Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Osteoarthritis; Rheumatoid arthritis; Ankylosing spondylitis 100 mg bid.
Should be taken with food. Take w/ or immediately after meals.
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. Patient Counselling This drug may cause dizziness, vertigo, drowsiness, fatigue, and visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Monitor for GI bleeding regularly. Closely monitor cardiac, hepatic, and renal function.
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.
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.
ATC Classification
M02AA25 - aceclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Disclaimer: This information is independently developed by CIMS 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 CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS 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 CIMS. All rights reserved. Powered by
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