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Airtal

Airtal

aceclofenac

Manufacturer:

Eurodrug

Distributor:

Pacific Healthcare
Concise Prescribing Info
Contents
Aceclofenac
Indications/Uses
Relief of pain & inflammation in OA, RA & ankylosing spondylitis.
Dosage/Direction for Use
Adult 200 mg daily (taken as 2 separate 100 mg in morning & evening). Hepatic insufficiency Initially 100 mg daily.
Administration
Should be taken with food: Swallow whole w/ sufficient amount of liqd.
Contraindications
Hypersensitivity. Previous hypersensitivity reactions (eg, asthma, rhinitis, angioedema or urticaria) to ibuprofen, aspirin, or other NSAIDs. Active, or history of recurrent peptic ulcer/haemorrhage. History of GI bleeding or perforation, related to previous NSAIDs therapy. Active bleedings, bleeding disorders or dengue fever. Patients w/ established CHF (NYHA II-IV), ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Hepatic & renal failure. Last trimester of pregnancy.
Special Precautions
Discontinue if abnormal LFTs persist or worsen clinical signs & symptoms consistent w/ liver disease develop or other manifestations occur (eosinophilia, rash); at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. W/draw treatment when GI bleeding or ulceration occurs. Avoid use in case of varicella. Increased risk of aseptic meningitis in patients w/ SLE & mixed connective tissue disorders. Exfoliative dermatitis, SJS, TEN; anaphylactic/anaphylactoid reactions. Fluid retention & oedema. Patients suffering from, or w/ previous history of, bronchial asthma; w/ cardiac impairment, those taking diuretics or recovering from major surgery; hepatic porphyria; CHF (NYHA-I), significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; history of cerebrovascular bleeding, GI ulceration, bleeding or perforation; upper or lower GIT disorders, ulcerative colitis or Crohn's disease, or haematological abnormalities. Monitor renal function in patients at greatest risk of prostaglandin reduction; hepatic function (elevation of liver enzymes) & blood counts in long-term treatment. May reversibly inhibit platelet aggregation. Consider combination therapy w/ protective agents (eg, misoprostol or PPIs) in patients w/ history of ulcer w/ haemorrhage or perforation & in elderly, & those taking concomitant low dose aspirin, or other drugs likely to increase GI risk. Avoid concomitant use w/ other NSAIDs including COX-2 selective inhibitors. Concomitant use w/ systemic corticosteroids, anticoagulants (eg, warfarin), SSRIs or antiplatelet agents eg, aspirin. May affect ability to drive & use machines. Mild to moderate renal & hepatic impairment. Liver dysfunction. May impair female fertility. Not recommended in women attempting to conceive. Increased risk of miscarriage, cardiac malformation or gastroschisis in early pregnancy. Not to be given during 1st & 2nd trimester of pregnancy. Avoid use in lactation. Not recommended in childn. Elderly.
Adverse Reactions
Dizziness; dyspepsia, abdominal pain, nausea, diarrhoea; increased hepatic enzyme. SJS, TEN.
Drug Interactions
Increased risk of adverse effects including GI bleeding/ulceration w/ ≥2 NSAIDs including aspirin; corticosteroids; anti-platelet agents & SSRIs. Reduced effect of antihypertensives; mifepristone. Increased risk of acute renal insufficiency w/ ACE inhibitors or AIIA. Inhibited activity of diuretics. Increased risk of nephrotoxicity w/ diuretics; cyclosporin or tacrolimus. Increased plasma levels of glycosides eg, digoxin. Increased serum conc of lithium. Increased plasma levels of MTX resulting in increased toxicity. May enhance effects of anti-coagulants eg, warfarin. Increased risk of developing convulsions w/ quinolones. Increased risk of haematological toxicity w/ zidovudine. Concomitant use w/ K-sparing diuretics; oral antidiabetic 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.
Presentation/Packing
Form
Airtal FC tab 100 mg
Packing/Price
40's
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