Difenac Plus (75 mg+20 mg)/2 ml (IM Injection)

Indications

• Relief of pain and inflammation in arthritic conditions
• Relief of pain and inflammation in musculoskeletal disorders
• Treatment of painful conditions resulting from trauma
• Use as a local anesthetic to minimize pain at injection site

Pharmacology

• Potent nonsteroidal anti-inflammatory drug (NSAID)
• Marked analgesic and antipyretic properties
• Inhibition of prostaglandin synthesis
• Rapid action and stability of Lidocaine as a local anaesthetic

Dosage & Administration

• Adult dosage: One ampoule once (or twice) daily by intramuscular injection
• Renal colic dosage: One ampoule once daily intramuscularly
• Children dosage: 1-3 mg of Diclofenac Sodium per kg body weight daily in divided doses
• Recommended lowest effective dosage for elderly patients

Interaction

• Increased plasma concentrations of Lithium and Digoxin
• Reports of increased risk of haemorrhage with combined use of Diclofenac and anticoagulant therapy
• Compatibility with oral antidiabetic agents
• Cases of nephrotoxicity with concomitant use of Cyclosporin and Diclofenac
• Risk of serious toxicity with concomitant use of Methotrexate and NSAIDs
• Potential convulsions with concomitant therapy of NSAIDs and quinolones
• Possible increased frequency of unwanted effects with co-administration of Diclofenac with other systemic NSAIDs and steroids

Contraindications

• Hypersensitivity to Diclofenac or local anaesthetics of the amide type
• Active or suspected peptic ulcer or gastrointestinal bleeding
• Precipitation of asthma, urticaria, or acute rhinitis by Aspirin or other NSAIDs
• Presence of Adams-Stokes syndrome or severe degrees of heart block
• Hypersensitivity to any of the excipients used in the formulation

Side Effects

• Mild and transient gastrointestinal discomfort
• Nausea, diarrhea, and occasional bleeding
• Rare instances of injection site disorder, abscesses, and local necrosis
• Adverse effects involving the CNS such as drowsiness, dizziness, disorientation
• CNS reactions manifested by lightheadedness

Pregnancy & Lactation

• Not recommended during pregnancy unless compelling reasons exist
• Use at lowest effective dosage during pregnancy
• Not recommended during the last trimester of pregnancy
• Detection of very small quantities of Diclofenac in breast milk

Precautions & Warnings

• Close observation for patients with severe hepatic, cardiac, or renal insufficiency
• Monitoring of renal function and use of lowest effective dose for at-risk patients
• Discontinuation of Diclofenac in case of abnormal liver function tests or other manifestations
• Precautionary monitoring for all patients on long-term NSAID treatment

Therapeutic Class

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

Storage Conditions

• Store at temperature not exceeding 30°C in a dry place
• Protected from light

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