Dexketoprofen


Concise Prescribing Info
Indications/Uses
Mild to moderate pain
Dosage/Direction for Use
Adult : PO 12.5 mg every 4-6 hr; or 25 mg every 8 hr. Max: 75 mg/day.
Dosage Details
Oral
Mild to moderate pain
Adult: 12.5 mg every 4-6 hr or 25 mg every 8 hr. Max: 75 mg/day.
Elderly: Initial total daily dose should not exceed 50 mg/day. May increase to the doses recommended for general population only if well tolerated.
Renal Impairment
Mild renal impairment: Reduce initial dose to 50 mg/day. Not to be used in moderate to severe renal impairment.
Hepatic Impairment
Mild to moderate impairment: Reduce initial dose to 50 mg/day. Not to be used in severe hepatic impairment.
Administration
Should be taken on an empty stomach. Take 30 min before meals, especially for quick relief of acute pain.
Contraindications
Hypersensitivity to Dexketoprofen, or other NSAIDs. Patients with history of asthma attacks, bronchospasm, angioedema, urticaria, acute rhinitis or nasal polyps that were precipitated by Aspirin or other NSAIDs. Active/suspected/recurrent peptic ulcer or haemorrhage. Chronic dyspepsia; GI bleeding or other active bleedings; Crohn's disease or ulcerative colitis; bronchial asthma; severe heart failure; severe hepatic impairment; moderate to severe renal impairment; haemorrhagic diathesis and other coagulation disorders. Pregnancy and lactation.
Special Precautions
History of GI disease, GI symptoms; NSAIDS are associated with serious GI side effects e.g. bleeding, ulceration or perforation. May cause deterioration of renal function, fluid retention and oedema; caution in renal and/or hepatic impairment, HTN, heart failure. May inhibit platelet aggregation and prolong bleeding time, concomitant use with warfarin or heparin is not recommended. Non-selective NSAIDs are also associated with a small increased risk of thrombotic events (e.g. stroke, MI). Long term use may impair female fertility. Safety and efficacy in children and adolescent have not been established. Increased risk of NSAIDS adverse reactions in elderly patients.
Adverse Reactions
Nausea, vomiting, dyspepsia, abdominal pain, diarrhoea, gastric, peptic ulcer, GI bleeding, dry mouth, flatulence, headache, dizziness, somnolence, insomnia, palpitations, paraesthesia, syncope, HTN, hypotension, bradypnoea, bronchosposm, fatigue, asthenia, malaise, rash, urticaria, acne, photosensitivity reactions, facial oedema, polyruria, nephritis or nephrotic syndrome, menstrual disorder, prostatic disorder, peripheral oedema, pancreatitis, abnormal LFT, increased plasma urea nitrogen, neutropenia, thrombocytopenia.
Potentially Fatal: Anaphylactic shock, Steven-Johnson Syndrome and toxic epidermal necrolysis.
Overdosage
Administer activated charcoal if more than 5 mg/kg has been ingested by an adult or a child within an hr. Symptomatic therapy should be provided. Dexketoprofen is dialysable.
Drug Interactions
Concomitant use of salicylates, other NSAIDs, anticoagulant (e.g. warfarin, heparin) or corticosteroids may increase risk of bleeding and combination use is not recommended. Caution if used with thrombolytics, anti-platelets, selective serotonin reuptake inhibitors, pentoxyfylline due to elevated bleeding risk. May increase toxic effects of hydantoines and sulphonamides. May reduce effects of antihypertensives. Increased risk of red cell line toxicity with zidovudine, monitor complete blood count and reticulocyte count. Renal function may be worsened when used with ciclosporin or tacrolimus. May increase hypoglycaemic effect of sulfonylureas. Probenacid may increase plasma concentration of Dexketoprofen.
Potentially Fatal: NSAIDS may increase blood lithium levels; and increase haematological toxicity of methotrexate.
Food Interaction
Reduced absorption rate when administered with food.
Action
Description: Dexketoprofen is an isomer of ketoprofen. It is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic properties. It is a non-steroidal anti-inflammatory drug (NSAID) that reduces prostaglandin synthesis via inhibition of cyclooxygenase pathway (both COX-1 and COX-2) activity.
Onset: About 30 min.
Duration: About 4-6 hr.
Pharmacokinetics:
Absorption: Cmax: About 30 min.
Distribution: Vd: <0.25 L/kg. Highly protein bound.
Excretion: Mainly eliminated via glucuronide conjugation and followed by renal excretion. Elimination half-life: About 1.65 hr.
Storage
Store at below 30°C; protect from light.
Disclaimer: This information is independently developed by MIMS based on Dexketoprofen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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