The active ingredient of Remethan is Diclofenac Sodium.
Remethan is a non-steroidal phenylacetic acid derivative which has marked
analgesic, and anti-inflammatory properties. Remethan is absorbed from the
gastrointestinal tract reaching peak plasma concentrations in two hours after
ingestion of the enteric-coated tablets. Remethan is metabolised and excreted
mainly in the urine.
Mechanism of Action inhibits prostaglandin synthesis by decreasing the
activity of the enzyme, cyclo-oxygenase, which results in decreased formation of
Absorption : Completely absorbed.
Protein binding : 99%
Metabolism : Metabolised in the liver
to inactive metabolites.
Half-life : 2 hours.
Time to peak serum concentration :
Within 2 hours
Elimination : Excreted primarily in
Remethan is indicated for the treatment of rheumatoid arthritis; ankylosing
spondylitis, osteoarthrosis; low back pain, frozen shoulder, tendinitis,
tenosynovitis, bursitis, strains, sprains and acute gout Remethan is also
indicated for the control of pain and inflammation in orthopedic, dental and
other minor surgery. In children, Remethan is indicated for the treatment of
Juvenile chronic arthritis.
For enteric-coated tablets:
The recommended adult dose of Remethan is 75-150mg daily given in two/or three
Children should be given 1,3mg/kg per day in divided doses. For elderly
patients the standard adult dose may be used.
For sustained release tablets:
Remethan Retard: One tablet daily, taken whole with liquid, preferably at meal
times. If necessary, the daily dosage can be increased to 150mg by
supplementation with conventional Remethan tablets. For milder cases, where a
lower dosage is sufficient other dosage forms of Remethan may be used.
Remethan suppositories are not suitable for use in children.
The recommended adult dose is one lOOmg suppository daily, usually administered
at night. In more severe cases, combined therapy with 25 or 60mg tablets is
recommended. The total daily dose should not 150mg.
Remethan is relatively free from serious side-effects. The side-effects
are often transient and disappear with continuation
of medication. These may include epigastric pain, nausea, diarrhoea, headache,
slight dizziness, skin rashes, peripheral oedema and abnormalities of serum
transaminases. Very rarely peptic ulcer and haematemesis or melaena have been
reported. In such cases Remethan should be withdrawn.
Occasional rashes or skin eruptions. Cases of hair loss, bullous eruptions,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's
syndrome) and photo-sensitivity reactions have been reported.
Local reactions include itching, burning and increased frequency of bowel
Precautions and Warnings
Remethan should be given with caution to patients with a history of peptic
ulcer, haematemesis or melaena, or bleeding
diathesis or with severe hepatic or renal insufficiency.
Severe cutaneous reactions, including Steven-Johnson Syndrome and toxic
epidermal necrolysis ( Lyell's syndrome ), have been reported with Diclofenac
Sodium. Patients treated with Diclofenac Sodium should be closely monitored for
signs of hypersensitivity reaction. Discontinue Diclofenac Sodium immediately if
Patients with severe hepatic, cardiac or renal insufficiency or the elderly
should be kept under close surveillance. All patients who are receiving
long-term treatment with non-steroidal anti-inflammatory agents should be
monitored as a precautionary measure eg renal, hepatic function and blood
Us of Diclofenac in patients with hepatic prophyria may trigger an attack.
Remethan should not be prescribed during pregnancy, unless there are compelling
reasons for doing so.
Remethan may cause increased blood concentrations of Digoxin and
Lithium. Although studies have demonstrated a pharmacokinetic interaction
between Remethan and Salicylates it has been stated that this has no clinical
significance. It has also been reported that Remethan, unlike some other
non-steroidal anti-inflammatory agents, does not potentiate the effects of oral
anticoagulants or hypoglycaemics. The natriuretic effects of Frusemide type
diuretics have been reported to be inhibited by some non-steroidal
Methotrexate excretion is inhibited by non-steroidal anti-Inflammatory drugs.
Simultaneous administration of Methotrexate and non-steroidal anti-inflammatory
drugs should probably be avoided. Occasional fatalities from renal failure have
been reported. Severe cutaneous reactions, including Stevens-Johnson Syndrome
and Mncspidermai necrolysis (Lyell's synorome) have been reported with
Diclofenac Sodium. Patients treated with Diclofenac Sodium should be closely
monitored for signs of hypersensitivity reactions. Discontinue I Diclofenac
Sodium immediately if rash occurs.
Clinical investigations do not appear to indicate that Remethan affects the
activity of anticoagulants but there have been isolated reports of an increased
risk of haemorrhage with the combined use of these agents. Close monitoring is
therefore recommeded. Clinical studies have shown that remethan can be given
together with oral antidiabetic agents without influencing their clinical
However, there have been isolated reports of hypoglycaemic and
hyperglycaemic effects which have required adjustments to the dosage of
Cyclosporin nephrotoxicity may be increased by the effect of
non-steroidal anti-inflammatory drugs on renal prostaglandins.
Caution should be exercised if NSAIDs and Methotrexate are administered
within 24 hours of each other, since NSAIDs may increase Methotrexate plasma
levels, resulting in increased toxicity. Concomitant therapy with other
systemic NSAIDs may increase the frequency of side-effects.
Various NSAIDs are liable to inhibit the activity of diuretics.
Concomitant treatment with Potassium-sparing diuretics may be associated
with increased serum Potassium levels, hence serum Potassium should be
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID.
Serious GI toxicity such as bleeding, ulceration and perforation can
occur at any time, with or without warning symptoms, in patients treated
with NSAID therapy. Although minor GI problems ( eg dyspepsia ) are
common, usually developing early in therapy, prescribers should remain
alert for ulceration and bleeding in patients treated with NSAIDs even
in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at
risk of developing peptic ulceration and bleeding. Patients with prior
history of adverse events and other risk factors associated with peptic
ulcer disease ( eg alcoholism, smoking, corticosteroid therapy ) are at
increased risk. Elderly or debilitated patients seem to tolerate
ulceration of bleeding less than other individuals and account for most
spontaneous reports for fatal GI events.
Remethan is contra-indicated in patients with peptic ulcer, previous
sensitivity to Remethan and during pregnancy.
Management of a non-steroidal anti-inflammatory drug-intoxication is
primarily supportive and symptomatic. Fluid therapy is commonly effective in
managing the hypotension that may occur following acute NSAID overdosage, except
when this is due to an acute blood loss. The therapeutic measures to be taken
are: absorption should be prevented as soon as possible after over dosage by
means of gastric lavage and treatment with activated charcoal.
Storage Conditions :
Remethan should be stored below 25°C, protected from light and moisture.