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Diclofenac Sodium Injection 3ml: 75mg
Composition:
Each 3ml ampoule contains:
Description:
Diclofenac Sodium is a nonsteroidal anti-inflammatory drug (NSAID) with potent analgesic, anti-inflammatory, and antipyretic properties. It works by inhibiting cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis, which is responsible for pain and inflammation.
Indications:
Diclofenac Sodium Injection is used for the short-term treatment of acute pain and inflammation, including:
- Postoperative pain
- Severe musculoskeletal pain (e.g., back pain, sprains, and fractures)
- Renal colic and biliary colic
- Acute gout attacks
- Pain and inflammation due to rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
Dosage & Administration:
Adults:
- Single dose: 75mg (1 ampoule) once daily via IM injection
- If needed, a second dose of 75mg can be given after 6-12 hours
- Maximum daily dose: 150mg (2 ampoules) per day
- Duration of treatment: Use for the shortest possible duration (usually 2-3 days). If needed, switch to oral or rectal Diclofenac for continued therapy.
Elderly Patients:
- Use the lowest effective dose due to increased risk of gastrointestinal and cardiovascular side effects.
Patients with Hepatic or Renal Impairment:
- Use with caution-dose adjustments may be needed.
- Severe renal or hepatic impairment: Use is not recommended.
Administration:
- Administer by deep intramuscular (IM) injection into the gluteal muscle.
- Do not inject intravenously (IV) or subcutaneously.
- Rotate injection sites to prevent muscle irritation.
Contraindications:
- Hypersensitivity to Diclofenac, other NSAIDs, or excipients
- Active peptic ulcer, gastrointestinal bleeding, or perforation
- Severe hepatic or renal impairment
- Severe heart failure
- Patients with a history of NSAID-induced asthma, urticaria, or angioedema
- Pregnancy (third trimester)
Precautions:
- Cardiovascular Risk: Long-term use may increase the risk of heart attack, stroke, and hypertension.
- Gastrointestinal Risk: Risk of gastric ulcers, bleeding, and perforation-use with caution in patients with a history of ulcers or gastrointestinal disease.
- Renal Effects: May cause fluid retention, hypertension, and kidney dysfunction-monitor renal function, especially in high-risk patients.
- Liver Toxicity: Monitor liver enzymes with prolonged use.
- Avoid Concomitant NSAIDs: Increases the risk of side effects.
Adverse Reactions:
- Common: Pain at the injection site, nausea, vomiting, dizziness, headache
- Serious: Gastrointestinal bleeding, hypertension, liver toxicity, kidney dysfunction, allergic reactions (rash, anaphylaxis)
Drug Interactions:
- Anticoagulants (Warfarin, Heparin): Increased bleeding risk
- Diuretics & ACE Inhibitors: May reduce effectiveness-monitor renal function
- Corticosteroids & Other NSAIDs: Increased risk of gastrointestinal bleeding
- Lithium & Methotrexate: May increase toxicity levels-monitor closely
Storage Conditions:
- Store below 25°C, in a dry place
- Protect from light and moisture
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