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remethanRemethan

ANALGESIC, ANTIPYRETIC, ANTI-INFLAMMATORY

Composition
The active ingredient of Remethan is Diclofenac Sodium.

Properties
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 prostaglandin precursors.

Pharmacodynamics/Kinetics

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 the urine.

Indications
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.

Dosage
For enteric-coated tablets:
The recommended adult dose of Remethan is 75-150mg daily given in two/or three divided doses.

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.

For Suppositories:
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.

Side-effects
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.

Dermatological :
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.

Suppository : 
Local reactions include itching, burning and increased frequency of bowel movement.

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 rash occurs.

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 counts.

Us of Diclofenac in patients with hepatic prophyria may trigger an attack.

Pregnancy
Remethan should not be prescribed during pregnancy, unless there are compelling reasons for doing so.

Drug Interactions 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 anti-inflammatory drugs.

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 effect.

However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects which have required adjustments to the dosage of hypoglycaemic agents.

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 monitored.

WARNINGS

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.

Contraindications
Remethan is contra-indicated in patients with peptic ulcer, previous sensitivity to Remethan and during pregnancy.

Overdosage
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.

Pharmaceutical Precautions

Storage Conditions :

Remethan should be stored below 25C, protected from light and moisture.

Incompatibilities:
None.

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