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Drug Details

FELDENE

• Drug Class Description
  Oxicams (non-steroidal anti- inflammatory drugs, NSAIDs).
• Generic Name
  Piroxicam
• Presentation
  Capsules (10mg and 20mg): capsules for oral administration. I.M.: solution for intramuscular injection. Melt tablets: fast dissolving dosage form (tablet).
• Description
  Active Ingredient: piroxicam Capsules: piroxicam 10mg or 20mg (anhydrous) I.M.: the intramuscular injection contains 1ml of piroxicam solution (20mg/ml) in ampoules of 1ml Melt tablets: piroxicam 20mg
• Indications
  

  Capsules, Melt tablets: Feldene is a non-steroidal anti-inflammatory agent indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity, such as rheumatoid arthritis, osteoarthritis (arthrosis, degenerative joint disease) ankylosing spondylitis, acute musculo-skeletal disorders and acute gout.

  Pain following orthopaedic, dental and other minor surgery. I.M. only: Feldene is a non-steroidal anti-inflammatory drug indicated for a variety of conditions requiring anti-inflammatory and/or analgesic activity. Feldene I.M. is indicated for initial treatment of acute conditions (acute gout, acute musculoskeletal disorders) and acute exacerbations of chronic conditions (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis). Pain following orthopaedic, dental and other minor surgery.

• Adult Dosage
  

  IM only: Feldene I.M. is for intramuscular administration only

  Therapy should be initiated at the lowest recommended dose, especially in elderly patients.

  Adults

  Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis: The recommended starting dose is 20mg given as a single dose. The majority of patients will be maintained on 20mg daily. A relatively small group of patients may require up to 30mg daily given in single or divided doses. Administration of doses exceeding 20mg daily (or more than several days duration) carries an increased risk of gastro-intestinal side-effects.

  Acute gout: Therapy should be initiated by a single dose of 40mg followed by the next 4 to 6 days with 40mg daily, given in a single or divided daily dosage. Feldene is not indicated for the long-term management of gout.

  Acute musculo-skeletal disorders: Therapy should be initiated with 40mg daily for the first 2 days, given in single or divided doses. For the remainder of the 7 to 14 day treatment period, the dose should be reduced to 20mg daily.

  Post-operative pain

  Dental and other minor surgery: The recommended starting and maintenance dose is 20mg once daily. Doses of 40mg daily, in single or divided doses, for the first two days of treatment may provide faster onset of action.

  Orthopaedic surgery: Therapy should be initiated with 40mg daily for the first two days, given in single or divided doses. For the remainder of the treatment period, the dose should be reduced to 20mg daily.

  Combined administration
  The total daily dosage of Feldene administered as capsules, melt tablets, and intramuscular injection, should not exceed the maximum recommended daily dosage as indicated above.

  I.M. only:

  The dosage of Feldene I.M. intramuscular injection is identical to the dosage of oral Feldene. For continuation of treatment, oral (capsules or dispersible tablets) or suppository dose forms should be used. Feldene I.M. intramuscular injection should be administered by deep intramuscular injection into the upper, outer quadrant of the buttock. Feldene I.M. intramuscular injection should not be administered intravenously.

  Melt tablets only:

  The fast dissolving dosage form may be swallowed with water, or placed on the tongue to disperse and then swallowed with the saliva. The fast dissolving dosage form dissolves almost instantly in the mouth in the presence of water or saliva.

  Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

• Child Dosage
  

  Capsules, IM and Melt tablets:

  Dosage recommendations and indications for use in children other than in juvenile chronic arthritis using Feldene Dispersible Tablets have not been established.

• Elderly Dosage
  

  Elderly, frail or debilitated patients may tolerate side-effects less well and such patients should be carefully supervised. As with other NSAID's, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function.

• Contra Indications
  

  1. Active peptic ulceration or history of recurrent ulceration.

  2. Feldene should not be used in those patients who have previously shown a hypersensitivity to the drug. The potential exists for cross-sensitivity to aspirin and other non-steroidal anti-inflammatory drugs.

  3. Feldene should not be given to patients in whom aspirin and other non-steroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or urticaria.

  4. Severe heart failure.

• Special Precautions
  

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

  Drug administration should be closely supervised in patients with a history of upper gastro-intestinal disease. Feldene should be withdrawn if peptic ulceration or gastro-intestinal bleeding occurs.

  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.

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

  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 Feldene.

  Feldene should be used with caution in patients with or a history of bronchial asthma.

  Feldene should be used with caution in patients with renal, hepatic and cardiac impairment. In rare cases, non-steroidal anti-inflammatory drugs may cause interstitial nephritis, glomerulitis, papillary necrosis and the nephrotic syndrome. Such agents inhibit the synthesis of the prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. In these patients, administration of a non-steroidal anti-inflammatory drug may precipitate overt renal decompensation, which is typically followed by recovery to pretreatment state upon discontinuation of non-steroidal anti-inflammatory therapy. Patients at greatest risk of such a reaction are those with congestive heart failure, liver cirrhosis, nephrotic syndrome and overt renal disease, such patients should be carefully monitored whilst receiving NSAID therapy. Because of reports of adverse eye findings with non-steroidal anti-inflammatory drugs, it is recommended that patients who develop visual complaints during treatment with Feldene have ophthalmic evaluation.

  Melt tablets only:

  Patients with phenylketonuria:

  Due to aspartame content of Feldene Melt, each tablet contains 0.07mg phenylalanine. Each 20mg tablet contains 0.14mg phenylalanine.

• Interactions
  

  Antacids: Concomitant administration of antacids had no effect on piroxicam plasma levels.

