ulcer/haemorrhage (≥2 distinct episodes of proven ulceration or bleeding) or chronic dyspepsia; NSAID-related GI bleeding or perforation; GI or other active bleedings or bleeding disorders; Crohn's disease or ulcerative colitis; history of bronchial asthma; severe heart failure; moderate to severe renal dysfunction (CrCl <50 mL/min); severe hepatic dysfunction (Child-Pugh score 10-15); haemorrhagic diathesis & other coagulation disorders. Pregnancy (3rd trimester) & lactation. Childn & adolescent. Inj: Neuraxial (intrathecal or epidural) administration.
Special Precautions
History of allergic conditions. Concomitant use w/ NSAIDs including COX-2 selective inhibitors, oral corticosteroids, anticoagulants eg, warfarin, SSRIs, antiplatelet agents eg, aspirin, diuretics. Discontinue use if GI bleeding, ulceration or perforation occurs. Patients w/ GI symptoms or history of GI disease (ulcerative colitis, Crohn's disease) & toxicity. Monitor digestive disturbances, especially GI bleeding. History of oesophagitis, gastritis &/or peptic ulcer. Monitor fluid retention & oedema in patients w/ a history of HTN &/or mild to moderate CHF. Patients w/ uncontrolled HTN, CHF, established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Risk factors for CV disease (eg, HTN, hyperlipidaemia, DM, smoking). Mild to moderate hepatic dysfunction & mildly impaired renal function. Not intended for long-term use. May impair ability to drive or operate machinery. Women attempting to conceive. Pregnancy (1st & 2nd trimester). Childn. Elderly. Inj: Increased risk of arterial thrombotic events (eg, MI or stroke). Serious skin reactions, some are fatal including exfoliative dermatitis, SJS & TEN. Discontinue use if first appearance of skin rash, mucosal lesions occur. Patients suffering from haematopoietic disorders, SLE or mixed connective tissue disease. Soft tissue & bacterial infections. Alcoholism. May impair female fertility. Patients w/ liver disease or epilepsy.
Adverse Reactions
Nausea &/or vomiting. Tab: Abdominal pain, diarrhoea, dyspepsia. Inj: Inj site pain & reaction including inflammation, bruising or haemorrhage.
Drug Interactions
Other NSAIDs including high doses of salicylates (≥3 g/day), corticosteroids & SSRI's may increase the risk of GI ulcers & bleeding. Enhanced effect w/ anticoagulants eg, warfarin. Increased risk of haemorrhage w/ heparin due to inhibition of platelet function & damage to the gastroduodenal mucosa. Decreased renal excretion of lithium. Increased haematological toxicity w/ methotrexate. Increased toxic effects w/ hydantoins & sulphonamides. May reduce the effect of diuretics, ACE inhibitors & angiotensin II receptor antagonists. Increased risk of bleeding w/ pentoxyfilline. Increased risk of red cell line toxicity w/ zidovudine. May increase the hypoglycaemic effect of sulfonylureas. May decrease antihypertensive effect w/ β-blockers. Enhanced nephrotoxicity w/ cyclosporine & tacrolimus. Increased risk of bleeding w/ thrombolytics. Increased plasma conc w/ probenecid. May alter the efficacy of mifepristone. Increased risk of developing convulsions w/ quinolone antibiotics.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE17 - dexketoprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Presentation/Packing
Form
Ketesse FC tab 25 mg
Packing/Price
20's (P33.75/film-coated tab)
Form
Ketesse infusion conc 25 mg/mL
Packing/Price
2 mL x 1's (P578.75/box)
Form
Ketesse soln for inj 25 mg/mL
Packing/Price
2 mL x 1's (P578.75/box)
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