Arthritic conditions: Rheumatoid Arthritis, Osteoarthritis, Ankylosing spondylitis, acute gout, acute musculoskeletal disorders such as periarthritis (e.g., frozen shoulder), tendinitis, tenosynovitis, bursitis, other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental & other minor surgery.
Nonsteroidal Anti-Inflammatory Drug
Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.
50 mg : Adults: 75 - 150 mg daily in 2 to 3 divided doses, preferably after food. The recommended maximum daily dose of diclofenac is 150 mg. Children: In juvenile chronic arthritis, 1-3 mg of diclofenac/kg body wt. daily in divided doses. Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended. Gel: Should be rubbed gently into the skin. Depending on the size of the affected site to be treated 2-4 gm gel should be applied 3 - 4 times daily & rubbed in lightly. Suppository: Should be administered rectally. Adults: 50 mg or 100 mg suppository only: 75- 150 mg daily, in divided doses. Children (1-12 years): 12.5 mg or 25 mg suppository only: 1-3 mg/kg daily, in divided doses.
Diclofenac Sodium may have the following drug interactions:
Lithium and digoxin: Diclofenac may increase plasma concentrations of lithium and digoxin.
Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect.
Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.
Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving cyclosporin and diclofenac concomitantly.
Methotrexate: Cases of serious toxicity have been reported when methotrexate and NSAIDs are given within 24 hours of each other.
Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs.
Therefore, caution should be exercised when considering concomitant therapy of NSAID and quinolones.
Other NSAIDs and steroids: Co-administration of diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With aspirin, the plasma levels of each is lowered, although no clinical significance is known.
Diclofenac is contraindicated for those patients who are hypersensitive to diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity, diclofenac is also contraindicated.
Epigastric pain, nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, anorexia. Rare: gastro-intestinal bleeding, peptic ulcer (with or without bleeding or perforation), bloody diarrhoea. In isolated cases: lower gut disorders (e.g., non-specific haemorrhagic colitis & exacerbations of ulcerative colitis or Crohn’s proctocolitis), pancreatitis, glossitis, constipation, etc.
Diclofenac tablets & injection should not be prescribed during pregnancy, very small quantities may be detected in breast milk but no undesirable effects on the infant are to be expected.
Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.
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