Generic Medicine Info
Should be taken with food. Take w/ or immediately after meals.
Hypersensitivity to aceclofenac, aspirin, ibuprofen or other NSAIDs. Active or history of peptic ulcer/haemorrhage, active bleeding or bleeding disorders, history of gastrointestinal bleeding or perforation related to previous NSAID therapy; CHF (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, severe heart failure, varicella infection. Severe hepatic and renal impairment. Pregnancy (3rd trimester).
Special Precautions
Patient with history of bronchial asthma, history of gastrointestinal disease (e.g. ulcerative colitis, Crohn's disease); fluid retention, hypertension, mild to moderate CHF or CHF (NYHA class I), history of MI, stroke, or cerebrovascular bleeding; coagulation disorders, anaemia, SLE, hepatic porphyria. Patient undergoing or after CABG. Mild to moderate hepatic and renal impairment. Elderly. Pregnancy (1st-2nd trimester) and lactation. Patient Counselling This drug may cause drowsiness, dizziness or blurred vision, if affected, do not drive or operate machinery. Monitoring Parameters Monitor LFTs periodically, renal function tests (urine output, serum BUN, creatinine), blood pressure, CBC, serum K, and occult blood loss. Perform ophthalmic exam as necessary (long-term use).
Adverse Reactions
Significant: CV thrombotic events, including MI and stroke; fluid retention and oedema, new-onset or exacerbation of hypertension, haematologic effects (e.g. decreased platelet adhesion and aggregation, prolonged bleeding time), hyperkalaemia, increased transaminases, renal effects (e.g. deteriorated renal function, precipitated renal failure), drowsiness, dizziness, blurred vision, photosensitivity; hypersensitivity reactions, including anaphylactic or anaphylactoid reactions. Rarely, blood dyscrasias (e.g. aplastic anaemia, thrombocytopenia, agranulocytosis), hepatitis, aseptic meningitis (particularly in patients with SLE and mixed connective tissue disorders). Gastrointestinal disorders: Nausea, diarrhoea, dyspepsia, abdominal pain, vomiting, constipation, flatulence, gastritis, mouth ulceration. Investigations: Increased blood BUN and creatinine. Skin and subcutaneous tissue disorders: Rash, pruritus, dermatitis, urticaria.
Potentially Fatal: Gastrointestinal bleeding, ulceration and perforation, severe bronchospasm. Rarely, serious skin reactions (e.g. Stevens-Johnsons syndrome, toxic epidermal necrolysis, exfoliative dermatitis).
Drug Interactions
Increased risk of gastrointestinal ulceration and bleeding with anticoagulants (e.g. warfarin), corticosteroids, and SSRIs. Increased risk of nephrotoxicity with diuretics, ciclosporin, and tacrolimus. May inhibit the renal clearance resulting in increased plasma levels of cardiac glycosides (e.g. digoxin) and lithium. May enhance the risk of renal insufficiency with ACE inhibitors or angiotensin II receptor antagonists. May increase the plasma levels and toxicity of methotrexate. May decrease the effects of mifepristone. May enhance the risk of convulsions with quinolones.
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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.
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