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Drug Details

KETOCID

• Drug Class Description
  Non-steroidal anti-inflammatory drugs (NSAIDs, propionic acid).
• Generic Name
  Ketoprofen
• Presentation
  Modified-release capsule Each size 1 hard gelatin capsule contains white to whitish pellets. The capsule shell has an opaque, pink cap and transparent body. "KET 200 CR" is axially printed on the cap.
• Description
  Each modified-release capsule contains 200mg ketoprofen
• Indications
  

  Ketoprofen is an analgesic, anti-inflammatory and antipyretic and is recommended for the treatment of:

  - rheumatoid arthritis, osteoarthritis and ankylosing spondylitis

  - other musculoskeletal conditions including bursitis, capsulitis, synovitis, tendinitis, fibrositis and low back pain

  - the relief of pain from sciatica, acute gout and dysmenorrhoea

• Adult Dosage
  

  Route of Administration

  For oral administration

  Dosage Recommendations

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

  The maximum daily dose is 200mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200mg daily, and higher doses are not recommended

  Adults

  One 200 mg capsule to be taken orally once daily, preferably with or after food.

  The Elderly

  As for adult dosage as there is no evidence that the pharmacokinetics of ketoprofen are altered in the elderly.

  The elderly are at risk of increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.

  Children

  There are no recommendations for the use of this product in children.

• Child Dosage
  Not recommended.
• Contra Indications
  

  Hypersensitivity to ketoprofen or to any of the excipients.

  Active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation

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

  Severe heart failure, hepatic failure and renal failure

  During the last trimester of pregnancy

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

• Special Precautions
  

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

  The use of Ketocid with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

  As with other drugs in the same therapeutic category, patients should be advised to take ketoprofen with food, to minimise gastric intolerance.

  Elderly

  The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which can 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 formulation 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.

  NSAIDs have been reported to cause nephrotoxicity in various forms: interstitial nephritis, nephrotic syndrome and renal failure

  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 ketoprofen.

  Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen 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).

  Gastrointestinal bleeding, ulceration and perforation

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

  Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses.

  The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should 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 patients requiring concomitant low dose aspirin, 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.

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

  When GI bleeding or ulceration occurs in patients receiving ketoprofen, 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.

  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 of 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. Ketocid should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

  Impaired female fertility

  The use of Ketocid 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 Ketocid should be considered.

• Interactions
  Anticoagulants, quinolones, sulphonamides, hydantoins, methotrexate, digoxin, lithium, diuretics.
• Adverse Drug Reactions
  

  Gastrointestinal

  The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, heartburn, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

  Hypersensitivity Reactions

  Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of:

  - non-specific allergic reactions and anaphylaxis

  - respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea

  - assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and less commonly, bullous dermatoses (including epidermal necrolysis, erythema multiforme and exfoliative dermatitis)

  Cardiovascular

  Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

  Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke)

  Other less common adverse events include:

  Renal

  Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

  Hepatic

  Abnormal liver function, hepatitis and jaundice

  Neurolocical and Special Senses

  Visual disturbances, optic neuritis, headaches, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, paraesthesia, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue, drowsiness, mood changes and insomnia.

  Haematological Reactions

  Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia

  Dermatological Reaction

  Bullous skin reactions. Photosensitivity

  Should any severe adverse event occur, treatment should be stopped immediately.