Generic
Diclofenac Sodium + Misoprostol
17 brands available in the market
At a glance
Diclofenac Sodium + Misoprostol is a combination medication used for the treatment of osteoarthritis and rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers.
Description
Diclofenac Sodium is an NSAID that inhibits cyclooxygenase, reducing prostaglandin synthesis to decrease pain and inflammation. Misoprostol is a gastrointestinal mucosal protective prostaglandin E1 analog that increases bicarbonate and mucous production in the gastric mucosa, preventing NSAID-induced ulcers.
Indications
- Osteoarthritis (patients at high risk of NSAID-induced ulcers)
- Rheumatoid arthritis (patients at high risk of NSAID-induced ulcers)
Therapeutic class
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Pharmacological class
NSAID + Gastroprotective Agent
Pharmacology
Diclofenac Sodium inhibits cyclooxygenase, reducing prostaglandin synthesis to decrease pain and inflammation. Misoprostol is a prostaglandin E1 analog that increases bicarbonate and mucous production in the gastric mucosa, preventing NSAID-induced ulcers.
Mechanism of action
Diclofenac reduces pain and inflammation by inhibiting prostaglandin synthesis; Misoprostol protects the gastric mucosa to prevent NSAID-induced ulcers.
Dosage
Osteoarthritis: 50 mg/200 mcg three times daily (max 200 mcg/dose, 800 mcg/day).
Rheumatoid arthritis: 50 mg/200 mcg three or four times daily (max 200 mcg/dose, 800 mcg/day).
If not tolerated, may reduce frequency to twice daily.
Administration
Swallow tablet whole, do not chew or crush. Do not take with antacids. May be taken with or without food.
Missed dose
If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.
Side effects
Common (>10%): Rash (18%), pyrexia (15%), urticaria (13%), flushing (13%).
Occasional (1-10%): Hypertension (10%), hyperhidrosis (8%), cough (8%), tachypnea (8%), tachycardia (8%), anaphylaxis (7%), vomiting (5%), peripheral edema (3%), pruritus (3%).
Rare (<1%): Fatigue, atrial fibrillation, congestive heart failure, myocardial infarction, peptic ulcer, vaginitis, dysmenorrhea, alopecia.
Precautions & warnings
Caution in patients with inflammatory bowel disease or dehydration. The pharmacological activity in reducing fever and inflammation may diminish the utility of these diagnostic signs.
Contraindications
Pregnancy Category X. Contraindicated in women who are pregnant due to the abortive property of Misoprostol.
Drug interactions
Aspirin: Concomitant administration is not recommended (decreased diclofenac plasma concentrations).
Digoxin: Elevated digoxin levels may occur.
Antihypertensives (ACE inhibitors): Activity may be inhibited.
Warfarin: Risk of GI bleeding is synergistic.
Antacids: Reduce misoprostol bioavailability; may delay diclofenac absorption.
Magnesium-containing antacids: Increased risk of misoprostol-induced diarrhea.
Food interactions
Do not take with antacids. May be taken with or without food.
Use in pregnancy
Pregnancy Category X. Contraindicated during pregnancy.
Pregnancy Category: X — always consult a doctor before taking during pregnancy.
Use in lactation
Diclofenac is excreted in breast milk; use is not recommended.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Elderly patients are likely to tolerate adverse events less well than younger patients; caution is required.
Renal / hepatic impairment
Caution in patients with renal or hepatic impairment; dose adjustment may be needed.
Overdose effects
Misoprostol overdose: convulsions, sedation, tremor, diarrhea, hypotension, bradycardia. Diclofenac overdose: lethargy, nausea, GI bleeding, acute renal failure, respiratory depression. Supportive treatment.
Storage conditions
Store in a cool and dry place below 25°C. Protect from light.
Chemical structure
Diclofenac Sodium + Misoprostol