Aceclofenac


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Osteoarthritis; Rheumatoid arthritis; Ankylosing spondylitis 100 mg bid.
Dosage Details
Oral
Ankylosing spondylitis, Osteoarthritis, Rheumatoid arthritis
Adult: 100 mg bid, in the morning and in the evening.
Renal Impairment
Moderate to severe: Contraindicated.
Hepatic Impairment
Reduce initial dose to 100 mg daily. Severe: Contraindicated.
Administration
Should be taken with food. Take w/ or immediately after meals.
Contraindications
Hypersensitivity to aceclofenac or other NSAIDs. Active or history of peptic ulcer/haemorrhage, history of active bleeding or bleeding disorders, history of bleeding or perforation related to previous NSAID therapy, CHF (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, severe heart failure. Moderate to severe renal and severe hepatic impairment. Pregnancy (3rd trimester).
Special Precautions
Patient w/ ulcerative colitis, Crohn’s disease, bleeding diathesis or haematological abnormalities. Patient w/ or previous history of asthma, history of HTN, mild to moderate CHF, and those at risk for CV disease and history of cerebrovascular bleeding. Hepatic and mild renal impairment. Pregnancy and lactation.
Adverse Reactions
GI disorders (e.g. dyspepsia, abdominal pain, nausea, vomiting, diarrhoea, flatulence, constipation, malaena, haematemesis, ulcerative stomatitis, gastritis), rash, ruber, urticaria, enuresis, headache, dizziness, paraesthaesia, drowsiness; asthma, bronchospasm, dyspnoea, pruritus, purpura, angioedema. MI, stroke, acute coronary syndrome, oedema, HTN, cardiac failure; nephritis, nephritic syndrome, renal failure; abnormal liver function, hepatitis, jaundice; visual disturbance, optic neuritis; thrombocytopenia, neutropenia, agranulocytosis, aplastic and haemolytic anaemias. Rarely, pancreatitis, exfoliative and bullous dermatoses (e.g. epidermal necrolysis, erythema multiforme, Steven Johnson syndrome, toxic epidermal necrolysis).
Potentially Fatal: GI bleeding, ulceration or perforation.
Patient Counseling Information
This drug may cause dizziness, vertigo, drowsiness, fatigue, and visual disturbances, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor for GI bleeding regularly. Closely monitor cardiac, hepatic, and renal function.
Overdosage
Symptoms: Headache, nausea, vomiting, epigastric pain, GI irritation and bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, resp depression, fainting, convulsions, renal failure, liver damage. Management: Symptomatic and supportive treatment. Employ gastric lavage or activated charcoal w/in 1 hr of ingestion. IV diazepam may be used for prolonged convulsions.
Drug Interactions
Increased risk of adverse effects, including risk of GI bleeding, w/ aspirin or other NSAIDs. May enhance the effect of anticoagulants (e.g. warfarin). Increased risk of nephrotoxicity w/ diuretics. May decrease the effect of diuretics. May increase serum concentration of lithium and digoxin. May cause hypo- and hyperglycaemic effects w/ antidiabetic agents.
Action
Description: Aceclofenac, a phenylacetic acid derivative, is a potent inhibitor of cyclooxygenase enzyme, involved in the production of prostaglandins, causing marked anti-inflammatory and analgesic properties.
Pharmacokinetics:
Absorption: Rapidly and completely absorbed from the GI tract. Time to peak plasma concentration: 1-3 hr.
Distribution: Penetrates into the synovial fluid. Volume of distribution: Approx 25 L. Plasma protein binding: >99%.
Metabolism: Metabolised into 4’-hydroxyaceclofenac.
Excretion: Via urine (approx 2/3, mainly as hydroxymetabolites). Plasma elimination half-life: Approx 4 hr.
Storage
Store at or below 30°C.
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Aceclofenac. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/08/2016.

Buckingham R (ed). Aceclofenac. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2016.

Clanza CR Tablet, Film Coated (United Douglas Pharm., Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/08/2016.

Joint Formulary Committee. Aceclofenac. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/08/2016.

Disclaimer: This information is independently developed by MIMS based on Aceclofenac 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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