Omefast® 20
Omefast® 20
Anti-ulcer (stomach and duodenal)
Indication
Omefast® is indicated for the treatment of:
- Peptic ulcer (gastric and duodenal ulcers).
- Reflux oesophagitis.
- Gastro-oesophageal reflux disease.
- Zollinger-Ellison syndrome.
Composition
Each capsule of Omefast® 20 contains:
- Omeprazole 20 mg (As enteric coated pellets)
Dosage
¤ Omefast® should be taken before meals.
♦ Peptic ulcers and reflux oesophagitis:
- 1 -2 capsules once daily in the morning for 4 -12 weeks.
- For the prevention of relapse a maintenance dose of 10- 20 mg once daily is recommended.
♦ Gastro-oesophageal reflux disease:
- 20 to 40 mg once daily for 4 to 12 weeks.
- Maintenance therapy: 20 mg once daily.
♦ Zollinger-Ellison syndrome:
- long term management requires administration of 60 mg up to 120 mg daily of Omefast® in divided doses,
- In some cases it may require more than 120 mg daily given in 2 or 3 divided doses.
♦ For the eradication of Helicobacter pylori in peptic ulceration:
Triple therapy regimens:
- Omefast® 40 mg daily combined with Amoxicillin 500 mg and Metronidazole 400 mg both three times daily or with Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500mg) both twice daily or with Amoxicillin 1 g and Clarithromycin 500 mg both twice daily. These regimens are given for 1 week.
Dual therapy regimens:
- Omefast® 40 -80 mg daily with Amoxicillin 1.5 g daily in divided doses for 2 weeks or Omefast® 40 mg once daily and Clarithromycin 500 mg three times a day for two weeks.
¤ or as directed by the physician.
- Omeprazole belongs to a new class of antisecretory compounds, that inhibits gastric acid secretion by irreversibly blocking the H+/K+ ATPase enzyme system, (the proton pump) of the gastric parietal cell, so it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
- Omefast® capsules contain an enteric coated pellets formulation of Omeprazole (because Omeprazole is acid-labile), so that absorption of Omeprazole begins only after the pellets leave the stomach. Omeprazole is rapidly absorbed from the small intestine and its absorption is not affected by food. Peak plasma levels of Omeprazole occurring within 0.5 to 3.5 hours. It is highly bound to plasma proteins (about 95%), extensively metabolized in the liver and rapidly eliminated as inactive metabolites mostly in the urine.
Each capsule of Omefast® 20 contains:
- Omeprazole 20 mg (As enteric coated pellets)
Omefast® is indicated for the treatment of:
- Peptic ulcer (gastric and duodenal ulcers).
- Reflux oesophagitis.
- Gastro-oesophageal reflux disease.
- Zollinger-Ellison syndrome.
- Hypersensitivity to Omeprazole.
- Omeprazole inhibits the cytochrome P450 system and alter the metabolism of some other drugs metabolised by these enzymes. It can prolong the elimination of Diazepam, Phenytoin and Warfarin.
- The decreased gastric acidity caused by Omeprazole may affect the absorption of other drugs given concomitantly such as: Ketoconazole, Ampicillin, esters and Iron salts.
- Plasma concentrations of Omeprazole and Clarithromy-cin are increased during concomitant administration.
- Omefast® should not be administered during pregnancy and lactation unless strictly indicated,and directed by the physician .
- Omefast® is well tolerated and adverse reactions have generally been mild and reversible.
- The most frequent side effects: are gastro-intestinal disturbances, in particular diarrhoea, skin rash, and headache.
- The rare side effects: include arthralgia, myalgia, and blood disorders.
¤ Omefast® should be taken before meals.
♦ Peptic ulcers and reflux oesophagitis:
- 1 -2 capsules once daily in the morning for 4 -12 weeks.
- For the prevention of relapse a maintenance dose of 10- 20 mg once daily is recommended.
♦ Gastro-oesophageal reflux disease:
- 20 to 40 mg once daily for 4 to 12 weeks.
- Maintenance therapy: 20 mg once daily.
♦ Zollinger-Ellison syndrome:
- long term management requires administration of 60 mg up to 120 mg daily of Omefast® in divided doses,
- In some cases it may require more than 120 mg daily given in 2 or 3 divided doses.
♦ For the eradication of Helicobacter pylori in peptic ulceration:
Triple therapy regimens:
- Omefast® 40 mg daily combined with Amoxicillin 500 mg and Metronidazole 400 mg both three times daily or with Clarithromycin 250 mg and Metronidazole 400 mg (or Tinidazole 500mg) both twice daily or with Amoxicillin 1 g and Clarithromycin 500 mg both twice daily. These regimens are given for 1 week.
Dual therapy regimens:
- Omefast® 40 -80 mg daily with Amoxicillin 1.5 g daily in divided doses for 2 weeks or Omefast® 40 mg once daily and Clarithromycin 500 mg three times a day for two weeks.
¤ or as directed by the physician.
- Omefast® is not recommended for patients with suspected gastric tumors as it might alleviate symptoms and delay diagnosis.
- Dosage should be reduced in hepatic impairment.
- Strips of 10 Capsules–Pack of ten Strips
- Store in a dry place at a temperature below 30ºC,
- protected from light and humidity.