Diclofix 50 Text



Composition: Each enteric-coated tablet contains Diclofenac Sodium BP 50 mg.

Description: Diclofenac Sodium is a non-steroidal anti-inflammatory drug with analgesic, antipyretic, and anti-inflammatory actions.

Mode of Action: Diclofenac selectively inhibits the cyclo-oxygenase enzyme, resulting in inhibition of prostaglandin synthesis and exhibiting anti-inflammatory, analgesic, and antipyretic properties.

Pharmacokinetics: Diclofenac is well absorbed from the GI tract after oral administration. About 60% of the oral dose reaches systemic circulation, with peak plasma levels achieved within 1-4 hours. Following a 75 mg injection, peak plasma concentrations are reached within 10-22 minutes. Approximately 60% of the administered dose is excreted via the kidneys. The mean elimination half-life is 1-2 hours.

Indications: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, pain following surgery, and other joint pains.

Dosage and Administration:

  • Adults: 50-150 mg daily in 2-3 divided doses.
  • Children (1-12 years): 1-3 mg/kg daily in divided doses (for juvenile arthritis).

Contraindications: Patients with hypersensitivity to Diclofenac, aspirin, or other NSAIDs. Also contraindicated in peptic ulcer and gastrointestinal bleeding.

Side Effects: Diclofenac is generally well tolerated. Common side effects include epigastric pain, nausea, headache, dizziness, and diarrhea.

Use in Pregnancy & Lactation: Diclofenac should not be used during pregnancy (USFDA pregnancy category D). Very small quantities may be detected in breast milk, but no undesirable effects on infants are expected.

Precautions: Use with caution in renal, cardiac, or hepatic impairment. Avoid concurrent use of multiple oral NSAIDs.

Drug Interactions: Concomitant use with acetylsalicylic acid lowers plasma concentrations of both drugs. Diclofenac increases plasma concentrations of digoxin and methotrexate and may antagonize diuretics.

Storage: Keep below 30��C, protect from light & moisture. Keep out of reach of children.

Packaging: Diclofix 50 Tablet: Each carton contains 100 (10X10��s) tablets in a blister pack.