ADMINISTRATION ROUTES:
PO, PR
ALTERNATIVE NAMES:
Cataflam, Flameril, Voltaren, Diclax, Voltfast
ICU INDICATIONS:
- Analgesic
PRESENTATION AND ADMINISTRATION:
PO:
Tablets:
Cataflam 25mg (pale red), Voltaren Rapid 25mg (pale red)
Dispersible Tablets:
Voltaren D Dispersible 50 mg for dispersal in water
Enteric Coated tablets:
Apo-Diclo EC tablets 25mg (yellow), Apo-Diclo EC tablets 50 mg (light brown), Flameril 25mg tablets (yellow), Flameril 50 mg tablets (light brown), Voltaren 50 mg tablets (light brown)
Sustained release tablets:
Apo-Diclo SR tablets 75mg (pink), Apo-Diclo SR tablets 100 mg (pink), Diclax SR tablets 75mg (pink), Diclax SR tablets 100 mg (light red), Flameril Retard 75mg (pale pink), Flameril Retard 100 mg (pink), Voltaren SR 75mg (pale pink)
PR:
Voltaren Suppositories 12.5mg and 25mg
DOSAGE:
PO or PR:
50 mg TDS or 75mg BD of sustained release
DOSAGE IN RENAL FAILURE AND RENAL REPLACEMENT THERAPY:
Dose in renal impairment
| GFR (ml/min) | DOSE |
|---|---|
| <10 | use only if on long-term dialysis; dose as in normal renal function |
| 10-20 | avoid if possible; dose as in normal renal function |
| >20-50 | dose as in normal renal function |
Dose in renal replacement therapy
| MODALITY | DOSE |
|---|---|
| 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:
1 mg/kg 8-12 hrly
CLINICAL PHARMACOLOGY:
Diclofenac is a non steroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities
CONTRAINDICATIONS:
- Known hypersensitivity to Voltaren
- 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 non-steroidal anti-inflammatory drugs (NSAIDs). Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID treatment
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
Haematological 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 IN 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.
Cyclosporin:
Diclofenac sodium, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with diclofenac sodium may increase cyclosporin's nephrotoxicity. Caution should be used when diclofenac sodium is administered concomitantly with cyclosporin
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 post-marketing 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, oesophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, haematemesis, hepatitis, jaundice
Haematological System:
Ecchymosis, eosinophilia, leukopaenia, melaena, purpura, rectal bleeding, stomatitis, thrombocytopaenia
Nervous System:
Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paraesthesia, somnolence, tremors, vertigo
Respiratory System:
Asthma, dyspnoea
Skin and Appendages:
Alopecia, photosensitivity, sweating increased
Urogenital System:
Cystitis, dysuria, haematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure