Indications

Diclofenac Sodium is indicated in-
  • The relief of pain and inflammation in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
  • Non-articular rheumatism, acute musculoskeletal disorders and back pain
  • Painful syndromes of the vertebral column
  • Acute gout
  • Painful post-traumatic and post operative inflammation and swelling such as dental or orthopedic surgery.
  • Painful inflammatory conditions in gynaecology and primary dysmenorrhoea.
  • In fever and pain associated with inflammatory infections of the upper respiratory tract.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Pharmacology

Diclofenac 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.

Dosage & Administration

Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

SR Tablet:
  • Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
  • Children: 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, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.
Dispersible Tablet:
  • Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
  • Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight.
  • Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.
Diclofenac gel: Depending on the size of the affected site, 2-4 gm gel, 3-4 times daily. After application, the hands should be washed unless they are the site being treated.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Interaction

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, making it necessary to monitor these levels. Patients taking Diclofenac and also receiving digoxin, methotrexate, cyclosporine or lithium should be observed for potential development of the specific toxicities of these drugs. Concomitant administration of other systemic non-steroidal anti-inflammatory agents or glucocorticoids may increase the occurrence of side effects e.g. gastrointestinal bleeding.

Contraindications

It is contraindicated in known hypersensitivity to Diclofenac or other non-steroidal anti-inflammatory drugs to patients with active peptic ulcer and to patients in whom aspirin induced asthma, acute rhinitis and urticaria were observed.

Side Effects

Generally, it is well tolerated. The common side effects include- gastro-intestinal discomfort, bleeding, nausea, vomiting, dizziness, headache, jaundice, insomnia, drowsiness, depression, anxiety, urticaria, hypersensitivity reactions (bronchospasm, angioneuratic edema, rashes) and hearing disturbances such as tinnitus.

Pregnancy & Lactation

The use of Diclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Precautions & Warnings

It should be used cautiously in patients with a history of cardiovascular disease, in patients with a history of gastro-intestinal disease or bleeding and in patients with severe hepatic or renal damage, asthma etc.

Storage Conditions

Keep in a dry place away from light and heat. Keep out of the reach of children.