What it's for (Indications)
- Management of pain and inflammation associated with muscular and skeletal disorders, rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis (arthritis affecting joints of the spine), acute gout (a complex form of arthritis with extreme pain and swelling of joints), and chronic juvenile arthritis.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | The dosage should be carefully considered, weighing potential benefits against risks. The lowest effective dosage for the shortest duration consistent with individual patient treatment goals should be used. After observing the response to initial therapy, the dose and frequency should be adjusted to suit an individual patient's needs. For the relief of rheumatoid arthritis and osteoarthritis, typical dosages are either 50 mg diclofenac sodium with 200 mcg misoprostol, or 75 mg diclofenac sodium with 200 mcg misoprostol. |
Safety & Warnings
Common Side Effects
- Common side effects include abdominal pain, diarrhea, dyspepsia, nausea, flatulence, gastritis, vomiting, constipation, headache, and dizziness.
- More serious adverse reactions can include gastrointestinal bleeding, ulceration and perforation, cardiovascular thrombotic events, hypertension, heart failure, edema, renal toxicity (including hyperkalemia), hepatotoxicity (manifested by increased alanine aminotransferase), hematologic toxicity (including decreased hematocrit), anaphylactic reactions, and serious skin reactions.
- Liver and kidney problems, skin allergy, and blood problems are also noted.
Serious Warnings
- Black Box Warning: WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH DEFECTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS. 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 a risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. It also increases the risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
- This medication requires caution in patients with a history of gastric lesions, renal, hepatic, or cardiac insufficiency.
- It is contraindicated in patients with hepatic porphyrias and hematologic abnormalities.
- Regular monitoring of liver function tests and blood tests is essential for elderly patients and those receiving long-term therapy.
- Patients should avoid driving as it may impair ability, and alcohol consumption should be avoided.
- The drug carries risks of serious cardiovascular thrombotic events, myocardial infarction, stroke, new onset or worsening hypertension, fluid retention, edema, and heart failure.
- There is an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation, which can be fatal.
- Hepatotoxicity, renal toxicity, hyperkalemia, and hematologic toxicity can occur.
- Anaphylactic reactions and serious skin reactions (e.
- g.
- , exfoliative dermatitis, Stevens-Johnson Syndrome, toxic epidermal necrolysis) have been reported.
- It is severely contraindicated in pregnancy due to risks of abortion, premature birth, birth defects, and uterine rupture associated with misoprostol.
- It is also advised that this medicine is not safe for use during breastfeeding, and medical consultation is necessary.
How it Works (Mechanism of Action)
Diclofenac, an NSAID, primarily acts by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis, which results in its analgesic, anti-inflammatory, and antipyretic properties. Misoprostol is a synthetic prostaglandin-1 (PGE1) analog that provides gastric antisecretory and mucosal protective effects.
Commercial Brands (Alternatives)
No other brands found for this formula.