Diclofenac Sodium (F Diclo) 25mg/ml (75mg/3ml) Solution for Injection (NSAID) 3ml x Ampoule 10's

Used to treat pain, swelling, stiffness, and joint pain in conditions like rheumatoid arthritis, osteoarthritis, and acute musculoskeletal injuries

Product Description:

Diclofenac Sodium (F Diclo) 25mg/ml (75mg/3ml) Solution for Injection is a non-steroidal anti-inflammatory drug (NSAID) used for the short-term management of pain and inflammation. This injectable formulation contains Diclofenac Sodium, a potent anti-inflammatory, analgesic, and antipyretic agent, commonly used for the treatment of acute pain, such as post-surgical pain, musculoskeletal injuries, and inflammatory conditions.

The 75mg per 3ml dosage is designed to provide fast and effective relief from pain and swelling. It comes in 3ml ampoules, and each pack contains 10 ampoules, making it convenient for hospital or clinical settings.

Key Features:

• Active Ingredient: Diclofenac Sodium 25mg/ml (75mg/3ml)

• Formulation: Solution for injection, administered intramuscularly (I.M) or intravenously (I.V.)

• Type of Medication: Non-steroidal anti-inflammatory drug (NSAID)

• Pack Size: 10 ampoules (3ml per ampoule)

Indications:

Diclofenac Sodium (F Diclo) 25mg/ml Solution for Injection is indicated for the following conditions:

1. Acute Pain: Effective for managing short-term pain such as post-operative pain, musculoskeletal pain, or traumatic injuries.

2. Inflammatory Disorders: Used to treat pain and inflammation associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and other inflammatory musculoskeletal disorders.

3. Acute Gouty Arthritis: To manage pain and inflammation during an acute gout attack.

4. Post-Surgical Inflammation and Pain: Used to alleviate pain and inflammation following surgery, including dental procedures, orthopedic surgery, or gynecological surgery.

5. Bursitis and Tendonitis: Effective for the treatment of inflammation caused by bursitis or tendonitis.

6. Dysmenorrhea (Painful Menstruation): For the relief of pain associated with severe menstrual cramps.

Dosage and Administration:

• Route of Administration: Intramuscular (I.M) or Intravenous (I.V.)

• Adults:

  • Initial Dose: 1 ampoule (75mg/3ml) can be administered once a day or divided into two doses (depending on the severity of the condition). The dose may be adjusted based on clinical response.

  • For Acute Pain: 75mg can be administered once daily for the first 2-3 days. Further doses can be adjusted based on the clinical response and as advised by the healthcare provider.

  • For Chronic Inflammatory Conditions: A maintenance dose may be given in divided doses or once daily, depending on the individual patient's needs.

• Maximum Daily Dose: Generally, the total daily dose should not exceed 150mg/day (administered over multiple doses), though the exact dose may vary depending on the individual condition and response to treatment.

• Administration Method:

  • Intramuscular injection should be performed by a healthcare professional, usually in the gluteal or thigh muscle.

  • For intravenous use, the injection should be administered slowly, and the solution must be diluted with a compatible IV fluid before administration.

• Duration of Use: Typically used for short-term pain management, not exceeding 2-3 days for acute pain. Prolonged use should be avoided unless instructed by a healthcare provider.

Side Effects:

Like all medications, Diclofenac Sodium (F Diclo) may cause side effects, although not everyone experiences them. Common side effects include:

1. Gastrointestinal Issues:

   • Nausea, vomiting, abdominal pain, indigestion, or dyspepsia.

   • Ulceration or bleeding in the gastrointestinal tract (especially with long-term use).

2. Renal and Hepatic Effects:

   • Kidney dysfunction, including renal failure in rare cases.

   • Liver enzyme elevations, jaundice, or other hepatic complications.

3. Cardiovascular Effects:

   • Increased risk of heart attack, stroke, or hypertension (especially with prolonged use).

4. Central Nervous System Effects:

   • Dizziness, headache, or somnolence (drowsiness).

5. Skin Reactions:

   • Rash, pruritus (itching), or other allergic skin reactions.

   • In rare cases, severe skin reactions such as Stevens-Johnson Syndrome or toxic epidermal necrolysis.

6. Respiratory Reactions:

   • Shortness of breath or signs of bronchospasm (particularly in patients with a history of asthma or allergies).

7. Other Effects:

   • Edema (fluid retention) or swelling.

   • Anemia, bruising, or elevated blood pressure.

Contraindications:

Diclofenac Sodium (F Diclo) 25mg/ml Solution for Injection should not be used in the following situations:

1. Hypersensitivity: If the patient is allergic to diclofenac, other NSAIDs, or any of the ingredients in the formulation, it should be avoided.

2. Active Gastrointestinal Bleeding or Ulceration: Diclofenac can exacerbate existing gastrointestinal bleeding, ulcers, or inflammatory bowel disease.

3. Severe Liver or Kidney Dysfunction: Contraindicated in patients with severe hepatic or renal impairment.

4. Cardiovascular Disease: Should be avoided in patients with a history of heart disease, coronary artery bypass surgery, stroke, or those with uncontrolled hypertension.

5. Third-Trimester Pregnancy: Diclofenac should not be used in the third trimester of pregnancy due to the risk of fetal harm, particularly related to premature closure of the ductus arteriosus.

6. Breastfeeding: Caution is advised in breastfeeding women as diclofenac is excreted in breast milk in small amounts.

7. History of Asthma: Caution should be taken for patients with asthma, as NSAIDs can provoke bronchospasm in sensitive individuals.

8. Children: Not recommended for children under 2 years of age.

Warnings and Precautions:

1. Long-Term Use: Prolonged use of Diclofenac Sodium should be carefully monitored, especially for kidney, liver, and cardiovascular side effects.

2. Renal Monitoring: Kidney function should be assessed periodically, especially in patients with pre-existing renal conditions or in elderly patients.

3. Fluid Retention and Edema: Diclofenac may cause fluid retention or exacerbate existing edema, particularly in patients with heart failure or kidney disease.

4. Monitor for GI Bleeding: Long-term or high-dose use of diclofenac can increase the risk of gastric ulceration and GI bleeding.

5. Pregnancy and Breastfeeding: Use only if absolutely necessary and prescribed by a healthcare provider during pregnancy, particularly avoiding use in the third trimester.

6. Drug Interactions: Diclofenac can interact with other medications, such as anticoagulants, other NSAIDs, antihypertensive drugs, and diuretics. Always inform your healthcare provider about any other medications you are taking.

Storage:

• Store at room temperature (15°C to 30°C) in a cool, dry place.

• Protect from light.

• Keep out of reach of children.

Conclusion:

Diclofenac Sodium (F Diclo) 25mg/ml Solution for Injection is an effective and fast-acting NSAID used to treat acute pain, inflammatory conditions, and musculoskeletal injuries. It provides relief from pain and swelling but should be used with caution, especially for long-term use or in patients with underlying health conditions. Always use under medical supervision, follow prescribed dosages, and monitor for potential side effects. If any adverse reactions occur or if pain persists, consult a healthcare provider for further guidance.