ERDON SUPER

Diclofenac Sodium+Misoprostol

Description:

Erdon Super Tablet is a combination of Diclofenac Sodium, a non-steroidal anti-inflammatory drug (NSAID) with analgesic & antipyretic properties and Misoprostol, a gastrointestinal (GI) mucosal prospective prostaglandin E1 analog..

Pharmacology:

Diclofenac Sodium inhibits prostaglandin synthesis by blocking prostaglandin synthetase enzyme. A deficiency of prostaglandins within the gastric and duodenal mucosa may lead to diminish bicarbonate and mucous secretion and may contribute to the mucosal damage. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcer.

Composition:

Erdon Super 50 Tablet: Each tablet contains 50 mg (in enteric-coated core) Diclofenac Sodium and 200 mcg Misoprostol.

Erdon Super 75 Tablet: Each tablet contains 75 mg (in enteric-coated core) Diclofenac Sodium and 200 mcg Misoprostol.

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 thrice daily. For patients who experience intolerance, Diclofenac Sodium 75 mg plus Misoprostol 200 mcg is twice daily or Diclofenac Sodium 50 mg plus Misoprostol 200 mcg is twice daily.

Rheumatoid Arthritis: The recommended dosage is Diclofenac Sodium 50 mg plus Misoprostol 200 mcg thrice or four times daily. For patients who experience intolerance, Diclofenac Sodium 75 mg plus Misoprostol 200 mcg is twice daily or Diclofenac Sodium 50 mg plus Misoprostol mcg is twice daily.

Contraindication:

Diclofenac Sodium and Misoprostol combination is contraindicated in women who are pregnant because of the abortive property of the Misoprostol component.

Adverse effects:

The most common reported side effects are abdominal pain, diarrhoea and other GI symptoms. Diarrhoea and abdominal pain developed early in the course of therapy and were usually self-limited ( resolved after 2-7 days).

Precautions:

Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium 50 mg plus Misoprostol 200 mcg is prescribed.

Use in lactating mother:

Diclofenac Sodium 50 mg plus Misoprostol 200 mcg is not recommended for use by nursing mother. Because of the potential for serious adverse effects in nursing infants.

Paediatric use:

Safety and effectiveness of Diclofenac Sodium 50 mg plus Misoprostol 200 mcg in paediatric patients have not been established.

Geriatric patients:

Not overall difference in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Drug interactions:

Aspirin: Concomitant administration with aspirin may result in lower plasma concentrations, peak plasma levels of Diclofenac Sodium.

Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium.

Antihypertensives: NSAIDs may inhibit the activity of antihypertensives including ACE inhibitors.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic.

Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.

Storage:

Store in cool and dry place, protected from light and moisture. Keep out of the reach of children.

Packing:

Erdon Super 50 Tablet: Each box contains 3x10's tablet in blister packs.

Erdon Super 75 Tablet: Each box contains 3x10's tablet in blister packs.