Zuellig Pharma
Concise Prescribing Info
Relief of pain & inflammation in OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult 200 mg daily in 2 divided doses. Hepatic impairment 100 mg daily.
Should be taken with food.
Hypersensitivity. ASA or other NSAID-induced asthma, acute rhinitis or urticaria. History of stroke; CVA; MI; CABG & recent revascularization procedures; uncontrolled HTN; CHF NYHA II-IV, ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease; GI bleeding or perforation, active, history or suspected recurrent peptic ulcer/haemorrhage. Bleeding or blood clotting disorder. Severe renal or hepatic failure. Women planning pregnancy, 3rd trimester of pregnancy & lactation.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if abnormal LFTs persist or worsen, clinical signs or symptoms consistent w/ liver disease develop or other manifestations eg, eosinophilia or rash occur. Avoid use in case of varicella infection. Active or previous history of bronchial asthma; cerebrovascular bleeding; serious GI ulceration, bleeding or perforation, ulcerative colitis or Crohn's disease, haematological abnormalities; CHF NYHA I, significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; SLE, mixed connective tissue disorders. May reversibly inhibit platelet aggregation. Monitor renal & hepatic function, blood counts regularly during long-term use. Avoid concomitant use w/ other NSAIDs eg, COX-2 selective inhibitors. Concomitant use w/ diuretics; systemic corticosteroids, anticoagulants eg, warfarin, SSRIs, antiplatelets eg, aspirin. May affect ability to drive & use machines. Hepatic porphyria. Mild to moderate renal & hepatic impairment. May impair female fertility. Not recommended in women of childbearing potential, during 1st & 2nd trimesters of pregnancy. Avoid use during lactation. Not recommended in childn. Elderly.
Adverse Reactions
Dizziness; dyspepsia, abdominal pain, nausea, diarrhoea; increased hepatic enzyme.
Drug Interactions
Increased plasma conc of lithium, digoxin, MTX. Increased risk of nephrotoxicity w/ diuretics, cyclosporine, tacrolimus. Reduced effect of antihypertensives, mifepristone. Enhanced action of anticoagulants. Increased risk of GI ulceration or bleeding w/ antiplatelet antiaggregants, corticosteroids, other anti-inflammatory drugs, SSRIs. Altered dose of oral antidiabetics. Increased risk of haematological toxicity w/ zidovudine. Increased risk of convulsions w/ quinolones.
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.
Airtal FC tab 100 mg
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