What it's for (Indications)
- Diclofenac sodium is indicated for the management of pain and inflammation associated with various conditions including muscular and skeletal disorders, rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute gout, chronic juvenile arthritis, back pain, post-operative pain, pain in trauma and fractures, and renal colic.
- It is effective in relieving swelling, pain, and joint stiffness in arthritis.
- The topical solution is specifically indicated for the relief of osteoarthritis pain of the knee.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | **General Dosing Principles (for all formulations):** Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Always follow the exact instructions of your doctor. **Oral Formulations (e.g., tablets, capsules, suppositories):** The recommended dose is typically 75 to 150 mg per day, administered 2 to 3 times daily. Take with or after food and with a glass of water to minimize gastrointestinal upset. Do not chew or break capsules; swallow them whole. Not recommended for children under 18 years of age. Effects are usually observed within 10-30 minutes and can last 1-2 hours. Complete the full prescribed course of therapy. Storage: Store at 15-30°C, away from moisture and light, out of reach of children and pets. **Topical Solution (e.g., for knee pain):** The recommended dose is 2 pump actuations (40 mg) on each painful knee, 2 times a day. Apply the solution to clean, dry skin, spreading it evenly around the front, back, and sides of the knee. Wash hands thoroughly after application. Allow the treated area to completely dry before covering with clothing, applying other substances, or engaging in skin-to-skin contact. Avoid contact with eyes, nose, or mouth. **Injectable Formulations:** These are typically administered by a medical professional within hospital settings. |
Safety & Warnings
Common Side Effects
- Common side effects include gastrointestinal disturbances such as abdominal pain, nausea, vomiting, diarrhea, constipation, gastric pain, and epigastric pain.
- Other common reactions are headache, dizziness, drowsiness, skin rashes, and tinnitus.
- More serious potential adverse effects, common to NSAIDs, include gastrointestinal bleeding, ulceration, or perforation; cardiovascular thrombotic events (e.
- g.
- , myocardial infarction, stroke); hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; and hematologic toxicity.
- Peripheral edema, pain and redness at injection site, disorientation, coma, and convulsions (especially with overdose) have also been reported.
- Patients may also experience increased sensitivity to sunlight (photosensitivity).
- For topical preparations, application site reactions are common.
Serious Warnings
- Black Box Warning: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Nonsteroidal anti-inflammatory drugs (NSAIDs), including diclofenac sodium, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. NSAIDs also cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. Diclofenac sodium is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- Patients with a history of heart disease, liver disease (hepatic insufficiency), kidney impairment (renal insufficiency or long-term use risk of kidney damage), gastrointestinal disorders (including gastric lesions, peptic ulcer, stomach/intestinal bleeding), and those who have undergone bypass surgery should use diclofenac with extreme caution and under medical supervision.
- Long-term therapy requires regular monitoring of liver function tests and blood tests, especially in elderly patients.
- Diclofenac may impact female fertility, and women planning pregnancy should avoid its use.
- Patients should be advised against consuming alcohol or tobacco during treatment due to increased risk of gastrointestinal bleeding.
- If dizziness or drowsiness occurs, avoid driving or operating machinery.
- Increased sensitivity to sunlight (photosensitivity) may occur, so unnecessary sun exposure should be avoided.
- Diclofenac should be used at the lowest effective dose for the shortest duration necessary to achieve treatment goals.
- Patients should take the medicine exactly as prescribed, avoid exceeding the prescribed dose, and complete the full course of therapy even if symptoms subside.
- Tablets/capsules should be swallowed whole and not chewed or broken.
- For topical solutions, apply to clean, dry skin, wash hands completely after administration, allow the area to dry before covering, and avoid skin-to-skin contact or contact with eyes, nose, or mouth until the treated area is dry.
- Inform your doctor about any serious side effects.
- Diclofenac is not generally recommended for children under 12 or 18 years of age depending on the formulation.
- Overdose can lead to headache, nausea, vomiting, diarrhea, disorientation, stomach bleeding, coma, dizziness, and convulsions; activated charcoal may be recommended immediately in such cases.
- Consult your doctor if you missed a dose, unless it is almost time for your next dose.
How it Works (Mechanism of Action)
Diclofenac sodium possesses analgesic, anti-inflammatory, and antipyretic properties. Its mechanism of action involves the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, which leads to a decrease in prostaglandin synthesis in peripheral tissues. Prostaglandins play a key role in sensitizing afferent nerves, potentiating pain induction, and mediating inflammation.