What it's for (Indications)
- Diclofenac sodium + misoprostol is indicated for the management of pain and inflammation associated with musculoskeletal disorders, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, and chronic juvenile arthritis.
- The misoprostol component helps to reduce the risk of NSAID-induced gastric ulcers.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Dosage should be individualized based on the patient’s age, condition, severity, and response to therapy. Always use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Typically, one or two tablets are taken each day with a glass of water or food. Diclofenac sodium and misoprostol delayed-release tablets are available in formulations such as 50 mg diclofenac sodium with 200 mcg misoprostol, and 75 mg diclofenac sodium with 200 mcg misoprostol. After observing the response to initial therapy, the dose and frequency should be adjusted to suit individual patient needs. |
Safety & Warnings
Common Side Effects
- Common side effects include abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, dizziness, fatigue, increased liver enzymes (alanine aminotransferase), and decreased hematocrit.
- More serious adverse reactions can include gastrointestinal bleeding, ulceration, and perforation; cardiovascular thrombotic events; hepatotoxicity; hypertension; heart failure and edema; renal toxicity and hyperkalemia; anaphylactic reactions; serious skin reactions; and hematologic abnormalities.
- Edema, ulcer formation, liver and kidney problems, skin allergy, and blood problems may also occur.
Serious Warnings
- Black Box Warning: WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. Diclofenac sodium and misoprostol delayed-release tablets contain diclofenac sodium and misoprostol. Administration of misoprostol to women who are pregnant can cause abortion, premature birth, birth defects, or uterine rupture. Uterine rupture has been reported when misoprostol was administered in pregnant women to induce labor or to induce abortion. This drug also carries serious risks of cardiovascular thrombotic events (myocardial infarction and stroke) and serious gastrointestinal events (bleeding, ulceration, and perforation of the stomach or intestines), which can be fatal.
- This medication may interact with anti-hypertensive medications; inform your doctor if you are taking blood pressure medication.
- Due to potential dizziness and fatigue, avoid driving or operating machinery immediately after use.
- Alcohol consumption should be avoided during treatment.
- Patients should inform their doctor of any kidney, heart, or intestinal disease before use.
- Caution is advised for patients with a history of gastric lesions, renal, hepatic, or cardiac insufficiency, and in the elderly.
- Regular monitoring of liver function tests and blood tests is required for patients on long-term therapy or in elderly individuals.
- Patients should ensure they are not allergic to any of the medicine's contents or NSAIDs, using with caution if an allergy to NSAIDs exists.
- The lowest effective dosage should be used for the shortest duration consistent with treatment goals.
How it Works (Mechanism of Action)
Diclofenac, an NSAID, exerts analgesic, anti-inflammatory, and antipyretic properties primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis. Prostaglandins are mediators of pain and inflammation. Misoprostol is a synthetic prostaglandin E1 (PGE1) analog that offers gastrointestinal mucosal protection and gastric antisecretory effects, countering the potential GI side effects of diclofenac.