This combination (Diclofenac Sodium 50 mg + Misoprostol 200 mcg Tablet) 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.
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Arthrofen 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.
Arthrofen is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E1 analog. Diclofenac Sodium inhibits prostaglandin synthesis, while Misoprostol increases bicarbonate and mucous production, preventing gastric and duodenal ulcers.
For osteoarthritis, the recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg three times daily. For rheumatoid arthritis, the dosage is the same, with the option to increase to four times daily if needed.
Overdose effects may include convulsions, sedation, dyspnea, diarrhea, abdominal pain, fever, hypotension, bradycardia, lethargy, nausea, vomiting, GI bleeding, hypertension, acute renal failure, respiratory depression, anaphylactoid reactions, and coma. Supportive treatment is recommended.
Common side effects include abdominal pain, diarrhea, and other GI symptoms. Rare instances of severe dehydration due to profound diarrhea have been reported with Misoprostol.
Concomitant administration with aspirin is not recommended due to the displacement of Diclofenac Sodium from its binding sites. Elevated digoxin levels have been reported with concomitant use of digoxin and Diclofenac Sodium. NSAIDs can inhibit the activity of antihypertensives and potentiate the effects of warfarin on GI bleeding. Antacids reduce the bioavailability of Misoprostol, and diuretics may increase serum potassium levels.
Arthrofen is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol, or other prostaglandins, as well as in patients with asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs.
Due to the abortifacient property of Misoprostol, Arthrofen is contraindicated in pregnant women. Diclofenac Sodium has been found in the milk of nursing mothers, so Arthrofen is not recommended for use during breastfeeding.
Patients with underlying conditions such as inflammatory bowel disease or dehydration should be monitored carefully when using Arthrofen. Its use in pediatric patients has not been established, and caution is advised in elderly patients.
Store Arthrofen in a cool and dry place below 25°C, protected from light.
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