Diclofenac Sodium suppository 50mg
Each suppository contains 100 mg Diclofenac Sodium.
Diclofenac sodium is a non-steroidal compound with analgesic,
anti-inflammatory, antirheumatic and antipyretic properties.
A single 50 mg dose of enteric coated tablets results in maximum
plasma concentrations of about 1500 ng/mL at 1,5 to 2 hours after
Diclofenac sodium is eliminated principally by metabolism and
subsequent urinary and biliary excretion of glucuronide and
sulphate conjugates of the metabolites. The principal metabolite in
man is the 4-hydroxy derivative of diclofenac sodium. The amount
excreted in urine accounts for 20 - 30% of the dose and that in
bile for 10 to 20%. The mean terminal elimination half-life is 1,2
to 1,8 hours.
Patients with porphyria. Children under the age of two years.
Patients with a history of active gastro-intestinal bleeding or
peptic ulceration. Severe hepatic or renal impairment.
Contra-indicated in aspirin-sensitive patients, patients sensitive
to any other non-steroidal anti-inflammatory agent, and in patients
sensitive to any of the ingredients in these products.
Safety during pregnancy and lactation has not yet been established.
The use of suppositories is contra-indicated in proctitis.
Rheumatoid arthritis, osteo-arthritis and ankylosing spondylitis.
Treatment of post traumatic pain and inflammation. For use as
initial therapy for inflammatory and degenerative rheumatic
Serious interactions have been reported after the use of high dose
methotrexate with diclofenac.
Caution is required in patients with a history of hypertension
and/or heart failure as fluid retention and oedema have been
reported in association with DICLOFENAC therapy.
Elderly: The elderly have an increased frequency of adverse
reactions to NSAIDs, especially gastrointestinal bleeding and
perforation (PUBs) which may be fatal.
The risk of gastrointestinal bleeding or perforation (PUBs) is
higher with increasing doses of DICLOFENAC, in patients with a
history of ulcers, and the elderly.
When gastrointestinal bleeding or ulceration occurs in patients
receiving DICLOFENAC, treatment with DICLOFENAC should be stopped.
DICLOFENAC should be given with caution to patients with a history
of gastrointestinal disease (eg. ulcerative colitis, Crohn's
disease, hiatus hernia, gastro-oesophegeal reflux disease,
angiodysplasia) as the condition may be exacerbated.
Serious skin reactions, some of them fatal, including exfoliative
dermatitis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis have been reported. DICLOFENAC should be discontinued at
the very first appearance of skin rash, mucosal lesions, or any
other sign of hypersensitivity.
DOSAGE AND DIRECTIONS FOR USE:
Suppositories should never be divided for administration as active
substance may be distributed unevenly.The average adult dose is 50
mg each evening.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disorders, including epigastric pain, eructation,
nausea and vomiting may occur.
Peptic ulceration and gastro-intestinal bleeding have been
reported. Other side-effects include vertigo, headache, skin
rashes, pruritis, tinnitus, depression, drowsiness, nervousness,
insomnia, irritability, agitation, minor hearing disorders, oedema,
palpitations, blurred vision and other ocular reactions.
Hypersensitivity reactions may occur and include fever and rashes.
Hepatotoxicity and aseptic meningitis which occur less frequently
may also be hypersensitivity reactions.
Diclofenac may cause cystitis and haematuria, as well as acute
renal failure, interstitial nephritis and nephrotic syndrome.
Other adverse effects include anaemia, thrombocytopenia,
neutropenia, eosinophilia, agranulocytosis and abnormalities of
liver function tests.
Patients with congestive heart failure, cirrhosis, diuretic-induced
volume depletion or renal insufficiency are at greater risk of
developing renal dysfunction due to non-steroidal anti-inflammatory
medicine-induced inhibition of renal prostaglandin synthesis.
It is advisable to perform blood counts in patients undergoing
DICLOFENAC should be given with care to patients with
cardiovascular disease, bleeding disorders, in those who are
receiving coumarin anti-coagulants, and in patients with impaired
hepatic or renal function.
Allergic reactions, which include angio-oedema, bronchospasm,
urticaria and anaphylactic reactions, have occurred. Because of the
possibility of cross-sensitivity due to structural relationships
which exist among non-steroidal anti-inflammatory medicines, acute
allergic reactions may be more likely to occur in patients who have
exhibited allergic reactions to these compounds.
Plasma concentrations are significantly decreased by the
concomitant administration of therapeutic doses of aspirin.
When given together with preparations containing lithium or
digoxin, diclofenac sodium may raise their plasma concentrations.
Concomitant administration of glucocorticoids or other
non-steroidal anti-inflammatory agents may aggravate
Concomitant administration with two or more non-steroidal
anti-inflammatory agents may promote the occurrence of
Should be used with caution in patients with asthma or
Use with care in elderly patients.
Decreased platelet aggregation with increased bleeding time may
May increase the half-life of probenecid.
Use with care with other protein-bound medicines e.g. Tolbutamide,
Coumarin and Hydantoin.
In view of the product’s inherent potential to cause fluid
retention, heart failure may be precipitated in some compromised
Protect from moisture.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.