Clofenac DT 46.5 mg

Description

Indications

Clofenac DT is commonly prescribed for the following conditions:

Rheumatology:

• Inflammatory and degenerative rheumatic conditions, including chronic involutive polyarthritis, ankylosing spondylitis, osteoarthritis, and spondylarthroses.
• Acute gout, peri-articular rheumatic disorders.

Surgery and Traumatology:

• Treatment for sprains, bruises, dislocations, fractures, soft tissue injuries, and post-surgical recovery.

Obstetrics and Gynecology:

• Primary dysmenorrhea (painful menstruation), episiotomy (surgical incision), adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology (ENT):

• Used pre-operatively to prevent pain, inflammation, and swelling.

Dentistry:

• Post-operative and post-traumatic treatment for pain, swelling, and inflammation.

Other Uses:

• Prevention and treatment of pain and inflammation in patients who have undergone surgeries in the urogenital tract or for renal and biliary colic.

Note: Please consult a registered healthcare professional before use.

Pharmacology

Clofenac DT contains Diclofenac Sodium, a powerful non-steroidal anti-inflammatory drug (NSAID). It exhibits significant anti-rheumatic, anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) properties. Additionally, Diclofenac has mild uricosuric effects (increases uric acid excretion).

The primary mechanism of action involves the inhibition of prostaglandin biosynthesis, a process crucial in causing pain, inflammation, and fever. When taken, Diclofenac is rapidly and fully absorbed from the gastrointestinal tract. It reaches peak plasma concentrations approximately two hours after ingestion. The drug is highly protein-bound (99.7%) and is metabolized by the liver with first-pass metabolism.

Dosage & Administration

• Clofenac FC Tablet:

  • Adults: 75–150 mg per day, divided into 2-3 doses, preferably taken after meals. For long-term use, the dose should be reduced.

• Clofenac SR Tablet:

  • Adults: 1 tablet per day with water, ideally during meal times. If needed, the dose can be increased up to 150 mg by adding conventional tablets.
  • Children: 1-3 mg/kg body weight, divided into daily doses.

• Clofenac Dispersible Tablet (DT):

  • Adults: 2-3 tablets per day, with a maximum daily dose of 150 mg. For milder cases, 2 tablets per day may suffice. Preferably take before meals.
  • Children: Diclofenac is not recommended for children for general conditions, except for juvenile rheumatoid arthritis, where the dosage is 1-3 mg/kg body weight. The tablet should be dissolved in half a glass of water and stirred before swallowing. Long-term use (over 3 months) is not recommended.

• Clofenac TR Capsule:

  • Adults: 1 capsule per day, preferably after meals.

• Clofenac Suppository:

  • Adults: 50 mg suppository 2-3 times a day, with a maximum of 150 mg per day.

• Clofenac Injection:

  • Adults: 1 ampoule daily. In severe cases, the dose may be increased to 2 ampoules per day.

• Clofenac Gel:

  • For external use: Apply 2-4 g of the gel to the affected area 3-4 times daily, rubbing in lightly. This may be used alongside other forms of Diclofenac treatment.

Note: Always follow your healthcare provider’s advice before using this medication.

Drug Interactions

Clofenac DT may interact with the following medications:

• Lithium and Digoxin: Clofenac DT may increase the blood levels of these drugs.
• Anticoagulants: There is a potential risk of bleeding when combined with anticoagulant therapy.
• Antidiabetic agents: Clofenac can be safely used alongside oral antidiabetic medications without affecting their clinical effectiveness.
• Cyclosporin: Concurrent use may lead to kidney toxicity.
• Methotrexate: There have been reports of serious toxicity when used together within 24 hours.
• Quinolone antibiotics: There is a risk of convulsions when used in combination.
• Other NSAIDs and Steroids: Co-administration may increase the frequency of side effects. The use of aspirin with Diclofenac may lower plasma levels, though the clinical significance is unclear.

Contraindications

• Hypersensitivity: Not suitable for patients allergic to Diclofenac or any of its components.
• Peptic Ulcers: Should not be used in individuals with active peptic ulcers.
• Asthma: Contraindicated in patients who experience asthma attacks, urticaria (hives), or acute rhinitis due to aspirin or other prostaglandin inhibitors.
• Clofence DT Gel: Should not be applied under airtight or occlusive dressings.

Side Effects

Clofenac DT is generally well tolerated, with mild and transient side effects. Common side effects include:

• Epigastric pain, nausea, dizziness, or headaches.
• Peripheral edema (swelling), skin reactions like rashes or eczema.
• Clofenac Gel: May cause local skin irritation, redness, or rashes at the application site.

Pregnancy & Lactation

• Pregnancy: Diclofenac should be used during pregnancy only when absolutely necessary, with the lowest effective dose. It is not recommended during the first trimester.
• Lactation: Small amounts of Diclofenac may be present in breast milk, but no harmful effects on the infant are expected.

Precautions & Warnings

• Gastrointestinal Risks: Peptic ulcers and gastrointestinal bleeding can occur, especially in long-term treatment.
• Elderly Patients: These patients should be closely monitored when using Clofenac DT.
• Clofenac Gel: Avoid contact with the eyes or mucous membranes. Wash hands thoroughly after applying and ensure the gel is not ingested.

Therapeutic Class

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

Storage Conditions

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

Note: Always consult a registered healthcare provider before using any medication.