  Anticoagulants: As with other non-steroidal anti-inflammatory drugs, bleeding has been reported rarely when Feldene has been administered to patients on coumarin-type anticoagulants. Patients should be monitored closely if Feldene oral anticoagulants are administered together.

  Aspirin and other Non-Steroidal Anti-Inflammatory Drugs: Feldene, like other non-steroidal anti-inflammatory drugs decreases platelet aggregation and prolongs bleeding time. This effect should be kept in mind when bleeding times are determined.

  As with other non-steroidal anti-inflammatory drugs, the use of Feldene with aspirin or the concomitant use of two non-steroidal anti-inflammatory drugs is not recommended because data are inadequate to demonstrate that the combination produces greater improvement than that with the drug alone and the potential for adverse reactions is increased.

  Studies in man have shown that the concomitant administration of Feldene and aspirin resulted in a reduction of plasma levels of piroxicam to about 80% of the normal values.

  Cimetidine: Results of two separate studies indicate a slight but significant increase in absorption of piroxicam following cimetidine administration but no significant changes in elimination rate constants or half-life. The small increase in absorption is unlikely to be clinically significant.

  Digoxin, Digitoxin: Concurrent therapy with Feldene and digoxin, or Feldene and digitoxin, did not affect the plasma levels of either drug.

  Diuretics: Non-steroidal anti-inflammatory drugs may cause sodium, potassium and fluid retention and may interfere with the natriuretic action of diuretic agents. These properties should be kept in mind when treating patients with compromised cardiac function or hypertension since they may be responsible for the worsening of those conditions.

  Highly protein-bound drugs: Feldene is highly protein-bound and therefore might be expected to displace other protein-bound drugs. The physician should closely monitor patients for change when administering Feldene to patients on highly protein-bound drugs.

  Lithium: Non-steroidal anti-inflammatory drugs, including Feldene, have been reported to increase steady state plasma lithium levels. It is recommended that these levels are monitored when initiating, adjusting and discontinuing Feldene.

  Feldene, like other non-steroidal anti-inflammatory drugs, may interact with the following drugs / classes of therapeutic agents:

  Antihypertensives -antagonism of the hypotensive effect

  Methotrexate - reduced excretion of methotrexate, possibly leading to acute toxicity

  Cyclosporin - possible increased risk of nephrotoxicity

  Corticosteroids - increased risk of gastro-intestinal bleeding and ulceration

  Quinolone antibiotics - possible increased risk of convulsions

  Mifepristone - NSAIDs could interfere with mifepristone-mediated termination of pregnancy

• Adverse Drug Reactions
  

  Gastro-intestinal: These are the most commonly encountered side-effects but in most instances do not interfere with the course of therapy. They include stomatitis, anorexia, epigastric distress, gastritis, nausea, vomiting, constipation, abdominal discomfort, flatulance, diarrhoea, abdominal pain and indigestion, rare cases of pancreatitis have been reported.

  Objective evaluations of gastric mucosa appearances and intestinal blood loss show that 20mg/day of Feldene administered either in single or divided doses is significantly less irritating to the gastro-intestinal tract than aspirin. Peptic ulceration, perforation and gastro-intestinal bleeding (including haematemesis and melaena) in rare cases fatal, have been reported with Feldene.

  Some epidemiological studies have suggested that piroxicam is associated with higher risk of gastro-intestinal adverse reactions compared with some NSAIDs, but this has not been confirmed in all studies. Administration of doses exceeding 20mg daily (of more than several days duration) carries an increased risk of gastro-intestinal side-effects, but they may also occur with lower doses. 

  Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. The possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.

  CNS: Dizziness, headache, somnolence, insomnia, depression, nervousness, hallucinations, mood alterations, dream abnormalities, mental confusion, paraesthesiae and vertigo have been reported rarely.

  Dermal hypersensitivity: Rash and pruritis. Onycholysis and analopoecia have rarely been reported. Photosensitivity reactions occur infrequently. As with other non-steroidal anti-inflammatory drugs, toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome may develop in rare cases. Vesiculo bullous reactions have been reported rarely.

  Hypersensitivity reactions: Hypersensitivity reactions such as anaphylaxis, bronchospasm, urticaria/angioneurotic oedema, vasculitis and serum sickness have been reported rarely.

  Renal function: Interstitial nephritis, nephrotic syndrome, renal failure and renal papillary necrosis have been reported rarely.

  Haematological: Decreases in haemaglobin and haematocrit, unassociated with obvious gastro-intestinal bleeding have occurred. Anaemia, thrombocytopenia and non-thrombocytopenia purpura (Henoch-Schoenlein), leucopenia and eosinophilia have been reported. Cases of aplastic anaemia, haemolytic anaemia and epistaxis have rarely been reported.

  Liver function: Changes in various liver function parameters have been observed. As with most other non-steroidal anti-inflammatory drugs, some patients may develop increased serum transaminase levels during treatment with Feldene. Severe hepatic reactions including jaundice and cases of fatal hepatitis have been reported with Feldene. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical symptoms consistent with liver disease develop, or if systemic manifestations occur e.g. eosinophilia, rash etc., Feldene should be discontinued.

  Other: The following have been reported rarely, palpitations and dyspnoea, anecdotal cases of positive ANA, anecdotal cases of hearing abnormalities, metabolic abnormalities such as hypoglycaemia, hyperglycaemia, weight increase or decrease. Swollen eyes, blurred vision and eye irritations have been reported. Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes. Malaise and tinnitus may occur.

  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).

  I.M. only: Intramuscular: Transient pain upon injection has occasionally been reported. Local adverse reactions (burning sensations) or tissue damage (sterile abscess formation, fatty tissue necrosis) may occasionally occur at the site of injection.