Trade Name: MISOCLO TABLET 75 MG
Generic Name:
Diclofenac Sodium BP 75 mg & Misoprostol INN 200 mcg
Presentation
Each tablet contains Diclofenac Sodium BP 50 mg & Misoprostol INN 200 mcg.
Indications
This combination is indicated for the 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
and administration
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is
Diclofenac Sodium 50 mg plus Misoprostol 200 mcg tid. For patients who
experience intolerance, Diclofenac Sodium 75 mg plus Misoprostol 200mcg bid or
Diclofenac Sodium 50 mg plus Misoprostol 200 mcg bid can be used.
Rheumatoid Arthritis: The recommended dosage is Diclofenac Sodium 50 mg plus
Misoprostol 200 mcg tid or qid. For patients who experience intolerance,
Diclofenac Sodium 75 mg plus Misoprostol 200 mcg bid or Diclofenac Sodium 50 mg
plus Misoprostol 200 mcg bid can be used.
Contraindications
It is contraindicated in women who are pregnant because its Misoprostol
component can cause abortion.
Precautions
Decreased kidney function and liver function and stomach ulcer or bleeding.
Side
effects
This drug can cause abdominal pain, diarrhea and other GI symptoms. Diarrhea
and abdominal pain develop early in the course of therapy and were usually self
limited (resolved after 2 to 7 days). Rare instance of profound diarrhea leading
to severe dehydration have been reported.
Drug
interactions
Concomitant administration with Aspirin
is not recommended. Diclofenac may increase the plasma concentration of Digoxin.
NSAIDs can inhibit the activity of antihypertensive, including ACE inhibitors.
The effects of Warfarin and NSAIDs on GI bleeding are synergistic. Antacid
reduces the bioavailabillity of Misoprostol. Other drugs that interact are Oral
ypopglycemics, Methotrexate, Lithium and Diuretics.
Use in pregnancy and lactation
Not recommended
Commercial Pack
Misoclo 50: Each box contains 2 blister strips of 10 enteric coated
tablets.
Misoclo 75: Each box contains 2 blister strips of 10 enteric coated
tablets.
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