Ultrafen Plus
Tablet
Beximco Pharmaceuticals Ltd.Generic:
Diclofenac Sodium + MisoprostolWeight:
50 mg+200 mcgbest Price:
? 10.00Generic
Diclofenac Sodium + Misoprostol
Indications
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.
Pharmacology
It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.
Dosage Administration
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 �g tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 �g bid or Diclofenac Sodium 50 mg & Misoprostol 200 �g bid can be used. Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 �g tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 �g bid or Diclofenac Sodium 50 mg & Misoprostol 200 �g bid can be used.
Contraindications
This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
Side Effects
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 And Lactation
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.
Therapeutic
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
Storage Conditions
This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
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