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This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Dosage & Administration
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg p& Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving Misoprostol.
Pregnancy & Lactation
Lactation: Diclofenac Sodium has been found in the milk of nursing mothers. It is unlikely that Misoprostol is excreted into milk since the drug is rapidly metabolized throughout the body. Excretion of the active metabolite (Misoprostol acid) into milk is possible, but has not been studied. Because of the potential for serious adverse reactions in nursing infants, Diclofenac Sodium and Misoprostol combination is not recommended for use by nursing mothers.
Precautions & Warnings
Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.
Use in Special Populations
Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
Store in a cool and dry place below 25º C. Protect from light.