This injection contains Diclofenac Sodium, which is used for the relief of all grades of pain and inflammation in a wide range of conditions, including:

• Arthritic conditions: Rheumatoid arthritis, Osteoarthritis, Juvenile chronic arthritis, Ankylosing spondylitis, Acute gout
• Acute musculoskeletal disorders: Periarthritis (e.g., frozen shoulder), Tendinitis, Tenosynovitis, Bursitis
• Other painful conditions due to trauma:, Fractures ,Low back pain, Sprains, Strains, Dislocations, Postoperative pain and inflammation in orthopaedic, dental and other minor surgeries, Renal colic pain.

This injection also contains Lidocaine, which acts as a local anaesthetic. Therefore, pain at the injection site—especially after intramuscular administration—is reduced when this formulation is used for the above indications.

Diclofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with strong analgesic and antipyretic properties. It also exhibits mild uricosuric activity. Its mechanism of action is mainly related to inhibition of prostaglandin synthesis. Diclofenac inhibits cyclooxygenase (COX), an enzyme responsible for converting arachidonic acid into prostaglandin precursors. Peak plasma concentration is achieved within 30 minutes after injection. Lidocaine is a widely used local anaesthetic agent. It acts rapidly and has a more stable effect compared to many other local anaesthetics. It is an effective surface anaesthetic. Like other local anaesthetics, Lidocaine blocks the generation and conduction of nerve impulses by slowing depolarization. The onset of action is rapid, and the duration of anaesthesia is approximately 1–2 hours.

Adult: One ampoule once (or in severe cases, twice) daily by intramuscular injection.

Renal colic: One ampoule once daily by intramuscular injection. A second dose may be given after 30 minutes if required.

Children: In juvenile chronic arthritis, 1–3 mg of Diclofenac Sodium per kg body weight daily in divided doses.

Elderly patients: In elderly or debilitated patients, the lowest effective dose is recommended, adjusted according to age and physical condition, or as prescribed by the physician.

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 NSAIDs 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 are lowered, although no clinical significance is known.

Diuretics: Various NSAIDs may inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels; therefore, serum potassium should be monitored.

It is contraindicated in patients hypersensitive to Diclofenac. It is also contraindicated in active or suspected peptic ulcer or gastrointestinal bleeding, and in patients in whom asthma, urticaria, or acute rhinitis is precipitated by Aspirin or other NSAIDs. Due to the presence of Lidocaine, it is contraindicated in patients hypersensitive to amide-type local anaesthetics, although this is rare. It is also contraindicated in patients with Adams-Stokes syndrome, severe SA, AV, or intraventricular heart block without an artificial pacemaker, and in those hypersensitive to any excipients (Sodium Metabisulphite, Disodium Edetate, Benzyl Alcohol, Sodium Hydroxide, Propylene Glycol).

Side effects are usually mild and transient; however, if serious effects occur, the drug should be discontinued. Gastrointestinal discomfort, nausea, diarrhoea, and occasionally bleeding may occur. In very rare cases, injection site reactions such as abscess or local necrosis may occur. Adverse effects due to Lidocaine mainly involve the CNS and are usually dose-related and short-lived, including drowsiness, dizziness, disorientation, confusion, and lightheadedness.

Diclofenac should not be used during pregnancy unless clearly necessary. The lowest effective dose should be used. NSAIDs are not recommended during the last trimester of pregnancy. Very small amounts may pass into breast milk, but adverse effects on the infant are not expected.

Renal: Patients with renal, cardiac, or hepatic impairment and elderly patients should be closely monitored, as NSAIDs may worsen renal function. The lowest effective dose should be used.

Hepatic: If abnormal liver function tests persist or clinical signs of liver disease appear, Diclofenac should be discontinued. Long-term NSAID users should be monitored regularly (renal, hepatic function, and blood counts).

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

Store below 30°C, protected from light and moisture. Keep out of the reach of children.