Diclomol® (Diclofenac Sodium Injection)
Diclomol contains non-steroidal compound with pronounced anti-inflammatory, analgesic and antipyretic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation, pain and fever.
In rheumatic disease, the anti-inflammatory and analgesic properties of Diclomol elicit a clinical response characterized by marked relief from signs and symptoms such as pain at rest or on movement, morning stiffness and swelling of the joints, as well as by an improvement in function. In post-traumatic and post-operative inflammatory conditions, Diclomol rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and oedema. In clinical trials diclofenac has also been found to exert a pronounced analgesic effect in moderately and severely painful states of non-rheumatic origin, an effect which sets in within 15-30 minutes.
Diclomol ampoules are particularly suitable as initial therapy for inflammatory and degenerative rheumatic disease, as well as for the treatment of painful conditions due to inflammation of non-rheumatic origin.
- Acute, severe pain due to inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondiylitis, osteoarthrosis.
- Painful syndromes of the vertebral column.
- Non-articular rheumatism
- Acute attacks of gout
- Painful post-traumatic and post-operative inflammation and swelling
Peptic ulcer, hypersensitivity to the active substance or excipients. Like other non-steroidal anti-inflammatory agents. Diclomol is also contraindicated in patients whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandins synthetase inhibiting activity.
Precautions and warnings
Strict accuracy of diagnosis and close medical surveillance are imperative in patients with symptoms indicative of gastrointestinal disorders, with a case history suggestive of gastrointestinal ulceration, with ulcerative colitis, or with Crohn’s disease, as well as in patients suffering from severe impairment of hepatic function.
Owning to the importance of prostaglandins for maintaining renal blood flow, particular caution is called for when using Diclomol in cases of impaired cardiac or renal function, in patients being treated with diuretics and in those recovering from major surgical operations.
In rare instances where peptic ulceration or gastrointestinal bleeding occur in patients receiving the medication, the drug should be withdrawn.
In patients of advanced age, caution is indicated on basic medical grounds.
During prolonged treatment with Diclomol, as with other highly active non-steroidal anti-inflammatory agents, blood counts and monitoring of hepatic and renal function are indicated as precautionary measures.
Patients who experience side effects related to the central nervous system should refrain from driving and operating hazardous machinery.
Pregnancy and lactation
Insufficient data are available as yet on the use of Diclomol ampoules during pregnancy and lactation. For this reason, their use is not recommended during pregnancy and lactation.
When given together with preparations containing lithium or digoxin, Diclomol may raise their plasma concentrations; but no clinical signs of overdosage in such cases have yet been encountered. Various non-steroidal anti-inflammatory agents are liable to inhibit the activity of diuretics.
Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, thus making it necessary to monitor the latter.
Concomitant administration of systemic noon-steroidal anti-inflammatory agents may increase the occurrence of side effects
Clinical investigations appear to indicate that diclofenac has no influence on the effect of anticoagulants. As a precaution, however, it is recommended that, when giving concomitant treatment, test should be performed in order to check that the desired response to the anticoagulant is being maintained. As with other non-steroidal anti-inflammatory agents, diclofenac in a high dose (200mg) can temporarily inhibiting platelet aggregation.
Clinical studies have shown that Diclomol can be given together with oral antidiabetic agents without influencing their clinical effect.
Caution should be exercised when non-steroidal anti-inflammatory drugs are administered less than 24 hours before or after treatment with methotrexate, since the blood concentration of methotrexate may rise and the toxicity of this substance be increased.
Adults: for adults the dosage is generally one ampoule daily injected deep intragluteally into the upper outer quadrant. By way of exception, in severe cases two injections separated by an interval of a few hours can be given per day (one into each buttock).
Alternatively, it is possible to combine one ampoule with oral Diclofenac tablets up to a maximum daily dosage of 150mg. Diclomol ampoules should not be given for more than 2 days; if necessary, the treatment can be continued with Diclomol Tablets
Diclomol ampoules are not suitable for children.
Management of acute poisoning with non-steroidal anti-inflammatory agents consists essentially of supportive and symptomatic measures.
The therapeutic measures to be taken should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression.
Specific therapies such as forced dieresis, dialysis or haemoperfusion are probably of no help in eliminating nonsteroidal anti-inflammatory agents, because of their high protein-binding rate and extensive metabolism.