Clofenac SR 100 mg

Description

Indications

Clofenac SR is commonly prescribed for the following medical conditions:

1. Rheumatology

   • Treatment of inflammatory and degenerative rheumatic conditions, including chronic polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, and peri-articular rheumatic disorders.

2. Surgery and Traumatology

   • Provides relief from sprains, bruises, dislocations, fractures, soft tissue injuries, and post-surgical recovery.

3. Obstetrics and Gynecology

   • Relieves symptoms of primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

4. Otorhinolaryngology

   • Used as pre-operative medication to prevent pain, inflammation, and swelling.

5. Dentistry

   • Effective in managing post-operative pain, inflammation, and swelling.

6. Other Indications

   • Prevents and treats inflammation and swelling after surgeries involving the urogenital tract, renal and biliary colic.

   Please take this medication according to the advice of a registered healthcare professional.

Pharmacology

Clofenac SR contains Diclofenac Sodium, a potent non-steroidal anti-inflammatory drug (NSAID) with effective anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. It also has some uricosuric effects.

Diclofenac exerts its therapeutic effects by inhibiting the biosynthesis of prostaglandins, which play a critical role in causing pain, inflammation, and fever. After oral administration, Diclofenac is rapidly and thoroughly absorbed from the gastrointestinal tract. It achieves peak plasma concentrations within 2 hours post-ingestion. It is 99.7% bound to plasma proteins at therapeutic levels, and it is metabolized in the liver, undergoing first-pass metabolism.

Dosage and Administration

1. Diclofenac FC Tablet

   • Adults: 75–150 mg daily in 2–3 divided doses, preferably after meals. For long-term use, the dose may need to be reduced.

2. Diclofenac SR Tablet

   • Adults: 1 tablet per day, taken whole with liquid, ideally at mealtime. The daily dose may be increased up to 150 mg if required, by adding conventional tablets.
   • Children: 1-3 mg per kg body weight per day, in divided doses.
   • Elderly: The lowest effective dose is recommended, though there is no significant alteration in pharmacokinetics for elderly patients.

3. Diclofenac Dispersible Tablet (DT)

   • Adults: The usual dosage is 2–3 tablets daily, with a maximum daily dose of 150 mg. For milder cases, 2 tablets may suffice.
   • Children: Diclofenac is not typically recommended for children, except for juvenile rheumatoid arthritis, where the dosage is 1–3 mg per kg body weight.
   • The dispersible tablets should be dissolved in a half-glass of water and stirred before swallowing.

4. Diclofenac TR Capsule

   • Adults: 1 capsule daily, taken preferably after meals.

5. Diclofenac Suppository

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

6. Diclofenac Injection

   • Adults: Typically, 1 ampoule daily, though in severe cases, the dose may be increased to 2 ampoules daily.

7. Diclofenac Gel (for external use only)

   • Apply 2–4 g of gel 3–4 times daily, depending on the treatment area. Rub the gel lightly into the affected area. This gel may be used alongside other Diclofenac dosage forms.

   Please take this medication as directed by a registered healthcare professional.

Drug Interactions

Clofenac SR may interact with several medications, including:

• Lithium and Digoxin: May increase plasma concentrations of these drugs.
• Anticoagulants: Combining Diclofenac with anticoagulant therapy may increase the risk of bleeding, although clinical studies have shown no significant change in the anticoagulant effect.
• Antidiabetic Agents: Diclofenac does not influence the clinical effect of oral antidiabetic agents.
• Cyclosporin: Use with Diclofenac may lead to nephrotoxicity.
• Methotrexate: Serious toxicity may occur when methotrexate and NSAIDs are used together within 24 hours.
• Quinolone Antimicrobials: The combination of quinolones with NSAIDs may increase the risk of convulsions.
• Other NSAIDs and Steroids: Combining Diclofenac with other NSAIDs or steroids may increase the frequency of unwanted side effects.

Contraindications

Clofenac SR should not be used in the following cases:

• Patients with hypersensitivity to any ingredients in the product.
• Individuals with peptic ulcers or a history of hypersensitivity to Diclofenac or other NSAIDs.
• Asthmatic patients who experience asthma, urticaria, or acute rhinitis triggered by acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis.
• Diclofenac Gel should not be applied under airtight or occlusive dressings.

Side Effects

Clofenac SR is generally well-tolerated. However, some individuals may experience:

• Common side effects: Mild epigastric pain, eructation, nausea, diarrhea, dizziness, or headache.
• Other reactions: Peripheral edema, skin reactions such as rash or eczema.
• Topical Gel reactions: Local irritation, reddening of the skin, or skin rash when using Diclofenac SR Gel.

Pregnancy and Lactation

• Diclofenac should only be used during pregnancy for compelling reasons, and the lowest effective dose should be used.
• These drugs are generally not recommended during the first trimester of pregnancy. Diclofenac Sodium Gel is not advised during pregnancy due to insufficient clinical data.
• While a small amount of Diclofenac may appear in breast milk, no adverse effects on the infant are expected.

Precautions and Warnings

• Gastrointestinal issues: Rare cases of peptic ulceration or gastrointestinal bleeding may occur during treatment. Patients, particularly the elderly, should be closely monitored.
• Eye and mucous membrane contact: Clofenac SR Gel should not come in contact with the eyes or mucous membranes. After applying the gel, wash your hands thoroughly and avoid ingestion.

Therapeutic Class

• NSAIDs used for the treatment of Osteoarthritis, Rheumatoid Arthritis, and other inflammatory conditions.

Storage Conditions

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