Adult: As conventional tab or soft gel cap: 100 mg bid, in the morning and the evening. As sustained-release tab: 200 mg once daily. Elderly: As conventional tab or soft gel cap: Use the lowest effective dose for the shortest possible duration.
Mild to moderate: As conventional tab or soft gel cap: Use the lowest effective dose for the shortest possible duration. Severe: Contraindicated.
Mild to moderate: As conventional tab or soft gel cap: Initially, 100 mg daily. Severe: Contraindicated.
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).
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.
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).
Patient Counseling Information
This drug may cause drowsiness, dizziness or blurred vision, if affected, do not drive or operate machinery.
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).
Symptoms: Headache, vomiting, nausea, epigastric pain, gastrointestinal irritation and bleeding, diarrhoea, disorientation, excitation, dizziness, drowsiness, tinnitus, hypotension, fainting, convulsions, respiratory depression, coma, and renal failure or liver damage for significant doses. Management: Symptomatic and supportive treatment. Give activated charcoal or perform gastric lavage within 1 hour of ingestion. Administer IV diazepam for frequent or prolonged convulsions. Closely monitor renal and hepatic function.
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. Potentially Fatal: Increased risk of gastrointestinal ulceration and bleeding with other NSAIDs, COX-2 selective inhibitors, and antiplatelets (e.g. aspirin).
Increased risk of gastrointestinal bleeding with alcohol.
May result in a false-positive aldosterone/renin ratio (ARR).
Description: Mechanism of Action: Aceclofenac, a phenylacetic acid derivative, a potent inhibitor of cyclooxygenase (COX) enzyme which is involved in the production of prostaglandins, thereby causing marked anti-inflammatory and analgesic effects. Pharmacokinetics: Absorption: Rapidly and completely absorbed from the gastrointestinal tract (conventional tab). Time to peak plasma concentration: 1-3 hours (conventional tab). Distribution: Penetrates the synovial fluid. Volume of distribution: Approx 25 L (conventional tab). Plasma protein binding: >99% (conventional tab). Metabolism: Metabolised into 4'-hydroxyaceclofenac. Excretion: Via urine (approx 2/3 mainly as hydroxymetabolites). Elimination half-life: Approx 4 hours (conventional tab).