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Drug Details

Aceclofenac 100 mg Tablets

• Presentation
  Film-coated tablets. White, circular, film-coated tablets with 'LG' embossed on one side and '100' on the other side of the tablet
• Description
  Each tablet contains Aceclofenac 100 mg
• Indications
  

  Aceclofenac 100 mg Tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

• Adult Dosage
  

  Aceclofenac tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. Aceclofenac should be taken preferably with or after food.

  Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

  Adults

  The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

  Renal insufficiency

  There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised.

  Hepatic insufficiency

  There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

• Child Dosage
  

  There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.

• Elderly Dosage
  

  The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

  As with other non-steroidal anti-inflammatory drugs (NSAIDs), caution should be exercised in the treatment of elderly patients, who are at increased risk of the serious consequences of adverse reactions, and who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication. The elderly should be monitored regularly for GI bleeding during NSAID therapy.

• Contra Indications
  

  Hypersensitivity to any of the constituents.

  NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.

  Severe hepatic and cardiac failure.

  Moderate to severe renal failure.

  During the last trimester of pregnancy

  Active or previous peptic ulcer.

  History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

  Use with concomitant NSAIDs including cyclooxygenase 2 specific inhibitors.

• Special Precautions
  

  Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

  Elderly:

  The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

  Respiratory disorders:

  Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.

  Cardiovascular, Renal and Hepatic Impairment:

  The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients. Effects on renal function are usually reversible on withdrawal of Aceclofenac.

  If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac should be discontinued. Hepatitis may occur without prodromal symptoms.

  Use of Aceclofenac in patients with hepatic porphyria may trigger an attack.

  Gastrointestinal bleeding, ulceration and perforation:

  GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

  The risk of GI bleeding, ulceration or performation is higher with increasing NSAID doses, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients shouls commence treatment on the lowest dose available.

  Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring conconminant low dose asprin, or other drugs likely to increase gastrointestinal risk.

  Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
  
  Cardiovascular and cerebrovascular effects:

  Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

  Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Aceclofenac.

  Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Aceclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

  Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin.

  When GI bleeding or ulceration occurs in patients receiving Aceclofenac the treatment should be withdrawn.

  NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated.

  Close medical surveillance is imperative in patients with bleeding diathesis or haematological abnormalities.

  SLE and mixed connective tissue disease:

  In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

  Dermatological:

  Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

  Female fertility:

  The use of Aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac should be considered.

  Hypersensitivity reactions:

  As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.

  Haematological:

  Aceclofenac may reversibly inhibit platelet aggregation (See anticoagulants under 'Interactions').

  Long-term treatment:

  All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal function, hepatic function (elevation of liver enzymes may occur) and blood counts. 

• Interactions
  

  Lithium: Aceclofenac, like many NSAIDs, may increase plasma concentrations of lithium.

  Cardiac Glycosides: Through their renal effects, NSAIDs may increase plasma glycoside (including digoxin) levels, exacerbate cardiac failure and reduce the glomerular filtration rate in patients receiving glycosides.

  Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Although it was not shown to affect blood pressure control when co-administered with bendroflumethiazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored. Diuretics can increase the risk of nephrotoxicity of NSAIDs.

  Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants such as warfarin. Close monitoring of patients on combined anticoagulant and Aceclofenac therapy should be undertaken.

  Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Aceclofenac, consideration should be given to adjustment of the dosage of hypoglycaemic agents.

  Methotrexate: Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase methotrexate plasma levels, resulting in increased toxicity.

  Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

  Ciclosporin: Ciclosporin nephrotoxicity may be increased by the effect of NSAIDs on renal prostaglandins.

  Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving a NSAID.

  Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects.

  Anti-hypertensives: Reduced anti-hypertensive effect.

  Corticosteroids: Increased risk of gastrointestinal ulceration or GI bleeding.

  Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

  Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

  Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

  Ritonavir: plasma concentration of Aceclofenac possibly increased by ritonavir.