Concise Prescribing Info
Relief of pain & inflammation in OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult 200 mg daily, taken as 2 separate 100 mg doses, 1 tab in the morning & 1 tab in the evening. Hepatic insufficiency Initially 100 mg daily.
Should be taken with food.
Hypersensitivity to aceclofenac, ibuprofen, aspirin or other NSAIDs. Active, or history of recurrent peptic ulcer/haemorrhage. Severe heart failure, hepatic & renal failure. History of GI bleeding or perforation related to previous NSAID therapy. Do not use during pregnancy, especially during the last trimester.
Special Precautions
Hypersensitivity; anaphylactic/anaphylactoid reactions. Avoid concomitant use w/ NSAIDs (including cyclooxygenase-2 selective inhibitors). May precipitate bronchospasm in patients w/ or a history of resp disorders eg, bronchial asthma. Monitor patients w/ a history of HTN, mild to moderate CHF for fluid retention & oedema associated w/ NSAID therapy. Uncontrolled HTN, CHF, ischemic heart disease, peripheral arterial disease & cerebrovascular disease. Patients w/ risk factors for CV disease eg, HTN, hyperlipidaemia, DM, smoking. Potentially fatal GI bleeding, ulceration & perforation. Monitor and commence treatment on the lowest dose or consider combination therapy w/ protective agents in patients w/ history of ulceration, ulcerative colitis, Crohn's disease, bleeding, diathesis, haematological abnormalities, & in patients requiring low dose ASA or drugs likely to increase GI risk. Risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. Serious skin reactions eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis; discontinue use at 1st appearance of hypersensitivity reactions. May impair ability to drive or operate machinery. Monitor renal function in patients w/ renal & cardiac impairment, hepatic dysfunction, those taking diuretics & the elderly for potential dose-dependent reduction in prostaglandin formation & renal failure. Discontinue if abnormal liver function test persists or worsens, clinical signs or symptoms consistent w/ liver disease develop or other manifestations occur; closely monitor patients w/ mild to moderate hepatic impairment; hepatitis may occur w/o prodromal symptoms; may trigger attack in patients w/ hepatic porphyria. Not recommended in women of childbearing potential. Pregnancy & lactation. Increased frequency of AR, especially GI bleeding & perforation, which may be fatal in the elderly. Not recommended in childn.
Adverse Reactions
Dizziness; dyspepsia, abdominal pain, nausea, diarrhoea; increased hepatic enzyme. Potentially, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Drug Interactions
May increase risk of adverse effects w/ other NSAIDs (including aspirin). May reduce effects of antihypertensives. Increased risk of acute renal insufficiency w/ ACE inhibitors & AIIA. Reduced diuretic effect; increased nephrotoxicity w/ diuretics; monitor serum K w/ K-sparing diuretics. Exacerbation of cardiac failure, reduced cardiac glycoside GFR, increased plasma glycoside levels. Increased serum lithium conc. May increase plasma levels & toxicity of methotrexate. Reduced effect of mifepristone. Do not use 8-12 days after mifepristone administration. Increased GI ulceration or bleeding w/ corticosteroids, antiplatelet agents & SSRIs. Enhanced effects of anticoagulants eg, warfarin. Increased risk of convulsion w/ quinolone antibiotics. Increased nephrotoxicity w/ cyclosporin & tacrolimus. Increased risk of haematological toxicity w/ zidovudine. Possible hypoglycaemic effects w/ hypoglycaemic agents.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AB16 - aceclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Diclotol FC tab 100 mg
10 × 10's
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