Indications

Osteoarthritis; Rheumatoid arthritis; Ankylosing spondylitis

Special Instructions

Should be taken with food. Take w/ or immediately after meals.

Contraindication

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.

Side Effects

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).

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.

Route of Administration

Oral

Dosage

As directed by the physician