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Drug Details

ECONAC

• Drug Class Description
  Non-steroidal anti-inflammatory drugs (NSAIDs).
• Generic Name
  Diclofenac sodium
• Presentation
  Suppositories, diclofenac sodium 100mg. Injection, diclofenac 75mg/3mL.
• Description
  Suppositories. Solution for injection.
• Indications
  

  Econac Suppositories: Relief of all grades of pain and inflammation in a wide range of conditions, including: arthritic conditions such as rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis, acute gout; acute musculoskeletal disorders such as peri-arthritis (eg, frozen shoulder), tendinitis, tenosynovitis, bursitis; other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

  Econac Injection: Acute forms of pain, including renal colic; exacerbations of osteo- and rheumatoid arthritis; acute back rheumatoid arthritis; acute back pain; acute gout; acute trauma and fractures; postoperative pain.

• Adult Dosage
  

  Econac Suppositories: One 100mg suppository may be given as a once daily treatment, usually at night. Where necessary, therapy may be combined with tablets up to a total maximum dose of 150mg diclofenac per day.

  Econac Injection: one ampoule once (or in severe cases twice) daily intramuscularly by deep intragluteal injection into the upper outer quadrant. If two injections daily are required, use the alternate buttock for the second injection. Econac injection should not be given for more than two days; if necessary, treatment can be continued with tablets or suppositories.

  Renal colic: one ampoule intramuscularly, repeated after 30 minutes if necessary.

• Child Dosage
  Not suitable.
• Elderly Dosage
  Use lowest effective dose.
• Contra Indications
  

  Active or suspected peptic ulcer or gastrointestinal bleeding. Previous sensitivity to diclofenac. Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory drugs. Suppositories: In ulcerative or acute inflammatory conditions of the anus, rectum (proctitis) and sigmoid colon. Injection: Hypersensitivity to the excipients mannitol, propylene glycol, benzyl alcohol, sodium metabisulphite, sodium hydroxide.

• Special Precautions
  

  Asthma, chronic obstructive diseases of the respiratory tract, allergic rhinitis or swelling of the nasal mucosa. Symptoms or history suggestive of gastrointestinal ulceration. Ulcerative colitis, Crohn's disease, bleeding diathesis or haematological abnormalities. Elderly. Hepatic, renal or Hypersensitivity reactions may occur. Pregnancy and lactation.

• Interactions
  

  Lithium, digoxin, anticoagulants, oral hypoglycaemics, cyclosporin, methotrexate, quinolone antibiotics. Other NSAIDs, steroids, potassium-sparing diuretics.

• Adverse Drug Reactions
  

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

  Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high doses (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

  If serious side-effects occur, Econac should be withdrawn

  Frequency estimate: frequent: >10%, occasional: >1-10%, rare: >0.001-1%, isolated cases: <0.001%.

   

  Gastrointestinal Tract:

  Occasional: Epigastric pain, other gastro-intestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia).

  Rare: Gastro-intestinal bleeding (haematemesis, melaena, bloody diarrhoea), gastro-intestinal ulcers with or without bleeding or perforation.

  Isolated cases: Aphthous stomatitis, glossitis, oesophageal lesions, lower gut disorders (e.g. non-specific haemorrhagic colitis and exacerbations of ulcerative colitis or Crohn's proctocolitis, colonic damage and stricture formation), pancreatitis, constipation.

   

  Suppositories only:

  Occasional: Local reactions (e.g. itching, burning and increased bowel movement).

  Isolated cases: exacerbation of haemorrhoids.

   

  Central Nervous System:

  Occasional: Headache, dizziness or vertigo.

  Rare: drowsiness, tiredness.

  Isolated cases: Disturbances of sensation, paraesthesia, memory disturbance, disorientation, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions aseptic meningitis.

   

  Special senses:

  Isolated cases: Disturbances of vision (blurred vision, diplopia), impaired hearing, tinnitus, taste disturbances.

  Skin:

  Occasional: Rashes or skin eruptions.

  Rare: Urticaria.

  Isolated cases: Bullous eruptions, eczema, erythema multiforme, Steven's-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reactions, purpura including allergic purpura.

   

  Kidney:

  Rare: Oedema.

  Isolated cases: Acute renal insufficiency, urinary abnormalities (e.g. haematuria, proteinuria), interstitial nephritis, nephrotic syndrome, papillary necrosis.

   

  Liver:

  Occasional: Elevation of serum aminotransferase enzymes (ALT, AST).

  Rare: Liver function disorders including hepatitis (in isolated cases fulminant) with or without jaundice.

   

  Blood:

  Isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, haemolytic anaemia, aplastic anaemia.

   

  Hypersensitivity:

  Rare: Hypersensitivity reactions (e.g. bronchospasm, anaphylactic/anaphylactoid systemic reactions including hypotension).

  Isolated cases: Vasculitis, pneumonitis.

   

  Cardiovascular system:

  Isolated cases: Palpitations, chest pain, hypertension, congestive heart failure.