Diclofenac Sodium

Diclofenac Sodium

[1 tablet 40 cents]

ADMINISTRATION ROUTES:

  • PO, PR

ALTERNATIVE NAMES:

  • Cataflam, Flameril, Voltaren, Diclax, Voltfast

ICU INDICATIONS:

  1. analgesic

PRESENTATION AND ADMINISTRATION:

  • PO:
    Tablets:
    Cataflam 25mg (pale red), Voltaren Rapid 25mg (pale red)
    Dispersible Tablets:
    Voltaren D Dispersible 50mg for dispersal in water
    Enteric Coated tablets:

    Apo-Diclo EC tablets 25mg (yellow), Apo-Diclo EC tablets 50mg (light brown), Flameril 25mg tablets (yellow), Flameril 50mg tablets (light brown), Voltaren 50mg tablets (light brown)
    Sustained release tablets:
    Apo-Diclo SR tablets 75mg (pink), Apo-Diclo SR tablets 100mg (pink), Diclax SR tablets 75mg (pink), Diclax SR tablets 100mg (light red), Flameril Retard 75mg (pale pink), Flameril Retard 100mg (pink), Voltaren SR 75mg (pale pink)
  • PR:
    Voltaren Suppositories 12.5mg and 25mg

DOSAGE:

  • PO or PR: 50mg 8 hourly or 75mg 12 hourly of sustained release

DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:

  • Dose in renal impairment [GFR (ml/min)]
    <10: use only if on long-term dialysis; dose as in normal renal function
    10-20: dose as in normal renal function but avoid if possible
    >20-50: dose as in normal renal function
  • Dose in renal replacement therapy
    CAPD: dose as in normal renal function
    HD: dose as in normal renal function
    CVVHDF: use only if on long-term dialysis; dose as in normal renal function

DOSAGE IN PAEDIATRICS:

  • PO or PR:
    1mg/kg 8-12 hourly

CLINICAL PHARMACOLOGY:

  • Diclofenac is a non steroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities.

CONTRAINDICATIONS

  1. known hypersensitivity to Voltaren
  2. should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

WARNINGS

  • Use in ICU:
    Risks often outweigh benefits in ICU patients; careful consideration is required
  • GI bleeding:
    Serious gastrointestinal toxicity such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy.
  • Anaphylactoid Reactions:
    As with other NSAIDs, anaphylactoid reactions may occur in patients without known prior exposure to diclofenac sodium. Diclofenac sodium should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.
  • Advanced Renal Disease:
    In cases with advanced kidney disease, treatment with diclofenac sodium is not recommended unless the patient is already on dialysis.

PRECAUTIONS

  • General:
    Hepatic Effects
    Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including diclofenac sodium. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
    Hematological Effects
    Anaemia is sometimes seen in patients receiving NSAIDs, including diclofenac sodium. This may be due to fluid retention, GI loss, or an incompletely described effect upon erythropoiesis.
    Fluid Retention and Oedema
    Fluid retention and oedema have been observed in some patients taking NSAIDs. Therefore, as with other NSAIDs, diclofenac sodium should be used with caution in patients with fluid retention, hypertension, or heart failure.
  • Laboratory Tests:
    No tests in addition to routine ICU tests are indicated
  • Drug/Laboratory Test Interactions:
    None known.

IMPORTANT DRUG INTERACTIONS FOR THE ICU

  • Aspirin:
    When diclofenac sodium is administered with aspirin, its protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.
  • Methotrexate:
    NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
  • Cyclosporine:
    Diclofenac sodium, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with diclofenac sodium may increase cyclosporine’s nephrotoxicity. Caution should be used when diclofenac sodium is administered concomitantly with cyclosporine. ACE-Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE- inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
  • Furosemide:
    Clinical studies, as well as postmarketing observations, have shown that diclofenac sodium can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.
  • Lithium:
    NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
  • Warfarin:
    The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

ADVERSE REACTIONS

  • Body as a Whole:
    Anaphylactic reactions
  • Cardiovascular System:
    Congestive heart failure, hypertension, tachycardia, syncope.
  • Digestive System:
    Abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, gross bleeding/ perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting, dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice.
  • Haematological System:
    Ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia.
  • Nervous System:
    Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo. Respiratory System: Asthma, dyspnea.
  • Skin and Appendages:
    Alopecia, photosensitivity, sweating increased.
  • Urogenital System:
    Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure.

Critical Care Drug Manual

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