Clofenac 25 mg

Indications: Clofenac is indicated for the following conditions:

• Rheumatology:

  • Inflammatory and degenerative forms of rheumatism, chronic involutive polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

• Surgery and Traumatology:

  • Sprains, bruises, dislocations, fractures, soft tissue injuries, and post-surgical interventions.

• Obstetrics and Gynecology:

  • Primary dysmenorrhea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

• Otorhinolaryngology:

  • Pre-operative medication for the prevention of pain, inflammation, and swelling.

• Dentistry:

  • Post-operative pain, inflammation, and swelling.

• Other Indications:

  • Prevention and treatment of pain, inflammation, and swelling in patients operated on in the urogenital tract, renal, and biliary colic.

Pharmacology: Clofenac (Diclofenac Sodium) is a potent NSAID (Non-steroidal Anti-inflammatory Drug) with significant anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. It works by inhibiting prostaglandin biosynthesis, which plays a key role in inflammation, pain, and fever.

• Absorption: Rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations reached within 2 hours after ingestion.
• Metabolism: It undergoes liver metabolism and first-pass metabolism.
• Plasma Protein Binding: It is 99.7% bound to plasma proteins at therapeutic concentrations.

Dosage & Administration:

• Diclofenac FC Tablets:

  • Adults: 75-150 mg daily in 2-3 divided doses, preferably after meals. The dose should be reduced for long-term use.

• Diclofenac SR Tablets:

  • Adults: 1 tablet daily with liquid, preferably with meals. If necessary, the daily dose can be increased to 150 mg by supplementing with conventional tablets.
  • Children: 1-3 mg/kg body weight daily in divided doses.

• Diclofenac Dispersible Tablets:

  • Adults: 2-3 tablets daily, maximum daily dose 150 mg. It should be taken before meals.
  • Children: Recommended only for juvenile rheumatoid arthritis, with doses of 1-3 mg/kg body weight.

• Diclofenac TR Capsules:

  • 1 capsule daily, preferably taken after meals.

• Diclofenac Suppositories:

  • Adults: 50 mg 2-3 times daily, with a maximum daily dose of 150 mg.

• Diclofenac Injection:

  • Adults: 1 ampoule daily, which may be increased to 2 ampoules in serious cases.

• Diclofenac Gel (Topical Use):

  • 2-4 g applied to the affected area 3-4 times daily.

Interaction:

• Lithium and Digoxin: Clofenac may increase plasma concentrations of lithium and digoxin.
• Anticoagulants: Caution when combining with anticoagulants due to an increased risk of bleeding.
• Antidiabetic agents: No significant effect on antidiabetic agents.
• Cyclosporin: Caution as nephrotoxicity has been reported when combined with diclofenac.
• Methotrexate: Serious toxicity has been reported when NSAIDs are given within 24 hours of methotrexate.
• Quinolone antimicrobials: Risk of convulsions when combined with NSAIDs.
• Other NSAIDs and steroids: Increased risk of side effects when combined.

Contraindications:

• Hypersensitivity to any ingredient of the product.
• Peptic ulcers, gastrointestinal bleeding, asthma (especially if aspirin or other NSAIDs trigger asthma, urticaria, or rhinitis).
• Pregnancy (First Trimester): Not recommended during the first trimester.
• Clofenc Gel should not be used under occlusive airtight dressings.

Side Effects:

• Common: Epigastric pain, nausea, diarrhea, dizziness, headache.
• Uncommon: Peripheral edema, skin rash, and eczema.
• Gel-Specific: May cause local irritation and skin reddening or rash.

Pregnancy & Lactation:

• Pregnancy: Clofenac should only be used during pregnancy when necessary. The lowest effective dose should be used.
• Lactation: A small quantity of Diclofenac may be present in breast milk, but it is not expected to affect the infant.

Precautions & Warnings:

• Monitor for peptic ulceration or gastrointestinal bleeding during treatment, particularly in elderly patients.
• Clofenc Gel: Should not come into contact with the eyes or mucous membranes. Hands should be washed after application.

Therapeutic Class:

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

Storage Conditions:

• Store in a cool, dry place, protected from light. Keep below 30°C. Keep out of the reach of children.